Shanghai Henlius Biotech

Shanghai Henlius biotech, Inc., founded in 2010, is a global biopharmaceutical company focused on developing high-quality, affordable, and innovative biologic medicines for patients worldwide. The company specializes in oncology, autoimmune diseases, and ophthalmic conditions. Henlius has established a fully integrated platform with capabilities spanning the entire biologics value chain, including research and development, manufacturing, and commercialization. As of 2024, Henlius has launched five products in China, with three approved for marketing in overseas markets. The company has received approval for 23 indications worldwide and has three marketing applications under review in China and the EU, respectively.

Henlius has built a diverse product pipeline covering over 50 molecules, with a particular focus on immuno-oncology combination therapies. The company's flagship product, HANSIZHUANG (serplulimab injection), is an innovative anti-PD-1 monoclonal antibody approved for multiple indications, including MSI-H solid tumors, squamous non-small cell lung cancer, extensive-stage small cell lung cancer, and esophageal squamous cell carcinoma. Notably, HANSIZHUANG became the world's first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer. Other key products include HANLIKANG (rituximab), China's first approved biosimilar, and HANQUYOU (trastuzumab), a biosimilar approved in China, Europe, and the US. Henlius has established global innovation centers and Shanghai-based commercial manufacturing facilities certified by China, EU, and US GMP standards. The company's integrated platform enables high-titer cell line development, proprietary cell culture production, and continuous manufacturing processes.

Key customers and partnerships

Henlius has established partnerships with global pharmaceutical companies to expand its reach outside China. The company has collaborated with Accord healthcare, Biosidus S.A., Cipla, and The Jacobson Group to bring its therapeutics to patients across the Americas, Asia, and Europe. In September, Henlius entered into a collaboration agreement with PT Kalbe Genexine Biologics (KGBio), granting exclusive rights to develop and commercialize HLX10 in the Philippines, Indonesia, and eight other Southeast Asian countries. Within China, Henlius has adopted an independent commercialization strategy, leveraging support from its parent company, Fosun Pharma. The company has conducted over 30 clinical studies for 16 products globally, expanding its presence in major markets as well as emerging markets.