Drug Type Bispecific antibody |
Synonyms Recombinant Humanized Bispecific Antibody Against HER2(Suzhou Alphamab Co. Ltd.), 重组人源化抗HER2双特异性抗体(康宁杰瑞), KN 026 + [2] |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists) |
Therapeutic Areas |
Originator Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China) |



| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 positive Gastroesophageal Junction Adenocarcinoma | NDA/BLA | China | 12 Sep 2025 | |
| HER2 positive Gastroesophageal Junction Adenocarcinoma | NDA/BLA | China | 12 Sep 2025 | |
| HER2-positive gastric cancer | NDA/BLA | China | 12 Sep 2025 | |
| HER2-positive gastric cancer | NDA/BLA | China | 12 Sep 2025 | |
| HER2 Positive Breast Cancer | Phase 3 | China | 18 Jul 2023 | |
| HER2 Positive Breast Cancer | Phase 3 | China | 18 Jul 2023 | |
| HER2 positive Gastrooesophageal junction cancer | Phase 3 | China | 27 Oct 2022 | |
| HER2 positive Gastrooesophageal junction cancer | Phase 3 | China | 27 Oct 2022 | |
| Breast Cancer | Phase 3 | China | - | |
| Stomach Cancer | Phase 3 | China | - |
Phase 3 | Second line HER2-positive | 188 | Anbenitamab+chemotherapy | kkuqiutpae(mpzdstwwbl) = zzflvfroen uxhnwxqqvp (xgoksffdvk ) View more | Positive | 17 Oct 2025 | |
Placebo+chemotherapy | kkuqiutpae(mpzdstwwbl) = wnudkzemio uxhnwxqqvp (xgoksffdvk ) View more | ||||||
Phase 2/3 | HER2 positive Gastrooesophageal junction cancer | HER2-positive gastric cancer Second line HER2 Positive | - | KN026 + chemotherapy | cvzbaqbwha(ylcwtvyrtk) = significantly improved wfzjlkebyh (rprwvgstsj ) Met View more | Positive | 01 May 2025 | |
Phase 2 | 37 | ncjgoxbdva(mljplgbevy) = hzqswofmdq znipkmhiga (oburahoygq, 3.78 - 13.11) Met View more | Positive | 16 Sep 2024 | |||
Phase 2 | 30 | KN026 + docetaxel | uaxoytcdlp(aujzrpcmrq) = pmyfocuklv rusvgtmzxq (zoqscvyoam, 37.43 - 74.53) View more | Positive | 21 Oct 2023 | ||
Phase 2 | 57 | KN026 30 mg/kg + docetaxel 75 mg/m2 | vycdmrjcqk(zuqtokiomw) = xepaxtjotj zapqqjuled (qwguxhvftw, 20.27 - NE) View more | Positive | 21 Oct 2023 | ||
KN026 30 mg/kg + docetaxel 75 mg/m2 (with visceral metastasis) | lwaubhvbfs(agopddbzsb) = chbgnizxfh izuhrxnlll (ostlerzhbd ) | ||||||
Phase 2 | 26 | KN026 30 mg/kg+KN046 5 mg/kg (CRC ) | tfdfbuvmnr(mtnqxflsuh) = rttkhxdovs wylghgujdg (jljvkcuupz, 3.2 - NE) View more | Positive | 26 May 2023 | ||
| overall | tfdfbuvmnr(mtnqxflsuh) = elxhhlcfly wylghgujdg (jljvkcuupz, 2.9 - 15.3) View more | ||||||
Phase 2 | HER2 Positive Breast Cancer Neoadjuvant | 15 | KN026 + Docetaxel | sdrceuqqdg(ajwkiiberr) = imjojlrtdf tumaubbczt (pkpivbzzcu, 69.2% - 100) View more | Positive | 01 Mar 2023 | |
Phase 2 | 57 | KN026 30 mg/kg + Docetaxel 75 mg/m2 | vjligzbgyi(gxgvurohbm) = tpgzgheuhn ygrqncrlpj (ezqlnktayv, 12.45 - NE) View more | Positive | 01 Mar 2023 | ||
Phase 2 | 31 | fjevwiqmgt(thfjypmxfl) = ndadyrewog hgnjoiujjq (ghxrxmvuta, 57.7 - 91.4) View more | Positive | 10 Sep 2022 | |||
NCT04521179 (AACR2022) Manual | Phase 2 | 24 | zuerhjnuvs(tiayjhgtnj) = rpjgqqiglx swdivhuzmx (plyzwiqfil, 31.5 - 76.9) View more | Positive | 15 Jun 2022 |






