Thaum Lub Rau Hli 19, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tshaj tawm tias Innovent Biologics' IBI343 tau raug pom zoo kom suav nrog hauv qhov kev pab cuam kho mob tshiab, uas yog rau kev kho mob qog nqaij hlav pancreatic uas tau kis mus rau lwm qhov chaw lossis kis mus rau lwm qhov chaw uas yog CLDN18.2-zoo thiab tau txais tsawg kawg yog ob txoj kev kho mob thoob plaws lub cev ua ntej.
IBI343 yog ib qho tshuaj antibody-drug conjugate (ADC) uas tau hloov kho dua tshiab los ntawm tib neeg. Thaum nws khi rau cov hlwb qog uas qhia CLDN18.2, nws yuav dhau los ntawm CLDN18.2-dependent ADC thiab tso tawm cov cytotoxic payload, ua rau DNA puas tsuaj thiab thaum kawg ua rau cov hlwb qog tuag.
Thaum Lub Kaum Ob Hlis 9, 2024, cov ntaub ntawv tshiab kawg los ntawm Theem I kev sim tshuaj (NCT05458219) ntawm IBI343 hauv kev mob qog nqaij hlav pancreatic ductal adenocarcinoma (PDAC) tau nthuav tawm ntawm European Society for Medical Oncology Asia (ESMO Asia) Lub Rooj Sib Tham Txhua Xyoo.
Tag nrho muaj 43 tus neeg mob uas muaj CLDN18.2-positive advanced PDAC tau kho nrog IBI343. Cov txiaj ntsig tau qhia txog qhov kev teb rov qab tag nrho (ORR) ntawm 32.6%, qhov kev teb rov qab tau lees paub (cORR) ntawm 23.3%, thiab qhov kev tswj kab mob tau lees paub (cDCR) ntawm 81.4%. Lub sijhawm teb nruab nrab (mDoR) yog 7.0 lub hlis, nrog rau 6-hli DoR tus nqi ntawm 63%, thiab qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (PFS) yog 5.3 lub hlis.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Lub Rau Hli-19-2025