李氏大藥廠(00950.HK):注射用那屈肝素鈣獲藥品註冊批件
格隆匯8月6日丨李氏大藥廠(00950.HK)宣佈,於2020年7月24日,公司全資附屬公司兆科藥業(合肥)有限公司的低分子量肝素,注射用那屈肝素鈣(商標名:立邁青)已獲得國家藥監局藥品註冊批件。
集團為藥品註冊批件申請進行了一項立邁青生物等效研究。審批結論為根據《中華人民共和國藥品管理法》及有關規定,經審查立邁青符合藥品註冊的有關要求,接受立邁青與那屈肝素鈣注射液原研進口產品(商品名:速碧林)生物等效的結論,批准立邁青增加以下2個規格:0.6ml:6150IU及0.4ml:4100IU,核發藥品批准文號。
集團於1998年推出立邁青,併成為中國低分子量肝素領先品牌之一。立邁青歸類為那屈肝素不但標誌着立邁青的質量,安全性和功效獲得驗證和肯定,並且大幅地擴展其當前的適應症。那屈肝素是一種抗凝劑,屬於一項特定類別的低分子量肝素,適用於預防術後靜脈血栓塞及治療深層靜脈栓塞。也適用於聯合阿司匹林用於不穩定性心絞痛和非Q波性心肌梗塞急性期的治療及在血液透析中預防血凝塊形成。
根據數字醫藥網(SZYY.COM.CN)的數據,2018年低分子量肝素產品在中國的銷售額約為人民幣58.43億元,那屈肝素於所有低分子量肝素產品中排名第三,銷售收入約為人民幣10億元。
公司表示,集團目前是中國抗血栓領域的市場領導者,除注射用那屈肝素鈣外,其亦擁有強大的抗血栓藥物的研發管線,如安菲博肽(II期抗血小板藥物)、特卡法林(III期華法林類抗凝劑),磺達肝癸鈉(合成抗血栓藥物)及GCC4401C(因數Xa抑制劑抗凝劑)。
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