聯康生物科技集團(00690.HK):匹納普®(伏立康唑片)通過NMPA生物等效性認證
格隆匯 12 月 9日丨聯康生物科技集團(00690.HK)發佈公告,集團匹納普®(伏立康唑片)已通過國家藥品監督管理局(“NMPA”)生物等效性(“BE”)認證,批准文號為H20055751(50mg)。為滿足國家提高仿製藥質量的要求,集團於2018年啟動了質量進步和療效測試。2019年8月,小組完成了所有BE實驗,並將實驗結果提交給NMPA。這項批准將有利於其醫院招標和上市,特別是在國家採購方面,以在抗真菌感染藥物市場取得更大的市場份額。本次批准非常及時,伏立康唑片已於2020年12月8日被列入國家採購公告,集團的匹納普®將有資格參與。雖然有三家廠家通過了該產品的一致性評價,但只有兩家廠家通過了50mg規格的認證,集團是其中之一。因此,該集團在迅速擴大其市場份額方面處於有利地位,在無需大幅降價的基礎上提供高質量的伏立康唑片。
匹納普®(伏立康唑片)是一種治療嚴重真菌感染的主要藥物。作為臨牀指南推薦的一線治療,它通過阻止細胞壁的生長來發揮作用,廣泛應用於腫瘤學、血液學、呼吸學、ICUs等免疫功能低下患者。
據IMS統計,2017年中國抗真菌藥市場規模為49億元,其中伏立康唑佔比最大,約50%。2014-2017年,抗真菌藥物的市場價值保持了兩位數的增長,超過了中國醫藥市場4%-9%的增長水平。根據PDB和Menet的數據,2019年伏立康唑片劑在所有伏立康唑劑型中佔比37%,而2017年為35%,口服劑型市場呈上升趨勢。由於伏立康唑片作為維持療法的使用,以及比注射劑型更方便的口服配方,在可預見的未來治療模式將繼續向口服伏立康唑轉變。
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