HLX14 Biosimilar Achieves Primary Endpoints in Phase 3 Study

Shanghai Henlius Biotech, Inc. and Organon have reported positive results from a phase 3 clinical trial for HLX14, a biosimilar to Prolia® and Xgeva® (denosumab). The trial aimed to evaluate the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to the European Union-sourced reference denosumab in postmenopausal women with osteoporosis at high risk for fractures. The study involved a randomized, double-blind, international multicenter approach and met its primary endpoints.

In 2022, Henlius and Organon entered into a licensing and supply agreement granting Organon exclusive commercialization rights for HLX14, along with another biosimilar candidate. The agreement covers major markets such as the United States, the European Union, and Canada, with the exception of China.

Henlius is a global biopharmaceutical company committed to providing high-quality, affordable, and innovative biologic medicines. They have a focus on oncology, autoimmune diseases, and ophthalmic diseases. The company has launched five products in China and has received marketing approvals for two products in overseas markets. Henlius has 19 indications approved worldwide and has seven marketing applications under review in China, the U.S., and the EU. Since its establishment in 2010, Henlius has developed an integrated biopharmaceutical platform with a strong emphasis on R&D, manufacturing, and commercialization.

Organon is a global healthcare company dedicated to improving women's health throughout their lives. They offer a diverse range of more than 60 medicines and products in women's health, along with a growing biosimilars business and established medicines across various therapeutic areas. Organon's strong cash flow supports investments in innovation and growth opportunities in women's health and biosimilars. The company also collaborates with biopharmaceutical innovators to commercialize their products in fast-growing international markets.

Organon has a significant global presence with a large workforce and headquarters in Jersey City, New Jersey. They are known for their commercial capabilities and geographic reach. The company's focus on women's health and biosimilars positions them to make a meaningful impact on patient care and contribute to the advancement of healthcare solutions.