fosun pharma biosimilar innovation breakthrough approval for clinical trials on bio-better of henlius biotech in mainland china, taiwan and san francisco
【october 14 2016, hong kong】on 14 october 2016, as disclosed in the latest a share announcement of shanghai fosun pharmaceutical (group) co., ltd. (“fosun pharma”, stock code: 600196.sh, 02196.hk), clinical trials on two injection-type drugs of henlius biotech, inc. (hereinafter referred to as “henlius biotech”), its controlling subsidiary, were approved by china food and drug administration (hereinafter referred to as the “cfda”), among which, the clinical trials on egfr monoclonal antibody injection (hereinafter referred to as the “hlx07”) were also approved by food and drug administration (abbreviated as the “usa fda”). in addition, dalian aleph biomedical company limited (hereinafter referred to as “dalian aleph”), another holding subsidiary of fosun pharma, has also received the drug registration approval from cfda for rabies vaccines (vero cells).
among the three injection-type drugs approved for clinical trials, the hlx07 of henlius biotech was approved for the clinical trials on various indications for solid cancers such as colorectal cancer. currently, registration applications of hlx07 of henlius biotech have been approved for clinical trials in mainland china, taiwan and usa. among which, the application progress in taiwan is the swiftest and the approval for clinical trials were obtained in june. this product is the first bio-better of henlius biotech, which is a breakthrough of henlius biotech from biosimilar drugs to the research and development of bio-better innovation with complete independent intellectual property rights and was complaint with internationalization strategy of product research and development through registration application in china, usa and taiwan.
recombinant anti-egfr murine/human chimeric monoclonal antibody injection, another approved new drug developed by henlius biotech, was approved to use in clinical trials indicated for head and neck squamous cell carcinoma. in august 2016, this new drug was approved by the cfda for clinical trials for metastatic colorectal cancer, and this approval was the second indication trial for the new drug.
in addition, a human rabies vaccine (vero cells) developed by dalian aleph, another holding subsidiary of fosun pharma, was also approved for clinical trials. the new drug is applicable for prevention of rabies and is able to stimulate the bodies to develop anti-rabies virus immunity after immunization.
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.