HENLIUS (02696): NDA for Hansizhuang® Combined with Chemotherapy in Gastric Cancer Neoadjuvant/Adjuvant Therapy Accepted by NMPA and Included in Priority Review

Stock News12-12

HENLIUS (02696) announced that the New Drug Application (NDA) for its self-developed Hansizhuang® (serplulimab injection) combined with platinum-based chemotherapy as neoadjuvant and adjuvant therapy for PD-L1-positive, resectable gastric cancer patients has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The application has been included in the priority review process, which will accelerate its approval timeline.

The NDA submission for this new indication of Hansizhuang® is primarily based on a randomized, double-blind, multicenter Phase 3 clinical study evaluating the efficacy and safety of Hansizhuang® plus chemotherapy versus placebo plus chemotherapy in neoadjuvant/adjuvant treatment for gastric cancer. Results demonstrated that Hansizhuang® combined with chemotherapy significantly prolonged event-free survival (EFS) compared to the placebo group, meeting the pre-specified superiority criteria. Additionally, the treatment showed better safety and tolerability than chemotherapy alone.

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