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Henlius Anti-HER2 Monoclonal Antibody HLX11 Received IND Application Acceptance Notification from NMPA


Shanghai, China, October 31, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that Henlius has received an investigational new drug (IND) application acceptance notification from the National Medical Products Administration (NMPA) for its HLX11, a recombinant anti- human epidermal growth factor receptor 2 (HER2) domain II humanized monoclonal antibody injection.

HLX11 is a proposed biosimilar of Pertuzumab (trade name: Perjeta®/帕捷特®) independently developed by Henlius. Pertuzumab was developed as the second-generation target therapy for the treatment of patients with HER2-positive breast cancer. It acts on HER2 extracellular domain II to inhibit dimerization and block downstream signalling pathways, further inhibit cell proliferation. It also enhances immune response by increasing cytotoxicity via antibody-dependent cell-mediated cytotoxicity (ADCC).

Pertuzumab has been granted approval by the NMPA for the treatment of: 1. metastatic breast cancer (in combination with trastuzumab and docetaxel, for patients with HER2-positive metastatic breast cancer without prior anti-HER2 or chemotherapy treatment); 2. early breast cancer (neoadjuvant treatment in combination with trastuzumab and chemotherapy for patients with HER2-positive, locally advanced, inflammatory, or early breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; adjuvant treatment for patients with HER2-positive early breast cancer with high risk of recurrence).Based on previously reported clinical studies, patients treated with Pertuzumab plus trastuzumab combined with chemotherapy showed prolonged progression-free survival, increased survival rate and improved response rate compared to patients under the treatment of trastuzumab combined with chemotherapy alone, which the regime of Pertuzumab plus trasutumab benefits patients significantly.

Henlius has established a diversified HER2-targeted product portfolio in which HLX02, a trastuzumab for injection developed by Henlius, and HLX22, a novel humanized lgG1 monoclonal antibody injection introduced from AbClon and researched and developed by Henlius further, both having potential indications of breast cancer and gastric cancer. In further, HLX11 in combination with HLX02 or HLX22 is expected be used as more effective therapy in the treatment of breast cancer and gastric cancer. Looking forward, Henlius will continue to promoting the implementation of the globalization strategy to achieve the vision of providing all patients with high-quality and affordable protein therapeutics.

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.

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