Be the most trusted biotech company

First Patient Dosed in Phase 3 Clinical Trial of Anti-PD-1 mAb HLX10 in Combination with Bevacizumab Biosimilar HLX04 in Patients with Metastatic nsNSCLC


Shanghai, China, December 13, 2019 – the first patient was dosed in a three-arm, randomised, doubled-blind, multicentre phase 3 clinical trial 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  carboplatin plus pemetrexed with or without HLX04, a bevacizumab biosimilar, to chemotherapy-only in the first line treatment of metastatic non-squamous non-small cell lung cancer (nsNSCLC) patients.

As a widely used immune checkpoint inhibitor in cancer treatment, anti-PD-1 mAbs have been used for the treatment of various types 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 for the treatment of advanced solid tumours, making HLX10+HLX04 the first approved dual mAb combination immunotherapy trial in China.

Henlius differentiates itself with the “Global plus Combo” strategy in immno-oncology combination therapy utilising proprietary anti-PD-1/PD-L1 mAbs as the backbones in combination with other products globally. Looking forward, Henlius will continue capturing future immuno-oncology opportunities with the aim of providing affordable and effective therapies for patients worldwide, achieving its long-term vision of becoming the most trusted and admired biotech company.  

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 HLX04

HLX04, a bevacizumab biosimilar developed by Henlius independently, can be potentially used in the treatment of metastatic colorectal cancer (mCRC), non-squamous non-small cell lung cancer (nsNSCLC), wet age-related macular degeneration (wAMD), and diabetic retinopathy (DR). The phase 3 clinical trial has been initiated for the treatment of mCRC in China. Currently, Henlius adopts a differentiated strategy to develop HLX04 for the treatment of wAMD and DR with the approval of the NMPA while the reference bevacizumab has not been approved for these indications in China.

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. The global multi-center clinical trials are ongoing in various countries and regions worldwide.