Maarso 31, 2025, Innovent Biologics waxay ku dhawaaqday in Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ay siisay Magacaabista Daaweynta Degdegga ah (BTD) IBI363, oo ah borotiin isku-darka unugyada difaaca jirka ee heerka koowaad ee PD-1/IL-2α-bias, oo ah daaweyn hal-ku-dheg ah oo loogu talagalay daaweynta melanoma xuubka xuubka ama acral ee aan la tirtiri karin ee maxalliga ah ama aan la daaweyn karin oo aan hore loo tirtirin.
Ku saabsan IBI363 (Borotiinka isku-dhafka antibody-ga ee heerka koowaad ee PD-1/IL-2α-bias)
IBI363 waa daawo heer sare ah oo si madax-bannaan loo sameeyay oo ay samaysay Innovent Biologics. Waa borotiin isku-darka antibody-ga laba-geesoodka ah ee PD-1/IL-2 oo loogu talagalay in lagu wanaajiyo waxtarka iyadoo la yareynayo sunta. Gacanta IL-2 ee IBI363 waxaa loo farsameeyay si loo wanaajiyo saameynta daaweynta iyadoo la yareynayo waxyeellooyinka, halka gacanta isku xidhka PD-1 ay suurtogal ka dhigayso xannibaadda PD-1 iyo keenista IL-2 ee xulashada ah. Iyadoo isla mar ahaantaana la joojinayo marinnada PD-1/PD-L1 iyo kicinta marinnada IL-2, IBI363 waxay fududaynaysaa bartilmaameedsiga iyo kicinta unugyada T-ga ee gaarka u ah burooyinka. Daraasadaha kahor-kiliinikada ayaa muujiyay in IBI363 ay muujinayso firfircooni xooggan oo ka-hortagga burooyinka ah oo ku baahsan noocyo badan oo daawooyin ah oo burooyinka leh, oo ay ku jiraan kuwa u adkaysta inhibitors-ka PD-1 iyo moodooyinka metastatic-ka ah. Intaa waxaa dheer, waxay muujisay muuqaal badbaado oo wanaagsan oo ku saabsan moodooyinka kahor-kiliinikada.
Tijaabooyin caafimaad oo IBI363 ah ayaa hadda ka socda Shiinaha, Mareykanka, iyo Australia si loo qiimeeyo badqabkeeda, dulqaadkeeda iyo waxtarkeeda hordhaca ah ee dadka qaba kansarka faafa ee horumarsan. Daraasaddii ugu horreysay ee muhiimka ahayd ee IBI363 ayaa la bilaabay, si loogu daaweeyo melanoma-ka xuubka xuubka ama acral.
Intaa waxaa dheer, IBI363 waxay heshay laba magac oo degdeg ah (FTD) oo ka yimid FDA-da Mareykanka, si loogu daaweeyo melanoma iyo squamous NSCLC, siday u kala horreeyaan. IBI363 waxay sidoo kale heshay magac daaweyn horumarsan oo ka timid NMPA ee Shiinaha si loogu daaweeyo melanoma.
Innovent wuxuu soo bandhigayaa Xogta Caafimaadka ee Wejiga 1aad ee Borotiinka Isku-dhafka Antibody-ga Bispecific (IBI363) ee heerka koowaad ee Melanoma shirkii sanadlaha ahaa ee ASCO ee 2024.
67 qof oo qaba melanoma-ka maxalliga ah ee horumarsan ama metastatic ah oo ku guuldareystay ama aan u dulqaadan karin daaweynta caadiga ah ayaa la diiwaan geliyay waxaana lagu siiyay IBI363 xididka heerarka qiyaasta u dhexeeya 100 μg/kg QW iyo 2 mg/kg Q3W. 89.6% dadka la siiyay daaweynta difaaca jirka ee hore, 61.2% dadka la siiyay ≥ 2 xariiq oo daaweyn nidaamsan oo hore. 25.4% dadka la siiyay waxay lahaayeen metastasis beerka oo asal ah halka 70.1% dadka la siiyay ay ahaayeen noocyo acral ama mucosal ah.
Laga bilaabo Janaayo 11, 2024, 57 qof ayaa la siiyay ugu yaraan 1 qiimeyn burooyinka ka dib saldhigga. Jawaabta guud ee ugu wanaagsan waxay ahayd jawaab dhammaystiran (CR) 1 qof, jawaab qayb ah (PR) 15 qof siday u kala horreeyaan. Heerka jawaab celinta guud (ORR) wuxuu ahaa 28.1% (95%CI: 17.0-41.5) DCR-na wuxuu ahaa 71.9% (95%CI: 58.5-83.0). 25 qof oo lagu daaweeyay immunotherapy (IO) oo lagu daaweeyay 1mg/kg kooxda qiyaasta Q2W (n=25), ORR wuxuu ahaa 32.0% (95%CI: 14.9-53.5), DCR wuxuu ahaa 80.0% (95%CI: 59.3-93.2).
Marka laga hadlayo badbaadada, 16 qof (23.9%) ayaa lahaa dhacdooyin soo noqnoqda oo daaweyn ah oo heerka ≥3 ah (TEAEs). Calaamadaha ugu badan ee TEAE waxay ahaayeen arthralgia (34.3%), hyperthyroidism (29.9%), iyo dhiig-yaraan (25.4%). Dhacdooyinka soo noqnoqda ee la xiriira difaaca jirka ee heerka ≥3 (IRAEs) waxay ka dhaceen 8 qof (11.9%). Ma jirin TRAE horseeday dhimasho.
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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Waqtiga boostada: Abriil-01-2025