By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the National Medical Products Administration’s Center for Drug Evaluation (CDE) has accepted the New Drug Application (NDA) for its self-developed denosumab biosimilar, HLX14 (Recombinant Anti-RANKL Fully Human Monoclonal Antibody Injection), in the 60 mg/mL specification.
Regulatory Milestone & Indication Scope
| Attribute | Details |
|---|---|
| Product | HLX14 (denosumab biosimilar) |
| Regulatory Status | NDA accepted by China CDE |
| Specification | 60 mg/mL |
| Indications | Postmenopausal women at high fracture risk, men, glucocorticoid-induced osteoporosis |
| Reference Product | Prolia (originator) – all indications approved in mainland China |
Biosimilar Development & Data Package
HLX14 was independently developed by Henlius in accordance with biosimilar regulations in China, the European Union, and the United States. The NDA submission is supported by comprehensive comparability studies versus Prolia:
- Analytical Similarity: Extensive structural and functional characterization
- Non‑Clinical Studies: Pharmacology and toxicology comparability assessment
- Clinical Comparative Studies: Pharmacokinetic and efficacy/safety data demonstrating high similarity in quality, safety, and efficacy
Global Commercialization & Partnership Strategy
Organon Licensing Agreement (2022):
- Henlius granted Organon exclusive rights to commercialize HLX14 outside China
- Territories: United States, European Union, Canada, and other global markets
- Structure: Licensing and supply collaboration
Regulatory Approvals Achieved (H2 2025):
- BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL) received marketing approval from:
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- UK Medicines and Healthcare products Regulatory Agency (MHRA)
Market Context & Competitive Landscape
- China Osteoporosis Market: ~90 million patients; denosumab sales projected to reach ¥2.5 billion by 2028
- Biosimilar Opportunity: Patent expiry for Prolia in China (2025) opens market for cost‑effective alternatives
- Henlius Advantage: First domestic denosumab biosimilar to reach NDA stage; global validation via Organon partnership
- Revenue Potential: Analysts forecast ¥800 million‑1.2 billion peak China sales for HLX14
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, market potential, and commercial prospects for HLX14. Actual results may differ due to regulatory, competitive, and market access uncertainties.-Fineline Info & Tech