Shanghai, China, January 21, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that Henlius has received clinical approval 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 (originator trade name: Perjeta®) independently developed by Henlius. Its potential indications include: 1. early breast cancer (neoadjuvant therapy 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 therapy for patients with HER2-positive early breast cancer with high risk of recurrence) and 2. metastatic breast cancer (in combination with trastuzumab and docetaxel, for the treatment of patients with HER2-positive, metastatic, or unresectable locally recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy) . Based on numerous clinical study data to date, patients treated with pertuzumab + trastuzumab + chemotherapy can receive significant benefits from the treatment with prolonged progression-free survival, enhanced survival rate, and improved response rate, compared with those only treated with trastuzumab + chemotherapy.
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 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.