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Henlius Novel Anti-PD-1 Antibody HLX10 Received Clinical Trial Approval in Taiwan for the Treatment of Hepatitis B


Henlius has recently received a clinical approval from the Taiwan Food and Drug Administration (TFDA) for its HLX10, a recombinant humanized anti-programmed death-1 (PD-1) monoclonal antibody, for the treatment of chronic hepatitis B infection.

HLX10, an innovative monoclonal antibody independently developed by Henlius, can be used with other therapies as combination immunotherapy for the treatment of various tumors. As of today, HLX10 has been approved to initiate clinical trials in the United States, Taiwan China and mainland China. For the combination immunotherapy, the first patient was dosed in a phase 3 study of HLX10 in combination with chemotherapy as first-line treatment in subjects with local advanced or metastatic esophageal squamous cell carcinoma (ESCC). The clinical trial application of HLX10 in combination with HLX07, a fully humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody, has been submitted to the National Medical Product Administration (NMPA) for review. Its HLX10 in combination with HLX04, a bevacizumab biosimilar, has already been approved to initiate clinical trials by the NMPA in China. The HLX10+HLX04 study in patients with advanced solid tumors is the first combination immunotherapy clinical trial being approved to initiate in China.

Henlius actively diversifies its combination immunotherapies of its core HLX10 (anti-PD-1) and HLX20 (anti-programmed death ligand-1, anti-PD-L1) with other therapies. Currently, Henlius is actively exploring and developing, in collaboration with partners, opportunity of cancer immunotherapy to provide patients with efficacious and affordable therapeutic treatments.

About chronic hepatitis B

Hepatitis B virus (HBV) is a double-stranded DNA virus belonging to the family of hepadnaviruses. It is estimated that there are more than 250 million HBV carriers in the world, of whom approximately 600,000 die annually from HBV-related liver disease. Insufficient T cell response to HBV antigen is characteristic of chronic HBV infection. Blockade of program cell death protein (PD-1) can rescue HBV specific T cell response and could cure chronic HBV.

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.