China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved an open, multi-center Phase Ib/II clinical study of its fusion protein SHR-1701 combined with Ameile (aumolertinib) for EGFR-mutated recurrent or advanced non-small cell lung cancer (NSCLC).
Drug Profile
SHR-1701 targets PD-L1 and TGF-βRII, aiming to enhance T cell activation and improve tumor microenvironment immune regulation. Ameile is a third-generation, irreversible EGFR inhibitor selectively targeting mutant EGFR kinases. No similar product exists globally, though Merck’s fusion protein is in trials for advanced malignancies.
Clinical Trial Details
The study will evaluate SHR-1701 + Ameile in EGFR-mutated NSCLC patients. SHR-1701 is also in trials for nasopharyngeal, cervical, non-squamous NSCLC, and colorectal cancers, either alone or with bevacizumab, famitinib, and others.-Fineline Info & Tech
