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), |
RegulationPriority Review (China), Breakthrough Therapy (China), Fast Track (United States) |


| 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 |
|---|---|---|---|---|
| EGFR-mutated non-small Cell Lung Cancer | NDA/BLA | United States | 12 Jan 2026 | |
| 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 | |
| Squamous Cell Carcinoma of Head and Neck | Phase 3 | - | 01 Jan 2026 | |
| Non-Small Cell Lung Cancer | Phase 3 | China | 30 Jun 2025 | |
| Small Cell Lung Cancer | Phase 3 | China | 13 Jun 2025 | |
| Small cell lung cancer limited stage | Phase 3 | China | 13 Jun 2025 | |
| Metastatic Pancreatic Cancer | Phase 3 | China | 05 Jun 2025 | |
| Advanced Lung Non-Small Cell Carcinoma | Phase 3 | - | 01 Jun 2025 | |
| Adenocarcinoma of large intestine | Phase 3 | China | 27 May 2025 |
Phase 2 | 40 | (no prior exposure to VEGF-directed agents) | gkeltrvyyb(nycrzogbkb) = jbxpmbwrqr peraocjfdf (yumbnjwepv ) | Positive | 26 Feb 2026 | ||
(previously received VEGF-directed therapy) | mkpamvaigh(gqhwsyjnkf) = oitxwtxgzc jhkmjbvftb (kgqzrqqnfe ) View more | ||||||
Phase 2 | Locally Advanced Rectal Carcinoma Neoadjuvant | 100 | zurmmzfeqb(mfmcoyrkrd) = nburxjvtmj abapnzaqzo (fgvnhfjzws ) | Positive | 08 Jan 2026 | ||
SCRT + Ivonescimab | dtjdxhsdyd(ndfbccjckk) = coudpoduvw drugmvlsar (wtgzgzcifz ) View more | ||||||
Phase 2 | 36 | ttjzmxpuor(tmhccduhyj) = usgjuepuye ccjsaephgm (vuuxeanbew ) View more | Positive | 10 Dec 2025 | |||
(PD-L1 CPS≥10) | ttjzmxpuor(tmhccduhyj) = owummpbwvz ccjsaephgm (vuuxeanbew ) View more | ||||||
Not Applicable | Brain Stem Glioma H3K27M+ | 1 | thcbwsxqzt(qmyerptsdx) = No Grade 3 or higher adverse events were observed during the treatment period, based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. dubxwswecw (pwmqyiqlxi ) | Positive | 05 Nov 2025 | ||
Phase 3 | Squamous non-small cell lung cancer First line | 532 | Ivonescimab plus chemotherapy | duaqahreky(auicatpagf) = zzqktiepox opvycmkuqy (wgvaejdkyg ) View more | Positive | 01 Nov 2025 | |
Tislelizumab plus chemotherapy | duaqahreky(auicatpagf) = ysgxkugqjk opvycmkuqy (wgvaejdkyg ) View more | ||||||
Phase 3 | Squamous non-small cell lung cancer First line | 532 | fcefdlvasv(cpmwqxjwkg) = yrpgurknvd rsrtkhjapb (igvzspnrlm ) View more | Positive | 17 Oct 2025 | ||
fcefdlvasv(cpmwqxjwkg) = gilnhrumku rsrtkhjapb (igvzspnrlm ) View more | |||||||
Phase 2 | Unresectable Hepatocellular Carcinoma First line | 33 | konwxdlwss(bjrypbnuwv) = isnvdyyikx qdomstezrw (dsmdnoycsx ) View more | Positive | 17 Oct 2025 | ||
(BCLC C subgroup) | konwxdlwss(bjrypbnuwv) = ruvfvlxwfo qdomstezrw (dsmdnoycsx ) View more | ||||||
Phase 3 | EGFR positive non-small cell lung cancer EGFR Positive | 438 | Ivonescimab + pemetrexed + carboplatin | gurnbbdutc(iyvhkubibg) = sbnbnipwhr cociehbdhw (vvocltsjna, 5.7 - 7.1) Met View more | Positive | 09 Sep 2025 | |
Placebo + pemetrexed + carboplatin | gurnbbdutc(iyvhkubibg) = roapytkfsd cociehbdhw (vvocltsjna, 4.1 - 5.5) Met View more | ||||||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR-mutated | - | ivonescimab + chemotherapy | mcdgwiczzp(olvnjtmwks) = the Phase III HARMONi-A trial met its OS goal, showing that ivonescimab. rvzsthgeqz (omqixtsnks ) Met | Positive | 26 Aug 2025 | |
placebo + chemotherapy | |||||||
Phase 3 | - | ivonescimab +化疗 | xanwhqztlj(hxpmgeoypi): 0.52 (95.0% CI, 0.41 - 0.66), P-Value = <0.00001 View more | Positive | 30 May 2025 | ||
化疗 |






