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萊美藥業(300006.SZ):取得丙氨酰谷氨醯胺注射液(50ml:10g和100ml:20g)的藥品補充申請批准通知書
格隆匯 11-26 15:49

格隆匯11月26日丨萊美藥業(300006.SZ)公佈,近日,重慶萊美藥業股份有限公司收到國家藥品監督管理局核准簽發的丙氨酰谷氨醯胺注射液50ml:10g和100ml:20g兩種規格《藥品補充申請批准通知書》。

丙氨酰谷氨醯胺注射液為德國費森尤斯公司開發的Ala-Glu二肽類營養液,商品名為Dipeptiven,該藥品作為臨牀營養方案的一部分,適用於需要補充谷氨醯胺患者的腸外營養,包括處於分解代謝和高代謝狀況的患者。

截至目前,除公司外,已有20家國產企業取得丙氨酰谷氨醯胺注射液註冊證書,其中15家通過了一致性評價。

根據藥融雲數據顯示,丙氨酰谷氨醯胺注射液2021-2023年在中國醫院(全終端)市場銷售額分別為16.01億元、14.58億元、11.01億元。

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