Deals and Financings
Boehringer Ingelheim will pay $50 million upfront and as much as $680 million in milestones for exclusive rights to a novel lung cancer treatment developed by Korea's Hanmi Pharma (see story). BI will have global rights (except South Korea, China and Hong Kong) to HM61713, a novel 3rd generation EGFR targeted therapy. BI also agreed to pay tiered double-digit royalties on all sales revenues. Presumably, Hanmi, which has a strong presence in China, plans to market the drug in China itself. It was the second blockbuster out-licensing deal for Hanmi this year.
ZAI Lab, an innovative Shanghai biotech, has in-licensed global rights to a novel Sanofi (NYSE: SNY) multi-kinase inhibitor aimed at non-small cell lung cancer and other oncology indications (see story). ZAI will assume responsibility for global development, manufacturing and commercialization of the molecule. The deal calls for ZAI to pay Sanofi development and regulatory milestones, along with tiered royalties from sales, though details of the agreement were not disclosed.
Jiangsu Hengrui Medicine (SHA: 600276) in-licensed China rights to an anti-nausea/vomiting drug from Tesaro (NSDQ: TSRO) of the US (see story). The drug, rolapitant, is a neurokinin-1 (NK-1) receptor antagonist currently under NDA review at the FDA, with a PDUFA ruling expected by September 5, 2015. Hengrui will make unspecified upfront and milestone payments, plus pay royalties on net China sales of the drug. Further financial details were not disclosed.
Hutchison Chi-Med (AIM: HCM) and Mitsui have revised Mitsui's investment in Chi-Med by exchanging Mitsui's 12.2% interest in Hutchison MediPharma, the drug development arm of Chi-Med, for a 5.7% interest in the Chi-Med parent company (see story). The 5.7% stake is worth $84 million. Chi-Med owns a TCM company and a consumer health company in addition to its drug development operation. In 2010, Mitsui paid $12.5 million for a 12.2% interest in Chi-Med's drug development arm.
Bloomage BioTechnology (HK: 00963) formed a JV with South Korea's Medytox (KS: 086900) to market Medytox's version of the wrinkle treatment Botox (Botulinum Toxin) in China (see story). The JV, which will be owned 50-50 by the two partners, will be called Medybloom. Bloomage is already involved in China's aesthetic care market as a producer of hyaluronic acid. It markets various grades of HA in China as orthopedic injections, ophthalmic solutions, cosmetic fillers, surgical anti-adhesion products and food supplements.
Shuwen Biotech, a Hangzhou diagnostic company focusing on cancer tests, will collaborate with Jiangsu Hengrui Medicine (SHA: 600276) to develop a companion diagnostic for an unspecified Hengrui cancer treatment (see story). Shuwen will screen clinical trial candidates for the drug at its lab, using the diagnostic, and it will manufacture the product, once Hengrui's cancer drug is approved for use.
Government and Regulatory
In a dramatic announcement, the CFDA declared it will hold drugmakers responsible for the accuracy of their clinical trial data (see story). The agency gave companies one month, until August 22nd, to conduct self-inspections and verify their current clinical trial data filings, according to a report by US-Asia healthcare law firm Sidley Austin. If the companies discover any discrepancies, they can withdraw their data without any penalties. Once the deadline is passed, the CFDA will begin making unannounced spot inspections. If the CFDA discovers discrepancies, it may level fines and penalties, up to a three-year prohibition of any new drug filings to the CFDA.
Trials and Approvals
Suzhou Connect Biopharma reported a successful Phase I study of CBP-307, its lead molecule and a drug candidate for several autoimmune diseases (see story). The single ascending dose study assessed the tolerability, pharmacokinetics and pharmacodynamics of CBP-307. According to Connect, CBP-307 exhibited "highly potent" immune modulation activity at each level in a dose-dependent manner. The study was conducted by Connect's Australian subsidiary in Melbourne.
Jun Wang, the CEO of BGI, the genomic sequencing behemoth located in Shenzhen, is relinquishing his CEO title (see story). A bioinformatics specialist, Dr. Wang is leaving to spend more time developing artificial intelligence, a long-time interest. Dr. Wang joined BGI seventeen years ago, at the age of 22, when BGI was still in Beijing. He is credited with being the force behind many of BGI's major scientific breakthroughs. In 2013, Dr. Wang told ChinaBio® Today, in an exclusive interview, “We are a dream-driven organization.” BGI is willing, he said, to enter any partnership that will advance genomic science, even if it doesn’t make economic sense. No doubt, he will bring the same driving idealism to his AI work.
Yabao Pharma (SHA: 600351) has begun preclinical work on an innovative drug candidate for sepsis based on annexin A5 (see story). In 2014, Yabao in-licensed greater China rights to discover, develop and commercialize the technology from Canada's Lawson Health Research Institute. So far, the program has completed discovery validation work. A team led by Dr. Qingping Feng, a scientist at Ontario's Lawson Institute and Western University, discovered the technology.
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