Drugs / HLX11
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | Her2-receptor negative breast cancer | 2025-03-28 | “today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11” henlius.com ↗ |
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | 2025-02-02 | “the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX11” henlius.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04411550 | Jul 2020 → Jul 2021 | — | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05346224 | Apr 2022 → May 2024 overdue | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07776132 Comparator | Nov 2026 → Jan 2027 expected | — | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-02-27 | Shanghai Henlius Biotech | Regulatory EMA CHMP Recommends EU Approval of Henlius’ Pertuzumab Biosimilar HLX11 henlius.com ↗
The positive opinion recommends approval of HLX11 for all indications approved for the reference product in the European Union, covering HER2-positive early and metastatic breast cancer. |
| 2025-12-10 | Shanghai Henlius Biotech | Results Henlius Highlights Dual Progress in Breast Cancer Pipeline as HLX11 and HLX78 Data Release at ESMO Asia 2025 henlius.com ↗
At the ESMO Asia Congress 2025, Henlius announced data readouts from two breast cancer–related studies: results from the phase 3 equivalence study (NCT05346224) of HLX11 (trade name: POHERDY® in U.S.), the first and only FDA-approved biosimilar to PERJETA®, and the phase 1 pharmacokinetic (PK) and safety findings of the innovative endocrine therapy HLX78 (lasofoxifene) in healthy Chinese female adults. |
| 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. |
| 2025-03-28 | Organon and Co | Regulatory European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗ |
| 2025-03-28 | Shanghai Henlius Biotech | Regulatory European Medicines Agency (EMA) Validates Henlius and Organon Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 henlius.com ↗
today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab). |
| 2025-02-02 | Shanghai Henlius Biotech | Regulatory US FDA Accepts Biologics License Application (BLA) for HLX11, Biosimilar Candidate of Perjeta® (pertuzumab) henlius.com ↗
Shanghai, China – Feb 2, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab). |
| 2024-12-04 | Shanghai Henlius Biotech | Regulatory China NMPA Accepts Henlius' NDA for HLX11, an Pertuzumab Biosimilar Candidate henlius.com ↗
the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) for its self-developed pertuzumab biosimilar HLX11 |
| 2024-09-30 | Organon and Co | Results Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) biosimilar HLX11 met the primary endpoint. |
| 2024-09-30 | Shanghai Henlius Biotech | Results Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11 henlius.com ↗
The primary endpoint of this study was met. |
| 2024-07-11 | Shanghai Henlius Biotech | Results Publication in Journal of Translational Medicine Highlighting Henlius' Dual HER2 Blockade Therapy Mechanism of Action henlius.com ↗
Therefore, trastuzumab (HLX02) and HLX11(pertuzumab biosimilar) combination disrupted HER2/EGFR heterodimer formation. |
| 2022-10-28 | Shanghai Henlius Biotech | Regulatory Henlius Pertuzumab Biosimilar HLX11 Received Clinical Trial Approval in EU for the Phase 3 MRCT henlius.com ↗
has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). |
| 2021-11-08 | Shanghai Henlius Biotech | Results Henlius Announces Successful Completion of Phase 1 Clinical Trial of Pertuzumab Biosimilar HLX11 henlius.com ↗
The results of this study demonstrated that HLX11 had similar pharmacokinetic and safety profiles to the reference drugs from different sources. |
| 2020-01-21 | Shanghai Henlius Biotech | Regulatory Henlius Anti-HER2 Domain II Monoclonal Antibody HLX11 Received Clinical Approval from NMPA henlius.com ↗
Shanghai, China, January 21, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that Henlius has received clinical approval from the National Medical Products Administration (NMPA) for its HLX11, a recombinant anti-human epidermal growth factor receptor 2 (HER2) domain II humanized monoclonal antibody injection. |
| 2019-10-31 | Shanghai Henlius Biotech | Regulatory Henlius Anti-HER2 Monoclonal Antibody HLX11 Received IND Application Acceptance Notification from NMPA henlius.com ↗
Henlius has received an investigational new drug (IND) application acceptance notification from the National Medical Products Administration (NMPA) for its HLX11 |
All press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04411550 ↗ |
| Modality | Monoclonal antibody | “Pertuzumab is a humanized monoclonal antibody for the treatment of breast cancer. HLX11 is a biosimilar of pertuzumab developed by Shanghai Henlius Biotech, Inc.” PMID 35594017 ↗ May 2022 |
| Route | Intravenous | “a single dose of 420 mg HLX11, US-, EU-, or CN-pertuzumab via intravenous infusion over 60 min” PMID 35594017 ↗ May 2022 |
| Target | ERBB2 | “Recombinant anti-HER2 domain II humanized monoclonal antibody injection” NCT05346224 ↗ |