By Fineline Cube 
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) announced on July 28, 2025, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for its self-developed denosumab biosimilar candidate, HLX14. This positive opinion covers all approved indications of the reference product, PROLIA/XGEVA, in the European Union. This significant step brings HLX14 closer to being accessible in the European market.
Indications Covered
The CHMP’s positive opinion includes recommendations for the following patient populations:
- Postmenopausal women and men with osteoporosis at high risk of fractures.
- Men with prostate cancer undergoing hormone ablation therapy at high risk of fractures.
- Adult patients at high risk of fractures due to long-term systemic glucocorticoid therapy.
- Prevention of skeletal-related events in adult patients with advanced malignancies involving bone.
- Adults and adolescents with mature skeletons who have giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe functional impairment.
Clinical Basis and Quality Assurance
The CHMP’s recommendation is based on a comprehensive series of studies demonstrating the similarity of HLX14 to the reference product in terms of quality, safety, and efficacy. Henlius has also received GMP certification from the Federal Agency for Medicines and Health Products of Belgium, covering production lines that include HLX14.
Global Licensing and Regulatory Progress
Previously, Henlius entered into a licensing partnership with Organon, granting it exclusive commercialization rights for products including HLX14 in global markets outside China, including Europe and the U.S. Applications for HLX14 have already been accepted by regulatory agencies in Canada and the United States.-Fineline Info & Tech