CSPC Pharma HER2 BsAb Granted Priority Review in China

China-based CSPC Pharma's HER2 bispecific antibody (BsAb) anbenitamab has been granted priority review by China's Centre for Drug Evaluation (CDE) for treating HER2-positive gastric cancer after trastuzumab therapy failure. Originally developed by Chinese compatriot Alphamab Oncology, the drug binds two non-overlapping HER2 epitopes to achieve superior signal blockade versus trastuzumab-pertuzumab combinations. CSPC in-licensed China rights in 2021 and reported positive Phase II/III results in May 2025 showing significant progression-free survival (PFS) improvement over chemotherapy.

Anbenitamab joins Jazz Pharma/BeOne's zanidatamab as one of only five global HER2 bispecific candidates in clinical development. The priority designation accelerates regulatory review for CSPC's gastric cancer program, which could establish China's first approved HER2 bispecific therapy. Competing candidates include Chia Tai Tianqing's TQB2930 in Phase III and earlier-stage assets from Combio and Bao Pharma.

PharmCube's NextBiopharm® database shows that there are an additional four HER2 BsAb projects in pre-clinical stage. Click here to request a free trial for NextBiopharm®.

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