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京新藥業(002020.SZ):匹伐他汀鈣分散片通過一致性評價
格隆匯 07-17 17:57

格隆匯 7 月 17日丨京新藥業(002020.SZ)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的化學藥品“匹伐他汀鈣分散片的《藥品補充申請批准通知書》,該藥品通過仿製藥一致性評價

匹伐他汀鈣是第三代他汀類藥物,是目前國際臨牀應用中治療高膽固醇血癥、家族性高膽固醇血癥效果較好的他汀類藥物之一,因其臨牀有效劑量為1-2mg/天,明顯低於其他已上市的他汀類藥物,具有糖代謝影響小的特點,具有良好的耐受性。根據IQVIA數據顯示,2019年度匹伐他汀鈣片內銷售額超過10億元

繼瑞舒伐他汀鈣片、辛伐他汀片先後通過一致性評價公司匹伐他汀鈣分散順利通過一致性評價。本次獲批有利於提升匹伐他汀鈣分散片市場競爭力,對公司做強心腦血管領域提升公司業績帶來積極影響同時為公司後續其他產品開展仿製藥一致性評價工作積累經驗。

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