Deals and Financings

MicroPort Scientific (HK: 00853) of Shanghai and Italy’s Sorin Group (MIL: SRN) reported that their $20 million China medical device JV received official regulatory approval (see story). The JV, which was announced in January, will develop its own cardiac rhythm devices and also import Sorin’s CRM devices for China. MicroPort will invest $10.2 million in the JV for a 51% stake; Sorin will contribute the remainder. Operations are scheduled to begin next month. 

Lee's Pharm (HK: 950) of Hong Kong in-licensed China distribution rights for Attila®, an orphan drug made by Abiogen, a privately held Italian pharma (see story). Attila is indicated for Osteogenesis Imperfecta (OI), also known as brittle bone disease, and Complex Regional Pain Syndrome (CRPS), a neurologic disorder. Lee’s will be responsible for obtaining CFDA approval of the drug.

Company News

InSightec Ltd., an Israeli medical device maker, opened three Shanghai centers that offer its ExAblate therapy as a non-invasive treatment for uterine fibroids (see story). ExAblate is a MR guided Focused Ultrasound machine that destroys the fibroids without surgery. InSightec is majority owned by GE Healthcare (NYSE: GE). The three centers are located in Shanghai First People's Hospital, Huashan Hospital and Fudan Cancer Center. The CFDA approved ExAblate last year. 

CRO/CMO News

WuXi PharmaTech (NYSE: WX) has begun high-potency active pharmaceutical ingredient (HPAPI) operations through its manufacturing subsidiary, Syn-The-All Pharma (see story). The Shanghai lab will support process development and clinical-trial supply of high-potency small molecules at kilogram scale. With every week, WuXi seems to be announcing a new construction project or adding a CRO service. The company said it would spend $85 million on capital expenditures in 2014. 

News from the ChinaBio® Partnering Forum

Navigating the obstacle course of China's regulatory system requires strategic thinking, long-term planning and creative problem solving – and deep pockets don’t hurt, according to the experts discussing cross-border approvals at the ChinaBio Partnering Forum held in Suzhou earlier this month (see story). BioWorld, the ThomsonReuters newsletter, summarized the panel discussion that analyzed the current state of China’s approval process.

Also at the ChinaBio® Partnering Forum, participants offered compelling evidence that Chinese biotechs are transforming cutting-edge discoveries into drug pipelines, creating partnering opportunities (see story). BioWorld described the overall landscape with particular focus on the innovative drug development underway at four China biopharmas: Ruiyi, Shenogen, Suzhou Alphamab and Mabspace.

Disclosure: none.