TAINAN, November 10, 2014 /PRNewswire/ — ScinoPharm Taiwan, Ltd (TWSE: 1789) and Nanjing King-friend Biochemical Pharmaceutical Co., Ltd. (hereinafter refer to as NKF) announced today 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 ScinoPharm CEO Dr. Chen Yung Fa. In 2013, Regadenoson’s global sales amounted to about USD530 million. Sales in China are expected to reach RMB200 to RMB300 million (USD 35 to 50 million) after the product becomes commercially available in the market.
The CEO of NKF Eric Tang stated: “This collaboration is a win-win strategy devised through the complementary advantages of both sides in terms of product portfolio and technologies. NKF is able to leverage its expertise in product development, combined with ScinoPharm high-end API technical capabilities, will achieve large scale of synergies.”
Nanjing King-friend Biochemical Pharmaceutical Co., Ltd. is located in Gaoxin Development Area, Pukou District, Nanjing City. The factory has received certifications from many countries, including China, the United States, the European Union (EU), 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.
Regadenoson is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. As Regadenoson dosing is not dependent on patient weight or renal impairment and can be administered by rapid injection, it has the potential to simplify the administration procedure, reduce costs, and streamline the working day for the staff of the nuclear medicine department.
ScinoPharm Taiwan, Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With research and manufacturing facilities in both Taiwan and China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry. The Company also provides a vertically integrated, one-stop-shopping service for drug product customers by expanding into the field of oncological injectable formulations. For more information, please visit the Company’s website at http://www.scinopharm.com.