Hutchmed Regulatory News (HCM)

HUTCHMED Reports 2021 Interim Results and Provides Business Updates

ELUNATE® in-market sales1 rose 186%, reflecting impact of in-house sales force

Received 1st approval in China for ORPATHYS® and 2nd approval in China for SULANDA®

U.S. and E.U. applications for surufatinib both accepted

Raised $615m2 gross proceeds from additional listing on HKEX3

Company to Host Interim Results Call & Webcast Today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, July 28, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2021 and provides updates on key clinical and commercial developments since the start of the year.

All amounts are expressed in U.S. dollar currency unless otherwise stated.

2021 Interim Results & Business Updates

"HUTCHMED's progress has been truly exceptional," said Mr. Simon To, Chairman of HUTCHMED. "Our novel drug discovery and development engine keeps powering ahead. Not only have we secured our third and fourth oncology drug NDA4 approvals in China, but also our first U.S. FDA5 and EMA6 applications for market approval have been accepted."

"Ten registrational studies are set to start this year on our five lead global assets. These are based on exciting data from proof-of-concept studies of both monotherapies and immunotherapy/TKI7 combinations. In addition, our early-stage portfolio is also progressing with our IDH1/28, ERK9 and third generation BTK10 inhibitors all starting development this year."

"In parallel, our commercial oncology operations are rapidly progressing."

"In China, our oncology team is now about 540 people on the ground marketing ELUNATE® and SULANDA®, recording in-market sales11 of $48.1 million in the first half of 2021. In the U.S., our oncology commercial team is building to support potential launches of surufatinib in 2022 and fruquintinib in 2023. On ORPATHYS®, our partner AstraZeneca12 will leverage its great commercial capabilities in lung cancer to market this important first-in-class drug."

"On the corporate-level we took several important steps during the first half to support our global plans. We changed our name to HUTCHMED, consolidating several legacy group and operating names into a single ubiquitous global corporate identity. We also built a balance of about $1.2 billion in cash and resources through our homecoming IPO13 on HKEX as well as through divestment of our non-core OTC14 drug business."

"Over the next three years, we will continue to rapidly build our global R&D15 and commercial organizations, supporting the anticipated global launches of our oncology drugs."

I. COMMERCIAL OPERATIONS

· Total revenues increased 47% to $157.4 million in the first half of 2021 (H1-20: $106.8m);

· Oncology/Immunology consolidated revenues increased 161% to $42.9 million (H1-20: $16.4m). Our China oncology commercial organization expanded to about 540 personnel (end 2020: ~390) covering over 2,500 oncology hospitals and over 29,000 oncology physicians;

· ELUNATE® (fruquintinib in China) in-market sales increased 186% to $40.1 million (H1-20: $14.0m), reflecting enhanced detailing, promotion and local & regional marketing in China through our organization;

· SULANDA® (surufatinib in China) launched for both extra-pancreatic NET16 (mid-January 2021) and pancreatic NET (June 2021), with sales of $8.0 million (H1-20: nil);

· ORPATHYS® (savolitinib) launched in July 2021, just three weeks after approval, through AstraZeneca's extensive, market-leading oncology commercial organization. HUTCHMED will receive a fixed royalty of 30% on all sales in China; and

· U.S. commercial organization continued to build for the potential surufatinib U.S. approval in the first half of 2022. The team is fully engaged on all aspects of launch readiness including supply chain, market access, marketing, sales and commercial operations.

II. REGULATORY ACHIEVEMENTS

· Received China NMPA17 NDA approval for ORPATHYS® (savolitinib) as a treatment for patients with MET18 exon 14 skipping alteration NSCLC19 in June 2021, making savolitinib the first-in-class selective MET inhibitor in China; and

· Received second China NMPA NDA approval for SULANDA® in June 2021 as a treatment for patients with advanced pancreatic NET.

· Completed submission of U.S. FDA NDA for surufatinib, which was accepted in June 2021, for the treatment of both pancreatic and extra-pancreatic NET. The assigned PDUFA20 goal date is April 30, 2022; and

· Fully submitted EMA MAA21 for surufatinib, which was validated and accepted in July 2021, for the treatment of both pancreatic and non-pancreatic NET.

III. CLINICAL DEVELOPMENT ACTIVITIES

· Initiated an international Phase Ib/II study of surufatinib combined with tislelizumab (NCT04579757), BeiGene's25 PD-126 antibody, in the U.S. and Europe, in March 2021;

· Presented NEC27 cohort preliminary data from the China Phase II study of surufatinib plus TUOYI®, Junshi's28 anti-PD-1 antibody, (NCT04169672) at the 2021 ASCO29 Annual Meeting. The combination demonstrated good preliminary efficacy and manageable tolerability. There are currently no standard second-line treatments available to NEC patients;

· Presented preliminary data from the gastric and gastroesophageal junction cancers cohort of the China Phase II study of surufatinib plus TUOYI® (NCT04169672) at the 2021 ASCO Annual Meeting, which also demonstrated good preliminary efficacy and manageable tolerability in this patient population. Registration design for gastric cancer is under discussion;

· Completed enrollment of a further four China Phase II cohorts for surufatinib plus TUOYI® (NCT04169672) including biliary tract, esophageal, small cell lung cancers and sarcoma, with further thyroid, NSCLC and endometrial cancer cohorts continuing to enroll;

· Presented updated results from U.S. Phase Ib monotherapy NET cohorts (NCT02549937) at the 2021 ASCO Annual Meeting. In heavily pretreated patients with NET, surufatinib demonstrated encouraging efficacy in patients refractory or intolerant to AFINITOR® and SUTENT®, with a manageable safety profile consistent with the completed Phase III trials SANET‑p and SANET‑ep;

· Presented a subgroup analysis by Ki-67 and baseline CgA30 of the Phase III monotherapy study in pancreatic NET (SANET-p) (NCT02589821) at the 2021 ASCO Annual Meeting. SANET-p had shown that surufatinib demonstrated statistically significant and clinically meaningful improvement in PFS31, and this exploratory analysis showed that surufatinib demonstrated benefit irrespective of Ki-67 expression levels or baseline CgA; and

· Presented Phase II data for surufatinib monotherapy in BTC32 patients (NCT02966821) at the 2021 ASCO Annual Meeting in U.S. patients after first-line chemotherapy. This data highlights surufatinib's potential in BTC. Emerging data from our Phase II cohort of the surufatinib combination plus TUOYI®, however, means we will prioritize development of the combination over the monotherapy.

· Initiate the first Phase III pivotal study for the SULANDA® plus TUOYI® combination in late 2021, in NEC patients in China;

· Submit for presentation further Phase II data for the SULANDA® plus TUOYI® combination in select indications in the second half of 2021, such as potentially biliary tract, esophageal, small cell lung cancers and sarcoma and updated NET/NEC cohort data; and

· Initiate pivotal study in NET patients in Japan in late 2021.

· Completed enrollment in four cohorts of the Phase II study of fruquintinib combined with TYVYT® (NCT03903705), Innovent's33 PD-1 antibody - in CRC34, HCC35, endometrial cancer and RCC36. Also initiated additional cohorts in gastric cancer, cervical cancer and NSCLC;

· Presented preliminary CRC cohorts data from the Phase Ib/II studies of fruquintinib combined with TYVYT® and of fruquintinib combined with geptanolimab, Genor's37 PD-1 antibody, at the 2021 ASCO Annual Meeting (NCT04179084 and NCT03977090, respectively). Both combination studies showed encouraging, durable benefit in advanced CRC patients with manageable safety profiles. A registration strategy for CRC is under discussion, as well as for additional indications; and

· Initiated a Phase II study in China and Korea for fruquintinib in combination with tislelizumab (NCT04716634, led by BeiGene) with advanced or metastatic, unresectable gastric cancer, CRC or NSCLC.

· Submit Phase Ib U.S. monotherapy expansion data in metastatic CRC (NCT03251378) in the second half of 2021 for publication in early 2022;

· Submit for presentation additional cohorts' data from the studies of fruquintinib combined with an anti-PD-1 antibody in the second half of 2021, such as HCC, endometrial cancer and RCC;

· Initiate a Phase Ib/II study in the U.S. for fruquintinib in combination with tislelizumab (NCT04577963) in patients with advanced, refractory triple negative breast cancer in the second half of 2021;

· Initiate a registrational study in China of fruquintinib combined with an anti-PD-1 antibody in endometrial cancer patients, in the second half of 2021, the first of several potential pivotal studies with this combination;

· Complete enrollment of the FRESCO-2 global Phase III registration study (NCT04322539) in refractory metastatic CRC in late 2021, which is expected to enroll over 680 patients from over 150 sites in 14 countries; and

· Complete enrollment of the FRUTIGA China Phase III registration study (NCT03223376) in advanced gastric cancer in late 2021, which is expected to enroll approximately 700 patients from approximately 35 sites in China.

· Presented CALYPSO Phase II study data in MET-driven patients (NCT02819596) for savolitinib in combination with IMFINZI®, AstraZeneca's PD-L138 antibody at the 2021 ASCO Annual Meeting. In MET-driven PRCC39 patients, the combination demonstrated encouraging synergy in efficacy and tolerability in line with single agent safety profiles;

· Published in The Lancet Respiratory Medicine updated data from the Phase II study (NCT02897479), which were the results reviewed by the NMPA when it approved savolitinib for the treatment of patients with MET exon 14 skipping alteration NSCLC;

· Presented final Phase II data for TATTON (NCT02143466) at WCLC40 2020 (held in January 2021), a global exploratory study in NSCLC aiming to recruit patients with MET amplification who had progressed after prior treatment with EGFR41 inhibitors. TATTON clearly confirmed the importance of the savolitinib plus TAGRISSO® combination; and

· Initiated Phase II study with potential for registration (NCT04923932) for savolitinib in metastatic gastric cancer in China in mid-2021.

· Initiate a confirmatory China Phase IIIb post-approval study (NCT04923945) of savolitinib monotherapy in MET exon 14 skipping alteration patients in mid-2021 following its market launch, which is expected to enroll approximately 160 patients from approximately 40 sites;

· Initiate SAMETA, a global Phase III pivotal study of the savolitinib plus IMFINZI® combination in MET-driven, unresectable and locally advanced or metastatic PRCC, based on the encouraging results of SAVOIR and CALYPSO studies, in the second half of 2021;

· Initiate SANOVO, a pivotal Phase III study in China for the savolitinib plus TAGRISSO® combination in treatment naïve patients with EGFR mutant positive NSCLC with MET aberration in the second half of 2021;

· Initiate SACHI, a pivotal Phase III study in China for the savolitinib plus TAGRISSO® combination in patients with NSCLC who have progressed following EGFR TKI treatment due to MET amplification in the second half of 2021; and

· Conclude the SAVANNAH Phase II study (NCT03778229) for the savolitinib plus TAGRISSO® combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression. SAVANNAH will inform final regulatory, biomarker and dose regimen strategy for the initiation of global Phase III development in late 2021.

· Initiated Phase II studies with potential for registration intent in China for the treatment of patients with follicular lymphoma and patients with marginal zone lymphoma in April 2021.

· Complete Phase Ib dose expansion study (NCT03128164) and submit interim data for presentation in the second half of 2021. Over 95 patients have enrolled at the RP2D43 in six non-Hodgkin's lymphoma sub-type cohorts;

· Complete Phase I dose escalation in the U.S. and Europe (NCT03786926) in mid-2021 and initiate Phase Ib expansion studies in multiple non-Hodgkin's lymphoma indications;

· Complete U.S. FDA regulatory discussions in the second half of 2021 followed by the initiation of registration intent studies in indolent non-Hodgkin's lymphoma by the end of 2021;

· Initiate additional Phase II studies with potential for registration intent in China in additional relapsed/refractory non-Hodgkin's lymphoma indications in late 2021 or early 2022; and

· Initiate studies in combination with other anti-cancer therapies in China in early 2022.

· Completed Phase Ib ITP45 dose expansion study (NCT03951623) in China with all patients having completed eight weeks treatment.

· Initiate dose expansion of the Phase I study (NCT03779113) in the U.S. and Europe, following completion of dose escalation, in the second half of 2021;

· Initiate a Phase III study in ITP in China in late 2021, after engagement with the CDE46;

· Initiate a Phase II study in AIHA47 in China in late 2021; and

· Submit for presentation Phase Ib study preliminary data in ITP (NCT03951623) in late 2021.

· Initiate studies in combination with other anti-cancer therapies in China in late 2021 or early 2022, based on the response to the late June 2021 submission of an IND48 to the NMPA.

· Initiated dose escalation portion of a Phase I study (NCT04764474) in the U.S. in patients with relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation in the first half of 2021; and

· Initiated dose escalation portion of a Phase I study (NCT04762602) in the U.S. in patients with solid tumors with an IDH1 and/or IDH2 mutation in the first half of 2021.

· Initiate dose expansion portion of the Phase I studies in China and the U.S. (NCT04272957, NCT04762602 and NCT04764474) in patients with relapsed or refractory hematological malignancies or solid tumors with an IDH1 and/or IDH2 mutation, after full enrollment of the dose escalation cohorts in late 2021 or early 2022.

· Initiated Phase I trial (NCT04908046) in patients with advanced solid tumors in China in July 2021.

· Initiate Phase I trial in the U.S. in patients with advanced hematological malignancies in late 2021, based on the IND submission in late June 2021 to the U.S. FDA to begin clinical trials; and

· Initiate Phase I trial in China in patients with advanced hematological malignancies in late 2021 or early 2022, based on the IND submission in late June 2021 to the China NMPA.

· Completed preclinical IND-enabling activities and submitted two INDs for HMPL-760 to the U.S. FDA and China NMPA.

· IND-enabling toxicity studies are underway for two additional in-house discovered oncology drug candidates, a potent and selective small molecule CSF-1R inhibitor (HMPL-653) and a CD47 antibody (HMPL-A83). If the outcomes of these studies are positive, we will follow with IND submissions in China and the U.S. in late 2021 and early 2022.

IV. MANUFACTURING

· Rapid progress being made in building our new flagship Shanghai manufacturing facility, since breaking ground in December 2020. This facility is designed to increase our novel drug product manufacturing capacity by over five-fold and is on-track to commence production in 2024. In the first half of 2021 we obtained all necessary approvals and permits; completed vendor selection process for both the primary construction and specific equipment; completed site preparation and pilings; and initiated construction of the central utility building.

V. OTHER CORPORATE DEVELOPMENTS

· Completed listing of ordinary shares and primary offering of 119,600,000 new ordinary shares50 on the Main Board of HKEX (the "Global Offering"), raising net proceeds of approximately $585 million, to advance our late-stage clinical programs as well as our pipeline of clinical-stage and preclinical drug candidates, further strengthening our oncology commercialization, clinical, regulatory and manufacturing capabilities and enabling funding of potential global business development and strategic acquisition opportunities and for general corporate purposes;

· Announced a divestment agreement to sell our entire indirect interest in HBYS51, a non-core and non-consolidated over-the-counter drug joint venture business, to GL Capital52 with the aggregate amount attributable to HUTCHMED of approximately $169 million in cash. This cash amount represents about 22 times HBYS's adjusted net profit attributable to HUTCHMED equity holders of $7.7 million in 202053. The transaction is subject to regulatory approval in China and is expected to close in the second half of 2021;

· Changed our group company name to HUTCHMED in April 2021, and the names of several of our key subsidiaries. All remaining key subsidiaries' names will change over the balance of 2021; and

· Announced a strategic partnership with Inmagene54 in January 2021 to further develop four novel preclinical drug candidates discovered by HUTCHMED for the potential treatment of multiple immunological diseases.

VI. IMPACT OF COVID-19

COVID-19 has not impacted our clinical studies in any material manner to date in 2021. We will continue to closely monitor the evolving situation.

Interim 2021 Financial Results

· Adjusted Group (non-GAAP55) net cash flows excluding financing activities in H1 2021 were -$63.1 million (H1-20: -$32.5m) mainly due to Oncology/Immunology R&D spending and partially offset by dividends received from our non-consolidated joint ventures totaling $42.1 million (H1-20: $35.3m); and

· Net cash generated from financing activities in H1 2021 totaled $578.3 million (H1-20: $96.3m) mainly resulting from the Global Offering in June 2021 and a private placement in April 2021 to a fund affiliated with BPEA56.

· Not included above is a further approximately $250 million from: $77 million in net proceeds in July 2021 from the exercise of the over-allotment option of the Global Offering; the $25 million milestone payment from AstraZeneca triggered by first commercial sales of ORPATHYS® in July 2021; and the approximately $150 million in remaining net proceeds receivable under our agreed divestment of HBYS to GL Capital.

· Oncology/Immunology consolidated revenues increased 161% (152% at CER57) to $42.9 million (H1-20: $16.4m) comprised of:

ELUNATE® revenues increased 244% to $29.8 million (H1-20: $8.6m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 186% to $40.1 million (H1-20: $14.0m), as provided by Lilly58;

SULANDA® sales revenues of $8.0 million since mid-January launch, initially to treat patients with advanced extra-pancreatic (non-pancreatic) NET, then also to treat patients with pancreatic NET in June 2021; and

R&D service fee revenues of $5.1 million (H1-20: $7.8m) primarily from AstraZeneca and Lilly.

ORPATHYS® $25 million payment and fixed royalty of 30% on all China sales from AstraZeneca not included, as the milestone payment was recently triggered by its first sales in China in July 2021. AstraZeneca has launched ORPATHYS® across China through its extensive, market-leading oncology commercial organization.

· Other Ventures consolidated revenues increased 27% (18% at CER) to $114.5 million (H1-20: $90.4m) mainly due to continued sales growth of third-party prescription drug products.

· Cost of Revenues were $123.2 million (H1-20: $83.6m), the majority of which were the cost of third-party prescription drug products marketed through our profitable Other Ventures, as well as costs associated with promotion and marketing services to Lilly which commenced in October 2020;

· R&D Expenses were $123.1 million (H1-20: $74.0m) mainly as a result of an expansion in the development of our eleven novel oncology drug candidates. With six now in global development, our rapidly scaling international clinical and regulatory operations in the U.S. and Europe incurred expenses of $59.3 million (H1-20: $19.9m) while R&D expenses in China were $63.8 million (H1-20: $54.1m);

· SG&A59 Expenses were $54.8 million (H1-20: $27.4m) primarily due to increases in staff costs and share-based compensation to support expanding operations. This included the build-up of a large-scale national oncology commercial infrastructure in China to support our oncology products; and

· Other Items60 generated net income of $41.3 million (H1-20: $28.5m) resulting primarily from an increase in our share of equity in the earnings from equity investees under our Other Ventures in China which delivered solid underlying net income growth of 19% (9% at CER) in the first half of 2021 and also benefited from a one-time land compensation of $5.1 million (H1-20: nil).

· As a result, the net loss attributable to HUTCHMED in the first half of 2021 was $0.14 per ordinary share / $0.70 per ADS61 compared to net loss attributable to HUTCHMED of $0.07 per ordinary share / $0.35 per ADS, in the six months ended June 30, 2020.

Financial Summary

(in $'000)

(Unaudited, in $'000, except share and per share data)

All amounts are expressed in U.S. dollar currency unless otherwise stated.

FINANCIAL GUIDANCE

During the first half of 2021, we performed as expected with commercial progress on ELUNATE®, SULANDA® and now ORPATHYS®. While results are encouraging, we leave guidance unchanged.

Use of Non-GAAP Financial Measures and Reconciliation - References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

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Conference Call and Audio Webcast Presentation scheduled today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT - Investors may participate in the call as follows: +852 3027 6500 (Hong Kong) / +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.), or access a live audio webcast of the call via HUTCHMED's website at www.hutch-med.com/event/. 

Additional dial-in numbers are also available at HUTCHMED's website. Please use participant access code "45675713#."

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development & commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel. has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and launched. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

Contacts

References

Unless the context requires otherwise, references in this announcement to the "Group," the "Company," "HUTCHMED," "HUTCHMED Group," "we," "us," and "our," mean HUTCHMED (China) Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "pipeline," "could," "potential," "first-in-class," "designed to," "objective," "guidance," "pursue," or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates and uncertainties regarding the impact of the COVID-19 pandemic. For further discussion of these and other risks, see HUTCHMED's filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

Inside Information

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).

Ends

OPERATIONS REVIEW

Oncology/Immunology

We discover, develop, manufacture and market targeted therapies and immunotherapies for the treatment of cancer and immunological diseases through a fully integrated team of approximately 720 scientists and staff (December 31, 2020: >600), and an in-house oncology commercial organization of about 540 staff (December 31, 2020: ~390).

Currently, we have eleven self-discovered oncology drug candidates in clinical trials in China, with six also in clinical development in the U.S. and Europe. Our first three drug candidates, fruquintinib, surufatinib and savolitinib, have all been approved and launched in China.

MARKETED PRODUCT SALES

In the first half of 2021, ELUNATE® in-market sales increased 186% to $40.1 million (H1-20: $14.0m), as provided by Lilly. ELUNATE® revenues consolidated by HUTCHMED increased 244% to $29.8 million (H1-20: $8.6m).

HUTCHMED took over development and execution responsibilities for all on-the-ground medical detailing, promotion and local and regional marketing activities for ELUNATE® in China from Lilly in October 2020. We estimate, for our approved indication in third-line metastatic CRC, there is an approximate incidence of 83,000 new patients per year in China.

During the first half of 2021, we conducted about 5,000 educational/scientific events involving approximately 70,000 healthcare professionals ("HCPs"). We increased medical sales coverage to over 2,500 cancer hospitals and secured hospital pharmacy listings for ELUNATE® in over 400 hospitals, in both cases more than double the level of October 2020 when HUTCHMED took over from Lilly. We estimate that during the first half of 2021 approximately 9,000 patients were treated with ELUNATE®.

We have confirmed a total of about 20 investigator-initiated studies, which target to explore ELUNATE® use in CRC, gastric cancer, NSCLC, pancreatic cancer, and several other indications. We believe that these studies combined with our promotion and marketing activities are rapidly raising awareness of ELUNATE® in China.

SULANDA® was first launched for the treatment of advanced NETs for tumors originating outside of the pancreas in mid-January 2021 and for those originating in the pancreas in late June 2021. Total sales in the first half of 2021 were $8.0 million (H1-20: nil).

During the first half of 2021, we introduced SULANDA® through a campaign of local, regional and national launch events involving approximately 12,000 HCPs. We have utilized means-tested early access and patient access programs to enable SULANDA® use by over 2,000 patients during the first half of 2021. We estimate, there is an approximate incidence of 34,000 new advanced NET patients per year in China.

We view this initial progress as encouraging and, over the balance of 2021, we expect to decide our long term pricing strategy for SULANDA® either by submitting for inclusion in the 2022 NRDL or by continuing to price at current levels and expanding our early access and patient access programs.

We have also confirmed a total of over 30 investigator-initiated studies in a broad range of exploratory solid tumor indications all of which are expected to gradually expand awareness of SULANDA® in China.

On June 22, 2021, ORPATHYS® became the first-in-class selective MET inhibitor to be approved in China. Our partner, AstraZeneca, then launched ORPATHYS® in mid-July 2021, less than three weeks after its conditional approval by the NMPA for patients with MET exon 14 skipping alteration NSCLC.

More than a third of the world's lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumors with MET exon 14 skipping alterations, representing an approximate incidence of 13,000 new patients per year in China. Importantly also, MET plays a role in multiple other solid tumors, with an estimated total incidence of 120,000 new patients per year in China.

In the second half of 2021, HUTCHMED will begin to consolidate revenues from ORPATHYS®, starting with a $25 million non-creditable and non-refundable first sale milestone payment from AstraZeneca and then ongoing manufacturing fees in addition to royalties of 30% of ORPATHYS® sales in China.

As a result of its approval prior to the mid-2021 cut off, ORPATHYS® will be eligible for potential inclusion in the 2022 NDRL, subject to negotiation and agreement with the relevant regulatory authorities.

RESEARCH & DEVELOPMENT

Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET. In global partnership with AstraZeneca, savolitinib has been studied in NSCLC, PRCC and gastric cancer in about 1,200 clinical trial patients to date, both as a monotherapy and in combinations.

MET plays an important role in NSCLC. The table below shows a summary of the clinical studies for savolitinib in lung cancer patients.

NMPA NDA Approval in MET exon 14 skipping alterations NSCLC (NCT02897479) - In June 2021, savolitinib was approved by the NMPA based on positive results from a Phase II trial conducted in China in patients with NSCLC with MET exon 14 skipping alterations, including patients with the more aggressive pulmonary sarcomatoid carcinoma subtype. Savolitinib demonstrated effective anti-tumor activity based on an independent review of ORR and DCR. The approval is conditional upon successful completion of a confirmatory study in this patient population (NCT04923945), which is expected to enroll approximately 160 patients from approximately 40 sites. In July 2021, the first commercial sales in China occurred.

EGFR TKI-resistance in NSCLC - MET-amplification is a major mechanism for acquired resistance to both first-generation EGFR TKIs, such as IRESSA® and TARCEVA®, as well as third-generation EGFR TKIs like TAGRISSO®. As many as 30% of EGFR mutation positive NSCLC patients develop MET amplification driven resistance to EGFR TKIs. Savolitinib has been studied extensively in these patients in the TATTON and SAVANNAH studies.

SAVANNAH Phase II study of combination with TAGRISSO® in patients who have progressed following TAGRISSO® due to MET amplification or overexpression (NCT03778229) - The SAVANNAH study is a global single-arm, open-label study that has now fully enrolled the savolitinib 300mg QD63 cohort, and is currently enrolling two additional cohorts of savolitinib 300mg BID64 and 600mg QD. The study will also determine optimal design of the planned global Phase III study regarding optimal biomarker strategy and dosage regimen. Enrollment is expected to be completed in mid-2021 and planning for the global Phase III study is now underway.

In-Planning - SACHI China Phase III study of combination with TAGRISSO® in 2L EGFR TKI refractory, MET amplified NSCLC patients - We intend to initiate a Phase III study in China targeting EGFR TKI refractory second-line NSCLC patients in the second half of 2021.

In-Planning - SANOVO China Phase III study of combination with TAGRISSO® in EGFR mutant and MET positive NSCLC patients - We intend to initiate a Phase III study in China targeting treatment naïve patients who are both EGFR mutation and MET aberrant in the second half of 2021.

MET is a clear genetic driver in RCC. The table below shows a summary of the clinical studies for savolitinib in kidney cancer patients.

Savolitinib and Immunotherapy Combinations - Evidence is emerging which demonstrates that MET plays an important role in the tumor microenvironment, leading to reduced anti-tumor activity of immune cells in many solid tumors. Therefore, combining immunotherapies with a MET inhibitor is hypothesized to enhance anti-tumor activity.

CALYPSO Phase II in combination with IMFINZI® PD-L1 inhibitor in RCC (NCT02819596) - The CALYPSO study is an investigator-initiated open-label Phase I/II study of savolitinib in combination with IMFINZI®. The study is evaluating the safety and efficacy of the savolitinib/IMFINZI® combination in patients with PRCC and clear cell RCC at sites in the U.K. and Spain.

CALYPSO PRCC cohort - Interim results of the PRCC cohort of the CALYPSO study were most recently presented at the ASCO 2021 and showed encouraging efficacy across all patients, particularly in MET-driven PRCC patients, where the combination demonstrated encouraging synergy in efficacy and tolerability in line with single agent safety profiles. In patients regardless of PD-L1 or MET status, ORR was 29%, while median PFS was 4.9 months (95% CI: 2.5-10.0) and median OS was 14.1 months (95% CI: 7.3-30.7). Importantly, for patients whose tumors are MET-driven, ORR was 57%, median PFS was 10.5 months (95% CI: 2.9-15.7) and median OS was 27.4 months (95% CI: 7.3-NR). Tolerability was consistent with established single agent safety profiles.

In-Planning - SAMETA Phase III in combination with IMFINZI® PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC - Based on the encouraging results of the SAVOIR (NCT03091192) and CALYPSO studies, we intend to initiate a global Phase III, open-label, randomized, controlled study of savolitinib plus IMFINZI® versus sunitinib monotherapy versus IMFINZI® monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC. The study is expected to begin enrollment by the second half of 2021.

MET-driven gastric cancer has a very poor prognosis. Multiple Phase II studies have been conducted in Asia to study savolitinib in MET-driven gastric cancer patients, demonstrating promising efficacy.

China Phase II study with potential for registration intent in 2L+ gastric cancer with MET amplification (NCT04923932) - In July 2021, we initiated a Phase II registration-intent study in MET-amplified gastric cancer in China. This is a two-stage, single-arm study which targets advanced gastric cancer patients who have failed at least one line of treatment. The primary endpoint is ORR. Subject to the results of the first stage of this study, we will discuss with the CDE of NMPA the appropriate approach and necessary criteria for registration.

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, both shown to be involved in tumor angiogenesis, and CSF-1R, which plays a key role in regulating tumor-associated macrophages, promoting the body's immune response against tumor cells. Surufatinib has been studied in over 950 clinical trial patients to date, both as a monotherapy and in combinations, and is approved in China.

We currently retain all rights to surufatinib worldwide. A summary of the clinical studies of surufatinib is shown in the table below.

NETs present in the body's organ system with fragmented epidemiology. About 65-75% of NETs originate in the GI67 tract and pancreas, 25-35% in the lung or bronchus, and a further 20-30% in other organs or unknown origins.

Global development of surufatinib in NET: U.S. NDA and E.U. MAA under review - In June 2021, the U.S. FDA accepted our filing of the NDA for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) NETs. The PDUFA goal date assigned by the FDA for this NDA is April 30, 2022. Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.

The NDA is supported by data from two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET-p and SANET-ep both previously reported in The Lancet Oncology, as mentioned below), and a surufatinib study conducted in the U.S. We have initiated an Expanded Access Protocol in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation.

We have also submitted the EMA MAA for surufatinib, which was validated and accepted in July 2021, for the treatment of both pancreatic and non-pancreatic NET. In addition, we are planning to initiate a pivotal study in NET patients in Japan in late 2021.

U.S. Phase Ib NET cohorts (NCT02549937) - Updated data from a multi-center, open-label, Phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetics of surufatinib in U.S. patients was presented at ASCO 2021, reinforcing the dosage, efficacy and safety profile as comparable to the China trials data. At data cut-off, in 32 patients treated between two and 23 months, confirmed response and DCR was observed in 18.8% and 87.5% of pancreatic NET patients, and 6.3% and 93.8% of extra-pancreatic NET patients, respectively. Median PFS was 11.5 months for patients in both cohorts (95% CI: 6.5-17.5).

Surufatinib approved and launched in extra-pancreatic NET (SANET-ep, NCT02588170) - Surufatinib was launched in mid-January 2021 after being granted approval by the NMPA for the treatment of extra-pancreatic (non-pancreatic) NET based on results from the SANET-ep study, a Phase III trial in patients with advanced extra-pancreatic NET conducted in China.

Surufatinib approved and launched in pancreatic NET (SANET-p, NCT02589821) - In June 2021, surufatinib was granted additional approval by the NMPA for the treatment of advanced pancreatic NETs, based on results from the SANET-p study, a Phase III pivotal study in patients with advanced pancreatic NETs conducted in China.

At ASCO 2021, we presented a subgroup analysis of SANET-p on the relationship of Ki-67 and baseline CgA on efficacy outcomes. SANET-p had showed that surufatinib demonstrated a statistically significant and clinically meaningful improvement in PFS, and this exploratory analysis showed that surufatinib demonstrated benefit irrespective of Ki-67 expression levels or baseline CgA. Median PFS was statistically longer in the surufatinib arm versus that in the placebo arm in subgroups of Ki-67 5-10% (11.0 vs 3.7 months), Ki-67 > 10% (11.1 vs 2.8 months) and CgA > 2 × ULN (11.0 vs 3.7 months).

Phase Ib/IIa study of surufatinib monotherapy in second-line BTC (NCT02966821) - We presented data at ASCO 2021, which highlighted surufatinib's potential in BTC. For a total of 39 BTC patients, 16-week PFS rate was 46.33% (95% CI: 24.4‒65.7), with median PFS of 3.7 months and median OS of 6.9 months. The top three Grade 3 or higher TRAEs68 included blood bilirubin increased (20.5%), hypertension (17.9%), and proteinuria (12.8%).

Phase IIb/III study of surufatinib monotherapy in second-line BTC (NCT03873532) - In March 2019, based on preliminary Phase Ib/IIa data, we initiated a Phase IIb/III study comparing surufatinib monotherapy with capecitabine in patients with unresectable or metastatic BTC. Enrollment for the Phase IIb portion (80 patients) of this study was completed in late 2020. Based on the emerging data from our Phase II cohort of the surufatinib combination plus TUOYI® in BTC (NCT04169672), we are now prioritizing the combination over surufatinib monotherapy for further development.

Surufatinib's ability to inhibit angiogenesis, block the accumulation of tumor associated macrophages and promote infiltration of effector T cells into tumors, could help improve the anti-tumor activity of PD-1 antibodies.

TUOYI® combinations (NCT04169672) - In a Phase I dose-finding study presented at the 2020 AACR Conference, data showed that surufatinib plus TUOYI® were well tolerated with no unexpected safety signals observed, with encouraging antitumor activity in patients with advanced solid tumors, particularly in severe settings such as grade 3 NET patients or NEC patients for whom no therapies have been approved. A Phase II China study is enrolling patients in nine solid tumor indications, including NENs, BTC, gastric cancer, thyroid cancer, SCLC, soft tissue sarcoma, endometrial cancer, esophageal cancer and NSCLC.

At ASCO 2021, encouraging preliminary data were disclosed for the surufatinib and TUOYI® combination in the NEC and gastric cancer cohorts.

For the 20 patients in the NEC cohort who received an average of 5 cycles of treatments and are efficacy evaluable, ORR was 20% while DCR was 70%. Median PFS was 3.9 months (95% CI: 1.3-NR). Grade 3 or higher TRAEs occurred in 33% of patients. We are preparing to initiate a Phase III study in second-line or above NEC.

Median duration of treatment for the gastric cancer cohort was 3 months, with 15 efficacy evaluable patients at the time of the analysis. For these 15 patients, confirmed ORR was 13% and an additional 20% of patients had unconfirmed response. DCR was 73% and median PFS was 3.7 months (95% CI: 1.4-NR). Grade 3 or higher TRAEs occurred in 14% of patients. Registration design for gastric cancer is under discussion.

Tislelizumab combinations (NCT04579757) - In addition to the TUOYI® and TYVYT® combination studies in China, in March 2021 we dosed the first patient in an open-label, Phase Ib/II study of surufatinib in combination with BeiGene's tislelizumab in the U.S. and Europe, evaluating the safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors, including CRC, NET, small cell lung cancer, gastric cancer and soft tissue sarcoma.

We are conducting multiple Phase Ib expansion cohorts in the U.S. to explore the use of surufatinib in BTC and soft tissue sarcoma. In China, we intend to initiate multiple exploratory studies, both as a single agent and in combinations, to evaluate the efficacy of surufatinib. We are also supporting dozens of investigator-initiated studies in various tumor settings.

Fruquintinib is a novel, selective, oral inhibitor of VEGFR 1/2/3 kinases that was designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability. Fruquintinib has been studied in over 2,800 clinical trial patients to date, both as a monotherapy and in combinations.

We retain all rights to fruquintinib outside of China and are partnered with Lilly in China. The table below shows a summary of the clinical studies for fruquintinib.

Fruquintinib capsules, sold under the brand name ELUNATE®, are approved in China for metastatic CRC patients.

FRESCO-2 Phase III global registration study in metastatic CRC (NCT04322539) - In the second half of 2020, we initiated a global Phase III registration study, known as the FRESCO-2 study, in refractory metastatic CRC which is expected to enroll over 680 patients from over 150 sites in 14 countries. Enrollment is targeted to be completed in late 2021.

FRUTIGA Phase III study of fruquintinib in combination with paclitaxel in gastric cancer (second-line) (NCT03223376) -The FRUTIGA study is a randomized, double-blind, Phase III study in China to evaluate the efficacy and safety of fruquintinib combined with paclitaxel compared with paclitaxel monotherapy, for second-line treatment of advanced gastric cancer. The FRUTIGA study is expected to enroll approximately 700 patients, with co-primary endpoints of PFS and OS. We expect to complete enrollment of FRUTIGA around the end of 2021.

Phase Ib/II dose expansion study in China of fruquintinib plus TYVYT® is underway in different tumor types, including HCC, endometrial cancer, RCC and GI tumors. Moreover, Phase Ib studies of fruquintinib plus geptanolimab, Genor's anti-PD-1 antibody, in second-line CRC and NSCLC are also underway.

At ASCO 2021, encouraging preliminary data were disclosed for fruquintinib in combination with two PD-1 inhibitors, TYVYT® and geptanolimab, in advanced CRC. Both preliminary data sets showed a five-fold increase in ORR and a doubling of mPFS as compared to the FRESCO study for fruquintinib monotherapy.

TYVYT® combinations (NCT03903705) - In the TYVYT® and fruquintinib combination study, 44 patients were enrolled into the CRC cohort, 22 of whom received the RP2D. ORR was 23% for all patients and 27% for those who received the RP2D. DCR was 86% for all patients and 96% for those who received the RP2D. Median PFS was 5.6 months for all patients, and 6.9 months for those who received the RP2D. Median OS was 11.8 months for all patients. A registration strategy for mCRC is under discussion.

Registration strategies for additional indications such as endometrial, liver and renal cancer are in various stages of being formulated. Three new cohorts are being added to the study.

Geptanolimab combination in CRC (NCT03977090) - For the 15 patients in the CRC cohort of the fruquintinib and geptanolimab Phase Ib study, ORR was 26.7% (including 1 patient with unconfirmed PR) and 33% in the group that received the RP2D (3mg/kg of geptanolimab every 2 weeks, 4mg of fruquintinib once daily for 3 weeks on, 1 week off). DCR for all evaluable patients was 80% and median PFS was 7.3 months (95% CI: 1.9-NR). Grade 3 TRAEs occurred in 47% of patients, and no incidences of grade 4 or 5 TRAEs were observed.

Tislelizumab combinations (NCT04577963 & NCT04716634): - In the second half of 2021, we plan to initiate an open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced refractory triple negative breast cancer, to be followed by a further study in additional solid tumor types. In addition, a Phase II study in China and Korea for fruquintinib in combination with tislelizumab was initiated and being led by BeiGene, for the treatment of advanced or metastatic, unresectable gastric cancer, CRC or NSCLC.

We are conducting multiple Phase Ib expansion cohorts in the U.S. to explore fruquintinib in CRC and breast cancer. In China, there are about 20 investigator-initiated studies in various solid tumor settings being conducted.

HMPL-689 is a novel, highly selective oral inhibitor targeting the isoform PI3Kδ, a key component in the B-cell receptor signaling pathway. HMPL-689's pharmacokinetic properties have been found to be favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical studies. We also expect that HMPL-689 will have low risk of drug accumulation and drug-to-drug interaction. We currently retain all rights to HMPL-689 worldwide. The table below shows a summary of the clinical studies for HMPL-689.

Phase II registration-intent trial in follicular lymphoma and marginal zone lymphoma (NCT04849351): In April 2021, we commenced a registration-intent Phase II trial in China in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma, two subtypes of non-Hodgkin's lymphoma. The multi-center, single-arm, open-label study is to evaluate the efficacy and safety of HMPL-689 once a day oral monotherapy in approximately 100 patients with relapsed/refractory follicular lymphoma and approximately 80 patients with relapsed/refractory marginal zone lymphoma. The primary endpoint is ORR, with secondary endpoints including CR72 rate, PFS, time to response and duration of response. The trial is being conducted in over 35 sites in China.

The initiation of the Phase II trial is based on the highly promising preliminary results from the Phase Ib expansion study ongoing in China (NCT03128164), which has shown thus far that HMPL-689 was well tolerated, exhibiting dose-proportional pharmacokinetics, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients.

Global development of HMPL-689 (NCT03786926): We have initiated a Phase I/Ib study in the U.S. and Europe, with patient enrollment underway. Dose escalation is near complete and we expect to engage with regulatory authorities in the second half of 2021 to discuss potential registration pathways.

HMPL-523 is a novel, selective, oral inhibitor targeting Syk, for the treatment of hematological cancers and immune diseases. Syk is a component in B-cell receptor signaling pathway. We currently retain all rights to HMPL-523 worldwide. The table below shows a summary of the clinical studies for HMPL-523.

Phase I/Ib dose escalation study of HMPL-523 in patients with ITP (NCT03951623) - In mid-2019, we initiated a Phase I study in patients with ITP, an autoimmune disorder characterized by low platelet count and an increased bleeding risk. Both dose escalation and dose expansion stages are now complete, with planning and preparation for a Phase III trial in China now underway. We plan to submit the results of the Phase Ib study for presentation in late 2021.

Phase I/Ib studies of HMPL-523 in indolent non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies (NCT02503033/NCT02857998) - Our Phase I/Ib dose escalation and expansion studies in Australia and China have now enrolled over 200 patients in a broad range of hematological cancers and have identified indications of interest for future development.

Phase I/Ib study of HMPL-523 in indolent non-Hodgkin's lymphoma (NCT03779113) - We have now initiated a Phase I/Ib study in the U.S. and Europe. Patient enrollment is underway in 11 sites, multiple dose cohorts have been completed and we will soon establish our RP2D.

Phase II dose escalation study of HMPL-523 in patients with AIHA (in planning) - following the encouraging data seen in our Phase Ib study in the autoimmune disorder ITP, we intend to initiate a Phase II study in patients with AIHA, another autoimmune disorder.

HMPL-453 is a novel, selective, oral inhibitor targeting FGFR 1/2/3. Aberrant FGFR signaling is associated with tumor growth, promotion of angiogenesis, as well as resistance to anti-tumor therapies. We currently retain all rights to HMPL-453 worldwide. The table below shows a summary of the clinical studies for HMPL-453.

In September 2020, we initiated a Phase II, single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in patients with advanced IHCC with FGFR2 fusion who had failed at least one line of systemic therapy. IHCC is a cancer that develops within the bile ducts, the second most common primary hepatic malignancy after HCC. Approximately 10-15% of IHCC patients have tumors that harbor FGFR2 fusion.

We submitted a new IND to the NMPA in late June 2021, with the intention to initiate studies in combination with other anti-cancer therapies in China in late 2021 or early 2022.

HMPL-306 is a novel small molecule dual-inhibitor of enzymes IDH1 and IDH2 enzymes. IDH1 and IDH2 mutations have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors, particularly among acute myeloid leukemia patients. We currently retain all rights to HMPL-306 worldwide. The table below shows a summary of the clinical studies for HMPL-306.

Our Phase I study in China has been initiated at multiple sites and we anticipate establishing the RP2D during 2021.

In March 2021, we initiated our Phase I development in the U.S. and Europe. These two trials are multi-center studies to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL-306, in either solid tumors, including but not limited to gliomas, chondrosarcomas or cholangiocarcinomas; or in IDHm+ hematological malignancies. Dose escalation in both trials is expected to be completed in the second half of 2021, to be followed by the start of the expansion phase.

HMPL-295 is a novel ERK inhibitor. ERK is a downstream component of the RAS-RAF-MEK-ERK signaling cascade (MAPK pathway). This is our first of multiple candidates in discovery targeting the MAPK pathway.

RAS-MAPK pathway is dysregulated in human diseases, particularly cancer, in which mutations or non-genetic events hyper-activate the pathway in more than 50% of cancers. Activating mutations in RAS genes occur in more than 30% of cancers. RAS and RAF predict worse clinical prognosis in a wide variety of tumor types, mediate resistance to targeted therapies, and decrease the response to the approved standards of care, namely, targeted therapy and immunotherapy. In the MAPK pathway, KRAS inhibitors are under clinical evaluation, and acquired resistance develops for RAF/MEK targeted therapies. ERK inhibition has the potential to overcome or avoid the intrinsic or acquired resistance from upstream mechanisms such as these.

We currently retain all rights to HMPL-295 worldwide. The table below shows a summary of the clinical studies for HMPL-295.

The clinical trial is to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-295, and to determine the maximum tolerated dose and RP2D in patients with advanced malignant solid tumors. Following the initial dose escalation stage, additional patients will be enrolled at the RP2D to further evaluate its safety and the preliminary efficacy of HMPL-295. The first patient was dosed in July 2021.

HMPL-760 is a novel third-generation BTK inhibitor and our eleventh in-house discovered small molecule oncology drug candidate. It is a reversible, non-covalent inhibitor of BTK designed to act against both the wild type and C481S mutant enzymes, a key resistance mechanism for first-generation BTK inhibitors such as IMBRUVICA®. We currently retain all rights to HMPL-760 worldwide.

We submitted IND applications with both the U.S. FDA and China NMPA in late June 2021 and the U.S. IND is allowed to proceed. We plan to initiate Phase I trials in patients with advanced solid tumors in late 2021 or early 2022.

We strive to create differentiated novel oncology and immunology treatments with global potential. These include furthering both small molecule and biologic therapies which address aberrant genetic drivers and cancer cell metabolism, modulate tumor immune microenvironment and target immune cell checkpoints. In addition to our eleven clinical-stage assets, we have two more novel oncology drug candidates in preclinical stage. HMPL‑653 is a potent and selective CSF-1R inhibitor designed to target CSF-1R driven tumors and potentially solid tumors in an adjuvant setting. HMPL-A83 is an anti-CD47 monoclonal antibody with unique epitope and high affinity, which has demonstrated a very high efficacy in animal tumor models and much reduced effect on red blood cells compared to other such antibodies. HMPL-A83 may have potential for combinations with other HUTCHMED assets such as HMPL-689 or HMPL-760. We retain all global rights to these pre-clinical drug candidates and are targeting dual U.S. and China IND submissions for some of them during 2021.

Beyond these clinical and preclinical stage candidates, we continue to conduct research into discovering new types of drug candidates, including among others, small molecules addressing cancer-related apoptosis, cell signaling, epigenetics and protein translation; biologic drug candidates including bispecific antibodies; and novel technologies including antibody-drug conjugates and heterobifunctional small molecules.

In January 2021, we entered into a strategic partnership with Inmagene, a clinical development stage company with a focus on immunological diseases, to further develop four novel preclinical drug candidates we discovered for the potential treatment of multiple immunological diseases. Funded by Inmagene, we will work together to move the drug candidates towards IND. If successful, Inmagene will then advance the drug candidates through global clinical development.

OTHER VENTURES

Our Other Ventures include drug marketing and distribution platforms covering about 320 cities and towns in China with around 4,700 mainly manufacturing and commercial personnel. Built over the past 20 years, it primarily focuses on prescription drug and consumer health products through several joint ventures and subsidiary companies.

In the first six months of 2021, our Other Ventures delivered encouraging growth with consolidated revenues up 27% (18% at CER) to $114.5 million (H1-20: $90.4m). Consolidated net income attributable to HUTCHMED from our Other Ventures increased by 17% (8% at CER) to $35.7 million (H1-20: $30.4m), excluding one-time land compensation of $5.6 million before withholding tax (H1-20: nil).

SHPL73: Our own-brand prescription drugs business, operated through our non-consolidated joint venture SHPL grew sales by 20% (10% at CER) to $180.4 million (H1-20: $150.7m). This sales growth and favorable product mix led to an increase of 19% (10% at CER) in net income attributable to HUTCHMED to $28.6 million (H1-20: $24.0m).

The SHPL operation is large-scale, with a commercial team of over 2,200 staff managing the medical detailing and marketing of its products not just in hospitals in provincial capitals and medium-sized cities, but also in the majority of county-level hospitals in China. SHPL's Good Manufacturing Practice-certified factory holds 74 drug product manufacturing licenses and is operated by over 510 manufacturing staff.

SXBX74 pill: SHPL's main product is SXBX pill, an oral vasodilator prescription therapy for coronary artery disease. SXBX pill is the third largest botanical prescription drug in this indication in China, with a national market share in January to April 2021 of 19.6% (2020: 18.2%). Sales increased by 22% (12% at CER) to $167.0 million during the first half of 2021 (H1-20: $137.0m).

SXBX pill is protected by a formulation patent that expires in 2029 and is one of less than two dozen proprietary prescription drugs represented on China's National Essential Medicines List, which means that all Chinese state-owned health care institutions are required to carry it. SXBX pill is fully reimbursed in all China.

Hutchison Sinopharm75: Our prescription drugs commercial services business, which in addition to providing certain commercial services for our own products, provides services to third-party pharmaceutical companies in China and sales grew by 29% (19% at CER) to $96.2 million in the first half of 2021 (H1-20: $74.4m).

Hutchison Sinopharm has a dedicated team of about 130 commercial staff focused on two key areas of operation. First, a team that markets third-party prescription drug products directly to over 540 public and private hospitals in the Shanghai region and through a network of about 50 distributors to cover all other provinces in China. Second, a team that markets HUTCHMED's science-based infant nutrition products through a network of over 30,000 promoters in China.

HBYS: Our own-brand OTC drugs business, operated through our non-consolidated joint venture HBYS grew sales 24% (14% at CER) to $153.7 million (H1-20: $124.1m), mainly as a result of a resumption of distribution channels after COVID-19. This growth combined with the land compensation led to an increase of 127% (118% at CER) in net income attributable to HUTCHMED to $11.5 million (H1-20: $5.0m).

HBYS disposal: In March 2021, we entered into an agreement with GL Capital to sell our entire investment in HBYS for an aggregate consideration of approximately $169 million. The divestment of our effective 40% share in this non-core business, valued at about 22 times of HBYS' adjusted 2020 net profit attributable to HUTCHMED equity holders of $7.7 million53. A deposit of approximately $15.9 million paid upon the signing of the agreement will be credited against the proceeds due on completion of the disposal. The disposal is subject to regulatory approval in China and is expected to be completed in the second half of 2021. The sale of this non-core consumer health products business will enable us to focus our resources on our Oncology/Immunology novel therapies.

Other Ventures dividends: The profits of our various Other Ventures businesses are passed to the HUTCHMED Group through dividend payments primarily from our non-consolidated joint ventures, SHPL and HBYS. In the first six months of 2021, dividends of $42.1 million (H1-20: $35.3m) were paid from these joint ventures to the HUTCHMED Group level with aggregate dividends received since inception of over $350 million.

Christian HoggChief Executive OfficerJuly 28, 2021

USE OF NON-GAAP FINANCIAL MEASURES AND RECONCILIATION

In addition to financial information prepared in accordance with U.S. GAAP, this announcement also contains certain non-GAAP financial measures based on management's view of performance including:

· Adjusted Group net cash flows excluding financing activities

· CER

Management uses such measures internally for planning and forecasting purposes and to measure the HUTCHMED Group's overall performance. We believe these adjusted financial measures provide useful and meaningful information to us and investors because they enhance investors' understanding of the continuing operating performance of our business and facilitate the comparison of performance between past and future periods. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. Other companies may define these measures in different ways.

Adjusted Group net cash flows excluding financing activities: We include the change in short-term investments for the period to the change in cash and cash equivalents for the period, and exclude the net cash generated from financing activities for the period to derive our adjusted Group net cash flows excluding financing activities. We believe the presentation of adjusted Group net cash flows excluding financing activities provides useful and meaningful information about the change in our cash resources excluding those from financing activities which may present significant period-to-period differences.

CER: We remove the effects of currency movements from period-to-period comparisons by retranslating the current period's performance at previous period's foreign currency exchange rates. Because we have significant operations in China, the RMB to U.S. dollar exchange rates used for translation may have a significant effect on our reported results. We believe the presentation at CER provides useful and meaningful information because it facilitates period-to-period comparisons of our results and increases the transparency of our underlying performance.

Reconciliation of GAAP change in cash and cash equivalents and short-term investments to Adjusted Group net cash flows excluding financing activities:

Reconciliation of GAAP revenues, net income attributable to HUTCHMED CER:

GROUP CAPITAL RESOURCES

LIQUIDITY AND CAPITAL RESOURCES

To date, we have taken a multi-source approach to fund our operations, including through cash flows generated and dividend payments from our Oncology/Immunology and Other Ventures operations, service and milestone and upfront payments from our collaboration partners, bank borrowings, investments from third parties, proceeds from our listings on various stock exchanges and follow-on offerings.

Our Oncology/Immunology operations have historically not generated significant profits or have operated at a net loss, as creating potential global first-in-class or best-in-class drug candidates requires a significant investment of resources over a prolonged period of time. As such, we incurred net losses of $102.4 million for the six months ended June 30, 2021 and net losses of $49.7 million for the six months ended June 30, 2020.

As of June 30, 2021, we had cash and cash equivalents and short-term investments of $950.4 million and unutilized bank facilities of $69.4 million. As of June 30, 2021, we had $26.9 million in bank loans. On July 15, 2021, we received total gross proceeds of approximately $80.2 million from the full exercise of the over-allotment option of the Global Offering.

Certain of our subsidiaries and non-consolidated joint ventures, including those registered as wholly foreign-owned enterprises in China, are required to set aside at least 10.0% of their after-tax profits to their general reserves until such reserves reach 50.0% of their registered capital. There is no fixed percentage of after-tax profit required to be set aside for the general reserves for our PRC joint ventures. Profit appropriated to the reserve funds for our subsidiaries and non-consolidated joint ventures incorporated in the PRC was approximately $8,000 and $17,000 for the six months ended June 30, 2021 and 2020, respectively. In addition, as a result of PRC regulations restricting dividend distributions from such reserve funds and from a company's registered capital, our PRC subsidiaries are restricted in their ability to transfer a certain amount of their net assets to us as cash dividends, loans or advances. This restricted portion amounted to $0.2 million as of June 30, 2021.

In addition, our non-consolidated joint ventures held an aggregate of $133.8 million in cash and cash equivalents and no bank borrowings as of June 30, 2021. These cash and cash equivalents are only accessible by us through dividend payments from these joint ventures. The level of dividends declared by these joint ventures is subject to agreement each year between us and our joint venture partners based on the profitability and working capital needs of the joint ventures.

CASH FLOW

Net cash used in operating activities was $28.4 million for the six months ended June 30, 2020, compared to net cash used in operating activities of $71.3 million for the six months ended June 30, 2021. The net change of $42.9 million was primarily attributable to an increase in research and development expenses of $49.1 million from $74.0 million for the six months ended June 30, 2020 to $123.1 million for the six months ended June 30, 2021.

Net cash used in investing activities was $139.1 million for the six months ended June 30, 2020, compared to net cash used in investing activities of $155.9 million for the six months ended June 30, 2021. The net change of $16.8 million was primarily attributable to an increase in net deposits in short-term investments of $28.4 million from $135.1 million for the six months ended June 30, 2020 to $163.5 million for the six months ended June 30, 2021. The net change was offset by our receipt of a $15.9 million deposit in March 2021 in connection with our planned divestment of HBYS.

Net cash generated from financing activities was $96.3 million for the six months ended June 30, 2020, compared to net cash generated from financing activities of $578.3 million for the six months ended June 30, 2021. The net change of $482.0 million was primarily attributable to total net proceeds of $614.9 million from the Global Offering in June 2021 and private placement in April 2021 as compared to $110.5 million from follow-on offering in the United States in January and February 2020. This net change was offset by purchases of treasury shares of $26.8 million for the six months ended June 30, 2021 as compared to $12.9 million for the six months ended June 30, 2020 and dividends paid to a non-controlling shareholder of a subsidiary of $9.3 million for the six months ended June 30, 2021 as compared to $1.2 million for the six months ended June 30, 2020.

LOAN FACILITIES

In November 2018, our subsidiary renewed a three-year revolving loan facility with HSBC76. The facility amount of this loan is HK$234.0 million ($30.0 million) with an interest rate at HIBOR77 plus 0.85% per annum. This credit facility is guaranteed by us and includes certain financial covenant requirements. No amount was drawn from this loan facility as of June 30, 2021.

In May 2019, our subsidiary entered into additional credit facility arrangements with HSBC for the provision of unsecured credit facilities in the aggregate amount of HK$400.0 million ($51.3 million). The 3-year credit facilities include (i) a HK$210.0 million ($26.9 million) term loan facility and (ii) a HK$190.0 million ($24.4 million) revolving loan facility, both with an interest rate at HIBOR plus 0.85% per annum. These credit facilities are guaranteed by us and include certain financial covenant requirements.

In October 2019, we drew down HK$210.0 million ($26.9 million) from the term loan facility and as of June 30, 2021, no amount was drawn from the revolving loan facility.

In August 2020, our subsidiary entered into a 24-month revolving credit facility with Deutsche Bank AG78 in the amount of HK$117.0 million ($15.0 million) with an interest rate at HIBOR plus 4.5% per annum. This revolving facility is guaranteed by us and includes certain financial covenant requirements. As of June 30, 2021, no amount was drawn from the revolving loan facility.

Our non-consolidated joint ventures SHPL and HBYS had no bank borrowings outstanding as of June 30, 2021.

CONTRACTUAL OBLIGATIONS AND COMMITMENTS

The following table sets forth our contractual obligations as of June 30, 2021. Our purchase obligations relate to property, plant and equipment that are contracted for but not yet paid. Our lease obligations primarily comprise future aggregate minimum lease payments in respect of various factories, warehouse, offices and other assets under non-cancellable lease agreements.

The following table sets forth the contractual obligations of our non-consolidated joint venture SHPL as of June 30, 2021. SHPL's purchase obligations comprise capital commitments for property, plant and equipment contracted for but not yet paid. SHPL's lease obligations primarily comprise future aggregate minimum lease payments in respect of various offices under non-cancellable lease agreements.

The following table sets forth the contractual obligations of our non-consolidated joint venture HBYS as of June 30, 2021. HBYS' purchase obligations comprise capital commitments for property, plant and equipment contracted for but not yet paid. HBYS' lease obligations primarily comprise future aggregate minimum lease payments in respect of various warehouses under non-cancellable lease agreements.

FOREIGN EXCHANGE RISK

Most of our revenues and expenses are denominated in renminbi, and our consolidated financial statements are presented in U.S. dollars. We do not believe that we currently have any significant direct foreign exchange risk and have not used any derivative financial instruments to hedge our exposure to such risk. In general, our exposure to foreign exchange risks is limited.

The value of the renminbi against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in China's political and economic conditions. The conversion of renminbi into foreign currencies, including U.S. dollars, has been based on rates set by the PBOC79. If we decide to convert renminbi into U.S. dollars for the purpose of making payments for dividends on our ordinary shares or ADSs or for other business purposes, appreciation of the U.S. dollar against the renminbi would have a negative effect on the U.S. dollar amounts available to us. On the other hand, if we need to convert U.S. dollars into renminbi for business purposes, e.g. capital expenditures and working capital, appreciation of the renminbi against the U.S. dollar would have a negative effect on the renminbi amounts we would receive from the conversion. In addition, for certain cash and bank balances deposited with banks in the PRC, if we decided to convert them into foreign currencies, they are subject to the rules and regulations of foreign exchange control promulgated by the PRC government.

CREDIT RISK

Substantially all of our bank deposits are in major financial institutions, which we believe are of high credit quality. We limit the amount of credit exposure to any single financial institution. We make periodic assessments of the recoverability of trade and other receivables and amounts due from related parties. Our historical experience in collection of receivables falls within the recorded allowances, and we believe that we have made adequate provision for uncollectible receivables.

INTEREST RATE RISK

We have no significant interest-bearing assets except for bank deposits. Our exposure to changes in interest rates is mainly attributable to our bank borrowings, which bear interest at floating interest rates and expose us to cash flow interest rate risk. We have not used any interest rate swaps to hedge our exposure to interest rate risk. We have performed sensitivity analysis for the effects on our results for the period from changes in interest rates on floating rate borrowings. The sensitivity to interest rates used is based on the market forecasts available at the end of the reporting period and under the economic environments in which we operate, with other variables held constant. According to the analysis, the impact on our net loss of a 1.0% interest rate shift would be a maximum increase/decrease of $0.1 million for the six months ended June 30, 2021.

OFF-BALANCE SHEET ARRANGEMENTS

We did not have during the periods presented, and we do not currently have, any material off-balance sheet arrangements.

CONTINGENT LIABILITIES

Other than as disclosed in note 11 to the interim financial statements, the Group does not have any other significant commitments or contingent liabilities.

GEARING RATIO

The gearing ratio of the Group, which was calculated by dividing total interest-bearing loans by total equity, was 2.7% as of June 30, 2021, a decrease from 5.2% as of December 31, 2020. The decrease was primarily attributable to the increase in equity due to the Global Offering on HKEX.

SIGNIFICANT INVESTMENTS HELD

Except for our investment in a non-consolidated joint venture SHPL with a carrying value of $66.5 million including details below and those as disclosed in note 7 to the interim financial statements, we did not hold any other significant investments in the equity of any other companies as of June 30, 2021.

Our own-brand prescription drugs business under Other Ventures is operated through SHPL. Dividends received from SHPL for the six months ended June 30, 2021 were $42.1 million.

FUTURE PLANS FOR MATERIAL INVESTMENTS AND CAPITAL ASSETS

Note 11 to the interim financial statements discloses our planned expenditures on capital assets as of June 30, 2021. At this date there were no other plans to incur material expenditures on additional investments or capital assets.

MATERIAL ACQUISITIONS AND DISPOSALS OF SUBSIDIARIES, ASSOCIATES AND JOINT VENTURES

During the six months ended June 30, 2021, except for the HBYS disposal as disclosed in note 7 to the interim financial statements, we did not have any other material acquisitions and disposals of subsidiaries, associates and joint ventures.

PLEDGE OF ASSETS

As of June 30, 2021, we did not have any pledge of assets (as of December 31, 2020: nil).

INFLATION

In recent years, China has not experienced significant inflation, and thus inflation has not had a material impact on our results of operations. According to the National Bureau of Statistics of China, the Consumer Price Index in China increased by 1.9%, 4.5%, 0.2% and 1.1% in 2018, 2019, 2020 and June 2021, respectively. Although we have not been materially affected by inflation in the past, we can provide no assurance that we will not be affected in the future by higher rates of inflation in China.

INTERIM DIVIDEND

The Board does not recommend any interim dividend for the six months ended June 30, 2021.

OTHER INFORMATION

CORPORATE STRATEGY

The primary objective of the Company and its subsidiaries (the "Group") is to become a fully integrated global leader in the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. The strategy of the Company is to leverage the highly specialized expertise of the drug discovery division, known as the Oncology/Immunology operations, to develop and expand its drug candidate portfolio for the global market while also building on the first-mover advantage in the development and launch of novel cancer drugs in China. The Chairman's Statement and the Operations Review contain discussions and analyses of the Group's opportunities, performance and the basis on which the Group generates or preserves value over the longer term and the basis on which the group will execute its strategy for delivering this objective.

HUMAN RESOURCES

As at June 30, 2021, the Group employed approximately 1,530 (December 31, 2020: ~1,230) full time staff members. Staff costs during the six months ended June 30, 2021, including directors' emoluments, totaled $85.5 million (H1-2020 $43.3 million).

The Group fully recognizes the importance of high-quality human resources in sustaining market leadership. Salary and benefits are kept at competitive levels, while individual performance is rewarded within the general framework of the salary, bonus and incentive system of the Group, which is reviewed annually. Employees are provided with a wide range of benefits that include medical coverage, provident funds and retirement plans, and long-service awards. The Group stresses the importance of staff development and provides training programs on an ongoing basis. Employees are also encouraged to play an active role in community care activities.

ENVIRONMENTAL, SOCIAL AND GOVERNANCE ("ESG") RESPONSIBILITY

The Group is committed to the long-term sustainability of its businesses and the communities in which it conducts business. The Group supports the proposition that enterprises should give back to society and bear social responsibility. It encourages its business units to contribute to the welfare of the communities in which it operates. Moreover, the Group's business is anchored to the purpose of serving medical needs of the public and distributing its drugs to those in need. While advancing breakthroughs with its novel drugs, the Group ensures every drug product is marketed and manufactured in a high quality, safe, traceable and affordable manner. Furthermore, the Group is continually improving its business practices and employee training in such best practices. It has adopted a proactive approach to ESG responsibility and has established a Sustainability Committee comprising four Directors to spearhead the ESG initiatives and activities of the Group and to enhance the Group's ESG efforts.

PURCHASE, SALE OR REDEMPTION OF LISTED SECURITIES

During the period from January 1, 2021 to June 30, 2021 (the "Reporting Period"):

(a) on April 14, 2021, the Company issued 16,393,445 ordinary shares to Pachytene Limited (an investment vehicle wholly-owned by Baring Private Equity Asia Fund VII) at the price of $30.50 per American depositary shares pursuant to a private placement; and

(b) on June 30, 2021, the Company issued 104,000,000 ordinary shares at the price of HK$40.10 per ordinary share pursuant to the Global Offering. After the Reporting Period, following the exercise of an over-allotment option granted by the Company in the context of the Global Offering, the Company issued an additional 15,600,000 ordinary shares at the same price per ordinary share on July 15, 2021. Details of the Global Offering and the over-allotment option are set out in the prospectus issued by the Company dated June 18, 2021.

Save as disclosed above, neither the Company nor any of its subsidiaries has purchased, sold or redeemed any of the listed securities of the Company during the Reporting Period.

COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE

The Company strives to attain and maintain high standards of corporate governance best suited to the needs and interests of the Company and its subsidiaries as it believes that an effective corporate governance framework is fundamental to promoting and safeguarding interests of shareholders and other stakeholders and enhancing shareholder value. Accordingly, the Company has adopted and applied corporate governance principles and practices that emphasize a quality board of Directors (the "Board"), effective risk management and internal control systems, stringent disclosure practices, transparency and accountability. It is, in addition, committed to continuously improving these practices and inculcating an ethical corporate culture.

Prior to the Global Offering, the Company has adopted the principles of the UK Corporate Governance Code ("UK CG Code") applicable to companies listed on the premium segment of the London Stock Exchange main market, despite its shares being traded on the AIM market and hence not required to comply with the UK CG Code. Please refer to the Corporate Governance Report contained in the 2020 annual report for compliance details in 2020.

Following the listing of the Company on the HKEX on June 30, 2021, the Board has adopted the Corporate Governance Code ("HK CG Code") as set out in Appendix 14 to the Rules Governing the Listing of Securities on HKEX in replacement of the UK CG Code and was in compliance with all code provisions of the HK CG Code. The Company will disclose the compliance of the HK CG Code in future announcements and financial reports.

COMPLIANCE WITH THE SHARE DEALINGS CODE FOR SECURITIES TRANSACTIONS BY DIRECTORS

The Board has adopted the Code on Dealings in Shares on terms no less exacting than the required standard set out in the Model Code for Securities Transactions by Directors of Listed Issuers set out in Appendix 10 to the Hong Kong Listing Rules as the protocol regulating Directors' dealings in securities of the Company. In response to specific enquiries made, all Directors have confirmed their compliance with the required standards set out in such code regarding their securities transactions throughout their tenure during the six months ended June 30, 2021.

USE OF NET PROCEEDS

On June 30, 2021, the Company issued 104,000,000 new ordinary shares for total gross proceeds of approximately $534.7 million from the listing of the Company's ordinary shares on HKEX.

On July 15, 2021, the over-allotment option was fully exercised and the Company issued an aggregate of 15,600,000 ordinary shares for total gross proceeds of approximately $80.2 million.

The intended use of total net proceeds of approximately $585 million from the Global Offering for the purposes and in the amounts (adjusted on pro rata basis based on the actual net proceeds) as disclosed in the prospectus of the Company dated June 18, 2021 is as below (the "Prospectus"):

Note: The expected timeline was based on the Company's estimation of future market conditions and business operations, and remains subject to change based on actual market conditions and business needs.

As of June 30, 2021, due to the proximity in time between completion of the Global Offering and the period-end date the net proceeds from the Global Offering had not been used. The proceeds are intended to be used for the purposes as disclosed in the Prospectus.

REVIEW OF INTERIM UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The interim unaudited condensed consolidated financial statements of the Group for the six months ended June 30, 2021 have been reviewed by the auditor of the Company, PricewaterhouseCoopers, in accordance with Hong Kong Standard on Review Engagements 2410 - "Review of Interim Financial Information Performed by the Independent Auditor of the Entity" issued by the Hong Kong Institute of Certified Public Accountants for the Hong Kong filing. The interim unaudited condensed consolidated financial statements of the Group for the six months ended June 30, 2021 have also been reviewed by the Audit Committee of the Company.

IMPORTANT EVENTS AFTER THE REPORTING DATE

Save as disclosed above, no important events affecting the Company occurred since June 30, 2021 and up to the date of this announcement.

PUBLICATION OF INTERIM RESULTS AND INTERIM REPORT

This interim results announcement is published on the websites of HKEX (www.hkexnews.hk), the U.S. Securities and Exchange Commission (www.sec.gov/edgar), the London Stock Exchange (www.londonstockexchange.com) and the Company (www.hutch‑med.com). The interim report of the Group for the six months ended June 30, 2021 will be published on the websites of HKEX and the Company, and dispatched to the Company's shareholders in due course.

REFERENCES AND ABBREVIATIONS

1 ELUNATE® In-market sales = total sales to third parties provided by Eli Lilly.

2 Gross proceeds of $534.7 million raised through the sale of new ordinary shares on June 30, 2021, and additional gross proceeds of $80.2 million raised via the sale of additional new ordinary shares from the full exercise of the over-allotment option on July 15, 2021.

3 HKEX = The Stock Exchange of Hong Kong Limited.

4 NDA = New Drug Application.

5 FDA = Food and Drug Administration.

6 EMA = European Medicines Agency.

7 TKI = Tyrosine kinase inhibitor.

8 IDH = Isocitrate dehydrogenase.

9 ERK = Extracellular signal-regulated kinase.

10 BTK = Bruton's tyrosine kinase.

11 In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®) and HUTCHMED (SULANDA®).

12 AstraZeneca = AstraZeneca PLC and its wholly owned subsidiary, AstraZeneca AB (publ).

13 IPO = Initial public offering.

14 OTC = Over the counter.

15 R&D = Research and development.

16 NET = Neuroendocrine tumors.

17 NMPA = National Medical Products Administration.

18 MET = Mesenchymal epithelial transition receptor.

19 NSCLC = Non-small cell lung cancer.

20 PDUFA = Prescription Drug User Fee Act.

21 MAA = Marketing Authorisation Application.

22 VEGFR = Vascular endothelial growth factor receptor.

23 FGFR = Fibroblast growth factor receptor.

24 CSF-1R = Colony stimulating factor-1 receptor.

25 BeiGene = BeiGene, Ltd.

26 PD-1 = Programmed Cell Death Protein-1.

27 NEC = Neuroendocrine carcinoma.

28 Junshi = Shanghai Junshi Biosciences Co., Ltd.

29 ASCO = American Society of Clinical Oncology.

30 CgA = Chromogranin A.

31 PFS = Progression-free survival.

32 BTC = Biliary tract cancer.

33 Innovent = Innovent Biologics, Inc.

34 CRC = Colorectal cancer.

35 HCC = Hepatocellular carcinoma.

36 RCC = Renal cell cancer.

37 Genor = Genor Biopharma Co. Ltd.

38 PD-L1 = Programmed death-ligand 1.

39 PRCC = Papillary renal cell carcinoma.

40 WCLC = World Conference on Lung Cancer.

41 EGFR = Epidermal growth factor receptor.

42 PI3Kδ = Phosphoinositide 3-kinase delta.

43 RP2D = Recommended Phase II dose.

44 Syk = Spleen tyrosine kinase.

45 ITP = Immune thrombocytopenia purpura.

46 CDE = Center for Drug Evaluation.

47 AIHA = Autoimmune hemolytic anemia.

48 IND = Investigational New Drug application.

49 MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.

50 119,600,000 new ordinary shares represented by 104,000,000 new ordinary shares issued on June 30, 2021 (raising net proceeds of ~$508 million) and additional 15,600,000 new ordinary shares from the full exercise of the over-allotment option on July 15, 2021 (raising net proceeds of $77 million).

51 HBYS = Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited.

52 GL Capital = GL Mountrose Investment Two Limited, a company controlled and managed by GL Capital Group.

53 HBYS' adjusted net profit attributable to HUTCHMED equity holders (after 20% non-controlling interest) in 2020 of $7.7 million is a non-GAAP measure which is 40% of HBYS' 2020 net profit of $91.3 million less $72.0 million gain on land compensation, net of tax.

54 Inmagene = Inmagene Biopharmaceuticals.

55 GAAP = Generally Accepted Accounting Principles.

56 BPEA = Baring Private Equity Asia.

57 We also report changes in performance at constant exchange rate ("CER") which is a non-GAAP measure. Please refer to "Use of Non-GAAP Financial Measures and Reconciliation" below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures.

58 Lilly = Eli Lilly and Company.

59 SG&A = Selling, general and administrative.

60 Other items = Includes other income, net of other expenses, income tax expense, equity in earnings of equity investees, net of tax and net income attributable to non-controlling interests.

61 ADS = American depositary share.

62 EGFRm = Epidermal growth factor receptor mutation.

63 QD = Once daily dose.

64 BID = Twice daily dose.

65 NENs = Neuroendocrine neoplasms.

66 SCLC = Small cell lung cancer.

67 GI = Gastrointestinal.

68 TRAE = Treatment related adverse event.

69 TN = Triple-negative.

70 HR+ = Hormone receptor-positive.

71 Her2 = Human epidermal growth factor receptor 2.

72 CR = Complete response.

73 SHPL = Shanghai Hutchison Pharmaceuticals Limited.

74 SXBX = She Xiang Bao Xin.

75 Hutchison Sinopharm = Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited.

76 HSBC = The Hongkong and Shanghai Banking Corporation Limited

77 HIBOR = Hong Kong Interbank Offered Rate

78 Deutsche Bank AG = Deutsche Bank AG, Hong Kong Branch

79 PBOC = People's Bank of China

CONSOLIDATED FINANCIAL STATEMENTS

HUTCHMED (China) LimitedCondensed Consolidated Balance Sheets(in US$'000, except share data)

The accompanying notes are an integral part of these interim unaudited condensed consolidated financial statements.

HUTCHMED (China) LimitedCondensed Consolidated Statements of Operations(Unaudited, in US$'000, except share and per share data)

The accompanying notes are an integral part of these interim unaudited condensed consolidated financial statements.

HUTCHMED (China) LimitedCondensed Consolidated Statements of Comprehensive Loss(Unaudited, in US$'000)