Henlius has recently received a clinical approval from the National Medical Products Administration (NMPA) for its HLX22, a monoclonal antibody injection, for the treatment of gastric cancer (GC) and breast cancer (BC).
HLX22 is a humanized lgG1 monoclonal antibody injection targeting human epidermal growth factor receptor 2 (HER2).Henlius introduced HLX22 from AbClon, Inc. (AbClon), researched and developed it independently as follows. As of now, Henlius has been granted exclusive rights to develop and commercialize HLX22 globally.
With the good performance in pre-clinical stage, HLX22 is expected not only to be used as mono-therapy in the treatment of GC and BC, but also in combination with HLX02 (a trastuzumab biosimilar developed by Henlius), making it a potentially first-in-class combination therapy in GC in the world. Looking forward, Henlius will continue to promote the implementation of the globalization strategy to achieve the vision of providing all patients with high-quality and affordable protein therapeutics.
About Henlius
Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in February 2010, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and auto-immune disease.
Until now, Henlius has completed IND/CTA filings of 13 products and 1 combination therapy with 22 indications and obtained 29 successful IND/CTA approvals (19 approvals from China; 3 from the United States; 3 from Taiwan; each 1 from the European Union, Ukraine, Philippines and Australia). Two products of Henlius have their New Drug Application under review and one of them, HLX01, is potentially the first biosimilar approved in China.