Ngalaba Mba Nile

Na Machị 21, 2025, Junshi Biosciences kwupụtara na National Medical Products Administration ("NMPA") akwadola ngwa ọgwụ ọhụrụ agbakwunyere ("sNDA") maka ngwaahịa ụlọ ọrụ ahụ, toripalimab, yana bevacizumab maka ọgwụgwọ mbụ nke enweghị ike iwepụ ma ọ bụ metastatic...GỤKWUO»

Na Machị 21, 2025, kwupụtara na enyerela ikike maka ojiji ọgwụ ọhụrụ ("NDA") maka TAZVERIK® (tazemetostat) na China maka ọgwụgwọ ndị okenye nwere ọrịa lymphoma follicular relapse ma ọ bụ refractory ("R/R") (FL) nwere mgbanwe EZH2 ndị natara opekata mpe abụọ tupu ...GỤKWUO»

Na Machị 10, 2025, Sichuan Kelun-Biotech kwupụtara na National Medical Products Administration (NMPA) kwadoro ọgwụ mgbochi trophoblast cell-surface antigen 2 (TROP2) nke ụlọ ọrụ ahụ na-eduzi antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, nke bụbu SKB264/MK-2870) maka ahịa...GỤKWUO»

Na Machị 18, 2025, Alphamab Oncology kwupụtara na e nyela ọgwụ mgbochi HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 Breakthrough Therapy Nhọpụta site na Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA). Nhọpụta a bụ maka ọgwụgwọ nke ...GỤKWUO»

Na Machị 10, 2025, Hansoh Pharma kwupụtara na National Medical Products Administration nke China ("NMPA") akwadola ojiji ọgwụ ọhụrụ nke atọ ("NDA") nke ọgwụ ọhụrụ nke otu Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) maka ọgwụgwọ ndị ọrịa nwere...GỤKWUO»

Na Machị 12, 2025, Zai Lab Limited kwupụtara na National Medical Products Administration (NMPA) nke China anabatala Ngwa ikike Biologics (BLA) maka TIVDAK (tisotumab vedotin-tftv) maka ọgwụgwọ nke ndị ọrịa nwere kansa cervical ugboro ugboro ma ọ bụ nke na-agbasa site na ọrịa na-aga n'ihu na...GỤKWUO»

Na Machị 5, 2025, Ascentage Pharma kwupụtara na Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) nke China enyela ọgwụ ya, olverembatinib, aha ọgwụgwọ Breakthrough (BTD), maka njikọta ya na obere chemotherapy maka nke mbụ...GỤKWUO»

Na Machị 4, 2025, BeiGene kwupụtara na US Food and Drug Administration (FDA) akwadola TEVIMBRA (tislelizumab-jsgr), yana ọgwụ chemotherapy nwere platinum, maka ọgwụgwọ mbụ nke ndị toro eto nwere ọrịa kansa squamous cell esophageal nke a na-apụghị ịgbasa ma ọ bụ metastatic (ESCC) nke ...GỤKWUO»

Na Febụwarị 25, 2025, Ụlọ Ọrụ Nlekọta Ngwaahịa Ahụike Mba nke China (NMPA) akwadola finotonlimab yana SCT510 maka ọgwụgwọ nke kansa imeju na-enweghị ike iwepụ ma ọ bụ nke na-anaghị enweta ọgwụgwọ sistemu mbụ. Finotonlimab bụ IgG4 nke a na-agbanwe agbanwe...GỤKWUO»

Na Febụwarị 8, 2025, National Medical Products Administration (NMPA) nke China akwadola finotonlimab nke Sinocelltech Group Ltd, nke bụ usoro ọgwụgwọ monoclonal antibody (mAb) nke a na-akpọ programmed-death 1 (PD-1), maka iji ya na ọgwụ chemotherapy nke dabeere na platinum dị ka ọgwụgwọ mbụ maka ọgwụgwọ ugboro ugboro na/ma ọ bụ metas...GỤKWUO»

Na Febụwarị 21, 2025, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) enyela Breakthrough Therapy Nomination (BTD) maka Satri-cel(CT041) (onye nwere ike itinye aka na CAR T-cell megide Claudin18.2), maka afọ ime afọ/esophagogastric dị elu...GỤKWUO»

Na Febụwarị 22, 2025, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) anabatala Ngwa Ọgwụ Ọhụrụ (NDA) maka ịgba ọgwụ ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) ma nye ya aha Priority Review na com...GỤKWUO»