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Deals and Financings

Simcere Pharma (NYSE: SCR) has signed a second drug development deal with Bristol-Myers Squibb (NYSE: BMY) (see story). Simcere will complete early development work on a potential cardiovascular drug at its own expense, and in return, Simcere will gain China rights to the molecule. BMS-795311 represents the second partnership for the two companies.

China Sky One Medical (NSDQ: CSKI), together with three partners, will invest $36.3 million to create a stem cell company, to be called Harbin Tian Xin Biological Engineering (see story). Besides providing umbilical cord cell banking, the new company will perform the clinical applications of bone marrow stem cells, intercord mesenchymal stem cells and other human stem cells.

ICON plc (NSDQ: ICLR), a global CRO based in Ireland, made good on a promise to increase its China presence by acquiring a China clinical-stage CRO, BeijingWits Medical Consulting (see story). Founded in 1997, BeijingWits offers Phase I-IV clinical trial services and claims expertise in China’s regulatory processes. ICON said the transaction would add 100 experienced personnel to its China staff. Terms were not disclosed.

Jilin Aodong Medicine (SHE: 000623) has put a hold on its $25 million investment in Vital Therapies, a US medical device maker, pending SFDA approval of Vital Therapies’ Extracorporeal Liver Assist Device (ELAD). In May, Jilin Aodong paid $2 million for a 5% stake in Vital Therapies. The deal included a provision for an additional $25 million investment after six months, contingent on SFDA approval of the ELAD, which hasn’t taken place.

Big Pharma in China

Boehringer Ingelheim announced a $91 million expansion of its Shanghai manufacturing facility, located in Zhangjiang High-Tech Park. The German company positioned the investment as a “for China” strategy. The latest boost to BI’s China facilities follows a $149 million investment two years ago at the same site, aimed at increasing the company’s offerings in vaccines and animal health.

In an interview with Reuters, Pfizer (NYSE: PFE) executives said the company has a two-fold R&D strategy: it will keep expanding its in-house China R&D team while also seeking to collaborate with external China pharmas. Pfizer already employs about 600 researchers at its three China R&D centers in Beijing, Shanghai and Wuhan.

Company News

Sihuan Pharmaceutical (HKEX: 0460) broke ground on a new $110 million campus that will house production, R&D and offices. The 175 acre site is located in the Zhangwan Development Area, Tongzhou District, Beijing. Founded in 2001, Sihuan claims to have the largest market share of cardio-cerebral drugs in China. After completing its IPO last year, the company has been very busy, completing several M&A deals and investing in new facilities.

CRO/CMO News

Quintiles, a global clinical-stage CRO based in North Carolina, will launch a new company, named Kun Tuo, to build its China presence. The new company, like its predecessor, Quintiles China, will offer clinical trial services. Although Quintiles employs 20,000 people worldwide, it currently has just 300 staff in its two China offices. Kun Tuo plans to double Quintiles’ China's staffing over the next year.

Government and Regulatory

China’s State Council has ordered measures that will more tightly regulate the production of TCM products. The goal is to increase the safety of TCM drugs and also improve their efficacy. The new rules will affect both how TCM raw materials are grown and how companies extract their active ingredients for botanical sources.

Disclosure: none.

Source: China Biotech Week In Review: Simcere, BMS Add Cardiovascular Drug To Partnership