華東醫藥(000963.SZ):獲得注射用利納西普複發性心包炎適應症藥品註冊上市許可受理通知書
格隆匯3月1日丨華東醫藥(000963.SZ)公佈,2024年3月1日,華東醫藥股份有限公司全資子公司杭州中美華東製藥有限公司(簡稱“中美華東”)收到國家藥品監督管理局(NMPA)簽發的《受理通知書》(受理號:JXSS2400016),由中美華東註冊代理申報的注射用利納西普(ARCALYST®,Rilonacept for Injection)用於治療複發性心包炎(RP)的上市許可申請獲得受理。
複發性心包炎為罕見的自身免疫性疾病。注射用利納西普國外關鍵性臨牀數據顯示本品能治療12歲及以上青少年複發性心包炎並降低其復發風險,國外上市後的臨牀經驗也表明本品治療RP具有顯著的療效和良好的安全性。由於患病率低,國內開發複發性心包炎相關藥物的製藥企業較少,如注射用利納西普順利獲批上市,有望為中國患者帶來更多治療選擇。
本次注射用利納西普RP適應症上市申請獲得受理,是該款藥品研發進程中的又一重要進展。注射用利納西普複發性心包炎適應症和冷吡啉相關的週期性綜合徵適應症在國內均為罕見病,且均已被納入優先審評品種名單,公司將繼續全力推進這款產品在中國的註冊上市,加速解決相關患者用藥可及性的問題,爭取早日惠及國內患者。
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