Shanghai Henlius Biotech Receives Breakthrough Therapy Designation for HANSIZHUANG in Gastric Cancer
Shanghai Henlius Biotech Inc. announced that its product HANSIZHUANG (serplulimab injection), in combination with chemotherapy, has been officially granted Breakthrough Therapy Designation by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the neo-/adjuvant treatment of gastric cancer. This designation is expected to accelerate the regulatory review and market approval process for HANSIZHUANG. As of the announcement date, no other monoclonal antibody drug targeting PD-1 has received global approval for this indication. There is no indication that this grant was obtained by multiple organizations; it is specific to Shanghai Henlius Biotech Inc.
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