Kutshanje, i-Ascentage Pharma ibhengeze ukuba i-Bcl-2 selective inhibitor lisaftoclax (APG-2575) yayo entsha ivunyiwe yi-National Medical Products Administration (NMPA) yaseTshayina yokunyanga izigulane zabantu abadala abane-chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) abaye bafumana ubuncinane unyango olunye lwenkqubo kuquka ne-Bruton's tyrosine kinase (BTK) inhibitors, nto leyo eyenza i-lisaftoclax ibe yi-Bcl-2 inhibitor yokuqala efumana imvume emiselweyo kunye nemvume yokuthengisa yokunyanga izigulane ezine-CLL/SLL eTshayina, kwaye i-Bcl-2 inhibitor yesibini ivunyiwe kwihlabathi liphela.
I-Lisaftoclax yi-inhibitor entsha, enikwe ngomlomo, ephuhliswe yi-Ascendage Pharma ukunyanga izigulana ezine-malignancies ngokuthintela ngokukhethekileyo iproteni ye-antiapoptotic Bcl-2 kwaye ngaloo ndlela ibuyisele inkqubo eqhelekileyo ye-apoptosis kwiiseli zomhlaza. Kwizilingo zeklinikhi, i-lisaftoclax ibonakalise amandla amaninzi okunyanga kwi-malignancies ezininzi ze-hematologic kunye ne-solid tumors, ngakumbi kwi-CLL/SLL, zombini njenge-monotherapy kunye ne-incombination.
Olu vunyiweyo lusekelwe kwiziphumo ezivela kuphando olubalulekileyo lweSigaba sesiBini sobhaliso (APG2575CC201) olwaluyilelwe ukuvavanya ukusebenza kakuhle kunye nokhuseleko lwe-lisaftoclax monotherapy kwizigulana ezine-CLL/SLL ephinde yabuyela kwisimo sayo okanye engayichaziyo, kunye nezinga lokuphendula ngokubanzi (ORR) njengesiphelo esiphambili. I-Lisaftoclax ibonakalise ukusebenza kakuhle okunyanzelekileyo kunye ne-ORR efikelele kwisiphelo esichaziweyo kwizigulana ezazinyange ngaphambili nge-BTK inhibitors kunye/okanye i-immunochemotherapy. Ngaphezu koko, i-lisaftoclax ibonise iprofayili yokhuseleko elungileyo ngaphandle kwe-tumor-lysis syndrome (TLS) eyenzeka ngexesha lophando, ubuninzi be-hematologic toxicities ezazilawuleka, kunye nobuninzi be-non-hematologic toxicities ezazikwibanga loku-1-2.
I-CLL/SLL sisifo segazi esibangelwa zii-neoplasms ze-B-cell ezivuthiweyo. Ngokuyintloko sichaphazela abantu abadala abane-diagnosis entsha engaphezu kwe-100,000 ebikwa kwihlabathi liphela minyaka le1. E-China, apho izinga lokuxhaphaka kwe-CLL/SLL liphantsi kunelo lamazwe asentshona, esi sifo senzeka ngesantya esinyuka ngokukhawuleza, kunye nobudala obuncinci bokuqala kunye nobukhali obuphezulu2. Njengendlela yangoku ephambili yonyango lokuqala lwe-CLL/SLL, ii-inhibitors ze-BTK ziphucule kakhulu iziphumo zonyango kwizigulane. Nangona kunjalo, ii-inhibitors ze-BTK zisajongene nemiba eyahlukeneyo efana nokukwazi okuncinci ukukhuthaza iimpendulo ezinzulu, umngcipheko omkhulu wokubuyela umva kunyango oluphakathi nolude, ubuthi kunye nokunganyamezelani okuhambelana nonyango olude; ngoko ke, imfuneko yeendlela zonyango ezikhuselekileyo nezisebenzayo ngakumbi kwizigulane ezine-CLL/SLL.
Ukwaziswa kwezithinteli ze-Bcl-2 kuye kwatshintsha ngakumbi unyango lwe-CLL/SLL. I-apoptosis suppressor factor Bcl-2, edla ngokubonakala kakhulu kwiintlobo ngeentlobo ze-hematologic monicancies, ngakumbi i-CLL/SLL, yindlela ephambili apho iiseli ze-tumor ziphepha i-apoptosis. Nangona kunjalo, ukufunyanwa kwe-Bcl-2 inhibitor njengethagethi yonyango kunzima kakhulu kuba indlela esebenza ngayo isekelwe kwi-protein-protein interaction (PPI). Ujongano lokubopha lwe-Bcl-2 lukhulu kakhulu, okwenza kube nzima ukuba izithinteli ze-molecule ezincinci zisebenzise iziphumo zokuthintela. Ukongeza, iproteni ye-Bcl-2 ikwi-mitochondria, enesakhiwo se-membrane ephindwe kabini, yenye yezona zinto zinzima nezinzima zeseli njengoko ifuna amayeza ukuba angene kuqala kwi-membrane yeseli ngaphambi kokuba asebenze ngakumbi kwi-membrane ye-mitochondrial. Ngaphambi koku, akukho inhibitor ye-Bcl-2 eyayivunyiwe kunyango lwe-CLL/SLL eTshayina. Olu vunyiweyo lwe-lisaftoclax luzalisa umsantsa kunyango kwi-CLL/SLL, luzisa ithemba elitsha kwizigulane ezininzi kweli lizwe.
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.
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Ixesha leposi: Julayi-15-2025