CSPC's KN026 new drug application accepted by China's NMPA

CSPC Pharmaceutical Group Limited announced that its new drug application for KN026 (Anbenitamab Injection) has been accepted by the National Medical Products Administration (NMPA) in China. This Class 1 therapeutic biological product, co-developed with CSPC Shanghai JMT-Bio Technology Co., Ltd. and Jiangsu Alphamab Oncology Co., Ltd., is for HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer patients who have failed prior systemic therapy.

The product previously received Breakthrough Therapy Designation on November 4, 2023, and Priority Review on August 28, 2025. This application is supported by a pivotal Phase II/III clinical trial (KC-WISE), which showed a 40.0% objective response rate, 8.6 months median progression-free survival, and 13.2 months median overall survival for KN026 in combination with chemotherapy, as assessed by the Independent Review Committee.

Interim analysis results from the Phase III clinical study indicated significant improvements in clinical efficacy, prolonging progression-free survival and overall survival compared to the current standard of care. The drug also demonstrated no new safety signals, low cardiotoxicity, and low immunogenicity. CSPC aims to benefit more patients, with the product’s development for gastric and breast cancer indications now in pivotal Phase III clinical trial stages.