Drugs / HLX01
HLX01
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-Hodgkin lymphoma 1 milestone | |||||
| Filed | China (NMPA) | — | non-Hodgkin lymphoma | — | “In October 2017, Henlius submitted New Drug Application (NDA) to CFDA for HLX01 Non-Hodgkins lymphoma (NHL) indication.” henlius.com ↗ |
| Filed rheumatoid arthritis 1 milestone | |||||
| Filed | China (NMPA) | 汉利康 | rheumatoid arthritis | 2020-12-17 | “the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of its rituximab injection HLX01 to treat rheumatoid arthritis (RA).” henlius.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03218072 | May 2014 → Jan 2015 | neoplasm of mature B-cells | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1/22 trials · 2 met primary | ||||||
| Phase 1/2 | NCT03355872 | Feb 2016 → Aug 2018 | rheumatoid arthritis | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 1/2 | NCT02584920 | Oct 2014 → Aug 2015 | B-cell non-Hodgkin lymphoma | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT07038382 | Aug 2025 → Jan 2027 expected | lupus nephritis, membranous glomerulonephritis | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT04671420 | Oct 2020 → Apr 2022 | B-cell non-Hodgkin lymphoma | Shanghai Henlius Biotech | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03522415 | May 2018 → Apr 2020 | — | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 3 | NCT02787239 | Oct 2015 → May 2018 | B-cell non-Hodgkin lymphoma | Shanghai Henlius Biotech | Completed | Met primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-04-09 | Shanghai Henlius Biotech | Regulatory The rituximab with the most approved indications domestically, Henlius' HANLIKANG has obtained approvals for two additional indications henlius.com ↗
On April 9, 2026, Henlius (2696.HK) announced that the supplemental application for two new indications under non-Hodgkin's lymphoma of HANLIKANG (rituximab), independently developed and manufactured by the company, was approved by the National Medical Products Administration (NMPA). |
| 2024-05-27 | Shanghai Henlius Biotech | Regulatory Henlius Rituximab Receives Marketing Approval in Peru henlius.com ↗
HANLIKANG (rituximab), independently developed and manufactured by Henlius, has been approved to be marketed in Peru under the trade name AUDEXA® by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). |
| 2023-11-28 | Shanghai Henlius Biotech | Regulatory Henlius Xuhui Facility Passes Colombian GMP Inspection for HANLIKANG henlius.com ↗
The GMP certification by Colombia, along with the GMP certification by Brazil, brings HANLIKANG a step further to South American countries. |
| 2023-10-20 | Shanghai Henlius Biotech | Regulatory Henlius Xuhui Facility Passes PIC/S Member ANVISA GMP Inspection for HANLIKANG and HANQUYOU henlius.com ↗
This is the first time that the production lines of HANLIKANG have passed GMP inspection conducted by an overseas authority. |
| 2022-03-01 | Shanghai Henlius Biotech | Regulatory 汉利康Ⓡ Approved by NMPA for New Indication Differentiated Strategy Benefits a Wider Patient Population henlius.com ↗
汉利康® is the only rituximab that gets the approval in China to treat rheumatoid arthritis and it was approved by NMPA for the treatment of adult patients in below indications: |
| 2021-05-21 | Shanghai Henlius Biotech | Results Phase 3 Clinical Results of Rituximab Injection in RA Patients Was First Released at the 25th National Congress of Chinese Rheumatology Association henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the abstract and poster of phase 3 clinical trial (HLX01-RA03，NCT03522415) results of HLX01, a rituximab injection which was independently developed by Henlius for the treatment of rheumatoid arthritis was reported at the 25th National Congress of Chinese Rheumatology Association by the Company. |
| 2020-12-17 | Shanghai Henlius Biotech | Regulatory NMPA Has Accepted The NDA of HLX01(Rituximab Injection) for the Treatment of Rheumatoid Arthritis henlius.com ↗
Shanghai, China, December 17th, 2020 –Shanghai Henlius Biotech, Inc. (2696.HK) announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of its rituximab injection HLX01 to treat rheumatoid arthritis (RA). |
| 2019-12-09 | Shanghai Henlius Biotech | Results First China Approved Rituximab Biosimilar HLX01: Pharmacokinetics, Safety and Efficacy Comparison to Reference Rituximab in the Phase 3 DLBCL Study henlius.com ↗
Here at the ASH 61st Annual Meeting 2019, we present the primary endpoint of both HLX01-NHL03 and HLX01-RA01, the development of PopPK model, ethnicity comparison and all external validations. |
| 2019-10-09 | Shanghai Henlius Biotech | Results Top Dialogue | Prof. Yuankai Shi &. Prof. J. Fitzgibbon: Efficacy and the outlook of HLX01（Hanlikang®）in non-Hodgkin’s lymphoma. henlius.com ↗
Under strict developed regulation， anti-CD20 biosimilar HLX01 showed favorable efficacy in Phase III clinical study of diffuse large B-cell lymphoma. |
| 2019-06-17 | Shanghai Henlius Biotech | Results Henlius Presented Data of Two Anti-inflammatory Candidates at EULAR 2019 henlius.com ↗
Shanghai Henlius Biotech, Inc. announced new data from the Phase 1 HLX01-RA01 study, which show that HLX01 is bioequivalent to European-Union (EU) sourced MabThera® in rheumatoid arthritis (RA). |
| 2019-02-25 | Shanghai Henlius Biotech | Regulatory Henlius Receives NMPA Approval for Its First Product HLX01 –The Beginning of a New Era for Biosimilar henlius.com ↗ |
| 2019-02-25 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma Has Opened a New Era for Biosimilar in China Henlius Receives NMPA Approval for Its First Product HLX01 fosunpharma.com ↗
Recently, HLX01 (rituximab injection), independently developed by Shanghai Henlius Biotech, Inc.(Henlius), Fosun Pharma’s biologics platform, has granted approval by the China National Medical Products Administration (NMPA). |
| 2019-01-29 | Shanghai Henlius Biotech | Results Henlius Completed Phase 1/2 Study of Its Rituximab Injection for Rheumatoid Arthritis henlius.com ↗
Results of the study met defined primary and secondary endpoints, demonstrating equivalence of pharmacokinetic, safety and immunogenicity profiles between HLX01 and reference rituximab. |
| 2018-05-24 | Shanghai Henlius Biotech | Results Important News! Henlius Completed Its First Phase III Study of HLX01(Rituximab Injection) henlius.com ↗
The top-line results met its primary efficacy endpoint for overall response rate (ORR) and secondary endpoints (safety, immunogenicity and pharmacokinetics profiles). |
All press releases naming this drug 17 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02787239 ↗ |
| Known as | rituximab | “Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with...” PMID 34321836 ↗ Jun 2021 |
| Known as | Rituximab Injection | “HLX79 (Human Sialidase Fusion Protein) in Combination With Rituximab Injection (HLX01, Anti-CD20 Antibody)” NCT07038382 ↗ |
| Modality | Monoclonal antibody | “HLX01,Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection is recombinant human-mouse chimeric anti-cd20 CD20 monoclonal antibody.” NCT03522415 ↗ |
| Route | Intravenous | “375mg/m2 iv single dose” NCT02584920 ↗ |