Chithandizo Chatsopano cha Ma genitourinary Tumors ndi odwala MIBC

Ntchito yofufuza mankhwala atsopano (IND) idavomerezedwa ndi US FDA mu June ndi Center for Drug Evaluation (CDE) ya National Medical Products Administration of China mu Okutobala chaka chatha motsatana.

Izi ndizolemba zotseguka, zowerengera zachipatala za Phase I / II zokhala ndi zolinga zotsatirazi: kuyesa chitetezo kwa odwala MIBC; kuti mudziwe mlingo wovomerezeka wa Phase 2 (RP2D), ndikuwunika kuthandizira ngati mankhwala a neoadjuvant a MIBC.

"APL-1202 kuphatikiza ndi tislelizumab monga mankhwala a neoadjuvant amatha kukhala njira yabwino kwambiri yothandizira odwala MIBC, ndife okondwa kwambiri kuti wodwala woyamba wapereka chithandizo ku US," adatero Dr. Xue Yong, MD, PhD, Chief Medical. Ofesi ku Asieris. "Tidakwanitsa kupititsa patsogolo mlanduwu pakati pa mliri wa COVID-19 womwe ukuwonetsa kuti gulu lathu likuchita bwino, komanso kudzipereka kwathu pakupititsa patsogolo thanzi la anthu."

APL-1202 ndi MetAP2 Inhibitor yosinthika yomwe imapezeka m'kamwa yokhala ndi anti-angiogenic, anti-chotupa ndipo imathanso kusintha mawonekedwe a chotupa. Pakali pano ili mu Phase III/mayesero ofunikira kwambiri azachipatala ku China, mwina ngati wothandizira yekha ngati chithandizo choyamba kwa odwala omwe ali ndi khansa ya m'chikhodzodzo yapakatikati yopanda minofu (NMIBC), kapena kuphatikiza ndi chemotherapy ngati chithandizo chachiwiri mu odwala omwe ali ndi pakati komanso omwe ali pachiwopsezo chachikulu cha chemo-refractory NMIBC. Tislelizumab ndi munthu wa IgG4 anti-PD-1 monoclonal antibody wopangidwa makamaka kuti achepetse kumangiriza ku FcγR pa macrophages. Bungwe la China National Medical Products Administration (NMPA) lavomereza tislelizumab m’zisonyezero zisanu, kuphatikizapo kuvomereza kotheratu kwa chithandizo choyamba cha odwala omwe ali ndi khansa yapamwamba ya m’mapapo yosakhala yaing’ono yotchedwa squamous non-small cell lung cancer (NSCLC) yophatikiza ndi mankhwala amphamvu komanso chithandizo choyamba kwa odwala. ndi NSCLC yapamwamba yopanda squamous kuphatikiza ndi chemotherapy. NMPA inaperekanso chilolezo chothandizira chithandizo cha odwala omwe ali ndi matenda a Hodgkin's lymphoma (cHL) omwe adalandira chithandizo chamankhwala osachepera awiri, pofuna kuchiza odwala omwe ali ndi khansa ya m'deralo kapena ya metastatic urothelial carcinoma (UC) ndi PD-L1 high expression yomwe matenda awo adakula panthawiyi. kapena kutsatira chemotherapy yokhala ndi platinamu kapena mkati mwa miyezi 12 ya chithandizo cha neoadjuvant kapena adjuvant ndi platinamu yokhala ndi chemotherapy, komanso pochiza odwala omwe ali ndi hepatocellular carcinoma (HCC) omwe adalandira chithandizo chimodzi chokhazikika. Chivomerezo chonse chazizindikirozi chimadalira zotsatira za mayesero achipatala omwe akupitilira mosasinthika, olamulidwa ndi otsimikizika.