司太立(603520.SH)：獲得國家藥監局簽發的碘克沙醇注射液《藥品註冊批件》
格隆匯 8 月 24日丨司太立(603520.SH)公佈，公司全資子公司上海司太立制藥有限公司(“上海司太立”)於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的碘克沙醇注射液《藥品註冊批件》。
該藥品適應症包括：心血管造影、腦血管造影、外周動脈造影、腹部血管造影、尿路造影、靜脈造影和CT增強檢查等。該藥品的藥品註冊分類為化學藥品4類。根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)文件相關規定，該藥品視為通過仿製藥質量和療效一致性評價。
該藥品提交註冊申請並獲得正式受理的時間為2017年10月20日，截至目前，該藥品累計研發投入共計1389.22萬元。
碘克沙醇由挪威奈科明(Nycomed)公司研製，屬於一種非離子型的等滲二聚體對比劑，水溶性好，與血漿等滲，滲透壓毒性低於低滲型造影劑。碘克沙醇於1996年經美國FDA批准上市，2001年以商品名“威視派克”(Visipaque)，英文名Iodixanol Injection在國內註冊上市。
碘克沙醇屬於X射線非離子型碘造影劑，同類品種包括碘海醇、碘帕醇、碘普羅胺、碘美普爾等。目前，國內共有6家公司在售碘克沙醇製劑，其中約90%市場份額由江蘇恆瑞醫藥股份有限公司和GE Healthcare AS佔據。據來自Newport Premium數據庫及中國醫藥工業信息中心的數據顯示，2018年碘克沙醇全球市場規模為5.74億美元，同比增長17.62%，增速創歷年新高。與碘海醇和碘帕醇市場格局一致，碘克沙醇在歐美地區規模佔比最高。2019年，碘克沙醇國內市場規模約為49.71億元，同比增長38.43%。2019年碘克沙醇在國內X射線造影劑中市場份額佔比35.65%，同時X射線造影劑在整個國內造影劑市場中佔比最高，所以碘克沙醇目前也是國內市場規模最大的造影劑產品。
上海司太立獲得國家藥監局簽發的碘克沙醇注射液《藥品註冊批件》，標誌着公司在向下遊產業鏈延伸的基礎上，造影劑產品品類進一步豐富，提升了公司在X射線造影劑領域的市場競爭力。
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