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Henlius Innovative Anti-HER2 Monoclonal Antibody HLX22 Have Dosed First Patient for Its Phase 1 Study


Recently, the first patient was dosed in a phase 1 study of HLX22, an innovative humanized lgG1 monoclonal antibody injection targeting human epidermal growth factor receptor-2 (HER2). The study is conducted to evaluate safety, tolerability and pharmacokinetics of HLX22 in patients with advanced solid tumors with over-expressed 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

Henlius is a leading biopharmaceutical company in China that offers high-quality, affordable and innovative drugs to patients worldwide. Founded in 2010 and headquartered in Shanghai with two R&D centers in Taipei and California, Henlius has established and continues to expand its comprehensive product pipeline of biosimilars and bio-innovative drugs to treat tumors and autoimmune diseases.

Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 13 products and 6 combination therapies worldwide. HLX01 (rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. Moreover, HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their New Drug Applications under primary review by the NMPA. HLX02 is the first biosimilar developed in China to enter a global multi-center phase 3 clinical trial in China, Poland, Ukraine and the Philippines. In June 2019, the Marketing Authorization Application for HLX02 was accepted to review by EMA.