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The Anti-PD-1 mAb Combined with Anti-EGFR mAb Therapy of Henlius Received Approvals to Conduct Clinical Trials by NMPA


Shanghai, China, December 9, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the company has received approvals from the National Medical Products Administration (NMPA) for its investigational new drug (IND) applications for the combination therapy of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, and HLX07, a recombinant anti-epidermal growth factor receptor (EGFR) humanised mAb injection, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma.

It is worth mentioning that Henlius has received the IND approvals of HLX10 in combination with HLX04, a bevacizumab biosimilar developed by Henlius independently, for the treatment of advanced solid tumors in September 2018. This is the first domestic dual mAbs combination therapy that has received IND approval in China. As the second domestic dual mAbs combination therapy of Henlius, HLX10 in combination with HLX07 further implements the combination immunotherapy strategy of Henlius and leads the development of mAbs combination therapies in China.

Development of combination therapies with anti-PD-1 mAbs has become a main trend globally to improve the efficacy of anti-PD-1 mono-therapies. Relying on its formidable talent reserve and integrated R&D platform, Henlius implements the differentiation strategy of “Combo plus Global” with its proprietary HLX10 and HLX20 (anti-PD-L1 mAbs) as backbones in combination with other therapies to conduct global multi-center clinical trials. Looking forward, the company will continue implementing the product development strategy and capturing future immunotherapy opportunities to provide more affordable and better therapeutic options for all patients.

About HLX10 and Combination Therapy

HLX10, an innovative mAb developed by Henlius independently, can be widely used in the treatment of solid tumors and also further developed for the treatment of chronic hepatitis b infection. Currently, HLX10 has received clinical trial approvals in the US, Taiwan China and Mainland China successively, with its phase 2 clinical study being conducted as mono-therapy. HLX10 in combination with other therapies can bewidely applied to immuno-oncology combination therapies for various solid tumors. Recently, first patient was dosed in a phase 2 clinical trial of HLX10 plus HLX04 for the treatment of advanced hepatocellular carcinoma. The IND application of HLX10 in combination with HLX04 and the IND application of HLX10 in combination with HLX07 have both received approval by the NMPA. First patient has been dosed in phase 3 clinical trials of HLX10 in combination with chemotherapy for the treatment of locally advanced/metastatic esophageal squamous-cell carcinomas (ESCC), squamousnon-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC).

About HLX07

HLX07, which targets the EGFR, is a biobetter of cetuximab developed by Henlius with independent intellectual property rights. HLX07 is bioengineered with the potential for the treatment of various solid tumors, such as colorectal cancer and head and neck cancer. HLX07 has been approved for clinical trials in Mainland China, Taiwan China and the United States, with Phase 1a study currently being conducted in Taiwan. In August 2018, Henlius has initiated HLX07 phase 1b/2 clinical trials 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.