Biocentury 1/26 Sep 2018 12:34
Interesting piece in Biocentury
Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said China's National Medical Products Administration (NMPA) approved Elunate fruquintinib to treat metastatic colorectal cancer (mCRC). According to Chi-Med, the drug is the first China-discovered and developed product for an oncology indication to receive unconditional approval based on a randomized clinical trial.
The drug, a small molecule inhibitor of VEGF receptors 1, 2 and 3, is indicated to treat mCRC patients who have failed at least two prior systemic antineoplastic therapies with or without prior use of anti-VEGF or anti-EGFR therapies.
Chi-Med was co-founded in 2000 by Samantha Du, who is founder, Chairman and CEO of Zai Lab Ltd. (NASDAQ:ZLAB). From 2001 to 2011, Du was Chi-Med's CSO; she also founded and was CEO of Chi-Med's R&D subsidiary Hutchison MediPharma over the same period.
Chi-Med is eyeing a wave of late-stage clinical and regulatory milestones for multiple programs, including Elunate, over the next couple of years. Chi-Med Executive Director and CEO Christian Hogg told BioCentury that within six months he expects to have 11 registrational trials running across four candidates.
Data from a Chinese Phase III trial of Elunate as a third-line treatment of non-small cell lung cancer (NSCLC) are expected in late October or early November. Data from another Chinese Phase III trial of the drug in second-line gastric cancer are due early next year.
With a positive Phase III NSCLC readout, Hogg said Chi-Med plans to submit an NDA to NMPA, and hopes it will spend less time under review than Elunate did for mCRC. Elunate's mCRC NDA -- which was reviewed under Priority Review -- took about 15 months from NDA submission to approval, Hogg said. He added the next NDA review should only take about 12 months now that Chi-Med's manufacturing facility has received GMP certification.
Beyond Elunate monotherapy programs, Hogg said Chi-Med will establish multiple partnerships in the next six months inside and outside of China to test the product in combination with immuno-oncology drugs including anti-PD-1 therapies.
Expansion into the U.S. is already under way. Elunate is in a Phase I bridging study in the U.S., where Chi-Med has established a clinical and regulatory team in New Jersey and where the company gained its dual stock listing in 2016. The trial is expected to be completed by year end and will enable expansion "into a whole line of development programs for fruquintinib" in the U.S. and EU, including combination studies, Hogg said.
With Elunate's approval, partner Eli Lilly and Co. (NYSE:LLY) will pay Chi-Med a $13.6 million milestone under a 2013 licensing, co-development and commercialization deal in China. Chi-Med is eligible to receive tiered royalties starting in the mid-teens.
Lilly did not respond to inquiries regarding a launch date or pricing.
Hogg called the approval "a sign of the progress of the China biotech
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