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Henlius Innovative Anti-c-MET Monoclonal Antibody HLX55 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 HLX55, an innovative monoclonal antibody(mAb) for injection, for the treatment of metastatic or recurrent solid tumors.

HLX55 is a novel humanized monoclonal antibody targeting c-MET. Henlius introduced HLX55 from Kolltan Pharmaceuticals, Inc., and subsequently researched and developeded independently. The pre-clinical studies demonstrate that HLX55 targeting the HGF/c-MET (hepatocyte growth factor/c-MET) signaling pathway has potent anti-tumor effect and safety both in vivo and in vitro, providing a scientific basis for the follow-up human clinical trials. According to the reports, there is no drugs with the same target in the global market. HLX55 is expected to provide more treatment options and benefit more tumor patients after it is launched.

Henlius actively implements the product development strategy and covers several advanced mAb biosimilar candidates with near-term commercial visibility. Leveraging the development experience of biosimilar, Henlius is developing comprehensive bio-innovative pipeline and driving worldwide clinical studies of novel products .In addition, Henlius actively diversifies versatile in-house combination therapy portfolio with a focus on anti-PD-1/PD-L1 mAb to capture future immuno-oncology opportunities with the aim of providing affordable and effective therapies.

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.