HONG KONG – Lack of proper staffing is the main reason for the huge drug approval backlog at the CFDA, which topped 18,000 applications last year. Though the regulator has plans to reduce the backlog in three years, it is facing other issues beyond the staffing problem.

SHANGHAI – China's Ebola vaccine, Ad5-EBOL, is setting a new standard for technological capability and speed having generated strong phase I immunogenicity and safety data in Chinese patients within just three months.

HONG KONG – China has released a draft of its long-awaited first-ever regulations on stem cell studies, which provide guidance for an industry with huge scientific and commercial potential.

TOKYO – A lack of a commercial mindset is holding back Japan's biotech industry as academics find it difficult to move ideas from paper to market.

HONG KONG – In a landmark study, Singapore-based researchers have identified a novel kinase feedback loop controlling autophagy in common RAS-driven cancers and have shown that combining a kinase inhibitor with an agent that prevents autophagy may offer an effective new approach to treating such tumors.

HONG KONG – Calling success in the first proof-of-concept trial for its cancer drug, fruquintinib, Hong Kong-based Hutchison Medipharma said the drug achieved primary efficacy endpoints. Phase III trials will now start for the colorectal indication of fruquintinib, even as development continues in two other indications.

Intas Pharmaceuticals Ltd., of Ahmedabad, India, has acquired the hospital drugs business in Spain and Portugal from Barcelona, Spain-based Combino Pharm through its subsidiary Accord Healthcare. The deal gives Accord certain rights over Combino’s hospital portfolio in a number of European and non-European countries while complementing Accord’s existing business in Spain, Intas said.

SHANGHAI – Upstart domestic biotech Ascletis Inc., with offices in the U.S. and China, is a step closer to realizing its dream of having the first effective hepatitis C virus (HCV) treatment on the market in China. But it is facing a race against time, going up against much heavier hitters such as Gilead Sciences Inc., of Foster City, Calif.

SHANGHAI – Brivanib, an oral kinase inhibitor for liver cancer, is getting another crack at getting on the market, and this time, if successful, it will be in China where almost half the world’s liver cancer patients reside.