Henlius ：Hetronifly®Serplulimabreceived marketing approval

On June 9, the NMPA official website showed that a new indication for Henlius’ PD-1 monoclonal antibody Serplulimab has been approved for marketing — in combination with oxaliplatin and tegafur/gimeracil/oteracil for neoadjuvant treatment of resectable gastric cancer with tumor PD-L1 expression CPS ≥5, followed by single-agent adjuvant therapy after surgery. This application had previously received dual designations from the CDE for Breakthrough Therapy and Priority Review. With this approval, Serplulimab becomes the first PD-(L)1 monoclonal antibody in China approved for perioperative treatment of gastric cancer, offering a new treatment option beyond chemotherapy for this patient population.

Serplulimab (H drug) is a PD-1 monoclonal antibody with a differentiated mechanism independently developed by Henlius. It not only exhibits stronger PD-1 internalization, reducing PD-1 receptors on the T cell surface to achieve rapid and potent immune activation, but also reduces PD-1 recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling to a greater extent, enhancing downstream AKT protein activity, and promoting sustained T cell activation.

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