Shanghai Henlius Biotech NDA for Denosumab Biosimilar Accepted by China NMPA
Shanghai Henlius Biotech Inc.'s New Drug Application for HLX14, a biosimilar of denosumab, has been accepted for review by China's National Medical Products Administration. HLX14 targets osteoporosis treatment in postmenopausal women and men at high risk of fractures. The NDA is supported by comprehensive studies comparing it to Prolia®. This announcement was made via the Hong Kong Stock Exchange's Issuer Information Service.
Shanghai Henlius Biotech Inc. announced that its New Drug Application (NDA) for HLX14, a biosimilar of denosumab (recombinant anti-RANKL human monoclonal antibody injection), has been accepted for review by the National Medical Products Administration (NMPA) of China. HLX14 is intended for all approved and marketed indications of the reference drug Prolia® in mainland China, including the treatment of osteoporosis in postmenopausal women and men at high risk of fractures, as well as glucocorticoid-induced osteoporosis. The NDA submission was supported by analytical, nonclinical, and clinical comparison studies with Prolia®. No grant or funding involvement from multiple organizations was mentioned. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251202-11939930), on December 02, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
