Ngomhlaka-19 Juni, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yamemezela ukuthi i-IBI343 ye-Innovent Biologics iphakanyisiwe ukuthi ifakwe ohlelweni lokukhetha ukwelashwa okuphumelelayo, oluhloselwe ukwelashwa komdlavuza we-pancreatic othuthukisiwe noma osakazeke endaweni one-CLDN18.2-positive futhi othole okungenani ukwelashwa okubili kwangaphambilini kwesistimu.
I-IBI343 iyi-recombinant humanized anti-CLDN18.2 antibody-drug conjugate (ADC). Uma ibopha kumaseli esimila aveza i-CLDN18.2, idlula ku-ADC internalization encike ku-CLDN18.2 futhi ikhipha umthwalo we-cytotoxic, okuholela ekulimaleni kwe-DNA futhi ekugcineni kubangele i-apoptosis yamaseli esimila.
Ngomhlaka-9 Disemba 2024, idatha yakamuva evela esivivinyweni somtholampilo seSigaba I (NCT05458219) se-IBI343 ku-advanced pancreatic ductal adenocarcinoma (PDAC) yethulwe eMhlanganweni Waminyaka Yonke we-European Society for Medical Oncology Asia (ESMO Asia).
Iziguli ezingu-43 ezine-CLDN18.2-positive advanced PDAC zelashwe nge-IBI343. Imiphumela ibonise izinga lokuphendula eliphelele (ORR) elingu-32.6%, izinga lokuphendula eliqinisekisiwe (cORR) elingu-23.3%, kanye nezinga lokulawula izifo eliqinisekisiwe (cDCR) elingu-81.4%. Isikhathi esimaphakathi sempendulo (mDoR) sasiyizinyanga ezingu-7.0, kanye nezinga le-DoR lezinyanga ezingu-6 elingu-63%, kanye nokusinda okumaphakathi okungenazo izinqubekela phambili (PFS) kwakuyizinyanga ezingu-5.3.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Juni-19-2025