Drugs / HLX87
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT07294508 | Feb 2026 → Jan 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07294534 | Jan 2026 → Sep 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Shanghai Henlius Biotech | Regulatory Henlius Receives NMPA Approval to Initiate Phase 2/3 Clinical Trials of HLX22 for Neoadjuvant and First-Line Treatment of HER2-Positive Breast Cancer henlius.com ↗
Henlius (2696.HK) announced today that the National Medical Products Administration (NMPA) has approved two phase 2/3 clinical trials evaluating the company’s novel-epitope HER2 monoclonal antibody HLX22 in combination with its innovative anti-HER2 antibody–drug conjugate (ADC) HLX87 for the neoadjuvant and first-line treatment of HER2-positive breast cancer. |
| 2025-12-09 | Alligator Bioscience AB | Regulatory Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer alligatorbioscience.se ↗
applications for Phase 2/3 clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) in combination with HLX87 (an antibody-drug conjugate targeting HER2) have been approved by China’s National Medical Products Administration (NMPA). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Shanghai Henlius Biotech | Henlius Receives NMPA Approval to Initiate Phase 2/3 Clinical Trials of HLX22 for Neoadjuvant and First-Line Treatment of HER2-Positive Breast Cancer henlius.com ↗ |
| 2025-12-09 | Alligator Bioscience AB | Alligator Bioscience comments on Henlius receiving regulatory approval in China to initiate Phase 2/3 trials of HLX22 in HER2-positive breast cancer alligatorbioscience.se ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX87 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07294508 ↗ |
| Modality | Other / unclassified | “HLX87 is a novel HER2-targeted ADC” NCT07294534 ↗ |