I-Alopecia: iSigaba esitsha sovavanyo lwezonyango

Ngomhla wama-24 kuNovemba ka-2021, uKintor Pharma wabhengeza ukuba uLawulo lweeMveliso zoNyango lwaseTshayina (NMPA) lukhanyise luhlaza inkqubo yophononongo olubalulekileyo lwesigaba sesi-III se-KX-826.

Ngomhla wama-20 kuDisemba, ngo-2021, intlanganiso yokukhaba phakathi kwabaphandi abaphambili kulingo lwezonyango lwe-KX-826 isigaba III yabanjwa ngempumelelo. Isibhedlele saBantu seYunivesithi yasePeking kunye neSibhedlele sase-Huashan esidityaniswe neYunivesithi yaseFudan sikhokela ulingo, kunye nezibhedlele ze-26 eziza kuthatha inxaxheba. Emva kokukhokela ngempumelelo isigaba II solingo lwezonyango lwe-KX-826 e-China kunyango lwe-AGA, uNjingalwazi Zhang Jianzhong ovela kwiSibhedlele saBantu seYunivesithi yasePeking kunye noNjingalwazi uYang Qinping ovela kwiSibhedlele saseHuashan esidityaniswe neYunivesithi yaseFudan basebenzisane kwakhona ukuba babe ngabaphandi abaphambili ( iiPIs ezikhokelayo) zeSigaba se-III sovavanyo lweKlinikhi olubalulekileyo lwe-KX-826. Kwintlanganiso yomphandi, phantse iingcali ze-100 ezivela kwizibhedlele ze-26 kulo lonke elase-China ziphulaphule ingxelo malunga nokusebenza kunye nokhuseleko lwe-KX-826 yeSigaba II solingo lwezonyango. Unjingalwazi uZhang Jianzhong uyiqukumbele intlanganiso kwaye wakhuthaza yonke i-PI ukuba izibandakanye nolu phononongo lubalulekileyo nomgangatho ophezulu kunye nokusebenza kakuhle.

UGqr. Youzhi Tong, umseki, uSihlalo, kunye neGosa eliLawulayo eliyiNtloko le-Kintor Pharma, uthe, “Iqela le-Kintor liphumeze ngobuchule obuphezulu ukusuka kugunyaziso lwe-NMPA ukuya kwidosi yokuqala yesi sigaba sesi-III solingo lwezonyango malunga nenyanga enye. Esi sigaba sesi-III solingo lweklinikhi luya kuqhutywa kumaziko angama-26 aphezulu e-dermatology kulo lonke elaseTshayina. Sijonge phambili ekugqibeni izifundo ezicwangcisiweyo ze-416 ezibhalisiweyo ngoJuni 2022, kunye novavanyo olulandelayo lwezonyango (isifundo seenyanga ezi-6 + ukulandelelana kwenyanga ye-1) kunyaka. Ngenjongo yokugqiba ulingo lwezonyango lwesigaba sesi-III kulo nyaka, siyayikhawulezisa inkqubo kwaye silindele ukuba i-KX-826 incede izigulana zehlabathi ngokukhawuleza.