China Biotech Week In Review: SFDA Releases 2010 Approval Data

Includes: SCR
by: ChinaBio Today

The SFDA has released a concise summary of its registration approvals last year, showing, to nobody's surprise, that China's pharmaceutical scene is active -- the number of approvals numbered exactly 1,000. To make the data more useful, our report details various metrics, presenting, for example, the totals by type of drug (chemical, TCM, biologic), the number of clinical trials approved, and the number of registration applications that were submitted. The data shows the SFDA had a very busy year.

Deals and Financings

Zhuhai Hokai Medical Instruments [SHE: 300273], a medical device maker, completed an IPO on the ChiNext Exchange, offering 33.35 million shares at 20 RMB each. The shares, which have begun trading, were priced at a PE ratio of 62 times earnings. The company provides minimally invasive cancer treatment technology and equipment.

Simcere Pharma (NYSE: SCR) signed a strategic cooperation agreement with Suzhou NeuPharma to develop and produce novel drugs (see story). The first candidate is a cancer drug. Simcere will contribute its production and marketing expertise, while NeuPharma will be responsible for developing drug candidates. Simcere is a China biopharma that is expanding from its base of branded generic drugs by entering numerous innovative research collaborations.

Amerigen Pharma signed a collaboration agreement with Stason Pharma to develop generic oral oncology drugs. Both companies are located in the US. Amerigen also has a China subsidiary, located in Suzhou, and according to Amerigen’s business plan, the company develops drugs for both markets.

Multinational Pharma in China

Lundbeck A/S [CPH: LUN], a Danish biopharma that specializes in CNS drugs, has established a research center in Shanghai. The center will do some of Lundbeck’s own work – work that is currently being performed by China CROs – and the center will also serve as a means of building Lundbeck’s relationships with innovative academic and pharma company researchers in China. The company intends to keep its focus on unmet CNS needs.


Medicilon, a Shanghai CRO, has agreed to complete the pre-clinical development of a new anti-depressant developed by SK Biopharmaceuticals of South Korea. Medicilon will prepare the work for both China and US approval of the small molecule, known as SKL-PSY, which is being developed as a treatment of depression and bipolar disorder.

Company News

Samantha Du, PhD, has quietly stepped back from her duties as CEO of Hutchison MediPharma and Chief Scientific Officer of its parent, Hutchison Chi-Med [AIM: CHM]. She apparently will remain involved with Hutchison as she has some time to evaluate her next career move. Dr. Du is a true pioneer in China pharma, having convinced Hutchison Whampoa to launch a drug development company in the early 2000s when most believed there was no novel drug development in China. She proved everyone wrong, bringing several novel entities to the clinic.

Shenzhen Hepalink Pharma [SHE: 002399], a maker of heparin products, reported its Q3 profits fell 58% to 148 million RMB ($23 million) (see story). Hepalink blamed the shortfall on a drop in the price of heparin API. In the past, Hepalink was the only China heparin API company whose products were certified by the FDA. It lost that advantage when a competitor was also granted FDA certification.

Disclosure: none.