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Pin to quick picksHutchmed Share News (HCM)

Share Price Information for Hutchmed (HCM)

London Stock Exchange
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Share Price: 290.00
Bid: 289.00
Ask: 293.00
Change: -14.00 (-4.61%)
Spread: 4.00 (1.384%)
Open: 312.00
High: 312.00
Low: 287.00
Prev. Close: 304.00
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Hutchmed China's amdizalisib secures breakthrough therapy designation

Mon, 13th Sep 2021 10:22

(Alliance News) - Hutchmed China Ltd on Monday said a Chinese watchdog has granted breakthrough therapy designation to amdizalisib for the treatment of relapsed or refractory follicular lymphoma.

The Hong Kong-based pharmaceutical company said the Center for Drug Evaluation of China's National Medical Products Administration grants breakthrough therapy designation to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies.

Hutchmed China highlighted that drug candidates with breakthrough therapy designation may be considered for conditional approval and priority review when submitting a new drug application.

"There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes. We look forward to important clinical data on amdizalisib being presented at the ESMO Congress next week and are continuing to accelerate global development of this novel therapy," said Chief Executive Christian Hogg.

Hutchmed China shares were trading 3.0% higher in London on Monday at 583.00 pence each.

By Evelina Grecenko; evelinagrecenko@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

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13 Jul 2022 09:35

IN BRIEF: Hutchmed presents solid results from lung cancer study

Hutchmed China Ltd - Hong Kong-based biopharmaceutical company - Presents positive results from the Savannah phase two trial of Hutchmed and AstraZeneca PLC's savolitinib in combination with Astra's osimertinib in epidermal growth factor receptor-mutated non-small cell lung cancer patients.

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6 Jul 2022 10:37

AIM WINNERS & LOSERS: Hutchmed down amid China Covid woes; Parkmead up

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6 Jul 2022 09:25

Hutchmed phase I trial for IMG-007 doses first patient

(Alliance News) - Hutchmed China Ltd on Wednesday announced the first patient has been dosed for its phase I trial for IMG-007.

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1 Jun 2022 10:07

IN BRIEF: Hutchmed China wins cancer drug Tazverik approval in Hainan

Hutchmed China Ltd - Hong Kong-based biopharmaceutical company - Receives approval for Tazverik from the Health Commission & Medical Products Administration of the Hainan province in China. The approval is for use in the Hainan pilot zone under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma.

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3 May 2022 12:14

LONDON MARKET MIDDAY: Stocks down as aggressive US Fed rate hike looms

(Alliance News) - Stock prices in London were lower at midday on Tuesday following the long bank holiday weekend in the UK, as markets globally prepare for a sharp US interest rate hike and similar moves by other central banks as they struggle to control inflation.

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3 May 2022 11:29

AIM WINNERS & LOSERS: Hutchmed sinks on US FDA drug rejection

(Alliance News) - The following stocks are the leading risers and fallers on AIM in London on Tuesday.

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3 May 2022 11:25

IN BRIEF: US FDA says Hutchmed's pancreatic drug needs more testing

Hutchmed (China) Ltd - Hong Kong-based biopharmaceuticals - The US Food & Drug Administration has rejected Hutchmed's surufatinib for treatment of pancreatic neuroendocrine tumours. In a complete response letter, the FDA says the current data package, based on two positive phase three trials in China and one bridging study in the US, does not support an approval in the US "at this time". The FDA said a multi-regional clinical trial of surufatinib required for US approval. Surufatinib was approved in China for the treatment of pNETs and extra-pancreatic neuroendocrine tumours in June 2021 and December 2020, respectively. Chief Executive Officer & Chief Scientific Officer Weiguo Su comments: "Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for NET patients and committed to making surufatinib available to patients globally. We look forward to working with the agency to evaluate its feedback."

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3 May 2022 08:57

LONDON MARKET OPEN: BP rises despite taking hit from Rosneft exit

(Alliance News) - Stock prices in London opened lower on Tuesday following the long bank holiday weekend, with BP shares rising as the oil major planned to return cash to shareholders amid calls by some UK politicians for a windfall profit tax on energy companies.

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3 May 2022 07:53

LONDON MARKET PRE-OPEN: BP swings to quarterly loss after Rosneft exit

(Alliance News) - Stock prices in London are seen opening lower on Tuesday, after the long bank holiday weekend in the UK, as concerns rise over aggressive monetary policy tightening by the US Federal Reserve.

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25 Apr 2022 10:45

AIM WINNERS & LOSERS: musicMagpie sells on new platform; Hutchmed down

(Alliance News) - The following stocks are the leading risers and fallers on AIM in London on Monday.

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20 Apr 2022 16:05

UK shareholder meetings calendar - next 7 days

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GlobalData PLCAGM
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Copyright 2022 Alliance News Limited. All Rights Reserved.

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31 Mar 2022 10:43

IN BRIEF: Hutchmed China named by SEC, might delist Nasdaq shares

Hutchmed China Ltd - Hong Kong-based biopharmaceutical company - US Securities & Exchange Commission identifies Hutchmed China under the new Holding Foreign Companies Accountable Act, which identifies public companies who have used auditors from overseas or auditors who are unable to be investigated completely. The new regulation has no impact on business operations, Hutchmed says.

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31 Mar 2022 10:04

Hutchmed China confident after being added to SEC list

(Sharecast News) - Hutchmed China updated the market on its status under the United States 'Holding Foreign Companies Accountable Act' on Thursday.

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11 Mar 2022 11:15

AIM WINNERS & LOSERS: Omega Diagnostics Visitect not available in UK

(Alliance News) - The following stocks are the leading risers and fallers on AIM in London on Friday.

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11 Mar 2022 10:38

IN BRIEF: Hutchmed China shares fall as US listing under threat

Hutchmed (China) Ltd - Hong Kong-based biopharmaceutical company - Says its depositary shares may be delisted from New York's Nasdaq exchange in early 2024 unless the Holding Foreign Companies Accountable Act is amended to exclude Hutchmed. The act is part of regulatory focus in the US on access to audit and other information. It requires the US Securities & Exchange Commission to prohibit the securities of any company from being traded on any of the US securities exchanges if the auditor of the company's financial statements is not subject to inspection by the US Public Co Accounting Oversight Board for three consecutive years. Another way for Hutchmed to be excluded from the act is if the PCAOB is able to conduct a full inspection of the company's auditor during the required timeframe.

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