(Yicai Global) May 18 -- A traditional Chinese medicine developed for cancers by Livzon Pharmaceutical Group Inc. has received the green light for clinical studies in the US.
Shenqi Fuzheng Injection won approval from the US Food and Drug Administration on May 16, the Zhuhai, South China-based company said yesterday. SFI's sales reached CNY1.6 billion (USD251 million) last year, or about 14 percent of the market for anticancer TCM injections in domestic hospitals, it said.
China's food and drug regulator approved SFI in November 1999 as an auxiliary treatment for lung and stomach cancers, the statement added. The preparation is listed in the national medical insurance catalog. But the divergent theoretical underpinnings of TCM make entry into Western markets very difficult for such medicines.
The company spent CNY5.7 million on researching and developing the preparation to make the running to apply for FDA clinical trials, it said. The preparation may not hit the market until a series of studies are conducted and FDA approval is forthcoming, according to relevant US regulations, the company added.
Editor: Ben Armour