fosun pharma completed phase i clinic study of its new drug for breast cancer
【october 20 2016, hong kong】on 20 october 2016, as stated in the a share announcement of fosun pharma, phase i clinic study of recombinant humanized anti-her2 monoclonal antibody for injection (“new drug”) developed by shanghai henlius biotech co., ltd.* (“shanghai henlius”), the controlling subsidiary of the company, has been completed. the results of phase i clinic trial confirmed that: the new drug is safe and has same effectiveness of herceptin®. shanghai henlius indicated that phase iii clinic trial of the new drug would be officially started in the near future.
the new drug, a biosimilar drug of monoclonal antibody biological drug self-developed by fosun pharma’s controlling subsidiary shanghai henlius, is suitable for breast cancer and metastatic stomach cancer treatments.
the new drug was approved for clinic trial on indications for breast cancer and metastatic stomach cancer by china food and drug administration in july 2015 and january 2016, respectively. according to the results of phase i clinic trial of the new drug, shanghai henlius and experts from 45 renowned hospitals including the cancer institute and hospital, chinese academy of medical sciences and the 307th hospital of military chinese people’s liberation army have provided adequate evidence for phase iii clinic study on the application of the new drug on indication for breast cancer. currently, preparation work for phase iii clinic trial of the new drug including ethics and trial drugs is being conducted orderly.
breast cancer incidence rate is the highest among all cancers for chinese women. it is the sixth most common cause of cancer death. according to the information of chinese anti-cancer association, the incidence of breast cancer continually increases over recent years. nearly 0.2 million women are diagnosed with breast cancer every year.
to date, trastuzumab injection (herceptin®) is the main her2 inhibitor launched in china (excluding hong kong, macau and taiwan). according to the information of ims midas, in 2015, the sales of trastuzumab injection (herceptin®) in china amounted to approximately rmb0.89 billion. if the new drug passes phase iii clinic trial, the launch will be subject to the approval of national department for drug evaluation according to relevant regulatory requirements of drug research.
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 and its holding subsidiaries have 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 pharmaceutical manufacturing and r&d, healthcare services, medical diagnosis, medical devices manufacturing and agent, as well as pharmaceutical distribution and retail, making contribution to improving people’s 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, central nervous system, blood system, metabolism and alimentary system, anti-infection and anti-tumor. 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 , external expansion and integrated development”, striving to be one of the leading enterprises in the global healthcare market.