This announcement is made by Shanghai Henlius Biotech, Inc. on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business development of the Company. The board of directors of the Company announced that, recently, two marketing authorization applications (MAAs) for the Prolia and Xgeva biosimilar, HLX14 (recombinant anti-RANKL human monoclonal antibody injection) ("HLX14") independently developed by the Company have been validated by the European Medicines Agency (EMA). The indications of the two marketing authorization applications (MAAs) are identical to thoseof Prolia® and Xgeva® (denosumab) approved for market by the European Union, including: (1) treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, (2) treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, (3) treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture, (4) prevention of skeletal related events in adults with advanced malignancies involving bone, and (5) 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.

HLX14, which was independently developed by the Company, is a proposed biosimilar to Prolia ® and Xgeva ® (denosumab). It is intended for the treatment of osteoporosis in postmenopausal women at high risk for fracture and/or for other indications consistent with the label of the reference biologic. Currently, denosumab, the reference biologic of HLX14, has been approved in different countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others.

In June 2022, the Company entered into an agreement with Organon LLC (a wholly-owned subsidiary of Organon & Co.), pursuant to which the Company granted an exclusive license to Organon and its affiliates to commercialise HLX14 globally except for mainland China, Hong Kong, Macau and Taiwan regions. In January 2024, the phase 1 clinical study of HLX14 in Chinese healthy adult male subjects was successfully completed. In April 2024, the international multi-centre phase 3 clinical study of HLX14 for the treatment of osteoporosis in postmenopausal women at high risk for fracture met the primary study endpoints.

The submission is based on data generated with HLX14 versus reference denosumab (Prolia ®), including analytical similarity and clinical comparative studies. CHMP Guideline on similar biological medicinal products (CHMP/437/04 Rev1) allows for extrapolation of clinical safety and efficacy data to other approved indications of a reference drug.