new drug for cancer treatment by fosun pharma approved for clinical trials in taiwan-凯发k8娱乐app下载

new drug for cancer treatment by fosun pharma approved for clinical trials in taiwan-凯发k8娱乐app下载

2016-06-20

new drug for cancer treatment by fosun pharma approved for clinical trials in taiwan

     [20 june hong kong] on 17 june 2016, shanghai fosun pharmaceutical (group) co., ltd. (“fosun pharma”; stock code: 600196.sh, 02196.hk) announced that its holding subsidiary, henlius biotech co., ltd. (established in taiwan, hereinafter referred to as “henlius biotech”) has received a letter regarding the consent of clinical trials for hlx07 (anti-egfr humanized monoclonal antibody) injection 100mg/5ml (hereinafter referred to as the “new drug”) from the ministry of health and welfare of taiwan.

     the new drug, independently developed by fosun pharma group and with its fully independent intellectual property rights owned by the group, is a monoclonal antibody-based modified innovative biological medicine to treat several solid tumors such as colorectal cancer. the announcement stated that the pilot plant and the scaled-up production of the new drug have been completed, and dozens of studies on physical and chemical properties of antibody molecule, biological activities, efficacy inside and outside the body, pharmacokinetics and toxicology were also completed.

      it is reported that currently the imported cetuximab injection and the home-made nimotuzumab injection are the only inhibitors of egfr available in china (hereinafter excluding hong kong, macao and taiwan). according to the information of ims health, the sales of cetuximab injection and nimotuzumab injection in the domestic market of china amounted to approximately rmb 265 million and rmb 238 million respectively in 2015. the announcement also stated that henlius biotech had authorized its shareholder, shanghai henlius biotech co., ltd., to apply for the new drug’s clinical trial in mainland china. as of may 2016, fosun pharma group has spent r&d expenses of approximately rmb 37 million on the new drug.

     shanghai henlius biotech co., ltd. serves as the r&d platform of biosimilars of fosun pharma group. currently, it has completed the reconstruction of the industrial base of monoclonal antibody and took the first move to adopt advanced one-off production technology at the base, which will fully satisfy the demand from clinical trials and the market in the future.

relevant risks were also indicated in the announcement of fosun pharma. pursuant to the regulatory requirements for the research and development of relevant new drugs in taiwan, the sale of new drug is still subject to a series of clinical trials and the examination and approval from taiwan evaluation authorities.

     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.  

 

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.