Spotlight On... China FDA plowed through trial and new drug applications in 2015, commissioner says; Mindray buyout set for EGM; LG Life Sciences to sell Zemiglo in India, Central America; and more...

CFDA Commissioner Bi Jingquan

China FDA went through 9,394 clinical trial and new drug applications in 2015, Commissioner Bi Jingquan said in a press release, which was almost double the previous year's tally, taking a chunk out of a backlog estimated earlier last year of around 20,000 applications. A self-audit push started last year saw 1,151 drug filings pulled with the majority coming from smaller domestic firms. In a broad review of the past year, known as a work report, and a look ahead, Bi said bio-equivalency evaluations will be stepped up for generic drugs and approvals will be bolstered by added manpower and facilities, while medical devices will be newly classified. The CFDA "will continue to push forward the reform of the drug review and approval system, the quality of generic drugs ... and accelerate the evaluation of the efficacy and consistency of medicines," Bi said in translated remarks. Release (Chinese language)

> Shenzhen-based Mindray Medical International ($MR) will hold an extraordinary general meeting on Feb. 26 that will take up a proposed buyout merger that would see it delist from the New York Stock Exchange. Release

> South Korea's LG Life Sciences plans to begin selling its diabetes drug Zemiglo in Central America and India in March. Report

> Seoul-based biosimilar developer Celltrion has adopted the Medidata ($MDSO) Clinical Cloud for use in its multi-regional clinical trials. Release

> Cocoon Networks backed by Chinese private equity firms China Equity Group and Hanxin Capital has dedicated a $720 million fund in London on the lookout for biotech and medical device investment among other areas in the U.K. Report

> China-focused CASI Pharmaceuticals ($CASI) received $10.3 million of a $25 million funding round announced in September last year. Release

> A huge challenge facing drugmakers is the ability--or lack thereof--to print drug labels in non-Latin languages such as Arabic, Cyrillic and Asian languages. Report

> Indian drugmakers Cipla, Emcure, Hetero and Natco have signed deals with Bristol-Myers Squibb ($BMY) and a UN's Medicines Patent Pool to sell hep C treatment daclatasvir in 112 countries. Report

Suggested Articles

The Shire bid Takeda’s been discussing is getting real. The Japanese drugmakers is gauging lender interest in financing the buy.

After initial doubts, some analysts now like Takeda's chances of pulling off a deal for embattled Shire.

Daiichi Sankyo, which has struggled since losing exclusivity for its blood pressure drug Benicar, is cutting another 280 jobs in the U.S.