Kwanan nan, Ascentage Pharma ta sanar da cewa Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da sabuwar na'urar hana Bcl-2 selective inhibitor lisaftoclax (APG-2575) ta kasar Sin don kula da manya da ke fama da cutar sankarar jini ta lymphocytic leukemia/ƙananan lymphocytic lymphoma (CLL/SLL) wadanda a baya suka sami akalla magani guda daya wanda ya hada da Bruton's tyrosine kinase (BTK) inhibitors, wanda hakan ya sa lisaftoclax ya zama na farko da ya sami amincewar sharaɗi da izinin tallatawa don kula da marasa lafiya da ke dauke da CLL/SLL a kasar Sin, kuma na biyu da ya hana Bcl-2 ya amince da shi a duk duniya.
Lisaftoclax wani sabon maganin hana ƙwayoyin cuta ne da aka yi amfani da shi ta baki wanda Ascentage Pharma ta ƙirƙira don magance marasa lafiya da ke fama da cutar kansa ta hanyar toshe furotin Bcl-2 da ke hana ƙwayoyin cutar kansa, don haka dawo da tsarin apoptosis na yau da kullun a cikin ƙwayoyin cutar kansa. A cikin gwaje-gwajen asibiti, lisaftoclax ya nuna fa'idodi masu yawa na warkewa a cikin cututtukan jini da yawa da ƙari mai ƙarfi, musamman a cikin CLL/SLL, duka a matsayin magani ɗaya kawai da kuma a cikin haɗuwa.
Wannan amincewar ta dogara ne akan sakamakon da aka samu daga wani muhimmin bincike na Mataki na II na rajista (APG2575CC201) wanda aka tsara don kimanta inganci da amincin maganin lisaftoclax monotherapy a cikin marasa lafiya da suka sake komawa ko suka yi rashin lafiya, tare da jimlar amsawar (ORR) a matsayin babban matakin ƙarshe. Lisaftoclax ya nuna ingantaccen tasiri da ORR wanda ya cika matsayin ƙarshe da aka ƙayyade a cikin marasa lafiya waɗanda a baya aka yi musu magani da masu hana BTK da/ko immunochemotherapy. Bugu da ƙari, lisaftoclax ya nuna kyakkyawan bayanin aminci ba tare da wata cuta ta tumor-lysis (TLS) da ta faru a lokacin binciken ba, ƙarancin yawan gubar hematologic waɗanda ake iya sarrafawa, da kuma ƙarancin yawan gubar da ba ta hematologic ba waɗanda galibi sune aji na 1-2.
CLL/SLL cuta ce ta jini da ke faruwa sakamakon manyan ƙwayoyin B-cell. Tana shafar tsofaffi waɗanda ke da sabbin cututtuka sama da 100,000 a duk duniya kowace shekara. A ƙasar Sin, inda yawan kamuwa da cutar CLL/SLL ya yi ƙasa da na ƙasashen yamma, cutar tana faruwa da sauri, tare da shekarun farko na kamuwa da cutar da kuma tsananin tashin hankali. A matsayin babban zaɓi na yanzu don maganin CLL/SLL na farko, masu hana BTK sun inganta sakamakon magani sosai ga marasa lafiya. Duk da haka, masu hana BTK har yanzu suna fuskantar matsaloli iri-iri kamar iyakantaccen ikon haifar da martani mai zurfi, babban haɗarin sake dawowa a magani na tsakiya da na dogon lokaci, guba da rashin haƙuri da ke da alaƙa da magani na dogon lokaci; don haka, buƙatar zaɓuɓɓukan magani mafi aminci da inganci ga marasa lafiya da ke fama da CLL/SLL.
Gabatar da masu hana Bcl-2 ya ƙara kawo sauyi ga maganin CLL/SLL. Maganin hana apoptosis Bcl-2, wanda aka fi yawan bayyanawa a cikin nau'ikan cututtukan jini daban-daban, musamman CLL/SLL, muhimmin tsari ne da ƙwayoyin ciwon daji ke guje wa apoptosis. Duk da haka, gano mai hana Bcl-2 a matsayin abin da ake so a yi amfani da shi wajen magance cutar yana da matuƙar ƙalubale musamman saboda tsarin aikinsa ya dogara ne akan hulɗar furotin-protein (PPI). Haɗin haɗin Bcl-2 yana da girma sosai, wanda hakan ke sa ya yi wa ƙananan masu hana ƙwayoyin cuta wahalar yin tasirin toshewa. Bugu da ƙari, furotin Bcl-2 yana kan mitochondria, tare da tsarin membrane biyu, yana ɗaya daga cikin abubuwan da suka fi rikitarwa kuma masu ƙalubale na ƙwayoyin halitta domin yana buƙatar magunguna su fara shiga membrane na ƙwayoyin halitta kafin su ƙara yin aiki a membrane na mitochondrial. Kafin wannan, babu wani mai hana Bcl-2 da aka amince da shi don maganin CLL/SLL a China. Wannan amincewa ga lisaftoclax ya cika gibin magani a CLL/SLL, yana kawo sabon bege ga marasa lafiya da yawa a ƙasar.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Yuli-15-2025