ISebe leHlabathi

Ngomhla we-17 kweyeKhala, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba isicelo sokuthengisa seTrastuzumab Deruxtecan (i-Enhertu®) sonyango lomhlaza wesisu lodidi lwesibini samkelwe ngokusesikweni yi-NMPA. Esi sicelo si...Funda ngokugqithisileyo»

Kutshanje, i-Ascentage Pharma ibhengeze ukuba i-Bcl-2 selective inhibitor lisaftoclax (APG-2575) yayo entsha ivunyiwe yi-National Medical Products Administration (NMPA) yaseTshayina ukuze inyange izigulane zabantu abadala abane-chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...Funda ngokugqithisileyo»

Kutshanje, iGenFleet Therapeutics ibhengeze ukuba i-Pharmaceutical Administration Bureau (ISAF) yeMacau Special Administrative Region yaseTshayina ivumile iDupert® (fulzerasib, GFH925/IBI351) yokunyanga izigulana ezine-advanced non-small cell lung cancer (NSCLC) ezine-KRAS G12C mutati...Funda ngokugqithisileyo»

Ngomhla wama-30 kuJuni, i-Avistone's ezimeleyo's MET inhibitor Vebreltinib yafumana imvume emiselweyo kwi-National Medical Products Administration (NMPA) yaseTshayina yokunyanga izigulane ezinesifo somhlaza wamaphaphu esingesincinci (NSCLC) esiqhubekekayo okanye esisasazekileyo esibangela i-MET amplifies...Funda ngokugqithisileyo»

Ngomhla wama-30 kweyeSilimela, ngo-2025, iHUTCHMED ibhengeza ukuba iSicelo seMithi emitsha (NDA) sokudityaniswa kwe-ORPATHYS (savolitinib) kunye neTAGRISSO (osimertinib) sivunyiwe yi-China National Medical Products Administration (NMPA) yokunyanga izigulane ezine-metastasis...Funda ngokugqithisileyo»

Ngomhla wama-30 kuJuni, iwebhusayithi esemthethweni ye-National Medical Products Administration (NMPA) ibhengeze ukuba i-Anlotinib, iyeza elitsha leKlasi 1 elenziwe yiChia Tai Tianqing, lifumene imvume yesalathiso esitsha eTshayina: unyango oludibeneyo kunye ne-chemotherapy kunyango lokuqala lwezigulane ...Funda ngokugqithisileyo»

Ngomhla wama-26 kuJuni, ngo-2025, i-CARsgen ibhengeza ukuba i-National Medical Products Administration (NMPA) yaseTshayina iyamkele iSicelo seMithi emitsha (NDA) se-satricabtagene autoleucel (“satri-cel”, CT041) (imveliso ye-CAR T-cell echasene ne-protein Claudin18.2) yonyango lwe-Claudi...Funda ngokugqithisileyo»

Ngomhla we-19 kuJuni, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba inaliti ye-LM-108 yeLivzon Pharmaceutical icetyisiwe ukuba ifakwe kunyango oluphambili. Udibaniso lwe-Kefeqibai monoclonal antibody injection (LM-1...Funda ngokugqithisileyo»

Ngomhla we-19 kuJuni, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba i-IBI343 ye-Innovent Biologics icetyisiwe ukuba ifakwe kwinkqubo yokuchonga unyango oluphumelelayo, ejoliswe kunyango lwe-pan ephucukileyo okanye eguqukileyo...Funda ngokugqithisileyo»

Ngomhla wesi-6 kweyeSilimela, ijenali yezonyango yamazwe ngamazwe iJournal of Hematology & Oncology yapapasha iziphumo zophando lwesigaba soku-1/II (KL264-01/MK-2870-001) lwe-TROP2 ADC sacituzumab tirumotecan (sac-TMT) entsha njengonyango olulodwa lwe-tumor eqinileyo engenakucocwa ekwindawo okanye eguqukileyo echasene ne-s...Funda ngokugqithisileyo»

Ngomhla we-10 kweyeSilimela, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba iTrastuzumab Deruxtecan (T-DXd, DS-8201a) icetywayo ukuba inikwe uphononongo oluphambili kunyango lwezigulane zabantu abadala abane-HER2-positive gastric osteoarthritis ephucukileyo okanye esasazekileyo...Funda ngokugqithisileyo»

Kutshanje, iMerck & Co., Inc. (Merck) ibhengeze ukuba i-PD-1 inhibitor yayo, i-pembrolizumab, ivunyiwe yiNational Medical Products Administration (NMPA) yaseTshayina ukuba isetyenziswe kunye ne-lenvatinib kunye ne-transarterial chemoembolization (TACE) kunyango lwezigulane ezingenazo iintsholongwane...Funda ngokugqithisileyo»