Shanghai, China, July 28, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for HLX14, the company’s independently developed investigational denosumab biosimilar referencing Prolia/Xgeva (denosumab). The positive opinion covers all approved indications of the reference products in the EU, including osteoporosis, prevention of skeletal-related events, and treatment of giant cell tumour of bone. This marks an important step towards patient access to HLX14 in Europe.

The CHMP recommends that HLX14 be approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture, prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said, "The positive CHMP recommendation on HLX14 demonstrates our high standards and continued breakthroughs in biosimilar development. We will continue to actively respond to global patients’ needs for high-quality and affordable biologics, and accelerate the advancement of more products into more markets to benefit a broader patient population."

The CHMP's positive opinion is mainly based on a series of head-to-head studies, including comparative quality analytical studies and clinical studies. These data prove that HLX14 is similar to the reference denosumab in terms of quality, safety and efficacy. This month, Henlius received a GMP certificate issued by the Federal Agency for Medicines and Health Products in Belgium, covering production lines for HLX14 and another product, indicating that the HLX14-related production lines meet the EU GMP standards.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. Prior to this positive opinion, marketing applications for HLX14 had already been accepted by Health Canada, the US FDA and other regulatory authorities.

Looking ahead, Henlius will continue to uphold high standards to advance its global footprint, work closely with partners to accelerate registrations and commercialisation, benefit more patients, and further strengthen the company's competitiveness and brand influence in the global biopharmaceutical industry.