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Henlius Biosimilar Innovation Breakthrough


On 14 October 2016, as disclosed in the latest A share announcement of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., 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”).

Between the two 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 China and USA. Among which, the application progress in Taiwan China 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 China.

Recombinant anti-EGFR murine/human chimeric monoclonal antibody injection, the other 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.