Maajo 22, 2025, Kelun Bio waxay ku dhawaaqday in codsiga tilmaan cusub oo ku saabsan antigen-ka dusha sare ee unugyada trophoblast-ka ee 2 (TROP2) ee lagu hago antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, oo sidoo kale loo yaqaan SKB264/MK - 2870) (®) ay aqbashay Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ee Shiinaha. Tilmaamahan cusub wuxuu u yahay daaweynta bukaanada qaangaarka ah ee qaba kansarka naasaha ee aan la tirtiri karin ee maxalliga ah ama hormoonka hidda-socodka ah (HR+) iyo epidermal growth factor receptor 2-negative (HER2-) ee aadanaha (BC) kuwaas oo hore u helay daaweynta endocrine-ka iyo daawaynta kale ee nidaamsan ee ku jira xaaladda horumarsan ama metastatic. Aqbalaaddan waxay ku salaysnayd natiijooyinka wanaagsan ee daraasadda diiwaangelinta Marxaladda 3 OptiTROP - Naasaha02. Codsigan waa codsiga tilmaamidda afraad ee sac - TMT oo ay aqbashay NMPA.
OptiTROP – Breast02 waa daraasad caafimaad oo aan kala sooc lahayn, furan, oo xarun badan leh, oo qiimeynaysa waxtarka iyo badbaadada daaweynta sacituzumab tirumotecan monotherapy oo ah 5 mg/kg labadii toddobaadba mar (Q2W) marka la barbar dhigo doorashada dhakhtar ee kiimoterabiga ee bukaanada qaba kansarka naasaha ee aan la tirtiri karin ee maxalliga ah ama metastatic HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, ama IHC 2+/in situ hybridization [ISH]-). Iyada oo lagu saleynayo falanqaynta ku-meel-gaarka ah ee hore loo cayimay, dhammaadka waxtarka koowaad ee daraasaddan kiliinikada ee Marxaladda 3 ayaa la daboolay. Marka la barbardhigo doorashada dhakhtarka ee kiimoterabiga, daaweynta sac - TMT monotherapy waxay muujisay horumar tirakoob ahaan muhiim ah oo macno leh oo ku yimid dhammaadka aasaasiga ah ee badbaadada aan horumarka lahayn (PFS) sida ay qiimeeyeen guddiga dib u eegista madax-bannaan ee indho la'aanta ah (BIRC), iyadoo si weyn loo yareeyay khatarta cudurka ama dhimashada. Sac - TMT sidoo kale waxay muujisay isbeddel wanaagsan oo ku yimid badbaadada guud (OS).
Maajo 16, 2024, bogga rasmiga ah ee CDE ayaa ku dhawaaqay in Codsiga dib loo eegi doono iyada oo loo marayo habka dib u eegista mudnaanta iyo ansixinta. Tani waxay ka dhigan tahay tilmaantii afraad ee sac-TMT ee lagu maro habka dib u eegista mudnaanta iyo ansixinta CDE, iyadoo saddex tilmaamood oo hore oo sat-TMT ah la ansixiyay ka dib dib u eegista mudnaanta.
Ku saabsan sac-TMT (佳泰莱®)
Sac-TMT, oo ah wax soo saar asaasi ah oo ka tirsan Shirkadda, waa TROP2 ADC cusub oo bini'aadam ah oo Shirkaddu ay leedahay xuquuq hanti-garaad oo gaar ah, oo bartilmaameedsanaya burooyinka adag ee horumarsan sida kansarka sambabada unugyada yaryar (NSCLC), BC, kansarka caloosha (GC), burooyinka haweenka, iyo kuwo kale. Sac-TMT waxaa lagu sameeyay isku xire cusub si uu isugu daro culayska, oo ah inhibitor topoisomerase I oo belotecan-derivative ah oo leh saamiga daawada-ilaa-antibody-ratio (DAR) oo ah 7.4. Sac-TMT si gaar ah ayay u aqoonsataa TROP2 dusha sare ee unugyada burooyinka iyadoo la adeegsanayo unugyada difaaca jirka ee monoclonal-ka ah ee dib-u-habaynta ah, kaas oo markaa ay ku sii daayaan unugyada burooyinka oo ay sii daayaan KL610023 gudaha unugyada. KL610023, oo ah inhibitor topoisomerase I ah, waxay keentaa dhaawac DNA ah oo ku yimaada unugyada burooyinka, taas oo iyaduna horseedda xidhitaanka wareegga unugyada iyo apoptosis. Intaa waxaa dheer, waxay sidoo kale sii daaysaa KL610023 jawiga burooyinka. Maadaama KL610023 uu xuubka ku dhex milmi karo, waxay awood u siin kartaa saameynta daawada, ama si kale haddii loo dhigo waxay dishaa unugyada burooyinka ee ku xiga.
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.
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Email：myimmnet@163.com
Waqtiga boostada: Maajo-27-2025