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Henlius Innovative Anti-cMET Monoclonal Antibody HLX55 Received Clinical Approval from NMPA


Shanghai, China, October 17, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that Henlius has received an clinical approval 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 licensed in HLX55 from Kolltan Pharmaceuticals, Inc., and subsequently researched and developed it 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. Earlier, Henlius has received a clinical approval in Taiwan China for HLX55 to treat patients with advanced solid tumors not eligible for other standard treatment in September, 2019. According to the reports, there is no drugs similar to HLX55 in the global market. HLX55 is expected to provide more treatment options and benefit more tumor patients after its launch.

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(2696.HK) is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization. On September 25, 2019, Henlius was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 2696.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar). The global multi-center clinical trials are ongoing in various countries and regions worldwide.