Janaayo 8, 2025, 9MW2821 waxaa la siiyay Magacaabista Daaweynta Degdegga ah (BTD) Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ee Shiinaha.9MW2821 waxaa la siiyaa iyadoo lagu darayo toripalimab, oo ah antibody monoclonal ah oo ka hortagga PD-1, si loogu daaweeyo kansarka urothelial ee aan la daaweyn karin, aan la tirtiri karin, oo heer deegaan ah ama metastatic metastatic ah.
Ku saabsan 9MW2821
9MW2821 waa ADC-ga cusub ee Nectin-4-bartilmaameedsan ee ugu horreeya goobta gaarka ah ee ay samaysay Mabwell iyadoo adeegsanaysa madal ADC iyo madal daahfurka unugyada hybridoma ee otomaatiga ah ee awoodda sare leh, waana musharixiintii ugu horreysay ee daawada ka qaybgasha daraasadda caafimaad ee ka dhaxaysa ADC-yada bartilmaameedsan Nectin-4 ee ay sameeyeen shirkadaha Shiinaha, iyo musharixiintii ugu horreysay ee daawada daaweynta ee beegsanaysa Nectin-4 adduunka si ay u shaaciso xogta waxtarka caafimaad ee kansarka ilmo-galeenka, kansarka hunguriga iyo kansarka naasaha. 9MW2821 waxaa la siiyay Magaca Degdegga ah (FTD) ee daaweynta kansarka unugyada squamous ee esophageal ee horumarsan, soo noqnoqda, ama metastatic bishii Febraayo 2024, waxaana sidoo kale si isdaba joog ah loo siiyay Magacaabista Daawada Agoonta (ODD) iyo FTD ee daaweynta kansarka hunguriga iyo kansarka ilmo-galeenka ee soo noqnoqda ama metastatic ee sii socda ama ka dib daaweyn hore oo leh daaweyn kiimiko ku salaysan platinum bishii Maajo 2024.
Natiijooyinka daraasad kiliinikada wejiga I/II oo la adeegsanayo 9MW2821 oo loogu talagalay burooyinka adag ee horumarsan ayaa lagu soo warramey Shirka Sanadlaha ah ee Bulshada Mareykanka ee Cudurrada Kiliinikada (ASCO) ee 2024.
Laga bilaabo Abriil 1, 2024, 240 bukaan oo ku jira kooxda qiyaasta 1.25 mg/kg ee tijaabada kiliinikada ee Wajiga II:
Kansarka kaadi mareenka (UC)
37-ka bukaan ee lagu qiimeeyay qiimaynta waxtarka, heerka jawaab celinta ujeeddada leh (ORR) iyo heerka xakamaynta cudurrada (DCR) waxay ahaayeen 62.2% iyo 91.9%, siday u kala horreeyaan, iyadoo badbaadada dhexdhexaadka ah ee aan horumarka lahayn (mPFS) ay ahayd 8.8 bilood halka badbaadada guud ee dhexdhexaadka ah (mOS) ay ahayd 14.2 bilood.
Kansarka Makaanka Afka (CC)
53-da bukaan ee lagu qiimeeyay qiimaynta waxtarka, 51% waxaa hore loogu daaweeyay kiimoterabiga labanlaabka ah ee ku salaysan platinum iyo bevacizumab, 58% waxay heleen kiimoterabiga labanlaabka ah ee ku salaysan platinum iyo ka hortagga difaaca jirka, iyadoo ORR iyo DCR ay ahaayeen 35.8% iyo 81.1%, siday u kala horreeyaan. mPFS waxay ahayd 3.9 bilood, iyadoo aan la gaarin mOS. Bukaannada qaba xoojinta wasakhda unugyada burooyinka Nectin-4 3+, ORR waxay ahayd 43.6% 39-ka bukaan ee la qiimeyn karo.
Kansarka Hunguri-mareenka (EC)
39-ka bukaan ee lagu qiimeeyay qiimaynta waxtarka, ORR iyo DCR waxay ahaayeen 23.1% iyo 69.2%, siday u kala horreeyaan, iyadoo mPFS ay ahayd 3.9 bilood iyo mOS oo ahayd 8.2 bilood; 37 ka mid ah waxaa hore loogu daaweeyay kiimoterabiga ku salaysan platinum iyo immunotherapy.
Kansarka Naasaha ee Saddex-geesoodka ah (TNBC)
20-ka bukaan ee qaba kansarka naasaha ee saddex-geesoodka ah ee horumarsan ama kansarka naasaha ee maxalliga ah oo la qiimeeyo si loo qiimeeyo waxtarka, ORR iyo DCR waxay ahaayeen 50.0% iyo 80.0% siday u kala horreeyaan. MPFS waxay ahayd 5.9 bilood, mOS-na weli lama gaarin, iyadoo hal bukaan uu gaaray jawaab dhammaystiran (CR) wuxuuna ku jiray CR muddo 20 bilood ah haddana waxaa la filayaa inuu noqdo CR.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
Lambarka Taleefanka: 4008803716
Email：myimmnet@163.com
Tixraacyada
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.Mabwell - Sahamin Nolosha, Faa'iidada Caafimaadka
Waqtiga boostada: Jan-15-2025