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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

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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United States , Josephl Leach , Wray Mcdermott , Michaelj Overman , Paoloa Asciert , Kalbe Genexine Biologics , Kostenloser Wertpapierhandel , 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 ,

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 ,

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

The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.

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 ,

Henlius Plans to File the NDA of Novel anti-PD-1 mAb HLX10 for the Treatment of MSI-H Solid Tumours, the Phase 2 Clinical Trial has Met the Primary Endpoint

Henlius Plans to File the NDA of Novel anti-PD-1 mAb HLX10 for the Treatment of MSI-H Solid Tumours, the Phase 2 Clinical Trial has Met the Primary Endpoint
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.

United States , Josephl Leach , Wray Mcdermott , Michaelj Overman , Paoloa Asciert , Kalbe Genexine Biologics , Shukui Qin , Aurelien Marabelle , Jin Li , Shanghai Henlius Biotech Inc , Hospital Of People Liberation Army , National Drug Products Administration , European Union , Drug Administration , Shanghai Tongji University , Shanghai Henlius Biotech , New Drug Application , Liberation Army , Shanghai East Hospital , Genexine Biologics , New Drug Applications , Manufacturing Practice , Cancer Res Clin , Microsatellite Instability High , Deficient Mismatch Repair , Solid Tumors ,