UMnyango Wezizwe Zonke

NgoMashi 21, 2025, i-Junshi Biosciences yamemezela ukuthi i-National Medical Products Administration (“NMPA”) ivumile isicelo esisha somuthi esengeziwe (“sNDA”) somkhiqizo wenkampani, i-toripalimab, kanye ne-bevacizumab yokwelashwa kokuqala kwemithi engasuswa noma esakazeka...Funda kabanzi»

NgoMashi 21, 2025, imemezela ukuthi i-New Drug Application (“NDA”) ye-TAVERIK® (tazemetostat) inikezwe imvume enemibandela eShayina yokwelapha iziguli ezindala ezine-follicular lymphoma (“FL”) ephinde yagula noma engaphili kahle (“R/R”) ene-EZH2 mutation ezithole okungenani ama-2 ngaphambilini ...Funda kabanzi»

NgoMashi 10, 2025, uSichuan Kelun-Biotech wamemezela ukuthi i-trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, eyayiyi-SKB264/MK-2870) yeNkampani ivunyelwe ukumaketha yi-National Medical Products Administration (NMPA...Funda kabanzi»

NgoMashi 18, 2025, i-Alphamab Oncology yamemezela ukuthi i-anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 inikezwe i-Breakthrough Therapy Designation yi-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA). Lesi sikhundla singesokwelashwa kwe ...Funda kabanzi»

NgoMashi 10, 2025, iHansoh Pharma yamemezela ukuthi i-New Drug Application yesithathu (“NDA”) yesidakamizwa esisha seQembu i-Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) ivunyiwe yi-National Medical Products Administration of China (“NMPA”) yokwelapha iziguli ezine-advanced center...Funda kabanzi»

NgoMashi 12, 2025, iZai Lab Limited yamemezela ukuthi iNational Medical Products Administration (NMPA) yaseShayina isamukele isicelo selayisensi ye-Biologics (BLA) se-TIVDAK (tisotumab vedotin-tftv) sokwelapha iziguli ezinomdlavuza wesibeletho ophindaphindayo noma osakazekile onezifo eziqhubekayo...Funda kabanzi»

Ngomhlaka-5 Mashi 2025, i-Ascentage Pharma yamemezela ukuthi umuthi wayo, i-olverembatinib, unikezwe i-Breakthrough Therapy Designation (BTD) yi-Center for Drug Evaluation (CDE) ye-China's National Medical Products Administration (NMPA), ngokuhlanganiswa ne-chemotherapy enamandla aphansi kokwelashwa kokuqala...Funda kabanzi»

NgoMashi 4, 2025, i-BeiGene yamemezela ukuthi i-US Food and Drug Administration (FDA) ivumile i-TEVIMBRA(tislelizumab-jsgr), kanye ne-chemotherapy equkethe i-platinum, yokwelashwa kokuqala kwabantu abadala abane-carcinoma ye-squamous cell carcinoma (ESCC) engasuswa noma esakazeka kalula ...Funda kabanzi»

Ngomhlaka-25 kuNhlolanja 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-finotonlimab ngokuhlanganiswa ne-SCT510 ekwelapheni i-carcinoma yesibindi engasuswa noma esakazeka kalula engakaze ithole ukwelashwa kwesistimu ngaphambilini. I-Finotonlimab iyi-IgG4 ephinde yahlanganiswa...Funda kabanzi»

Ngomhlaka-8 kuNhlolanja 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-finotonlimab ye-Sinocelltech Group Ltd, i-programmed-death 1 (PD-1) monoclonal antibody (mAb), ukuze isetshenziswe kanye ne-chemotherapy esekelwe eplatinum njengokwelashwa kokuqala kwezifo eziphindaphindayo kanye/noma ama-meta...Funda kabanzi»

Ngomhlaka-21 kuNhlolanja 2025, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina inikeze i-Breakthrough Therapy Designation (BTD) ye-Satri-cel (CT041) (umkhiqizo we-CAR T-cell owuhlobo lwe-autologous ngokumelene ne-Claudin18.2), ye-advanced gastric/esophagogastric jun...Funda kabanzi»

Ngomhlaka-22 kuNhlolanja 2025, i-New Drug Application (NDA) yomjovo we-ipilimumab (anti-CTLA-4 monoclonal antibody; Ikhodi ye-R&D: IBI310) yamukelwe yi-Center for Drug Evaluation (CDE) ye-China's National Medical Products Administration (NMPA) futhi yanikezwa i-Priority Review position ku-com...Funda kabanzi»