New anticancer drugs of Fosun Pharmaceutical holding subsidiary obtained clinical approval again

Fosun Pharmaceutical announced today that the recombinant anti HER2 humanized monoclonal antibody for injection developed by its holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd (acceptance No.: cxsl1400065 Shanghai, referred to as "the new drug") has been approved by the clinical trial of the State Food and Drug Administration for the indication of metastatic gastric cancer According to the announcement, on July 8, 2015, the indication of the new drug for breast cancer treatment was approved by the clinical trial of the State Food and drug administration On May 27, 2014, Fuhong Hanlin submitted a clinical trial application to the State Food and Drug Administration for the indication of the new drug for metastatic gastric cancer and was accepted According to reports, the new drug is a bio similar drug of monoclonal antibody bio drug independently developed by Fosun Pharmaceutical and its holding subsidiary As of the announcement date, the pilot production process of the new drug has been enlarged In the pharmaceutical quality research results, including the physical and chemical characteristics of antibody molecules, biological activity, in vitro and in vivo efficacy, pharmacokinetic and toxicological data, the new drug has achieved a highly similar effect with the original drug trastuzumab injection It is reported that in 2014, the sales volume of trastuzumab injection in China was about 950 million yuan From January to November 2015, the sales volume has reached 980 million yuan, with great market potential However, Fosun Pharmaceutical also reminded investors in the announcement that although the clinical research of the new drug is expected to be good, there are certain risks in the research and development process according to the experience of new drug research and development at home and abroad For example, the phase I, II and III clinical trials may be terminated due to safety and effectiveness issues In addition, according to the regulatory requirements of new drug research and development in China, the new drug still needs to carry out a series of clinical studies and be approved by the national drug review department before it can be put on the market.