翰宇藥業(300199.SZ)獲醋酸阿託西班注射液藥品註冊批件
格隆匯1月9日丨翰宇藥業(300199.SZ)公佈，公司收到國家藥品監督管理局(“國家藥監局”)下發的關於醋酸阿託西班注射液《藥品註冊批件》。
(1)規格一：藥品名稱：醋酸阿託西班注射液；劑型：注射劑；規格：0.9ml:6.75mg(以阿託西班計)；註冊分類：原化學藥品第6類；藥品批准文號：國藥準字H20193394；藥品批准文號有效期：至2024年12月25日。
(2)規格二：藥品名稱：醋酸阿託西班注射液；劑型：注射劑；規格：5ml:37.5mg(以阿託西班計)；註冊分類：原化學藥品第6類；藥品批准文號：國藥準字H20193395；藥品批准文號有效期：至2024年12月25日。
醋酸阿託西班注射液適用於有下列情況的妊娠婦女，以推遲即將來臨的早產：1、每次至少30秒的規律子宮收縮，每30分鐘內≥4次；2、宮頸擴張1～3cm(初產婦0～3cm)和子宮軟化度/變薄≥50％；3、妊娠24至33足周；4、年齡≥18；5、胎心率正常。
阿託西班是子宮內及蜕膜、胎膜上受體的催產素競爭性拮抗劑。使用本品後可劑量相關性地抑制宮縮，並使催產素介導的前列腺素分泌減少，達到保胎的目的。根據米內網統計的市場數據顯示，2018年全國阿託西班注射劑的銷售額1.42億元，成長性良好，五年複合增長率達110.98%。
醋酸阿託西班作為目前歐洲藥物總署批准用於治療早產的唯一具有子宮特異性的宮縮抑制劑，優點是保胎效果好，對母體及胎兒安全性高，早於2007年歐洲早產指南就建議阿託西班用於抗早產一線用藥。在國內，由於原研價格昂貴，限制了在臨牀上的應用，因此阿託西班注射液的國產化尤為迫切，市場前景良好。
阿託西班因其較高的臨牀價值，未來市場前景良好，公司的醋酸阿託西班注射液獲批上市，進一步完善了公司在婦產生殖藥物領域的產品結構，有利於公司在相應治療領域市場的推廣和銷售渠道的進一步下沉，提升公司在該治療領域產品市場的競爭力，對公司未來業績的提升有積極作用。
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