Henlius Secures NMPA Acceptance for 120 mg Denosumab Biosimilar HLX14 NDA

Bulletin Express09-11

Shanghai Henlius Biotech, Inc. (Henlius) announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for the 120 mg (1.7 mL) per vial presentation of HLX14, the company’s recombinant anti-RANKL human monoclonal antibody injection and biosimilar to denosumab.

The filing seeks approval for two indications: 1) Prevention of skeletal-related events in patients with bone metastases from solid tumors or multiple myeloma. 2) Treatment of unresectable or function-impairing giant cell tumor of bone in adults and skeletally mature adolescents (body weight ≥ 45 kg).

Regulatory dossier: The submission is supported by analytical, non-clinical and clinical comparative studies demonstrating high similarity to the reference denosumab in quality, safety and efficacy.

Product background: HLX14 is Henlius’s independently developed denosumab biosimilar. Two associated products—marketed as BILDYOS and BILPREVDA in the United States, European Union and United Kingdom—received approvals in the second half of 2025, followed by Canadian approval (BILDYOS/TUZEMTY) in March 2026. A separate NDA for the 60 mg/1.0 mL strength was accepted by the NMPA in December 2025.

Market landscape: Global denosumab sales reached approximately USD 8.09 billion in 2025 (IQVIA MIDAS), underscoring the sizeable commercial opportunity for biosimilar entrants.

Regulatory acceptance of the 120 mg formulation positions Henlius to expand HLX14’s presence in China’s oncology and bone health markets, pending final approval.

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(Henlius) announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for the 120 mg (1.7 mL) per vial presentation of HLX14, the company’s recombinant anti-RANKL human monoclonal antibody injection and biosimilar to denosumab.</p>\n<p>The filing seeks approval for two indications:\n1) Prevention of skeletal-related events in patients with bone metastases from solid tumors or multiple myeloma.  \n2) Treatment of unresectable or function-impairing giant cell tumor of bone in adults and skeletally mature adolescents (body weight ≥ 45 kg).</p>\n<p>Regulatory dossier: The submission is supported by analytical, non-clinical and clinical comparative studies demonstrating high similarity to the reference denosumab in quality, safety and efficacy.</p>\n<p>Product background: HLX14 is Henlius’s independently developed denosumab biosimilar. 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