China's ZAI Lab in manufacturing pact with Boehringer Ingelheim

Samantha Du, founder and CEO of ZAI Lab  

Shanghai-based biotech ZAI Lab will use manufacturing and process services from Germany's Boehringer Ingelheim in China for a new monoclonal antibody candidate that targets autoimmune diseases licensed from Belgium's UCB late last year, according to a press release. ZAI has finished preclinical work and is in the process of filing an Investigational New Drug Application with China FDA. Boehringer Ingelheim's Shanghai manufacturing facility expanded biologic capacity in 2013 as it moved to sell a U.S. operation to a Chinese firm. The company also entered a strategic alliance to help Zhangjiang Biotech & Pharmaceutical Base Development build a plant to develop and manufacture biologic drugs using mammalian cell culture technology. China FDA has apparently eased rules on biologic manufacturing by third parties, with oncology-focused biotech and Beijing-based BeiGene ($BGNE) added as a customer this month. "China's State Food and Drug Administration has recently released a series of inspiring reform measures," David Preston, chairman and CEO of Boehringer Ingelheim China, Hong Kong and Taiwan, said in the release. "Among them, the pilot program of Marketing Authorization Holder will help spur R&D of new medicines and propel rapid growth of China's pharmaceutical industry." ZAI has in-licensed four molecules in its two years of operation, most recently a novel multikinase inhibitor aimed at a non-small cell lung cancer target from Sanofi ($SNY). Release (PDF)