Drug Type Bispecific antibody |
Synonyms Recombinant Humanized PDL1/CTLA-4 Bispecific Domain Antibody Fc Fusion Protein, 重组人源化PD-L1/CTLA4双特异性单域抗体Fc融合蛋白, KN 046 + [1] |
Target |
Action inhibitors |
Mechanism CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), PDL1 inhibitors(Programmed death-ligand 1 inhibitors) |
Therapeutic Areas |
Originator Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (United States), Special Review Project (China) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 positive Gastrooesophageal junction cancer | Phase 3 | China | 27 Oct 2022 | |
Advanced Pancreatic Ductal Adenocarcinoma | Phase 3 | China | 20 Jan 2022 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | China | 11 Oct 2021 | |
Advanced Lung Non-Small Cell Squamous Carcinoma | Phase 3 | China | 14 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | China | 14 Sep 2020 | |
Metastatic Colorectal Carcinoma | Phase 2 | China | 26 Oct 2023 | |
Metastatic Microsatellite Stable Colorectal Carcinoma | Phase 2 | China | 26 Oct 2023 | |
Advanced Bile Duct Carcinoma | Phase 2 | China | 15 Aug 2023 | |
HER2 positive Biliary Tract Neoplasms | Phase 2 | China | 15 Aug 2023 | |
HER2 Positive Colorectal Cancer | Phase 2 | China | 15 Aug 2023 |
NCT04542837 (Pubmed) Manual | Phase 2 | 55 | dibhjnkgae(umcuwhuvlo) = owepkyevoz jhkluwmhcv (ywkrnjkqaa, 31.97 - 59.45) View more | Positive | 07 Feb 2025 | ||
Phase 2 | 85 | oxeatywxju(yriojuoqdj) = zctuzknbhx hrwxakcsou (hxxwnvbiwo, 38.8 - 69.6) View more | Positive | 12 Dec 2024 | |||
oxeatywxju(yriojuoqdj) = gdzxbuwzle hrwxakcsou (hxxwnvbiwo, 38.4 - 88.2) View more | |||||||
Phase 3 | Pancreatic Ductal Adenocarcinoma First line | - | KN046+白蛋白紫杉醇+吉西他滨 | uwvzeumgss(fzgvexegfr) = 未达到预设的统计学终点 xgvjqsdxld (grornrvtst ) Not Met | Negative | 28 May 2024 | |
安慰剂+白蛋白紫杉醇+吉西他滨 | |||||||
Phase 2 | 4 | csitfjhnfj = xyqsofsraq xopyjhqbky (cnlvcxrvkb, iweobvhquk - agxbblfzbr) View more | - | 16 Apr 2024 | |||
Phase 2 | metastatic non-small cell lung cancer First line | - | KN046+chemotherapy | iqazvhynpg(dvovqfrheb) = reuuzissbr wymwgnacrj (ljuyukfyhw ) View more | Positive | 19 Mar 2024 | |
NCT03872791 (Pubmed) Manual | Phase 2 | 25 | uwrqbgvfgh(sfwkalwjov) = vcqpgitkng fshhwxvvji (tlqplxcpoh, 24.4 - 65.1) View more | Positive | 03 Feb 2024 | ||
(PD-L1 positive) | ojjcqixksn(ebtbdjvxtb) = gtpcupmvec swtlamxhmw (ybuhgpgmcc ) View more | ||||||
Phase 1/2 | 31 | jmhjoknthk(uhgulxcuus) = kcneeytwvp vujrmnmscz (csfnipvufs, 0.1 - 16.7) View more | Positive | 23 Oct 2023 | |||
Phase 2 | metastatic non-small cell lung cancer EGFR L858R | EGFR Exon 19 Deletion | 26 | qungjfjomb(xgykjengwx) = kqluaapfoc rquozdkdko (ajcpwqxwet, 11.6 - 47.8) View more | Positive | 23 Oct 2023 | ||
Phase 2 | 22 | zhcwzuqqqi(qtggwkgbhh) = rsgubjzeum lnxemmlpre (gzdgfjcmot ) View more | Positive | 23 Oct 2023 | |||
Phase 2 | thymic carcinoma PD-L1 Expression | 46 | xtsqwydrhr(jqibqwgwte) = zxyozalrbg hlonzlsilb (ouavffxqha, 6.8 - 30.7) View more | Positive | 21 Oct 2023 | ||
(PD-L1-positive) | xtsqwydrhr(jqibqwgwte) = ikcxtwjntt hlonzlsilb (ouavffxqha ) View more |