Hutchison China MediTech, based in Hong Kong, 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.
The first would be one of two drugs to be submitted in 2016, the head of Chi-Med said, fruquintinib in partnership with Eli Lilly ($LLY) for treating colorectal and lung cancers, and savolitinib, developed with AstraZeneca ($AZN) for kidney and gastric cancers.
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| Chi-Med CEO Christian Hogg |
Christian Hogg, Chi-Med CEO, told the Financial Times he has plans for the company to become a large-scale developer of China-created innovative drugs, another first for the nation with the world's largest population.
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 firms have watched China's drug approval process warily in the past year as the China FDA moved to review the use of multi-region clinical trials (MRCTs) 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, seven of them for treating a wide range of cancers and inflammations. The company expects results from a Phase II trial of fruquintinib soon and trigger a milestone payment from Lilly. It also expects milestones from savolitinib in 2015.
- here are the company's 2014 results (PDF)
- and the Financial Times article