中國抗體-B(03681.HK):SM17新藥研究申請獲FDA受理
格隆匯2月16日丨中國抗體-B(03681.HK)宣佈,於2022年2月11日(美國東部當地時間),公司已就治療哮喘的第一類(First-in-Class)治療產品SM17(注射用人源化抗IL17RB單克隆抗體),提交新藥研究申請("IND"),有關申請已獲美國食品藥品監督管理局(U.S.Foodand Drug Administration,"FDA")受理。一旦新藥研究申請獲FDA批准,公司計劃最早於2022年第一季度在美國啟動首次人體臨牀(FIH)研究。
SM17為以IL-17RB為靶點的人源化IgG4-κ單克隆抗體,IL-17RB則是屬於IL-17受體家族的一種I型單跨膜糖蛋白。SM17結合IL-17RB後,可抑制由一類被稱為"警戒素"的細胞因子導致的Th2細胞相關免疫反應,而"警戒素"已被證明與過敏性疾病的病理過程及氣道細胞的病毒感染反應有關。患有未受控制的嚴重哮喘的患者,會承受哮喘反覆發作及住院的風險;而未受控制的嚴重哮喘疾病會引發羣體死亡率╱患病率升高、生活質素下降以及醫療支出增加。目前已獲批上市的嚴重哮喘療法(包括生物製劑),可一定程度降低哮喘年度發作率。然而,嚴重哮喘的有效治療仍存在未滿足的醫療需求,尤其是對當前療法無應答的患者而言。作為哮喘治療的新路徑,靶向Th2炎性細胞因子通路上游介質(例如"警戒素")的療法,預計將對氣道炎症相關的病理變化產生更廣譜的作用,從而較現有療法更為有效地控制哮喘症狀;目前已有針對警戒素相關信號通路,與SM17具有相若作用機制的嚴重哮喘療法獲FDA批准。
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