ISebe leHlabathi

Ngomhla wama-21 kuMatshi 2025, iJunshi Biosciences yabhengeza ukuba iNational Medical Products Administration (“NMPA”) ivumile isicelo esitsha esongezelelweyo samayeza (“sNDA”) kwimveliso yenkampani, i-toripalimab, kunye ne-bevacizumab kunyango lokuqala lwe-non-recovery okanye i-metastatic...Funda ngokugqithisileyo»

Ngomhla wama-21 kuMatshi 2025, ibhengeza ukuba iSicelo esitsha seMithi (“NDA”) seTAZVERIK® (tazemetostat) sinikwe imvume emiselweyo eTshayina yokunyanga izigulane zabantu abadala abane-relapse okanye refractory (“R/R”) follicular lymphoma (“FL”) abane-EZH2 mutation abafumene ubuncinci ezimbini ngaphambili ...Funda ngokugqithisileyo»

Ngomhla we-10 kweyoKwindla, ngowama-2025, uSichuan Kelun-Biotech wabhengeza ukuba i-trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, eyayisakuba yi-SKB264/MK-2870) yeNkampani ivunyiwe ukuba ithengiswe yiNational Medical Products Administration (NMPA...Funda ngokugqithisileyo»

Ngomhla we-18 kweyoKwindla, ngo-2025, i-Alphamab Oncology yabhengeza ukuba i-anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 inikwe iBreakthrough Therapy Designation yiZiko loVavanyo lwaMayeza (CDE) leSizwe leeMveliso zezoNyango (i-NMPA). Eli gama lelokunyanga ...Funda ngokugqithisileyo»

Ngomhla we-10 kweyoKwindla, ngo-2025, iHansoh Pharma yabhengeza ukuba isicelo sesithathu esitsha seziyobisi (“NDA”) seyeza elitsha leQela i-Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) sivunyiwe yiNational Medical Products Administration yaseTshayina (“NMPA”) kunyango lwezigulane ezine-advanced clinic...Funda ngokugqithisileyo»

Ngomhla we-12 kweyoKwindla, ngo-2025, iZai Lab Limited yabhengeza ukuba i-National Medical Products Administration (NMPA) yaseTshayina isamkele isicelo seLayisensi yeBiologics (BLA) ye-TIVDAK (tisotumab vedotin-tftv) yokunyanga izigulana ezinomhlaza wesibeleko ophindaphindayo okanye osasazekayo onesifo esiqhubekekayo...Funda ngokugqithisileyo»

Ngomhla wesi-5 kweyoKwindla, ngo-2025, i-Ascentage Pharma yabhengeza ukuba iyeza layo, i-olverembatinib, linikwe iBreakthrough Therapy Designation (BTD) yiZiko loVavanyo lwaMayeza (i-CDE) le-China's National Medical Products Administration (i-NMPA), ukuze lidityaniswe ne-chemotherapy engaphantsi kwamandla onyango lokuqala...Funda ngokugqithisileyo»

Ngomhla wesi-4 kweyoKwindla, ngo-2025, iBeiGene yabhengeza ukuba i-US Food and Drug Administration (FDA) iyamkele i-TEVIMBRA(tislelizumab-jsgr), kunye ne-chemotherapy equlethe iplatinum, kunyango lokuqala lwabantu abadala abane-carcinoma ye-squamous cell carcinoma engasuswayo okanye esasazekayo (ESCC) aba ...Funda ngokugqithisileyo»

Ngomhla wama-25 kuFebruwari, ngo-2025, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-finotonlimab kunye ne-SCT510 kunyango lwe-carcinoma ye-hepatocellular engasuswayo okanye esasazekayo engakhange ifumane unyango lwenkqubo yangaphambili. I-Finotonlimab yi-IgG4 ehlanganisiweyo eyenziwe yangumntu...Funda ngokugqithisileyo»

Ngomhla wesi-8 kuFebruwari 2025, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-finotonlimab yeSinocelltech Group Ltd, i-programmed-death 1 (PD-1) monoclonal antibody (mAb), ukuba isetyenziswe kunye ne-chemotherapy esekelwe kwi-platinum njengonyango lokuqala lwe-recurrent kunye/okanye i-metastases...Funda ngokugqithisileyo»

Ngomhla wama-21 kuFebruwari, ngo-2025, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) yaseTshayina linike iBreakthrough Therapy Designation (BTD) ye-Satri-cel (CT041) (imveliso ye-CAR T-cell emelene ne-Claudin18.2), ye-advanced gastric/esophagogastric jun...Funda ngokugqithisileyo»

Ngomhla wama-22 kuFebruwari, ngo-2025, isicelo esitsha seziyobisi (NDA) sokufakwa kwe-ipilimumab (i-anti-CTLA-4 monoclonal antibody; ikhowudi ye-R&D: IBI310) samkelwe yiZiko loVavanyo lwaMayeza (CDE) le-China's National Medical Products Administration (NMPA) kwaye sanikwa i-Priority Review position kwi-com...Funda ngokugqithisileyo»