Drugs / HLX02
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse gastric and lobular breast cancer syndrome with or without cleft lip and/or palate 2 milestones | |||||
| Filed | EU (EMA) | — | diffuse gastric and lobular breast cancer syndrome with or without cleft lip and/or palate | 2019-06-21 | “Henlius trastuzumab biosimilar HLX02 has been accepted by the European Medicines Agency (EMA) for reviewing its Marketing Authorization Application (MAA)” henlius.com ↗ “the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02.” fosunpharma.com ↗ “Moreover, the business partner Accord submitted a Marketing Authorisation Application (MAA) for HLX02 to European Medicines Agency (EMA).” henlius.com ↗ “HLX02 is the first Chinese monoclonal antibody (mAb) biosimilar with marketing applications filed both in China and in the EU.” henlius.com ↗ |
| Filed | China (NMPA) | — | diffuse gastric and lobular breast cancer syndrome with or without cleft lip and/or palate | 2019-04-25 | “received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02” henlius.com ↗ “HLX03 (adalimumab injection) and HLX02 (trastuzumab injection) have been accepted by the NMPA for new drug marketing registration” sanyoubio.com ↗ “HLX02 is the first Chinese monoclonal antibody (mAb) biosimilar with marketing applications filed both in China and in the EU.” henlius.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | US (FDA) | — | breast cancer, gastric/gastroesophageal junction adenocarcinoma | 2023-02-15 | “FDA has accepted the Biologics License Application (BLA) for Henlius’ HLX02” henlius.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT04670796 | Mar → Jun 2021 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1 | NCT02581748 | Sep 2015 → May 2016 | — | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03084237 | Nov 2016 → Nov 2018 | breast cancer | Shanghai Henlius Biotech | Completed | Met primary |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2025-02-26 | Shanghai Henlius Biotech | Results Updated Long-term Survival Results from the International Multicenter Phase 3 Clinical Trial of HANQUYOU Published in The Breast henlius.com ↗
The follow-up analysis results demonstrated that HANQUYOU exhibited comparable long-term efficacy, safety, and immunogenicity to the reference trastuzumab in patients with previously untreated HER2-positive metastatic breast cancer, further validating their clinical equivalence. |
| 2024-10-23 | Shanghai Henlius Biotech | Results HLX22 Dual HER2 Blockade Therapy Featured on the Cover of Med henlius.com ↗
The study reveals that the treatment regimen significantly extended progression-free survival and improved antitumor response in these patients, with manageable safety profiles, supporting the clinical benefits of dual HER2 blockade. |
| 2024-08-22 | Shanghai Henlius Biotech | Regulatory Henlius Trastuzumab Receives Approval in Canada henlius.com ↗
The product has been approved under the trade name of Adheroza in Canada for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. |
| 2024-07-11 | Shanghai Henlius Biotech | Results Publication in Journal of Translational Medicine Highlighting Henlius' Dual HER2 Blockade Therapy Mechanism of Action henlius.com ↗
Both in vitro and in vivo studies demonstrated that HLX22 in combination with trastuzumab (HLX02) exhibit enhanced anti-tumour activity and induced cancer cell apoptosis in HER2-positive human gastric cancer cell lines, gastric cancer CDX models, and PDX models. |
| 2024-07-10 | Shanghai Henlius Biotech | Results Advances in HER2+ GC: Dual HER2 Blockade Therapy Presented on MED and ESMO GI henlius.com ↗
The results showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. |
| 2024-04-26 | Shanghai Henlius Biotech | Regulatory Henlius Trastuzumab Receives FDA Approval in the United States henlius.com ↗
The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. |
| 2023-02-15 | Shanghai Henlius Biotech | Regulatory Henlius Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02 henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Henlius’ HLX02 (trastuzumab for injection, trade name in Europe: Zercepac®, trade name in China: HANQUYOU; trade names in Australia: Tuzucip® and Trastucip®) submitted by the company’s business partner Accord BioPharma Inc. (Accord US). |
| 2021-04-29 | Shanghai Henlius Biotech | Results Biodrugs Published the Results of the International Multicentre Phase 3 Clinical Trial of 汉曲优® henlius.com ↗
Recently, Biodrugs published the results of the global multicentre Phase 3 clinical trial (HLX02-BC01, NCT03084237 and EudraCT: 2016-000206-10) of 汉曲优®, (trastuzumab, EU brand name: Zercepac®) which was led by Professor Binghe Xu, the director of the National New Drug Clinical Research Centre of Cancer Hospital Chinese Academy of Medical Sciences. |
| 2020-09-17 | Shanghai Henlius Biotech | Results The Updated Multi-Centre Phase 3 Clinical Study Data of Trastuzumab 汉曲优® Released in ESMO henlius.com ↗
At this conference, Henlius released the updated multi-centre Phase 3 clinical study of Trastuzumab 汉曲优® (HLX02, EU brand name: Zercepac®). |
| 2020-08-14 | Shanghai Henlius Biotech | Regulatory China's First Trastuzumab Biosimilar 汉曲优® Approved by NMPA henlius.com ↗
Shanghai, China, 14th August, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the trastuzumab biosimilar 汉曲优® (HLX02, EU brand name: Zercepac®), developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). |
| 2020-07-29 | Shanghai Henlius Biotech | Regulatory Henlius and Accord Healthcare Receive EMA Approval for Zercepac®, trastuzumab biosimilar henlius.com ↗
Zercepac® (HLX02) is the first China-developed monoclonal antibody (mAb) biosimilar that has successfully entered the EU market. |
| 2020-05-31 | Shanghai Henlius Biotech | Regulatory Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab) henlius.com ↗
We are very proud to receive CHMP positive opinion for HLX02 and that Henlius’ quality in the development and manufacture of biologics has been recognized by an international drug regulatory agency. |
| 2020-04-23 | Shanghai Henlius Biotech | Regulatory Henlius Receives EU GMP Certificate for HLX02 (Trastuzumab for Injection) henlius.com ↗
With the EU GMP Certificates, Henlius’ Xuhui Facility has become China's first EU certified GMP site to manufacture a self-developed antibody drug and HLX02 trastuzumab biosimilar is the first China-developed biosimilar that has passed the EU GMP inspection. |
| 2019-11-26 | Shanghai Henlius Biotech | Results First China-Manufactured Trastuzumab Biosimilar HLX02 Global Phase 3 Trial Met Primary Endpoint in Breast Cancer henlius.com ↗
Here in the 2019 ESMO-Asia congress, we announced the Week 24 efficacy result and the updated safety profile of this Phase 3 study. |
| 2019-10-12 | Shanghai Henlius Biotech | Results The breakthrough of China-manufactured trastuzumab biosimilar (HLX02) for metastatic breast cancer︱Interview of Prof. Binghe Xu and Prof. Igor Bondarenko at ESMO Congress 2019 henlius.com ↗
We know the primary outcome was ORR at week 24， which was approximately 71.0% in both treatment groups. |
| 2019-09-07 | Shanghai Henlius Biotech | Results The Confirmatory Phase 3 Study Results of First China-Manufactured Trastuzumab Biosimilar, HLX02, will be Presented at Both CSCO and ESMO This Year henlius.com ↗
The results have demonstrated equivalence in safety and efficacy between HLX02 and EU-trastuzumab in patients with HER2-positive recurrent or previously untreated metastatic breast cancer. |
| 2019-06-21 | Shanghai Henlius Biotech | Regulatory EMA Accepted First “China-Developed” Biosimilar - Henlius HLX02 Marketing Authorization Application for Review henlius.com ↗
Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02. |
| 2019-06-21 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Marking a New Milestone in Overseas Markets Henliu’s HLX02, the First China-developed Trastuzumab Biosimilar Receives Marketing Authorization Application for Review from EMA fosunpharma.com ↗
June 21, 2019, Shanghai, China – Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02. |
| 2019-04-26 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Henlius Trastuzumab HLX02 Filed New Drug Application fosunpharma.com ↗
Shanghai Henlius Biotech, Inc. has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02, a trastuzumab for injection. |
| 2019-04-25 | Shanghai Henlius Biotech | Regulatory Henlius Trastuzumab HLX02 Filed New Drug Application henlius.com ↗
Shanghai Henlius Biotech, Inc. has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02, a trastuzumab for injection. |
All press releases naming this drug 22 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04670796 ↗ |
| Route | Intravenous | “intravenous infusion over 90 min” PMID 33169186 ↗ Nov 2020 |