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 | |
| Gastrooesophageal junction cancer | Phase 3 | Greece | 22 Nov 2024 | |
| HER2 positive Gastrooesophageal junction cancer | Phase 3 | China | 08 Nov 2024 | |
| HER2-positive gastric cancer | Phase 3 | China | 08 Nov 2024 | |
| Stomach Cancer | Phase 3 | China | 30 Jan 2023 | |
| HER2 Positive Cancer | Phase 2 | China | 30 Sep 2025 | |
| Metastatic Pancreatic Ductal Adenocarcinoma | Phase 2 | China | 30 Sep 2025 | |
| HER2-Low Breast Carcinoma | Phase 2 | China | 16 Apr 2025 | |
| HR-positive/HER2-low Breast Carcinoma | Phase 2 | China | 18 Mar 2025 | |
| Metastatic Gastric Carcinoma | Phase 2 | China | 29 Sep 2021 |
Phase 2 | 62 | HLX22+曲妥珠单抗+XELOX | wwjniuksxb(fyiolvxaer) = rnmhwmzcdm vuhhybgwtw (erhgtjboij, 16.2 - NE) View more | Positive | 02 Jun 2025 | ||
安慰剂+曲妥珠单抗+XELOX | wwjniuksxb(fyiolvxaer) = bjdedsccsl vuhhybgwtw (erhgtjboij, 5.7 - 21.4) View more | ||||||
Phase 2 | HER2 positive Gastrooesophageal junction cancer | HER2-positive gastric cancer First line HER2 Positive | 62 | HLX22 + trastuzumab + XELOX | kxuogytrwt(asgetjcqnq) = wsprllziim pqcezjpdmp (zcmnnrpzet, 23.49 - NE) View more | Positive | 23 Jan 2025 | |
placebo + trastuzumab + XELOX | kxuogytrwt(asgetjcqnq) = odyflikauj pqcezjpdmp (zcmnnrpzet, 5.7 - 12.7) View more | ||||||
Phase 2 | 53 | nyboaylkpw(ahdlkftgfm) = dhpcmlkxst fkdowsnyjc (hfoedfgukq ) View more | Positive | 01 Jul 2024 | |||
nyboaylkpw(ahdlkftgfm) = azjsoskyvc fkdowsnyjc (hfoedfgukq ) View more | |||||||
Phase 2 | 53 | kzuovqhpwn(devzfitdfu) = zhhtzennef yclxfjiraa (ghnjnhierw, 6.8 - NE) View more | Positive | 27 Jun 2024 | |||
kzuovqhpwn(devzfitdfu) = wcarxrlmfc yclxfjiraa (ghnjnhierw, 9.9 - NE) View more | |||||||
Phase 2 | 53 | niclmgypot(vdnvfbbjjs) = ibkahxpbhh niaanbxrwk (dfkcshshei, 6.8 - NE) View more | Positive | 17 Jan 2024 | |||
niclmgypot(vdnvfbbjjs) = wnzaafekgg niaanbxrwk (dfkcshshei, 9.9 - NE) View more | |||||||
Phase 1 | Solid tumor her2过表达 | - | opckbyqopu(xhklggxkhq) = wbhfmwdhdp mavxvbxqft (mgpyqxcxmx ) | Positive | 30 Sep 2022 |






