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泰恩康(301263.SZ):子公司收到聚多卡醇注射液藥品註冊受理通知書
格隆匯 04-15 19:50

格隆匯4月15日丨泰恩康(301263.SZ)公佈,公司子公司山東華鉑凱盛生物科技有限公司於近日收到國家藥品監督管理局簽發的聚多卡醇注射液境內生產藥品註冊上市許可申請《受理通知書》,國家藥監局根據《中華人民共和國行政許可法》第三十二條的規定,對上述藥品的藥品註冊上市許可申請進行了審查,決定予以受理。

聚多卡醇又名聚桂醇,聚多卡醇是一種非離子型表面活性劑,通過破壞血管內皮細胞,引發局部炎症反應,促進血管內血栓形成及纖維化,最終閉合異常血管。聚多卡醇適用於蜘蛛網樣靜脈的中心靜脈、網狀靜脈及小靜脈曲張的硬化治療,中等大小至大靜脈曲張硬化治療。

聚多卡醇憑藉其療效確切、安全性好、疼痛輕微等臨牀優勢,已成爲目前臨牀應用最廣泛的一種硬化劑。中國下肢靜脈曲張患者超1億人,且隨着老齡化加劇、久坐久站人羣增加,患者基數持續擴大。聚多卡醇作爲一線硬化劑,具有微創、恢復快的優勢,未來市場潛力顯著。

米內網數據顯示,近年中國城市公立醫院、縣級公立醫院、城市社區中心以及鄉鎮衛生院(簡稱中國公立醫療機構)終端聚桂醇(聚多卡醇)注射液銷售額穩步增長,2020年超過2億元。2022年聚桂醇注射液銷售額約爲2.3億元。

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