Shanghai, China, December 31, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) announced first patient dosed in a Phase 2 study（HLX10/HBV-01）of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection developed by Henlius, for the treatment of chronic hepatitis B, in Taiwan, China.
HLX10/HBV-01 is a Phase 2, multi-centre, open labelled, single-arm study planning to enroll approximately 44 patients infected with hepatitis B virus. Patients enrolled in the study will be treated with HLX10 via intravenous injection at a dose of 1mg/kg once every four weeks, with a maximum of three doses. The primary endpoint is the proportion of the subjects who achieve 0.5 log decline in hepatitis B surface antigen (HBsAg) level from baseline at 12th week after the last dose of HLX10. Secondary endpoints include the proportion of subjects who achieve HBsAg loss at 24th week after receiving the last dose and toxicity.
HLX10, an innovative mAb independently developed by Henlius, once approved can be widely used in the treatment of different advanced solid tumours and chronic hepatitis B infections. Currently, HLX10 received the approvals of clinical trials in the US, Taiwan China and Mainland China, with its Phase 2 clinical study being conducted as mono-therapy.
Henlius’ main focus in combination strategies consists of immune checkpoint inhibitor mAb HLX10 and other co-stimulatory therapies (i.e., radiation and/or chemotherapy) and targeted therapy (such as anti-VEGF, anti-VEGFR2 and anti-EGFR pathways), particularly for tumour types that have shown little responses to anti-PD-1/anti-PD-L1. First patients have been dosed in four Phase 3 clinical trials of HLX10 with chemotherapy for the treatment of locally advanced/metastatic esophageal squamous-cell carcinomas (ESCC), squamous non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (ES-SCLC) and neo-/adjuvant treatment for gastric cancer. Additionally, HLX10 can be combined with other mAb products. The first patient was recently dosed in a Phase 2 clinical trial evaluating HLX10 in combination with HLX04, a bevacizumab biosimilar, for the treatment of advanced hepatocellular carcinoma and a Phase 3 clinical trial evaluating HLX10-HLX04 combination therapy for the treatment of metastatic non-squamous NSCLC respectively. Henlius also received IND approvals to initiate clinical trials in China evaluating HLX10 in combination with HLX07, an anti-EGFR mAb for the treatment of head and neck squamous cell carcinoma (SCCHN).
About Chronic Hepatitis B
Hepatitis B virus (HBV) is a partially double-stranded DNA virus belonging to the family of hepadna viruses. More than 250 million HBV carriers live in the world and approximately 887,000 die annually of HBV-related diseases. Insufficient immune response to HBV antigen could be rescued by blocking the program cell death protein (PD-1), and help T cell to target the HBV virus.
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.HK.
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 7 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) and HLX07 (anti-EGFR mab). The global multi-center clinical trials are ongoing in various countries and regions worldwide.