眾生藥業(002317.SZ)：一類創新藥ZSP1603已啟動用於治療特發性肺纖維化患者的Ⅰb/Ⅱa期臨牀試驗
格隆匯10月22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”)組織開展的擬用於特發性肺纖維化的治療及晚期複發性、難治性或轉移性實體瘤治療的一類創新藥ZSP1603，已啟動用於治療特發性肺纖維化患者的Ⅰb/Ⅱa期臨牀試驗，首例受試者已入組。
ZSP1603是眾生睿創研發的具有明確作用機制和全球自主知識產權的用於治療特發性肺纖維化及晚期複發性、難治性或轉移性實體瘤的化學藥1類創新藥物。
眾生睿創已完成ZSP1603膠囊在健康成人受試者中的Ia期臨牀研究，正在特發性肺纖維化(IPF)患者中進行Ⅰb/Ⅱa期臨牀研究。目前，ZSP1603膠囊Ⅰb/Ⅱa期試驗已完成臨牀試驗方案和專家論證，獲得組長單位上海市肺科醫院和其餘5家參研中心醫學倫理委員會的批准，陸續在各家參研中心啟動，於近日完成首例受試者入組和給藥，按相關法規要求在中國藥物臨牀試驗登記信息公示平台完成登記並予以公示(登記號：CTR20211366)。
公吿稱，此次首例入組，是ZSP1603膠囊治療IPF患者臨牀研究的里程碑事件，標誌着ZSP1603膠囊臨牀進度有了實質性進展。眾生睿創將按照《藥物臨牀試驗質量管理規範》和ICH-GCP要求，繼續認真組織和開展臨牀試驗。ZSP1603膠囊的Ⅰb/Ⅱa期臨牀試驗的順利開展將有助於為後續臨牀試驗提供科學依據，有望為IPF的治療提供新的選擇，滿足IPF患者未被滿足的臨牀治療需求。
眾生睿創開發的ZSP1603膠囊，屬於境內外均未上市的創新藥。ZSP1603膠囊是一種多靶點酪氨酸激酶抑制劑，既抑制血管內皮細胞的異常增生，同時也抑制成纖維細胞的活化，進而抑制新生血管的生成及纖維化的進程。ZSP1603項目的成功開發將為IPF的臨牀治療提供更多的治療選擇，滿足患者的臨牀治療需求。ZSP1603項目將進一步充實眾生睿創在呼吸系統疾病研發領域的管線。除了ZSP1603外，眾生睿創呼吸管線產品還有ZSP1273，該藥物已完成甲型流感患者的II期臨牀試驗並取得了積極的結果，正在III期臨牀試驗招募中。
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