Drugs / HLX14
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed osteoporosis 2 milestones | |||||
| Filed | US (FDA) | — | osteoporosis | 2024-10-30 | “announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14” henlius.com ↗ |
| Filed | EU (EMA) | — | osteoporosis | 2024-05-24 | “the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14” henlius.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | China (NMPA) | — | bone metastases, giant cell tumor of bone | 2026-09-11 | “the New Drug Application (NDA) for 120 mg/1.7 mL strength of its self-developed denosumab biosimilar, HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection),...” henlius.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04534582 | Nov 2020 → Sep 2023 | — | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05352516 | Jun 2022 → Dec 2023 | postmenopausal osteoporosis | Shanghai Henlius Biotech | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | Shanghai Henlius Biotech | Regulatory NMPA Accepts for Review Henlius' NDA for 120 mg HLX14, China’s First Domestically Developed Denosumab to Enter Global Markets henlius.com ↗ |
| 2025-12-02 | Shanghai Henlius Biotech | Regulatory Henlius’ Denosumab HLX14 New Drug Application Accepted by NMPA henlius.com ↗ |
| 2025-07-28 | Shanghai Henlius Biotech | Regulatory CHMP Recommends EU Approval of Henlius’ Denosumab Biosimilar HLX14 henlius.com ↗
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. |
| 2025-07-02 | Shanghai Henlius Biotech | Regulatory Henlius Receives New EMA GMP Certification, Accelerating European Market Entry of Two Biosimilar Candidates henlius.com ↗
According to the GMP mutual recognition system among European Union (EU) member states, it marks that the related production lines have met the EU GMP standards. |
| 2025-02-18 | Shanghai Henlius Biotech | Results Clinical and Translational Science Publishes Phase 1 Clinical Results of Henlius’ HLX14 henlius.com ↗
The results of this study suggest that HLX14 had highly similar pharmacokinetic (PK) and pharmacodynamics (PD), as well as comparable safety, tolerability, and immunogenicity to the US-, EU-, and China-sourced reference denosumab (Prolia®). |
| 2025-02-12 | Shanghai Henlius Biotech | Results Phase 3 MRCT Results of Denosumab Biosimilar HLX14 Released at ORS 2025 henlius.com ↗
On February 11, 2025, the results of the international multicenter phase 3 study (NCT05352516) of denosumab biosimilar candidate HLX14 were released at the 2025 Orthopaedic Research Society (ORS) Annual Meeting. |
| 2024-10-30 | Organon and Co | Regulatory US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) organon.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). |
| 2024-10-30 | Shanghai Henlius Biotech | Regulatory US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) henlius.com ↗
Shanghai, China & JERSEY CITY, NJ – October 30, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). |
| 2024-05-24 | Organon and Co | Regulatory European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 organon.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. |
| 2024-05-24 | Shanghai Henlius Biotech | Regulatory European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. |
| 2024-04-08 | Organon and Co | Results Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints organon.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. |
| 2024-04-08 | Shanghai Henlius Biotech | Results Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. |
| 2024-02-01 | Shanghai Henlius Biotech | Results Henlius Announces Successful Completion of Phase 1 PK Similarity Clinical Study of Denosumab HLX14 henlius.com ↗
The results of this study suggest that HLX14 had highly similar PK and PD, as well as comparable safety, tolerability, and immunogenicity to the reference drugs from different sources. |
| 2022-07-19 | Shanghai Henlius Biotech | Regulatory Henlius Denosumab Biosimilar HLX14 Received Clinical Trial Approval in Australia for the Phase 3 MRCT henlius.com ↗ |
| 2020-05-27 | Shanghai Henlius Biotech | Regulatory Henlius Received IND Approval for Denosumab Biosimilar HLX14 from NMPA henlius.com ↗
an investigational new drug (IND) application has been approved by the National Medical Products Administration (NMPA) of HLX14 |
| 2020-03-10 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Henlius Received Acceptance Notification for Clinical Trial Application from NMPA for its Denosumab Biosimilar HLX14 fosunpharma.com ↗ |
| 2020-03-09 | Shanghai Henlius Biotech | Regulatory Henlius Received Acceptance Notification for Clinical Trial Application from NMPA for its Denosumab Biosimilar HLX14 henlius.com ↗
an investigational new drug (IND) application has been accepted by the National Medical Products Administration (NMPA) for HLX14, a Denosumab biosimilar independently developed by Henlius, indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. |
All press releases naming this drug 19 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX14 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04534582 ↗ |
| Modality | Monoclonal antibody | “Denosumab is a human IgG2 monoclonal antibody against receptor activator of nuclear factor kappa-B ligand (RANKL) for the treatment of osteoporosis and bone loss. HLX14 is a...” PMID 39700054 ↗ Dec 2024 |
| Route | Subcutaneous | “All study drugs were administered via subcutaneous injection at a single dose of 60 mg.” PMID 39700054 ↗ Dec 2024 |