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Ku ya 21 Werurwe 2025, Junshi Biosciences yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (“NMPA”) cyemeje ikoreshwa ry’umuti mushya (“sNDA”) ku muti w’ikigo, toripalimab, hamwe na bevacizumab mu kuvura indwara zidakira cyangwa zifata...Soma byinshi»
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Ku itariki ya 21 Werurwe 2025, yatangaje ko Porogaramu nshya y'imiti ("NDA") kuri TAVERIK® (tazemetostat) yemerewe mu Bushinwa kuvura abarwayi bakuru bafite indwara yo kurwara follicular lymphoma ("FL") bafite EZH2 mutation bamaze nibura inshuro ebyiri ...Soma byinshi»
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Ku ya 10 Werurwe 2025, Sichuan Kelun-Biotech yatangaje ko ikigo cya trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yahoze ari SKB264/MK-2870) cyemerewe kugurishwa n'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA...Soma byinshi»
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Ku ya 18 Werurwe 2025, Alphamab Oncology yatangaje ko anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 yahawe Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu gishinzwe imiti (NMPA). Iki kigo ni icyo kuvura ...Soma byinshi»
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Ku ya 10 Werurwe 2025, Hansoh Pharma yatangaje ko Porogaramu nshya ya gatatu (“NDA”) y'umuti mushya wa Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) yemewe n'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (“NMPA”) mu kuvura abarwayi bafite indwara ziteye imbere mu gace...Soma byinshi»
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Ku ya 12 Werurwe 2025, Zai Lab Limited yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeye ubusabe bw’uruhushya rwa Biologics License (BLA) kuri TIVDAK (tisotumab vedotin-tftv) mu kuvura abarwayi barwaye kanseri y’inkondo y’umura isubira inyuma cyangwa ikwirakwira ry’indwara ku...Soma byinshi»
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Ku ya 5 Werurwe 2025, Ascentage Pharma yatangaje ko umuti wayo, olverembatinib, wemerewe guhabwa icyitegererezo cyo kuvura indwara (BTD) n'Ikigo gishinzwe gusuzuma imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (NMPA), kubera ko uvanze na chemotherapy yoroheje ku nshuro ya mbere...Soma byinshi»
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Ku ya 4 Werurwe 2025, BeiGene yatangaje ko Ikigo gishinzwe Ibiribwa n'Imiti muri Amerika (FDA) cyemeje TEVIMBRA (tislelizumab-jsgr), hamwe na platine irimo imiti ya chimiotherapie, mu kuvura abantu bakuru bafite kanseri y'uturemangingo idakira cyangwa ikwirakwira mu ruhu (ESCC) bafite ...Soma byinshi»
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Ku ya 25 Gashyantare 2025, Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (NMPA) cyemeje finotonlimab hamwe na SCT510 mu kuvura kanseri y'umwijima idakira cyangwa itarakira itaravurwa mbere. Finotonlimab ni umuti wa IgG4 wahinduwe umuntu...Soma byinshi»
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Ku ya 8 Gashyantare 2025, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyo mu Bushinwa cyemeje umuti wa finotonlimab wa Sinocelltech Group Ltd, antibody ya monoclonal (mAb) yateguwe na gahunda yo gukoreshwa hamwe na platine-based chemotherapy nk'uburyo bwa mbere bwo kuvura indwara zisubira inyuma cyangwa zisubira inyuma...Soma byinshi»
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Ku ya 21 Gashyantare 2025, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (NMPA) cyatanze inyito yo kuvura indwara ya “Breakthrough Therapy Designation (BTD)” ku birebana na Satri-cel (CT041) (umuti wa CAR T-cells ukomoka kuri Claudin18.2) ku ndwara y’igifu/esophagogastric jun...Soma byinshi»
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Ku ya 22 Gashyantare 2025, Porogaramu nshya y’imiti (NDA) yo gutera inshinge za ipilimumab (anti-CTLA-4 monoclonal antibody; Kode y’ubushakashatsi n’iterambere: IBI310) yemejwe n’Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) kandi yemerewe isuzuma ry’ibanze mu ...Soma byinshi»