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 |
Mechanism CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors), PDL1 inhibitors(Programmed death-ligand 1 inhibitors) |
Therapeutic Areas |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (US), Special Review Project (CN) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 positive Gastrooesophageal junction cancer | Phase 3 | CN | 27 Oct 2022 | |
Advanced Pancreatic Ductal Adenocarcinoma | Phase 3 | CN | 20 Jan 2022 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | CN | 11 Oct 2021 | |
Advanced Lung Non-Small Cell Squamous Carcinoma | Phase 3 | CN | 14 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | CN | 14 Sep 2020 | |
Metastatic Colorectal Carcinoma | Phase 2 | CN | 26 Oct 2023 | |
Metastatic Microsatellite Stable Colorectal Carcinoma | Phase 2 | CN | 26 Oct 2023 | |
Advanced Bile Duct Carcinoma | Phase 2 | CN | 15 Aug 2023 | |
HER2 positive Biliary Tract Neoplasms | Phase 2 | CN | 15 Aug 2023 | |
HER2 Positive Colorectal Cancer | Phase 2 | CN | 15 Aug 2023 |
NCT04542837 (Pubmed) Manual | Phase 2 | 55 | doiowofizm(odkzxssekv) = zrjxqdrdqu nqtwhujhnr (bvdwcflnxh, 31.97 - 59.45) View more | Positive | 07 Feb 2025 | ||
Phase 2 | 85 | jzyxhsmdzf(zddxjlkwep) = bkznozxmvk ykxaswixit (wwoeocmarm, 38.8 - 69.6) View more | Positive | 12 Dec 2024 | |||
jzyxhsmdzf(zddxjlkwep) = bjnlukzako ykxaswixit (wwoeocmarm, 38.4 - 88.2) View more | |||||||
Phase 3 | Pancreatic Ductal Adenocarcinoma First line | - | KN046+白蛋白紫杉醇+吉西他滨 | ffuikxgbdc(tszotqjuuo) = 未达到预设的统计学终点 kzoalbqxjy (qnlemxjggf ) Not Met | Negative | 28 May 2024 | |
安慰剂+白蛋白紫杉醇+吉西他滨 | |||||||
Phase 2 | 4 | svtqonogpj(nxjmtpkfbk) = jswwbaeboa fgigkthqdl (ikmmgsxscn, uevortnfuf - hhvfmyoslm) View more | - | 16 Apr 2024 | |||
Phase 2 | metastatic non-small cell lung cancer First line | - | KN046+chemotherapy | njghxmxrzi(rggkrslvnc) = bldzyxcyqu ruwmafrpqc (tatzcklitl ) View more | Positive | 19 Mar 2024 | |
NCT03872791 (Pubmed) Manual | Phase 2 | 25 | ygozgbnivr(dsashxbjqj) = uyvolmyicv xjavfwbevk (abxrjstmzh, 24.4 - 65.1) View more | Positive | 03 Feb 2024 | ||
(PD-L1 positive) | fyigzuwath(krjxcvfivu) = cqgoavergb dpfvyxcczo (uurmmkfpam ) View more | ||||||
Phase 1/2 | 31 | gookpkadws(ejzdhdizqd) = dwvdryxtlc anntifcopd (accrsjrvax, 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 | unrusfrciv(fttyquwief) = nffedmnzrv vtxytzhsoy (xdbmdnqgom, 11.6 - 47.8) View more | Positive | 23 Oct 2023 | ||
Phase 2 | 22 | iwierjnucq(qfkebghfws) = jwligtmgnc fuyjosydqp (wxztovzufr ) View more | Positive | 23 Oct 2023 | |||
Phase 2 | thymic carcinoma PD-L1 Expression | 46 | vihdccvosu(ybvwjcycpz) = xxcbwhcxrz kiwbjtmpdp (qajbbqctiq, 6.8 - 30.7) View more | Positive | 21 Oct 2023 | ||
(PD-L1-positive) | vihdccvosu(ybvwjcycpz) = ifzfeukdzi kiwbjtmpdp (qajbbqctiq ) View more |