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The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review


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SHANGHAI, April 22, 2021 /PRNewswire/ Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy, has been accepted by the National Medical Products Administration (NMPA) and proposed to be granted priority review. Serplulimab is potentially to be the first anti-PD-1 mAb in MSI-H solid tumors in China. For this indication, patients are screened for specific MSI-H tumor markers, rather than classifying the tumor types, covering a wide range of cancer types. Henlius adopts the Combo+Global development strategy for serplulimab, focusing on indication differentiation and combination therapy, with a total of 10 clinical trials conducted worldwide. ....

United States , Josephl Leach , Wray Mcdermott , Michaelj Overman , Paoloa Asciert , Kalbe Genexine Biologics , Wenjie Zhang , Shukui Qin , Aurelien Marabelle , Prnewswire Shanghai Henlius Biotech Inc , European Union , Cancer Center , National Medical Products Administration , Drug Administration , Henlius Biotech , New Drug Application , Pprofessor Shukui Qin , Nanjing Jinling Hospital , Chief Executive Officer , Genexine Biologics , New Drug Applications , Manufacturing Practice , Cancer Res Clin , Microsatellite Instability High , Deficient Mismatch Repair , Solid Tumors ,