(Yicai Global) Aug. 20 -- Jiangsu Hengrui Medicine, a well-known Chinese pharmaceutical product developer, has recently received a new drug certificate from China’s food and drug agency and approval for registration of its new medicine to treat breast cancer.
This is the first innovative compound for the treatment of solid tumors based on the results of phase II clinical studies that has won conditional approval for marketing in China.
The company's independently developed new medication has passed the priority review process of the regulator and has obtained conditional approval for marketing, the Jiangsu province-based innovative pharmaceutical developer said in a recent statement.
The product will bring new treatment options for patients with HER2-positive advanced breast cancer in China. The company has invested a total of about CNY556 million (USD81 million) into research and development of the treatment to date, per the statement.
The company has completed phase II clinical trials and is currently conducting a number of phase III clinical trials, it said.
Phase II clinical trials showed a significant prolongation of life, a 64 percent reduction in the risk of disease progression or death compared with the control group, and improved drug resistance with enhanced efficacy, the statement added.
Editor: Ben Armour