Deals and Financings

Aslan Pharma of Singapore signed a global license agreement to develop an anti-IL13 receptor monoclonal antibody from CSL Limited (ASX: CSL), an Australian biopharma (see story). The molecule, CSL334, is currently in preclinical development for the treatment of asthma. Aslan will be responsible for developing CSL334 through clinical proof-of-concept, primarily in Asia. At that time, Aslan will identify a global partner for the Phase III trial and commercialization. CSL will receive a portion of the proceeds, though further financial details were not disclosed.

NeoStem (NSDQ: NBS) out-licensed exclusive China rights for its liver cancer treatment to Cellular Biomedicine Group (OTCQB: CBMG) of China (see story). The patient-specific cancer immunotherapy, DC-TC, is ready to begin a Phase II trial in patients with hepatocellular carcinoma. CBMG will be responsible for the costs of the trial and most other aspects of the treatment’s development in China. NeoStem, however, will make the regulatory filings and manufacture DC-TC. If all goes well, NeoStem could receive up to $30 million in milestones.

CSPC Pharmaceutical Group (HK: 1093), headquartered in China's Hebei Province, partnered with Dexcel Pharma Technologies to co-develop and commercialize a generic oncology drug in the US, Europe and elsewhere (see story). Dexcel is a privately held Israeli generic drug company, with a presence in more than 30 countries. Dexcel will pay CSPC $2 million to defray the pre-clinical and cGMP compliance certification costs. It will also be liable for up to $5 million in milestones, and Dexcel will be responsible for obtaining approvals of the product. 

Lannett Company (NYSE: LCI), a US-based generic drug company, set up bilateral distribution and contract manufacturing agreements with HEC Pharm Group of Shenzhen (see story). Lannett will become the exclusive US distributor of zidovudine for HEC’s US subsidiary, Sunshine Lake. The two companies plan to add products to the agreement as they are approved, and Lannett will use Sunshine Lake’s contract manufacturing and distribution services to lower costs and market its generic drugs in China. 

ChinaBio® News

The ChinaBio® Partnering Forum 2014, China’s largest life science partnering event, concluded last week in Suzhou, China with record attendance of 848 delegates from 425 companies, an increase of nearly 100 delegates over 2013 (see story). Delegates from 25 countries, representing senior leadership in multinational pharmaceutical and large biotech drug development companies, met with their China counterparts. Many companies attended specifically to initiate cross-border partnerships with China-based developers of novel technologies.

Trials and Approvals

Jiangsu Hengrui Medicine (SHA: 600276) received CFDA permission to begin China clinical trials of Huanmidegib, a hedgehog pathway inhibitor that is a biosimilar to Roche’s visomodegib (see story). Visomodegib was approved in the US in 2012 as a treatment for metastatic basal cell carcinoma. The CFDA regards Huanmidegib as a Class 1.1 drug – an innovative drug candidate that has never been approved anywhere in the world.

DelMar Pharma moved its lead brain cancer treatment into a new dosage level after the drug was well-tolerated at lower levels (see story). The drug, VAL-083, produced no significant adverse effects at 30mg/m2, so DelMar opened a new cohort, 40mg/ m2, for enrollment. DelMar discovered the drug by searching NIH records. When looking for suppliers, DelMar found that Guangxi Wuzhou Pharma already marketed the drug in China for leukemia and lung cancer. The two companies formed a partnership to develop the drug.

CRO/CMO News

WuXi PharmaTech (NYSE: WX) completed construction of a new biologics biosafety testing facility in Suzhou (see story). The 38,000 square foot facility will house labs and support areas in a building next to WuXi's Suzhou GLP preclinical drug safety facility. This is the third new building project that WuXi has announced in the last three weeks: last week, the company began construction of a $100 million R&D and small-molecule cGMP manufacturing site in Changzhou, and the previous week it broke ground on a new cell therapy manufacturing facility in Philadelphia.

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