福森藥業(01652.HK):"艾曲泊帕乙醇胺片"獲批上市
格隆匯10月21日丨福森藥業(01652.HK)公吿,集團全資附屬公司嘉亨(珠海橫琴)醫藥科技有限公司研發的"艾曲泊帕乙醇胺片"(商品名:艾復生)已獲得中國國家藥品監督管理局的上市批准,批准用於既往對糖皮質激素、免疫球蛋白等治療反應不佳的成人和6歲及以上兒童慢性免疫性(特發性)血小板減少症(ITP)患者,使血小板計數升高並減少或防止出血。本品僅用於因血小板減少和臨牀條件導致出血風險增加的ITP患者。
艾曲泊帕乙醇胺片是一款口服、小分子、非肽類血小板生成素受體激動劑(TPO-RA),其作用為增加血小板的數量。在《成人原發免疫性血小板減少症診斷與治療中國指南(2020年版)》中,艾曲泊帕是唯一具有最高等級(1a)證據並獲得A級推薦的藥物,同時也是我國唯一獲批6歲及以上兒童ITP適應症的促血小板生成類藥物。
相比其他ITP藥物,艾曲泊帕乙醇胺片具有以下優勢:1.起效快:此類藥物於1–2周起效,可以有效幫助重症ITP患者迅速升高血小板計數,減少出血事件的發生;2.應答較強,有效率高:無論短期或者長期治療ITP,均能明顯增加血小板計數,減少出血癥狀;3.可通過個性化持續用藥獲得長期緩解,從而改善生活質量;4.用藥方便,依從性高:口服給藥,簡單方便。無需空腹服用,解除了食物對於服藥的限制,依從性大幅提升;5.長期服用安全性較高;6.説明書明確可用於治療兒童慢性ITP的藥物:目前中國國家藥品監督管理局批准的7款治療慢性ITP的藥物中,艾曲泊帕乙醇胺片是説明書中明確批准可以用於兒童適應症的藥物。
此外,TPO類藥物還可聯合利妥昔單抗治療糖皮質激素無效或復發ITP患者,總體有效率更高。正是基於上述種種優勢,TPO類藥物成為ITP二線治療首選。
艾復生與原研劑型一致,通過空腹、餐後人體生物等效性試驗,全面證實艾復生與參比製劑生物等效。艾復生的獲批,將進一步豐富ITP患者的治療選擇,降低治療成本,減輕患者用藥的經濟壓力,同時為我國兒童用藥發展貢獻力量。未來,公司將持續推出臨牀需要、優質經濟的藥物,為廣大患者帶來福音。
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