Antengene Wins China IND Approval for ATG-022 Combo Study with Keytruda
Antengene Corporation Limited has received approval from China's NMPA for its IND application to conduct a Phase Ib/II clinical study. The study will test ATG-022, a CLDN18.2 antibody-drug conjugate, in combination with KEYTRUDA and chemotherapy. This approval enables Antengene to begin clinical trials in China.
Antengene Corporation Limited announced that the China National Medical Products Administration (NMPA) has approved its investigational new drug (IND) application for a Phase Ib/II clinical study. The study will evaluate ATG-022, a CLDN18.2 antibody-drug conjugate, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as well as in combination with pembrolizumab and chemotherapy. This regulatory approval allows Antengene to proceed with clinical testing of these combinations in China. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Antengene Corporation Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251202-11939160), on December 02, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
