Tongjitang Chinese Medicines to Seek FDA Approval for Osteoporosis Treatment

Tongjitang Pharmaceutical Co. Ltd. (NYSE: TCM) Chairman and CEO Wang Xiaochun announced Oct. 24th that the company will seek FDA approval for its osteoporosis treatment Xianling Gubao.

As reported in the Shanghai First Finance and Economics Daily, he anticipates that the company plans to invest over US$10 million in the effort, which is expected to take three to five years. Tongjitang has engaged Synarc, a US based clinical testing provider, to test the clinical effectiveness Xianling Gubao.

The clinical studies, announced Oct. 2005 in Beijing, were reportedly designed to meet FDA requirements for clinical trials. The trials are being performed in Synarc's clinical research center in Beijing. Obtaining FDA approval is part of a long term strategy for the company. Such approval is expected to increase acceptance of the company's products by Western consumers.

A traditional Chinese medicine, Xianling Gubao has been approved by China's SFDA as treatment for osteoporosis, osteoarthritis, ischemic necrosis and bone fracture. Sales of Xianling Gubao were CNY374.6 (US$48 million) in 2006.

Disclosure: none