Ua hāʻawi ʻia ka IBI343 a Innovent i ka hoʻohanohano lapaʻau holomua no ka maʻi kanesa pancreatic holomua CLDN18.2-Positive

Ma Iune 19, ua hoʻolaha ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) ua hāpai ʻia ʻo Innovent Biologics' IBI343 no ka hoʻokomo ʻia ʻana i loko o ka papahana hoʻolālā lapaʻau holomua, i manaʻo ʻia no ka mālama ʻana i ka maʻi ʻaʻai pancreatic kūloko a i ʻole metastatic i CLDN18.2-positive a ua loaʻa iā ia ma ka liʻiliʻi ʻelua mau lāʻau lapaʻau systemic ma mua.

He hui hoʻohuihui antibody-drug anti-CLDN18.2 recombinant (ADC) ʻo IBI343. Ma hope o ka hoʻopaʻa ʻana i nā pūnaewele tumor e hōʻike ana i ka CLDN18.2, hana ia i ka internalization ADC e pili ana iā CLDN18.2 a hoʻokuʻu i kahi ukana cytotoxic, e alakaʻi ana i ka hōʻino ʻana o ka DNA a i ka hopena e hoʻoulu ai i ka apoptosis o nā pūnaewele tumor.

Ma ka lā 9 o Dekemaba, 2024, ua hōʻike ʻia nā ʻikepili hou loa mai ka hoʻokolohua lapaʻau Phase I (NCT05458219) o IBI343 i ka advanced pancreatic ductal adenocarcinoma (PDAC) ma ka European Society for Medical Oncology Asia (ESMO Asia) Annual Meeting.

Ua mālama ʻia he 43 mau maʻi me ka PDAC holomua CLDN18.2-positive me IBI343. Ua hōʻike nā hopena i kahi helu pane pahuhopu holoʻokoʻa (ORR) o 32.6%, kahi helu pane pahuhopu i hōʻoia ʻia (cORR) o 23.3%, a me kahi helu kaohi maʻi i hōʻoia ʻia (cDCR) o 81.4%. ʻO ka lōʻihi waena o ka pane (mDoR) he 7.0 mahina, me ka helu DoR 6 mahina o 63%, a ʻo ka awelika o ke ola ʻole holomua (PFS) he 5.3 mahina.

I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

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Ka manawa hoʻouna: Iune-19-2025