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Shanghai Henlius Biotech and women’s health pharma company Organon have announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational biosimilar for Prolia and Xgeva (denosumab). This biosimilar aims to provide an alternative treatment for osteoporosis in postmenopausal women at high risk for fractures and for preventing skeletal-related events in patients with bone metastases.

In 2019, an estimated 32 million Europeans aged 50 and above had osteoporosis, with 25.5 million of these being women. This significant health concern underlines the need for effective and accessible treatments.

The MAAs for HLX14 were supported by a phase 3 clinical study, which was randomized, double-blind, and international in scope. This study compared the efficacy, safety, tolerability, and immunogenicity of HLX14 with the EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fracture.

Henlius entered into a license and supply agreement with Organon in 2022, granting Organon exclusive commercialization rights to HLX14 and another biosimilar candidate. This agreement covers key markets including the European Union, the United States, and Canada, with the exception of China.

Henlius is a global biopharmaceutical company focused on providing biologic medicines. With a product portfolio that includes treatments for oncology, autoimmune diseases, and ophthalmic diseases, Henlius has launched five products in China and has two approved for marketing in overseas markets to date. The company has built a robust biopharmaceutical platform encompassing R&D, manufacturing, and commercialization, and it operates manufacturing facilities certified by GMP standards in China, the EU, and the U.S. Henlius continues to expand its product pipeline, exploring immuno-oncology combination therapies, and conducting over 30 clinical studies for 16 products globally.

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