Keʻena Honua

Ma Malaki 21, 2025, ua hoʻolaha ʻo Junshi Biosciences ua ʻāpono ka National Medical Products Administration (“NMPA”) i ka noi lāʻau lapaʻau hou (“sNDA”) no ka huahana o ka hui, ʻo toripalimab, i hui pū ʻia me bevacizumab no ka lāʻau lapaʻau laina mua o ka hiki ʻole ke hoʻopau ʻia a i ʻole ka metastatic...E heluhelu hou aku»

Ma Malaki 21, 2025, hoʻolaha ʻia ua hāʻawi ʻia ka ʻae ʻia ʻana o ka New Drug Application ("NDA") no TAZVERIK® (tazemetostat) ma Kina no ka mālama ʻana i nā maʻi makua me ka lymphoma follicular relapsed a refractory paha ("R/R") ("FL") me ka mutation EZH2 i loaʻa ma ka liʻiliʻi he ʻelua ma mua ...E heluhelu hou aku»

Ma Malaki 10, 2025, ua hoʻolaha ʻo Sichuan Kelun-Biotech ua ʻāpono ʻia ka trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, ʻo SKB264/MK-2870 ma mua) no ke kūʻai aku ʻana e ka National Medical Products Administration (NMPA...E heluhelu hou aku»

Ma Malaki 18, 2025, ua hoʻolaha ʻo Alphamab Oncology ua hāʻawi ʻia ka anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 i ka Breakthrough Therapy Designation e ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA). ʻO ke koho ʻana no ka mālama ʻana i ...E heluhelu hou aku»

Ma Malaki 10, 2025, ua hoʻolaha ʻo Hansoh Pharma i ke kolu o ka Noi Lāʻau Lapaʻau Hou ("NDA") o ka lāʻau lapaʻau hou a ka Hui ʻo Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) i ʻāpono ʻia e ka National Medical Products Administration of China ("NMPA") no ka mālama ʻana i nā maʻi me ka holomua kūloko,...E heluhelu hou aku»

Ma Malaki 12, 2025, ua hoʻolaha ʻo Zai Lab Limited ua ʻae ka National Medical Products Administration (NMPA) o Kina i ka Biologics License Application (BLA) no TIVDAK (tisotumab vedotin-tftv) no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai cervical recurrent a metastatic paha me ka holomua o ka maʻi ma...E heluhelu hou aku»

Ma Malaki 5, 2025, ua hoʻolaha ʻo Ascentage Pharma ua hāʻawi ʻia kāna lāʻau lapaʻau, ʻo olverembatinib, i kahi Breakthrough Therapy Designation (BTD) e ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina, no ka hui pū ʻana me ka chemotherapy haʻahaʻa no ka mua-...E heluhelu hou aku»

Ma Malaki 4, 2025, ua hoʻolaha ʻo BeiGene ua ʻāpono ka US Food and Drug Administration (FDA) iā TEVIMBRA (tislelizumab-jsgr), i hui pū ʻia me ka chemotherapy i loaʻa ka platinum, no ka mālama mua ʻana i nā pākeke me ka unresectable a i ʻole metastatic esophageal squamous cell carcinoma (ESCC) nona ...E heluhelu hou aku»

Ma Pepeluali 25, 2025, ua ʻāpono ka ʻOihana Hoʻokele Huahana Lapaʻau Lahui o Kina (NMPA) i ka finotonlimab i hui pū ʻia me SCT510 no ka mālama ʻana i ka carcinoma hepatocellular hiki ʻole ke hoʻopau ʻia a i ʻole ka metastatic i loaʻa ʻole ka lāʻau lapaʻau systemic ma mua. ʻO Finotonlimab kahi IgG4 humanized recombinant...E heluhelu hou aku»

Ma Pepeluali 8, 2025, ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka finotonlimab a Sinocelltech Group Ltd, kahi antibody monoclonal (mAb) i hoʻolālā ʻia no ka make ʻana o 1 (PD-1), no ka hoʻohana ʻana me ka chemotherapy platinum-based ma ke ʻano he lāʻau lapaʻau mua no ka recurrent a/a i ʻole metas...E heluhelu hou aku»

Ma Pepeluali 21, 2025, ua hāʻawi ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina i ka Breakthrough Therapy Designation (BTD) no Satri-cel（CT041）(he moho huahana CAR T-cell autologous e kūʻē iā Claudin18.2), no ka ʻōpū gastric/esophagogastric holomua...E heluhelu hou aku»

Ma ka lā 22 o Pepeluali, 2025, ua ʻae ʻia ka New Drug Application (NDA) no ka inikini ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) e ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) o Kina a ua hāʻawi ʻia i ka hoʻolālā Priority Review ma ke ʻano he...E heluhelu hou aku»