Tari Ao Whānui

I te 21 o Poutū-te-rangi, 2025, i panuitia e Junshi Biosciences kua whakaaetia e te National Medical Products Administration (“NMPA”) te tono rongoā hou tāpiri (“sNDA”) mō te hua a te kamupene, te toripalimab, me te bevacizumab mō te maimoatanga raina-tuatahi o te kore e taea te tango, te mate pukupuku rānei...Pānuihia atu»

I te 21 o Poutū-te-rangi, 2025, e kī ana kua whakaaetia te Tono Rongoā Hou ("NDA") mō TAZVERIK® (tazemetostat) i Haina mō te maimoatanga o ngā tūroro pakeke me te lymphoma follicular ("FL") kua hoki mai, kua ātete rānei ki te mate ("R/R") me te whakarerekētanga EZH2 kua whiwhi i te iti rawa e rua o mua ...Pānuihia atu»

I te 10 o Poutū-te-rangi, 2025, i panuitia e Sichuan Kelun-Biotech kua whakaaetia te trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, i mua ko SKB264/MK-2870) a te Kamupene mō te hokohoko e te National Medical Products Administration (NMPA...Pānuihia atu»

I te 18 o Poutū-te-rangi, 2025, i panuitia e Alphamab Oncology kua whakawhiwhia te tohu Breakthrough Therapy ki te anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA). Ko te tohu nei mō te maimoatanga o ...Pānuihia atu»

I te 10 o Poutū-te-rangi, 2025, i panuitia e Hansoh Pharma te tuatoru o ngā Tono Rongoā Hou (“NDA”) o te rongoā auaha a te Rōpū, a Ameile (阿美乐®) (Ngā Papa Aumolertinib Mesilate) kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (“NMPA”) mō te maimoatanga o ngā tūroro e pāngia ana e te mate urutā ā-rohe,...Pānuihia atu»

I te 12 o Poutū-te-rangi, 2025, i panuitia e Zai Lab Limited kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te Tono Raihana Koiora (BLA) mō te TIVDAK (tisotumab vedotin-tftv) hei rongoā mō ngā tūroro e pāngia ana e te mate pukupuku waha kōpū e hokihoki mai ana, e horapa ana rānei, me te whanaketanga o te mate...Pānuihia atu»

I te 5 o Poutū-te-rangi, 2025, i panuitia e Ascentage Pharma kua whakawhiwhia tana rongoā, te olverembatinib, ki te Tohu Whakaora Pakari (BTD) e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA) o Haina, mō te whakakotahitanga me te chemotherapy iti-kaha mō te tuatahi-...Pānuihia atu»

I te 4 o Poutū-te-rangi, 2025, i panuitia e BeiGene kua whakaaetia e te US Food and Drug Administration (FDA) te TEVIMBRA (tislelizumab-jsgr), me te chemotherapy kei roto he platinum, hei maimoatanga tuatahi mō ngā pakeke e pangia ana e te mate pukupuku squamous esophageal kāore e taea te tango, e horapa ana rānei (ESCC) ko rātou ...Pānuihia atu»

I te 25 o Pēpuere, 2025, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te finotonlimab me te SCT510 hei rongoā mō te mate pukupuku hepatocellular kāore e taea te tango, te mate pukupuku rānei kua horapa, kāore anō kia whiwhi rongoā pūnaha i mua. Ko te Finotonlimab he IgG4 tangata kua hurihia...Pānuihia atu»

I te 8 o Pēpuere, 2025, i whakaaetia e te National Medical Products Administration (NMPA) o Haina te finotonlimab a Sinocelltech Group Ltd, he paturopi monoclonal (mAb) mate-whakarite 1 (PD-1), kia whakamahia tahitia me te chemotherapy e ahu mai ana i te platinum hei maimoatanga tuatahi mō te mate pūmau me/ranei te mate metastasis...Pānuihia atu»

I te 21 o Pēpuere, 2025, i whakawhiwhia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) te Breakthrough Therapy Designation (BTD) mō Satri-cel（CT041）(he hua CAR T-cell autologous hei ārai i a Claudin18.2), mō te puku/esophagogastric matatau...Pānuihia atu»

I te 22 o Pēpuere, 2025, kua whakaaetia te Tono Rongoā Hou (NDA) mō te werohanga ipilimumab (anti-CTLA-4 monoclonal antibody; Waehere R&D: IBI310) e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) o Haina, ā, kua whakawhiwhia ki te tohu Priority Review i roto i te com...Pānuihia atu»