Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 approved for marketing in overseas markets, 13 indications approved worldwide, and 5 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practices (GMPs), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (serplulimab，anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDAs for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) , and esophageal squamous cell carcinoma (ESCC) are under review. What's more, Henlius has conducted over 20 clinical studies for 13 products and 11 combination therapies worldwide, expanding its presence in major markets as well as emerging markets.
In addition to 5 products and 13 indications launched commercially and 5 NDAs accepted for review, Henlius has conducted over 20 clinical studies for 13 products and 11 immuno-oncology combination therapies worldwide. HANLIKANG (rituximab injection), the first product of Henlius, has been approved by the National Medical Products Administration (NMPA) as China's first biosimilar. The second product HANQUYOU (trastuzumab, Zercepac® in the EU，Trade names in Australia: Tuzucip® and Trastucip®) is the first Chinese mAb biosimilar approved both in the EU and China, bringing more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In March 2022, the company’s first self-developed innovative monoclonal antibody, HANSIZHUANG (serplulimab injection), was approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors. Meanwhile, its NDAs for the treatment of squamous non-small cell lung cancer, extensive-stage small cell lung cancer (ES-SCLC) , and esophageal squamous cell carcinoma (ESCC) are under review.
NDAs accepted for review
Candidates/Combo Therapies under Clinical Studies