Na June 19, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) kwupụtara na a tụrụ aro IBI343 nke Innovent Biologics ka ọ tinye na mmemme nhazi ọgwụgwọ breakthrough, nke e zubere maka ọgwụgwọ nke kansa pancreatic nke dị n'ógbè ma ọ bụ nke nwere CLDN18.2-positive ma nwetala opekata mpe ọgwụgwọ sistemu abụọ gara aga.
IBI343 bụ ọgwụ mgbochi CLDN18.2 antibody-drug conjugate (ADC) nke a na-ejikọta ọnụ. Mgbe ọ na-ejikọta na mkpụrụ ndụ tumor nke na-egosipụta CLDN18.2, ọ na-abanye n'ime CLDN18.2-dependent ADC ma na-ewepụta ibu cytotoxic, nke na-ebute mmebi DNA ma na-ebute apoptosis nke mkpụrụ ndụ tumor.
Na Disemba 9, 2024, e gosipụtara data kachasị ọhụrụ sitere na nnwale ahụike nke Phase I (NCT05458219) nke IBI343 na advanced pancreatic ductal adenocarcinoma (PDAC) na Nzukọ Kwa Afọ nke European Society for Medical Oncology Asia (ESMO Asia).
E jiri IBI343 gwọọ mmadụ 43 nwere CLDN18.2-positive PDAC dị elu. Nsonaazụ ya gosiri na ọnụego nzaghachi ebumnuche (ORR) zuru oke nke 32.6%, ọnụego nzaghachi ebumnuche (cORR) nke 23.3%, na ọnụego njikwa ọrịa akwadoro (cDCR) nke 81.4%. Oge etiti nke nzaghachi (mDoR) bụ ọnwa 7.0, yana ọnụego DoR ọnwa 6 nke 63%, yana ndụ na-enweghị ọganihu (PFS) nke etiti bụ ọnwa 5.3.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Jun-19-2025