new drug of monoclonal antibody by fosun pharma approved for clinical trials-凯发k8娱乐app下载

new drug of monoclonal antibody by fosun pharma approved for clinical trials-凯发k8娱乐app下载

2016-05-30

new drug of monoclonal antibody by fosun pharma approved for clinical trials

[30 may hong kong] may 30, 2016, shanghai fosun pharmaceutical (group) co., ltd. (“fosun pharma”; stock code: 600196.sh, 02196.hk) announced that the recombinant anti-vegf humanized monoclonal antibody injection (hereinafter referred to as the " new drug") developed by shanghai henlius biotech co., ltd. (hereinafter referred to as "shanghai henlius"), a controlled subsidiary of fosun pharma, has been officially approved by cfda for the use of the new drug for clinical trials for the indications of non-small cell lung cancer.

  the new drug is a bio-similar of monoclonal antibody biologics independently developed by fosun pharma and its controlled subsidiary. as revealed in the announcement, the scale-up pilot production has been completed for the new drug , which remained highly similar to bevacizumab injection (trade name: avastin), the original drug, in dozens of studies including physicochemical properties of the antibody molecules, biological activities, in vitro and in vivo efficacy, pharmacokinetic and toxicology data.

   it is reported that currently the bevacizumab injection is the only vegf inhibitor available in china (hereinafter excluding hong kong, macao and taiwan). according to information of ims midastm (provided by ims health, a world-leading provider of business intelligence and strategic consulting services for the pharmaceutical and healthcare industry), in 2015, the sales of bevacizumab injection in the domestic market of china amounted to approximately rmb517 million. it is mentioned in the aforesaid announcement that fosun pharma has spent r&d expenses of approximately rmb24 million (note: the clinical trials for the new drug for the indications of metastatic colorectal cancer were approved by the cfda in december 2015) on the new drug (including indications of non-small cell lung cancer and metastatic colorectal cancer) for the time being.

   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, taiwan 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.  

 

about shanghai fosun pharmaceutical (group) co.,ltd.

   established in 1994, shanghai fosun pharmaceutical (group) co., ltd. (“fosun pharma”; stock code: 600196.sh, 02196.hk) is a leading healthcare group in the prc. fosun pharma strategically covers important segments of the healthcare industry value-chain, including research and development, pharmaceutical manufacturing, medical diagnosis, medical devices, pharmaceutical distribution and retail, and healthcare services, making contribution to improving public health. fosun pharma maintains a national recognized enterprise technology centre and a highly capable international r&d team, focusing on innovation and research of therapeutic areas including cardiovascular system, metabolism and digestive tract system, central nervous system, blood system, anti-tumor and anti-infection diseases. with its commitment to innovation for good health and creating a better future, fosun pharma will continue insisting on the strategic development approach of “organic growth with external expansion and integrated business operation”. the company strives to be one of the first-class enterprises in the global healthcare market.