眾生藥業(002317.SZ)：子公司治療NASH一類創新藥ZSP1601片將繼續開展IIb期臨牀試驗
格隆匯10月18日丨眾生藥業(002317.SZ)公佈，近日，公司控股子公司廣東眾生睿創生物科技有限公司(“眾生睿創”)組織開展的用於治療非酒精性脂肪性肝炎(NASH)的一類創新藥物ZSP1601片已結束Ib/Ⅱa期臨牀研究入組，完成數據庫清理、盲態數據審核、揭盲和統計分析，收到統計分析報吿初稿。
頂線(TopLine)數據初步分析表明，ZSP1601對於NASH患者具有較好的安全性和藥代動力學特性，在丙氨酸氨基轉移酶(ALT)、門冬氨酸氨基轉移酶(AST)、脂肪含量(PDFF)等多個觀察指標獲得積極性的改變，試驗獲得了積極結果，達到了主要終點，支持ZSP1601片繼續開展IIb期臨牀試驗。
ZSP1601片是具有全新作用機制和全球自主知識產權的用於治療NASH的一類創新藥物，屬於First-in-class藥物，為境內首個進入臨牀試驗用於治療NASH的創新藥物。臨牀前多個NASH動物藥效模型研究結果表明，ZSP1601可改善肝組織炎症、水樣變性和壞死，以及改善纖維化，其強效抗肝纖維化作用是該領域治療的最重要關注點，未來可能成為NASH聯合用藥治療的基石藥物。
ZSP1601片在NASH患者中多中心、隨機、雙盲、安慰劑對照的Ib/Ⅱa期臨牀試驗的主要研究目的是評價ZSP1601片在NASH患者中的安全性、耐受性、藥代動力學特徵和早期藥效學，為ZSP1601片治療NASH患者的進一步臨牀研究提供支持。該研究由吉林大學第一醫院牛俊奇教授、丁豔華教授作為主要研究者，參加單位包括南方醫科大學南方醫院和首都醫科大學附屬北京友誼醫院。目前已完成了ZSP1601片Ib/Ⅱa期臨牀研究入組及頂線數據初步分析工作。
基於ZSP1601片獲得積極的Ib/Ⅱa期臨牀試驗結果，眾生睿創將組織實施ZSP1601片用於治療非酒精性脂肪性肝炎患者的Ⅱb期臨牀試驗。
頂線數據初步表明，ZSP1601片中高劑量組在NASH患者中，可改善肝臟炎性和損傷的相關生物標誌物，試驗結果良好。這項研究提供了重要的安全性、藥代動力學和初步療效數據，達到該項目臨牀研究的目的和預期，支持進一步在非酒精性脂肪性肝炎患者中開展臨牀試驗。
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