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Henlius' Serplulimab (anti-PD-1 mAb) Granted Breakthrough Therapy Designation by China NMPA for Neo-/Adjuvant Treatment for Gastric Cancer
Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, Hetronifly® in Europe), in combination with chemotherapy for neo-/adjuvant treatment for gastric cancer, has been officially granted the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks the first gastric cancer perioperative drug to receive the CDE's BTD. Previ
About this update from Shanghai Henlius Biotech, Inc. Class H
[{"type":"list","items":[{"val":[{"type":"text","content":"The first CDE-designated Breakthrough Therapy for perioperative gastric cancer, promising accelerated patient access.","length":117,"tagName":"p"}]},{"val":[{"type":"text","content":"The world's first gastric cancer perioperative regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting has met primary endpoints in its phase 3 clinical trial, significantly reducing recurrence risk and improving cure rates. ","length":252,"tagName":"p"}]},{"val":[{"type":"text","content":"No immunotherapy has been approved globally for gastric cancer perioperative treatment – HANSIZHUANG is poised to address this unmet medical need.","length":146,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":515,"olType":false},{"type":"text","content":"SHANGHAI, Nov. 20, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed innovative anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, Hetronifly® in Europe), in combination with chemotherapy for neo-/adjuvant treatment for gastric cancer, has been officially granted the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks the first gastric cancer perioperative drug to receive the CDE's BTD. Previously, the phase 3 clinical trial of this therapy met its primary endpoints. As the world's first perioperative gastric cancer treatment regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting, it demonstrates potential to deliver dual breakthroughs in survival benefits and quality of life for patients.","length":876,"tagName":"p"},{"type":"text","content":"In accordance with the relative measures of Administration of Drug Registration and the Announcement of the NMPA on the Release of Three Documents including the Working Procedures for Review of Breakthrough Therapeutics (Trial) (No. 82 of 2020), the BTD procedure is designed to expedite the development and review of therapies that are intended for treatment of a seriously debilitating or life-threatening condition for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options. According to the CDE, drug candidates with BTD may...