China’s NMPA has greenlit Suzhou Alphamab’s HER2 bispecific anbenitamab (KN-026) for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who progressed after at least one trastuzumab-containing regimen. The agency approved the antibody via priority review. The approval targets a defined biomarker-positive population and sets up competition in HER2-driven gastric cancer, where sequencing with chemotherapy and existing HER2-directed therapies will matter. Priority review also signals the regulator’s willingness to accelerate specific oncology bispecifics when evidence supports clinical benefit. In the US, Camurus received another FDA complete response letter for its monthly acromegaly drug candidate (CAM-2029, octreotide), following prior rejection rounds. The CRL marks a repeat denial for the subcutaneous extended-release program, extending the gap until the company can address the agency’s concerns for US approval.