FiercePharmaAsia—China’s new drug policy guidelines, Mylan-Biocon’s Neulasta biosim, C-Bridge hire

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China's drug policy overhaul, Biocon and C-Bridge made the news this week.

Welcome to this week’s FiercePharmaAsia report, which includes stories about China’s recent drug policy change, Mylan and Biocon’s Neulasta biosimilar setback, Chinese private equity firm C-Bridge’s appointment of ex-GlaxoSmithKline pharma chief Abbas Hussain and more.

1. China may relax trial requirements for new drugs, allowing foreign data

China’s national authorities have released a 36-item-long, wide-ranging guideline for policies on drugs and medical devices. Though it’s pretty much a combination of recent proposals previously submitted by China’s FDA, the fact that they’re coming from the top of the country’s government bodies means the country will for sure move them along. Some key changes include allowing foreign data for new drug applications.

2. Mylan and Biocon biosimilar of Amgen’s Neulasta hit with manufacturing-related CRL

FDA concerns over manufacturing at Biocon’s Bangalore biosimilar plant have dealt the Indian company and its partner Mylan a blow, as the FDA had issued a complete response letter for the pair’s copy of Amgen’s Neulasta. Amgen's chemotherapy companion netted $4.72 billion in sales last year. According to Biocon, the CRL isn’t about their biosim’s safety or efficacy, but about updates to its facility.

3. China’s C-Bridge hires ex-GlaxoSmithKline executive for U.S. investment drive

Chinese private equity firm C-Bridge Capital, which has invested in some prominent biotechs, has tapped former GlaxoSmithKline pharma chief Abbas Hussain as senior partner to help run its $700 million fund. The company has put together a U.S. team with offices in Boston, New York and San Diego, run by biopharma veterans who have served in biotech and Big Pharma.

4. India's Piramal investing $55M in API production

Indian CDMO Piramal Pharma Solutions is investing $55 million to beef up its global API production. In addition to upgrades in manufacturing automation and IT across its entire network, specific projects include expanding its early development capabilities at a site in Morpeth, the U.K., and its high-potency drug capabilities at its site in Riverview, Michigan.

5. OmniComm targets China as country revamps clinical trial regulations

U.S.-based electronic data capture service provider OmniComm Systems is taking advantage of recent clinical trial and drug policy changes happening in China. It just signed Beijing Hospital of the Ministry of Health as its seventh TrialOne client in China, less than a year since the early-phase EDC and site automation solution debuted in the country with a trio of contracts.