Antengene Corporation Limited (6996.HK) announced that the China National Medical Products Administration has approved its investigational new drug application to initiate the Phase Ib/II CLINCH-2 study. This trial will evaluate ATG-022 (a CLDN18.2 antibody-drug conjugate) in combination with MSD’s KEYTRUDA® (pembrolizumab), as well as in combination with pembrolizumab and chemotherapy.

According to Antengene, ATG-022 is part of the company’s global, R&D-driven pipeline, which spans from preclinical to commercial stages. The company reports having obtained 32 investigational new drug approvals in the U.S. and Asia. Its lead commercial asset, XPOVIO® (selinexor), has been approved in multiple markets including Mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, Indonesia, and Australia, and is incorporated into national insurance schemes in several of those markets.

The board of directors states that this newly approved study represents an important advancement in Antengene’s ongoing efforts to develop first-in-class or best-in-class therapeutics for diseases with substantial unmet medical needs, with the latest approval dated December 2, 2025.