Hutchison China MediTech has met the primary endpoint of progression-free survival in a Phase II clinical trial for its metastatic colorectal cancer candidate fruquintinib (HMPL-013), putting it one step closer to China approval.
The company's majority-owned unit, Hutchison MediPharma Ltd. R&D, said the secondary efficacy endpoints, including objective response rate, disease control rate and overall survival, are still being monitored.
The trial compared fruquintinib against a placebo in patients with metastatic colorectal cancer.
In December, the unit started a Phase III study of the small molecule that selectively inhibits the tyrosine kinase activity associated with VEGF receptors to treat metastatic colorectal cancer patients who have failed at least two prior therapies
The subsidiary also started a Phase Ib study of the compound in October 2014 to treat gastric cancer, and a Phase II study in June 2014 to treat non-small cell lung cancer.
In March, Hutchison China MediTech, based in Hong Kong, said it expects to file for its first drug approval next year for what it said would be the first modern drug from China since artemisinin was developed in the 1970s to treat malaria.
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| Chi-Med CEO Christian Hogg |
The first would be one of two drugs to be submitted in 2016, Christian Hogg, Chi-Med CEO said, commenting on the candidate that is part of a partnership with Eli Lilly ($LLY) for treating colorectal and lung cancers, and savolitinib, developed with AstraZeneca ($AZN) for kidney and gastric cancers.
Chi-Med granted Eli Lilly rights to commercialize fruquintinib in China under a 2013 deal.
Hogg called China "a passenger in drug development" for the past 20 years and added he was about to change that. He has the backing of Li Ka-shing, one of Asia's richest men and head of Chi-Med's parent company, Hutchison Whampoa group.
Western companies have watched China's drug approval process warily in the past year as the China FDA moved to review the use of multiregion clinical trials and lags on in-country approvals.
That in turn has prompted companies to look at other ways to enter the market in China for drugs that require extensive regulatory scrutiny. Eli Lilly has also done a license deal for a neuroscience candidate with China-based firm Denovo Biopharma recently that is also hoped to lead to clinical trials.
Chi-Med counts 16 drugs in clinical trials, 7 of them for treating a wide range of cancers and inflammations. The company expects results from a Phase II trial of fruquintinib soon and a trigger for a milestone payment from Lilly. It also expects milestones from savolitinib in 2015.
- here's the release