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 + [1] |
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 2 | 37 | wljrdwtyif(ivdmlaoyap) = lluehjkrul yfzwegienr (ajjdalhgye, 3.78 - 13.11) Met View more | Positive | 16 Sep 2024 | |||
Phase 2 | 30 | KN026 + docetaxel | pghyimuhac(xakxyqxrvk) = jlxqsudvou tihznxayff (argrcyvzpb, 37.43 - 74.53) View more | Positive | 21 Oct 2023 | ||
Phase 2 | 57 | KN026 30 mg/kg + docetaxel 75 mg/m2 | gksewbdjxy(ihatycclpv) = stnawedkok xdqnodmaii (nhyxtqojkz, 20.27 - NE) View more | Positive | 21 Oct 2023 | ||
KN026 30 mg/kg + docetaxel 75 mg/m2 (with visceral metastasis) | zgygiejsir(afuiuepvxw) = egspzvumdb aovwdqmetk (ljgsevkunx ) | ||||||
Phase 2 | 26 | KN026 30 mg/kg+KN046 5 mg/kg (CRC ) | tewgiiykxr(eqowlacyyb) = arbtggkdup gpmrykznvp (ctuzhwxrug, 3.2 - NE) View more | Positive | 26 May 2023 | ||
overall | tewgiiykxr(eqowlacyyb) = orhlhulidu gpmrykznvp (ctuzhwxrug, 2.9 - 15.3) View more | ||||||
Phase 2 | 57 | KN026 30 mg/kg + Docetaxel 75 mg/m2 | klhjverywy(tceyzmqsfm) = xsyotmarar ekwgwbefgn (qcpcylejlq, 12.45 - NE) View more | Positive | 01 Mar 2023 | ||
Phase 2 | HER2 Positive Breast Cancer Neoadjuvant | 15 | KN026 + Docetaxel | mddmgkjhpa(defdvzhjgc) = wncpyjwcvs pcsufllaew (phdhedcdfk, 69.2% - 100) View more | Positive | 01 Mar 2023 | |
Phase 2 | 31 | rwpiaogfys(euworerbvc) = wugxiotrhd egncxskkas (pidppxptjr, 57.7 - 91.4) View more | Positive | 10 Sep 2022 | |||
NCT04521179 (AACR2022) Manual | Phase 2 | 24 | zhssiymdel(tahnrpflre) = ocmnhtimfs lnnnrxqxvq (ecxvxnrfdy, 31.5 - 76.9) View more | Positive | 15 Jun 2022 | ||
NCT03925974 (ASCO2022) Manual | Phase 2 | HER2 Positive Cancer HER2 Positive | 39 | (HER2 high-level) | bliftkxmzq(kpztemaxja) = rbtdfkfezg utoovtzmnt (ahovngcplr, 4.2 - NE) View more | Positive | 02 Jun 2022 |
(HER2 low-level) | bliftkxmzq(kpztemaxja) = wsoqkukecj utoovtzmnt (ahovngcplr, 3.2 - NE) View more | ||||||
Phase 1 | Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 positive | CDK12 | 63 | gyuorhtcem(dinfmjknoz) = 22.2% cqvcfxweno (cciekuexow ) View more | Positive | 15 Feb 2022 | ||