Deals and Financings

WuXi PharmaTech, China's largest CRO/CMO, is planning to conduct a Hong Kong IPO of its biologics subsidiary, according to a Bloomberg report (see story). Biologics is WuXi's fastest growing subsidiary, and the IPO will value the unit at $1.5 billion, said Bloomberg. The Hong Kong Stock Exchange requires a company to list at least 25% of a company's stock in an IPO. which implies WuXi will raise at least $367 million. The transaction is a very fast turnaround for WuXi, which completed a $3.3 billion privatization of the entire company in late November 2015. 

Impact Therapeutics, a Nanjing innovative drug developer, completed a $10 million Series B funding from China venture capitalists (see story). The company, which specializes in novel and best-in-class cancer drugs, has several anti-tumor drugs in pre-clinical and clinical stages. Impact filed a China class 1.1 IND application for one of its candidates in late 2015. The company said it would use the new capital for clinical trials and pre-clinical projects. 

Trials and Approvals

Canada's Aurinia Pharma (TSX: AUP; NSDQ: AUPH) reported Luveniq (voclosporin), a potential treatment for lupus nephritis, produced positive data in early results from a Phase IIb trial, currently underway in Malaysia (see story). 3SBio (HK: 1530) licensed China rights to the drug in 2010. Out of 7 patients with the disease, there were four with complete remission at week eight and a mean reduction in proteinuria (abnormal quantities of protein in urine) of 72%, also at week eight. Complete results of the trial are expected in Q3 of 2016. 

Bristol-Myers Squibb (NYSE: BMY) released results from a successful Phase III trial of its all-oral hepatitis C combination treatment in an Asian group of patients, who were predominantly Chinese (see story). Among the China patients, 91% achieved a sustained virologic response at post-treatment week 24 (SVR24). The BMS test, which enrolled patients with genotype 1b HVC, did not include either interferon or ribavirin as part of the regimen. 

Government and Regulatory

The CFDA has suspended its electronic drug monitoring system, which is designed to prevent counterfeit drugs from entering China's retail drug supply, while it makes changes to the system (see story). The system is owned by the CFDA, but it is administered by Alibaba Health (HK: 241) Information Technology. The Product Identification, Authentication and Tracking System (PIATS) is based on bar code technology. Almost all of Ali Health's revenue derives from PIATS.

Company News

JHL Biotech (TPEX: 6540), a Taiwan and China biotech, completed mechanical construction of its Wuhan biotech manufacturing facility, located in Biolake Park (see story). The building itself is a prefabricated building made by GE Healthcare (NYSE: GE), complete with equipment, which was assembled in eleven days. The past four months have been spent getting the plant running. JHL will use the Wuhan facility for cell line development, process development, and cGMP manufacturing of its late-stage clinical and commercial biosimilar products. The company will also offer contract manufacturing on a limited basis. 

Disclosure: none.