Sinobiomed Nears Launch of Ulceration Drug

Sinobiomed (SOBM.OB) has begun producing recombinant acidic Fibroblast Growth Factor (aFGF), a treatment for ulceration. The production will take place at its 82%-owned subsidiary in China, Shanghai Wanxing Bio-pharmaceuticals Co., Ltd.

Shanghai Wanxing’s production facility for aFGF recently received its GMP (Good Manufacturing Practice) Certification by the Chinese SFDA.

The SFDA approved aFGF to treat ulceration including deep burns (more than 2nd degree burns) and chronic ulcers caused by burn wounds, diabetes, vascular diseases and bed sores. Shanghai Wanxing intends to launch aFGF in August 2007 with a production volume of approximately 20 million boxes per year. It will retail for $15.50 per box. Shanghai Wanxing is negotiating with 200 distributors to distribute the product.

In September 2004, Shanghai Wanxing received a patent for aFGF that runs for 20 years. However, following usual Chinese practice, the company is protected from competition on the drug for just 7 years.

Sinobiomed also recently reported that its recombinant batroxobin (rBAT) completed the first of two parts of a Phase II trial, involving 120 patients. Natural batroxobin, which is produced from viper venom, is the world's most prescribed anti-bleeding agent, but Sinobiomed maintains that natural sources do not provide an adequate supply of the drug and that impurities can sometimes cause neurotropic side effects.

Sinobiomed has designed a larger test, as part of the Phase II trial, which will enroll 400 patients, testing the drug against natural batroxobin in patients undergoing gynecological surgery, those with menorrhagia, excessive or prolonged menstrual bleeding, and those with gastrointestinal bleeding not associated with surgery.

Sinobiomed develops genetically engineered recombinant protein drugs and vaccines. It has two products on the market, another approved and awaiting a GMP certificate prior to market introduction. It also has four products in clinical trials and three in research and development. These drugs address malaria, hepatitis, surgical bleeding, cancer, rheumatoid arthritis, diabetic ulcers and burns, and blood cell regeneration.

Disclosure: none.