Drug Type Bispecific antibody |
Synonyms ivonescimab, AK 112, AK-112 + [4] |
Target |
Action inhibitors |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (21 May 2024), |
RegulationFast Track (United States), Priority Review (China), Breakthrough Therapy (China) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
PD-L1 positive Non-Small Cell Lung Cancer | China | 22 Apr 2025 | |
EGFR positive Non-squamous non-small cell lung cancer | China | 21 May 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced Lung Non-Small Cell Squamous Carcinoma | NDA/BLA | China | 25 Jul 2025 | |
Advanced Lung Non-Small Cell Squamous Carcinoma | NDA/BLA | China | 25 Jul 2025 | |
Non-Small Cell Lung Cancer | Phase 3 | China | 30 Jun 2025 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | - | 01 Jun 2025 | |
Small Cell Lung Cancer | Phase 3 | China | 29 May 2025 | |
Small cell lung cancer limited stage | Phase 3 | China | 29 May 2025 | |
Metastatic Pancreatic Cancer | Phase 3 | China | 14 May 2025 | |
Adenocarcinoma of large intestine | Phase 3 | China | 09 May 2025 | |
Metastatic Colorectal Carcinoma | Phase 3 | China | 09 May 2025 | |
PD-L1 negative Triple Negative Breast Cancer | Phase 3 | China | 07 Feb 2025 |
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR-mutated | - | ivonescimab + chemotherapy | xkxaottjtw(jctdipctza) = the Phase III HARMONi-A trial met its OS goal, showing that ivonescimab. szawhgbmpp (fuoedkkods ) Met | Positive | 26 Aug 2025 | |
placebo + chemotherapy | |||||||
Phase 3 | - | ivonescimab +化疗 | agzkrzvhdm(dpcilojciv): 0.52 (95.0% CI, 0.41 - 0.66), P-Value = <0.00001 View more | Positive | 30 May 2025 | ||
化疗 | |||||||
Phase 2 | Unresectable Hepatocellular Carcinoma First line HBV infection | portal vein tumor thrombosis | extrahepatic spread | 27 | Ivonescimab + HAIC | btiixvoakn(cwpcxacuec) = lpfwlqvnqd bnzorztufe (mqyhtucule ) View more | Positive | 30 May 2025 | |
Phase 3 | metastatic non-small cell lung cancer First line | Maintenance | 1,080 | Ivonescimab plus chemotherapy | swvwktxbdy(evrdadjkml) = jmqonvzgjf iwfnrzhrre (oasmkirisz ) View more | Positive | 30 May 2025 | |
Pembrolizumab plus chemotherapy | swvwktxbdy(evrdadjkml) = xeudvelqvh iwfnrzhrre (oasmkirisz ) View more | ||||||
Phase 3 | Squamous non-small cell lung cancer First line | 532 | ivonescimab + chemotherapy | duodrfufhr(awuyzbquan) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). wwutbgxyrp (kzzfrqcwle ) Met View more | Superior | 22 Apr 2025 | |
tislelizumab + chemotherapy | |||||||
NEWS Manual | Phase 2 | Resectable Lung Non-Small Cell Carcinoma Neoadjuvant | - | 伊沃西单抗 20 mg/kg (队列1) | ivjvclitrl(bziurymokr) = jgwewpaznw ujjhngjmzq (bpasipmevn ) View more | Positive | 20 Jan 2025 |
伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗 (队列2) | ivjvclitrl(bziurymokr) = arfzftbxcs ujjhngjmzq (bpasipmevn ) View more | ||||||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 322 | Ivonescimab (Ivo) + Pemetrexed/Carboplatin | rbmpoewnyq(akfmznqjwu) = yfjhpqigds xmlmbkhgrc (erhnkuwdyn ) View more | Positive | 12 Dec 2024 | |
Placebo + Pemetrexed/Carboplatin | rbmpoewnyq(akfmznqjwu) = jshiytwdcv xmlmbkhgrc (erhnkuwdyn ) View more | ||||||
NCT05227664 (SABCS2024) Manual | Phase 2 | Triple Negative Breast Cancer First line | 30 | qogmgretcs(conwvrvsox) = aejfrrxflb tbllvdwkkm (quoqsrwytv ) View more | Positive | 26 Nov 2024 | |
(PD-L1 CPS ≥10) | qogmgretcs(conwvrvsox) = cdochxngxl tbllvdwkkm (quoqsrwytv ) View more | ||||||
NCT05227664 (ESMO2024) Manual | Phase 2 | 30 | qvfviybatw(yjrazzjfds) = jvntmvhjza dicjfafquj (kjcxqhmqul ) View more | Positive | 16 Sep 2024 | ||
qvfviybatw(yjrazzjfds) = uenwglwxma dicjfafquj (kjcxqhmqul ) View more | |||||||
NCT05229497 (ESMO2024) Manual | Phase 2 | 30 | Ivonescimab monotherapy | ojlvtbyvhk(bksrqpwmjm) = svqmewrsjm bglavizpfk (klknxfndmz ) View more | Positive | 14 Sep 2024 | |
ojlvtbyvhk(bksrqpwmjm) = xxpzivxvan bglavizpfk (klknxfndmz ) View more |