A ranar 29 ga Mayu, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da tallan Zanidatamab, wanda BeiGene ya gabatar, don maganin marasa lafiya da ke fama da cutar kansar hanji (BTC) wadda ba a iya cirewa a gida ba ko kuma wadda ta kamu da cutar kansar hanji (BTC) waɗanda a baya suka sami maganin da ya dace kuma suka nuna yawan HER2 (IHC 3+).
Zanidatamab wani maganin rigakafi ne na HER2 wanda aka yi niyya ga bispecific wanda zai iya ɗaure epitopes guda biyu marasa haɗuwa na mai karɓar HER2, wanda aka sani da binding biparatopic. Wannan ƙira ta musamman da ƙaruwar binding yana haifar da hanyoyi da yawa na aiki, gami da toshe siginar HER2 guda biyu, cire furotin HER2 daga saman tantanin halitta, da kuma gubar da ke haifar da garkuwar jiki wanda ke haifar da ƙarfafa aikin hana ƙari a cikin marasa lafiya.
Kinasin kinase mai karɓar tyrosine-protein, wanda aka fi sani da Human Epidermal Growth Factor Receptor 2 (HER2) ko CD340, yana kan saman ƙwayoyin halitta. Wannan furotin memba ne na dangin Epidermal Growth Factor Receptor (EGFR) kuma an tsara shi ta hanyar kwayar halittar Erythroblastic oncogene B (ERBB2). Kwayar halittar ERBB2 tana da mahimmanci ga hanyoyin yau da kullun kamar rarraba ƙwayoyin halitta, bambance-bambance, da rayuwa. Ta hanyar hanyoyi daban-daban na sigina, masu karɓar HER2 suna haɓaka yaduwar ƙwayoyin halitta kuma suna hana apoptosis (mutuwar ƙwayoyin halitta da aka tsara). Yana da mahimmanci a daidaita waɗannan masu karɓar don hana haɓakar ƙwayoyin halitta ba tare da kulawa ba. Ana kiran ciwon daji waɗanda ke bayyana ko haɓaka kwayar halittar HER2 a matsayin cutar HER2-positive. Wannan kwayar halitta tana aiki a matsayin muhimmiyar alamar alama kuma babbar manufa ce ga maganin magunguna.
Duk da haka, idan aka ƙara girman HER2 ko aka ƙara girmansa, yaduwar ƙwayoyin halitta da rarrabuwarsu ba tare da an tantance su ba suna hanzarta ci gaban ciwon daji. Wannan ƙaruwa ko yawan ƙaruwa yawanci ana samunsa a cikin nau'ikan ciwon daji daban-daban kuma yana iya samun mahimmancin magani ga cututtukan daji waɗanda ba a tsammanin za su yi kyau ga magungunan hana HER2 ba.
Ana samun HER2-positive a cikin nau'ikan cututtukan daji daban-daban kamar ciwon ciki, hanji, nono, esophagus, ovarian, da mahaifa. Ana samun faruwar cutar, bayaninta, da kuma hanyoyin magani ga kowane nau'in ciwon daji na HER2-positive yana nan a cikin Tebur. Kwanan nan, an gano alaƙa da ciwon daji na pancreas da biliary tract (BTC). Marasa lafiya da ke fama da ciwon daji na HER2-positive suna da ƙarancin hasashen idan aka kwatanta da waɗanda ke fama da ciwon daji na HER2-positive, saboda waɗannan cututtukan daji sun fi tsanani. Duk da haka, sabbin dabarun magani sun nuna sakamako masu kyau.
Wannan amincewar ta dogara ne akan sakamakon babban binciken asibiti na HERIZON-BTC-01 (NCT04466891). Wannan wani bincike ne na duniya, mai cibiya da yawa, mai lakabin hannu ɗaya, wanda aka tsara don kimanta inganci da amincin zanidatamab a cikin marasa lafiya da aka yi wa magani a baya, waɗanda ba za a iya cire su ba, waɗanda aka yi wa magani a baya, waɗanda ba za a iya cire su ba, waɗanda aka yi wa HER2-amplified advanced ko metastatic BTC.
Binciken ya yi rijistar marasa lafiya 87 na BTC, ciki har da 62 masu yawan HER2. Sakamakon ya nuna cewa maganin Zanidatamab guda ɗaya ya nuna inganci mai mahimmanci a asibiti a cikin marasa lafiya da aka yi wa magani a baya waɗanda ke da babban HER2 BTC. An sake duba ƙimar amsawar da aka tabbatar da ita (ORR) da kanta da kashi 51.6%, tare da matsakaicin tsawon lokacin amsawa (mDoR) na watanni 14.9, matsakaicin rayuwa ba tare da ci gaba ba (mPFS) na watanni 7.2, da matsakaicin rayuwa gaba ɗaya (mOS) na watanni 18.1.
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: Yuni-06-2025