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First Patient Dosed in Phase 3 Study of Anti-PD-1 mAb in Combination with Chemotherapy in Neo-/Adjuvant Treatment for Patients with Gastric Cancer


Shanghai, China, December 13, 2019 – the first patient was dosed in a randomised, doubled-blind, multi-centre phase 3 clinical study conducted by Shanghai Henlius Biotech, Inc., aiming to compare efficacy, safety and tolerability of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, in combination with chemotherapy to chemotherapy-only in neo-/adjuvant treatment of gastric cancer patients.

As a widely used immune checkpoint inhibitor in cancer treatment, anti-PD-1 mAbs have been treated for various type of malignancies. In order to improve the efficacy of anti-PD-1 monotherapy, combination of other treatments for synergistic effects based on the results of primary anti-PD-1 studies has become a global trend. Relying on its integrated global R&D platform, Henlius has developed several fully-owned combination immunotherapies. As of today, Henlius has initiated different trials evaluating HLX10 in combination with HLX04, a bevacizumab biosimilar, for the treatment of advanced solid tumours, resulting in the first approved combination immunotherapy trial of anti-PD-1 with anti-VEGF in China.

Henlius differentiates itself with the“Combo plus Global” strategy in immno-oncology combination therapy utilising proprietary anti-PD-1/L1 mAbs as the backbones in combination with other products globally. Henlius has recently granted KG Bio an exclusive license to develop and commercialize HLX10 in relation to certain treatments and indications in 10 Southeast Asian countries. Looking forward, the company will continue implementing the product development strategy and capturing immunotherapy opportunities to provide affordable and effective therapies for patients worldwide.

About HLX10 and Combination Therapy

HLX10, an innovative mAb independently developed by Henlius, can be potentially widely used in the treatment of different advanced solid tumours and chronic hepatitis b infections. Currently, HLX10 received the approval 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. Henlius investigated the efficacy of HLX10 in combination with different effective chemotherapy regimens. First patients in the 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 (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC) all have been dosed. Additionally, HLX10 can be combined with other mAb products. The first patient with advanced hepatocellular carcinoma was recently dosed in a phase 2 clinical trial evaluating HLX10 in combination with HLX04. Henlius also received IND approval to initiate clinical trials in China evaluating HLX10 in combination with HLX07 (an anti-EGFR antibody) for the treatment of head and neck squamous cell carcinoma.

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.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 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) and HLX07 (anti-EGFR mab). The global multi-center clinical trials are ongoing in various countries and regions worldwide.