ScinoPharm Taiwan, Nanjing King-friend Biochemical Pharmaceutical JV new drug in China

ScinoPharm, Nanjing King-friend Biochemical JV for new drug in China

5:39 AM, 11th November 2014
ScinoPharm Taiwan, Nanjing King-friend Biochemical Pharmaceutical JV for new drug in China

TAINAN, TAIWAN: ScinoPharm Taiwan, Ltd and Nanjing King-friend Biochemical Pharmaceutical Co Ltd (NKF) announced the joint research and development of a new drug, Regadenoson. Given each company’s strengths and expertise, both sides aim to exploit business opportunities in the Chinese market for new drugs.

ScinoPharm will be responsible for the development and manufacturing of the Active Pharmaceutical Ingredient (API) for Regadenoson. Both sides will jointly develop the injection technology and conduct clinical trials. NKF will take charge of the actual sterile injection production and drug certificate applications with the China Food and Drug Administration. The application for approval of human clinical trials in China is expected in late 2015 and the drug products are planned to be commercialized by 2020 there. Both parties will share the profits after launch. Regadenoson was approved for sale in the United States in 2008, but its drug license has not yet been applied in China. Hence, per the classification of chemical drug registration in China, Regadenoson requires human pharmacokinetic studies and at least 100 pairs of randomized and controlled clinical trials.

“ScinoPharm is pleased to become a strategic partner of NKF in order to advance the company’s original expertise in generic API’s further into the development of new drugs, thus enhancing the company’s market value and long-term competitiveness. This is ScinoPharm’s first new drug development project in Chinese market, thus furthering the implementation of the company’s strategy to become a fully integrated pharmaceutical company,” said Dr. Chen Yung Fa, CEO, ScinoPharm.

 

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