Ngomhla wama-29 kuCanzibe, iNational Medical Products Administration (NMPA) yavuma ukuthengiswa kweZanidatamab, engeniswe yiBeiGene, ukuze kunyangwe izigulane ezinomhlaza we-biliary tract ongenakunyangwa (BTC) okwindawo ethile okanye osasazekayo, ezazikhe zafumana unyango lwe-systemic kwaye zibonisa ukubonakaliswa okuphezulu kwe-HER2 (IHC 3+).
I-Zanidatamab yi-antibody ye-bispecific ejoliswe kwi-HER2 enokubopha ngaxeshanye ii-epitopes ezimbini ezingadibaniyo ze-HER2 receptor, eyaziwa ngokuba yi-biparatopic binding. Olu yilo lukhethekileyo kunye nokwanda kokubopha kubangela iindlela ezininzi zokusebenza, kubandakanya ukuvalwa kwesignali ye-HER2 kabini, ukususwa kweproteni ye-HER2 kumphezulu weseli, kunye ne-immune-mediated cytotoxicity ekhokelela ekukhuthazeni umsebenzi wokulwa ne-tumor kwizigulana.
I-Receptor tyrosine-protein kinase, eyaziwa ngokuba yi-Human Epidermal Growth Factor Receptor 2 (HER2) okanye i-CD340, ikwindawo ephezulu yeeseli. Le protein lilungu losapho lwe-Epidermal Growth Factor Receptor (EGFR) kwaye ibhalwe yi-Erythroblastic oncogene B (ERBB2) gene. I-ERBB2 gene ibalulekile kwiinkqubo eziqhelekileyo ezifana nokwahlukana kweeseli, ukwahlukana, kunye nokusinda. Ngeendlela ezahlukeneyo zokubonisa, ii-HER2 receptors zikhuthaza ukwanda kweeseli kwaye zithintele i-apoptosis (ukufa kweeseli okucwangcisiweyo). Kubalulekile ukulawula ezi receptors ukuthintela ukukhula kweeseli okungalawulwayo. Umhlaza oveza kakhulu okanye okwandisa i-HER2 gene ubizwa ngokuba yi-HER2-positive malignancies. Le gene isebenza njenge-biomarker ebalulekileyo kwaye yeyona nto iphambili ekujoliswe kuyo kunyango lwamayeza.
Nangona kunjalo, xa i-HER2 isanda okanye isasazeka kakhulu, ukwanda kweeseli kunye nokwahlukana okungajongwanga kuyakhawulezisa ukuqhubela phambili komhlaza. Oku kukhula okanye ukubonakaliswa okugqithisileyo kudla ngokufumaneka kwiintlobo ezahlukeneyo zeethumba kwaye kunokuba nentsingiselo ebalulekileyo yonyango lwezifo ezinobungozi ezingalindelwanga ukuba zisabele kakuhle kunyango lwe-anti-HER2.
I-HER2-positivity ifumaneka kwiintlobo ezahlukeneyo ze-malignancies ezifana nomhlaza wesisu, we-biliary tract, webele, we-esophageal, we-ovarian, kunye nowe-uterine. Ukwenzeka, inkcazo, kunye neendlela zonyango ze-HER2-positive tumors nganye zikhona kwiTheyibhile. Kutshanje, kufunyenwe unxulumano nomhlaza we-pancreatic kunye ne-biliary tract (BTC). Izigulana ezine-HER2-positive cancers zihlala zingenaso isiqinisekiso esifanelekileyo xa kuthelekiswa nezo zine-HER2-negative cancers, njengoko ezi malignancies zinamandla ngakumbi. Nangona kunjalo, iindlela ezintsha zonyango zibonise iziphumo ezithembisayo.
Olu vunywa lusekelwe kwiziphumo zophando olubalulekileyo lweklinikhi iHERIZON-BTC-01 (NCT04466891). Olu yayiluphando lweSigaba sesi-2b lwehlabathi, oluneziko elininzi, oluvulekileyo, olunengalo enye, oluyilwe ukuvavanya ukusebenza kakuhle kunye nokhuseleko lwe-zanidatamab kwizigulane ezine-BTC ephuculweyo ngaphambili, engasuswayo, ene-HER2-amplified advanced okanye esasazekayo.
Olu phononongo lubhalise izigulane ezingama-87 ze-BTC, kuquka ezingama-62 ezine-HER2 expression ephezulu. Iziphumo zibonise ukuba i-Zanidatamab monotherapy ibonakalise ukusebenza kakuhle ngokwezonyango kwizigulane ezazinyangwe ngaphambili ezine-HER2-high BTC. Ireyithi yokuphendula eqinisekisiweyo (ORR) ehlaziyiweyo ngokuzimeleyo yayiyi-51.6%, kunye nexesha eliphakathi lokuphendula (mDoR) leenyanga ezili-14.9, ukusinda okuphakathi okungenankqubela phambili (mPFS) kweenyanga ezi-7.2, kunye nokusinda okuphakathi ngokubanzi (mOS) kweenyanga ezili-18.1.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Ixesha leposi: Juni-06-2025