Janaayo 8, Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa u aqoonsatay Magacaabista Daaweynta Degdegga ah (BTD) IBI343, oo ah TOPO1i anti-CLDN18.2 ADC oo heer sare ah, inay tahay daaweyn hal-hal ah oo loogu talagalay bukaanada CLDN18.2-positive ee horumarsan ee kansarka qanjidhada ductal adenocarcinoma (PDAC) kuwaas oo horumar sameeyay ka dib ugu yaraan hal saf oo daaweyn nidaamsan ah oo hore.
BTD ee IBI343 waxaa la bixiyay iyadoo lagu saleynayo xog laga helay daraasad Wajiga 1aad ah oo socota oo laga sameeyay Shiinaha, Australia iyo Mareykanka (NCT05458219), taasoo muujisay badbaado iyo dulqaad wanaagsan, iyo sidoo kale firfircooni ka-hortagga burooyinka oo rajo leh oo IBI343 ah oo loogu talagalay bukaanada PDAC ee horumarsan. Xogta laga helay kooxda fidinta qiyaasta daawada daraasadda waxaa si afka ah loogu soo bandhigay Shirweynihii Aasiya ee ESMO ee 2024:
Laga bilaabo Sebtembar 6, 2024, wadarta 43 bukaan oo qaba CLDN18.2-positive (≥60% unugyada burooyinka oo leh xoojinta wasakhda xuubka ≥1+ by IHC) oo heer sare ah ayaa helay daaweynta IBI343 6 mg/kg Q3W oo keliya. Dhammaan ka qaybgalayaashu waxay hore u heleen ugu yaraan 1 khad oo daaweyn hore ah, 60.5% waxay heleen 2 khad ama in ka badan oo daaweyn ka hortagta kansarka ah.
43 bukaan ayaa lagu qiimeeyay waxtarka iyadoo heerka jawaab celinta guud ee ujeeddada leh (ORR) uu yahay 32.6%, heerka jawaab celinta ujeeddada leh (cORR) uu yahay 23.3%, iyo heerka xakamaynta cudurrada (cDCR) oo ah 81.4%.
Markii taariikhda goynta xogta la sameeyay, 4 ka mid ah 10 bukaan oo cORR ah ayaa horumar sameeyay, muddada dhexdhexaadka ah ee jawaab celinta (mDoR) waxay ahayd 7.0 (4.0-NC) bilood, heerka DoR ee 6-biloodna wuxuu ahaa 63%. 26 bukaan ayaa dhacay dhacdooyin PFS ah, iyadoo badbaadada aan horumarka lahayn (mPFS) ay ahayd 5.3 (4.1-7.4) bilood, xogta OS-na weli ma aysan bislaan.
Natiijooyinka badbaadada ee la cusbooneysiiyay waxay muujiyeen muuqaalka badbaadada wanaagsan ee IBI343 iyadoo si joogto ah u hooseysa heerka sunta caloosha iyo mindhicirka mana jirin calaamado badbaado oo cusub. 97.7% ka qaybgalayaashu waxay la kulmeen dhacdooyin daaweyn ah oo soo noqnoqda (TEAEs), iyadoo TEAE-yada ugu badan ay ahaayeen dhiig-yaraan, tirada neutrophils-ka oo yaraatay, rabitaanka cuntada oo yaraatay, lallabbo, iyo tirada unugyada dhiigga cad oo yaraatay. 51.2% ka qaybgalayaashu waxay la kulmeen TEAE-yo ≥ fasalka 3aad, mana jirin lallabbo iyo matag ≥ fasalka 3aad. Ma jirin TEAE horseeday dhimasho.
Ku saabsan IBI343(Anti-CLDN18.2 ADC)
IBI343 waa dawo isku-dhafan oo ka hortagta CLDN18.2 monoclonal antibody-drug conjugate (ADC) oo ay samaysay Innovent Biologics. IBI343 waxay ku xidhaa unugyada burooyinka ee muujiya CLDN18.2, gudaha ADC ee ku tiirsan CLDN18.2 ayaa dhici doona, daawadana waa la sii daayaa taasoo keenta dhaawac DNA ah iyo ugu dambayntii apoptosis unugyada burooyinka. Daawada la sii daayay waxay sidoo kale ku faafi kartaa xuubka plasma si ay u gaarto oo u disho unugyada deriska ah, taasoo keenta "saameyn dil ah oo ka hortagta".
Iyada oo ah TOPO1i ADC oo cusub, IBI343 waxay muujisay badbaado la dulqaadan karo iyo calaamado waxtar leh oo dhiirrigelin leh daraasadaha kiliinikada ee Wejiga 1. Awoodda daaweynta ee IBI343 hadda waxaa lagu baarayaa noocyada burooyinka sida kansarka caloosha iyo ganaca.
Bishii Maajo 2024, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa IBI343 u qoondeeyay daaweynta degdegga ah (BTD) si loogu isticmaalo hal wakiil oo keliya bukaannada qaba CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma kuwaas oo la kulmay horumarka cudurka ka dib laba saf oo hore oo daaweyn nidaamsan ah. Tijaabada Wajiga 3aad (NCT06238843) ee IBI343 ee tilmaantan waa socotaa.
Bishii Juun 2024, IBI343 waxay heshay Magacaabista Degdegga ah ee Maamulka Cuntada iyo Dawooyinka ee Mareykanka (FDA) si loogu daaweeyo adenocarcinoma-ka qanjirka 'pancreatic ductal adenocarcinoma' (PDAC) ee horumarsan ee aan la tirtiri karin ama metastatic ah oo ku dhaca xuubka hore ee daaweynta. Tijaabada Wajiga 1aad ee gobollo badan (NCT05458219) ee IBI343 ee PDAC hore loo daaweeyay ayaa socota.
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.https://cn.innoventbio.com/#/
Waqtiga boostada: Jan-17-2025