Business
Antengene Announces IND Approval in China for Phase Ib/II Study of ATG-022 (CLDN18.2 ADC) in Combination with KEYTRUDA® (Pembrolizumab) ± Chemotherapy
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, today announced that the China National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for the Phase Ib/II CLINCH-2 study evaluating ATG-022 (
About this update from Antengene Corporation Limited
[{"type":"text","content":"SHANGHAI and HONG KONG, Dec. 2, 2025 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, today announced that the China National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for the Phase Ib/II CLINCH-2 study evaluating ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as well as ATG-022 in combination with pembrolizumab and chemotherapy.","length":795,"tagName":"p"},{"type":"image","alt":"Logo (PRNewsfoto/Antengene Corporation Limited)","displaySize":"","headline":null,"caption":"Logo (PRNewsfoto/Antengene Corporation Limited)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":170,"url":"https://media.zenfs.com/en/prnewswire.com/80e76465ee715e6705d5fcce90b9f583"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/5j2U0HrCj8zISzT4Iv1xLg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTMwMDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/80e76465ee715e6705d5fcce90b9f583","width":400,"height":170}},"href":"https://mma.prnewswire.com/media/2355066/ANTENGENE_EN_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"CLINCH-2 is a Phase Ib/II study that will be led by its principal investigator Prof. Lin Shen at Beijing Cancer Hospital, the lead trial center. The study is designed to evaluate two combination regimens in patients with CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1) unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC): ATG-022 in combination with pembrolizumab (A+P); and ATG-022 in combination with pembrolizumab plus the CAPOX chemotherapy regimen (A+P+C). The primary objective of the study is to assess the safety and tolerability of the two combination regimens, while the secondary objectives include evaluating the regimens' preliminary antitumor activity, assessing ATG-022's immunogenicity, and characterizing its pharmacokinetic (PK) profile.","length":820,"tagNam...