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Henlius HLX22 Received IND Application Acceptance Notification from NMPA


Henlius has recently received an investigational new drug (IND) application acceptance notification 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) and researched and developed it independently as follows. Since 2016, Henlius successively signed license agreement and amendment agreement with AbClon, being 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 December 2009, 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, biobetter and bio-novel monoclonal antibody, to treat tumor and autoimmune diseases. 

As of today, Henlius has completed IND/CTA filings of 13 products and 1 combination immuno-oncology therapy with 22 indications and obtained 27 successful IND/CTA fillings (17 approvals from mainland China; 3 from Taiwan; 3 from United States, and 1 each from the European Union, Ukraine, the Philippines and Australia). 

Henlius has submitted its first New Drug Application (NDA) of its HLX01 (MabThera®/Rituxan®biosimilar), rituximab developed by Henlius, to National Medical Products Administration (formerly CFDA), which soon assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China.