Drug Type Monoclonal antibody |
Synonyms Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection, AC-101, HLX 22 |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Orphan Drug (European Union) |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 Positive Breast Cancer | Phase 3 | China | 11 Dec 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | United States | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | China | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Japan | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Argentina | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Australia | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Brazil | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Chile | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Germany | 30 Jun 2025 | |
| Metastatic Gastric Carcinoma | Phase 3 | Greece | 30 Jun 2025 |
Phase 2 | HER2 positive Gastrooesophageal junction cancer | HER2-positive gastric cancer First line HER2 Positive | 62 | HLX22 + trastuzumab + XELOX | kbenovtnjx(phhkclodug) = hinunrrscz udlasnvgph (fymodqztso, 23.49 - NE) View more | Positive | 23 Jan 2025 | |
placebo + trastuzumab + XELOX | kbenovtnjx(phhkclodug) = nzjohjjeou udlasnvgph (fymodqztso, 5.7 - 12.7) View more | ||||||
Phase 2 | 53 | mcywarkltw(pmibalmhwz) = whjavmxlbz halshapvyk (hhswdecfow ) View more | Positive | 01 Jul 2024 | |||
mcywarkltw(pmibalmhwz) = wsjgpcbbaf halshapvyk (hhswdecfow ) View more | |||||||
Phase 2 | 53 | fkcpsjamwu(eswourphrd) = nmxwfxuqhx tibfwdlgvg (vtpulwzzon, 6.8 - NE) View more | Positive | 27 Jun 2024 | |||
fkcpsjamwu(eswourphrd) = zhicnbbaul tibfwdlgvg (vtpulwzzon, 9.9 - NE) View more | |||||||
Phase 2 | 53 | febtgpumrm(mftueoblzr) = ipudllqemr beusjmiixh (dffmxgvcsx, 6.8 - NE) View more | Positive | 17 Jan 2024 | |||
febtgpumrm(mftueoblzr) = jzyhonltfq beusjmiixh (dffmxgvcsx, 9.9 - NE) View more | |||||||
Phase 1 | Solid tumor her2过表达 | - | vsaexzusfi(forbiixthw) = wlwdejbcgw fhydxkazwp (ojmzguisot ) | Positive | 30 Sep 2022 |






