李氏大藥廠(00950.HK)附屬苯丁酸鈉顆粒獲批上市
格隆匯5月21日丨李氏大藥廠(00950.HK)宣佈,於2021年5月13日,由公司全資附屬公司兆科藥業(廣州)有限公司(“兆科廣州”)開發並生產的苯丁酸鈉顆粒(規格:150g/瓶,每1g含苯丁酸鈉0.94g)獲國家藥監局的藥品註冊證書,並已於該公佈日期完成首次發貨。
苯丁酸鈉作為輔助治療藥物,用於氨基甲酰磷酸合成酶缺乏症、鳥氨酸氨甲酰基轉移酶缺乏症或精氨基琥珀酸合成酶缺乏症引起的尿素循環異常患者的長期治療,適用於所有新生兒期(出生28天內)出現完全酶缺乏症的患者,也適用於有高血氨性腦病病史的遲髮型(部分酶缺乏症,發生於出生1個月後)患者。兆科廣州開發並生產的苯丁酸鈉顆粒為國內首仿藥物,因用於治療罕見病且為兒童用藥品,被國家藥監局藥品審評中心納入優先審評審批品種名單。
根據美國的統計數據,以上提及的罕見疾病的發病率大約1/35,000,根據該數據預估,中國每年的新增患者約有300至400人。對於這類患者,肝移植是最終治療方法。如果診斷為不適合進行肝移植治療就需要長期服用氮清除劑,而苯丁酸鈉是目前首選的藥品之一,目前中國沒有原研苯丁酸鈉銷售,兆科廣州首仿的苯丁酸鈉顆粒正好填補國內的空白。高血氨症通常在嬰幼兒期就會發生,且對嬰幼兒的神經系統危害巨大,甚至導致死亡。因此需要儘早、及時給予對症治療,同時考慮到臨牀上嬰幼兒患者用藥的依從性和安全性問題,選擇一種安全、有效且能適用於患兒治療的藥物成為臨牀上的當務之急,具有巨大的臨牀需求。
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