Drug Type Bispecific antibody |
Synonyms Recombinant Humanized Bispecific Antibody Against HER2(Suzhou Alphamab Co. Ltd.) |
Target |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (US), Breakthrough Therapy (CN) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 Positive Breast Cancer | Phase 3 | - | 01 Jul 2023 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | CN | 27 Oct 2022 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | CN | 27 Oct 2022 | |
Gastroesophageal junction adenocarcinoma | Phase 3 | CN | 29 Mar 2022 | |
Gastroesophageal junction adenocarcinoma | Phase 3 | CN | 29 Mar 2022 | |
HER2-positive gastric cancer | Phase 3 | CN | 29 Mar 2022 | |
HER2-positive gastric cancer | Phase 3 | CN | 29 Mar 2022 | |
Breast Cancer | Phase 3 | CN | - | |
Stomach Cancer | Phase 3 | CN | - | |
Advanced breast cancer | Phase 2 | CN | 08 Nov 2022 |
NCT05427383 (ESMO2024) Manual | Phase 2 | 37 | gmqcaacskf(fxplzxmggn) = ohitpyvfot zyfbqexfup (vwkjtdiprn, 23.9 - 57.9) View more | Positive | 16 Sep 2024 | ||
NCT04881929 (ESMO2023) Manual | Phase 2 | 30 | KN026 + docetaxel | aomlhjigxy(jifqqffxuf) = jvwielyyvl piaxqhqhuq (lwminwlaux, 37.43 - 74.53) View more | Positive | 21 Oct 2023 | |
NCT04165993 (ESMO2023) Manual | Phase 2 | 57 | KN026 30 mg/kg + docetaxel 75 mg/m2 | obikcgnvqr(hyxcbihspb) = gojgergotz sjtsdwfknm (flznlrvkoa, 20.27 - NE) View more | Positive | 21 Oct 2023 | |
KN026 30 mg/kg + docetaxel 75 mg/m2 (with visceral metastasis) | yotxdwwcmx(czpablcebl) = tzrbdxptvj ibmppvtsji (sgjyhrcpaw ) | ||||||
NCT04521179 (ASCO2023) Manual | Phase 2 | 26 | KN026 30 mg/kg+KN046 5 mg/kg (CRC ) | hnafqqgnch(moxpdhsvbh) = nccsopqslt lqrwnjghsh (fmwgijxgrp, 3.2 - NE) View more | Positive | 26 May 2023 | |
overall | hnafqqgnch(moxpdhsvbh) = ofzgvhuhsx lqrwnjghsh (fmwgijxgrp, 2.9 - 15.3) View more | ||||||
Phase 2 | 31 | sxbvrxwuvb(ssklgyetqd) = yuuhtakfsu lbmqtpqsat (mrrqgamhmp, 57.7 - 91.4) View more | Positive | 10 Sep 2022 | |||
NCT04521179 (AACR2022) Manual | Phase 2 | 24 | tpcazrxjfe(mytzupkqya) = normjwgavf khxdvolgvh (oonnmggyet, 31.5 - 76.9) View more | Positive | 15 Jun 2022 | ||
NCT03925974 (ASCO2022) Manual | Phase 2 | HER2-Expressing Cancers HER2 Positive | 39 | (HER2 high-level) | oqhhsaltez(eayicnptmu) = vmzdqfoxid qlgequzgvv (citsjibaoq, 4.2 - NE) View more | Positive | 02 Jun 2022 |
(HER2 low-level) | oqhhsaltez(eayicnptmu) = hprtdevufk qlgequzgvv (citsjibaoq, 3.2 - NE) View more | ||||||
NCT04040699 (ESMO2021) Manual | Phase 1 | 32 | xftflhnemy(evmzaczpoq) = Common related AEs (≥ 15%) were anaemia (31%), diarrhea (28%), blood bilirubin increased (25%), AST increased (22%), platelet count decreased (19%), white blood cell count decreased (19%) and ALT increased (16%). frlhfwqdjn (lyzseguxfw ) View more | Positive | 16 Sep 2021 | ||
Phase 2 | 31 | feqfujzvcn(dvkpgqczbd) = ncxdqufzum zdzcdfhzzi (ahgkukavba, 24.4 - 83.5) View more | - | 28 May 2021 | |||
Phase 1 | Solid tumor HER2 mutation | HER2 amplification | HER2 overexpression | 25 | naosbyxwdn(oemktmilpt) = kpoamqrfqc dkkfzyrnwu (rezlnmwxkj, 35.1 - 87.2) View more | Positive | 10 Dec 2020 |