New Drugs Independently Developed by Fosun Pharma Approved for Clinical Trials
【6 July 2016, Hong Kong】On 6 July 2016, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as “Fosun Pharma”; Stock Code: 600196.SH, 02196.HK) announced that its holding subsidiaries, Shanghai SunTech Pharmaceutical Co., Ltd. (hereinafter referred to as “SunTech Pharma”) and Guilin Pharmaceutical Co., Ltd. (hereinafter referred to as “Guilin Pharma”) recently received approval from China Food and Drug Administration (hereinafter referred to as “CFDA”) regarding the clinical trials on enzalutamide capsules and enzalutamide APIs (hereinafter collectively referred to as the “New Drugs”).
The New Drugs, independently developed by Fosun Pharma and its holding subsidiaries, are original class 3.1 chemical drugs to treat castration-resistant prostate cancer (CPRC). The announcement stated that there’s no enzalutamide capsule sold in the market of China (hereinafter excluding Hong Kong, Macau and Taiwan, the same below) yet at present. According to the information of IMS MIDAS (a world-leading provider of business intelligence and strategic consulting services for the pharmaceutical and healthcare industry), the sales of enzalutamide capsules in the global markets amounted to approximately US$1,605 million in 2015. Fosun Pharma said that it has spent R&D expenses of approximately RMB 8.1 million on the New Drugs at the current stage.
Relevant risks were also indicated in the announcement of Fosun Pharma. As provided under the regulations with respect to the research and development of new drugs in China, the launch of the New Drugs is subject to a series of clinical research and the approval from the national authority for drug evaluation.
Fosun Pharma always regards independent innovation as essential to its corporate development and continuously optimizes its pharmaceutical R&D system that integrates imitation and manufacture. In recent years, Fosun Pharma has been increasing investment in R&D and gained competitive edge in internationalized R&D capability. Up to now, the company has a staff of nearly 900 in its R&D team, spreading over Shanghai, Chongqing, Taipei and San Francisco, forming a systematic research system by interacting and integrating with each other. The company continues to raise investment in its four major platforms, aiming to establish highly-effective R&D platforms covering small-molecular drugs, large-molecule bio-similars, high-value generic drugs and specialized pharmaceutical technology.