ScinoPharm Taiwan, Ltd, a contract provider of process R&D and active pharmaceutical ingredient (API) manufacturing services,  and Nanjing King-friend Biochemical Pharmaceutical Co., Ltd. (NKF)  will cooperate in the joint research and development of a new drug, Regadenoson, for commercialization in China. Regadenoson is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress.

ScinoPharm will be responsible for the development and manufacturing of the 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. Therefore, 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.

This is ScinoPharm's first new drug development project in Chinese market, In 2013, Regadenoson's global sales amounted to approximately $530 million. Sales in China are expected to reach RMB 200 million to RMB 300 million ($35 million to 50 million) after the product becomes commercially available in the market, according to ScinoPharm.

NKF is located in the Gaoxin Development Area, Pukou District, Nanjing City. Its factory has received certifications from many countries, including China, the United States, the European Union, Japan, and Germany. The company has also engaged in long-term cooperation with several of the top 500 global pharmaceutical companies, involving the production of heparin sodium and a low molecular weight heparin product. In particular, NKF's heparin sodium production accounts for over 10% of global demand, according to the company.

Source: ScinoPharm