通化東寶(600867.SH):門冬胰島素注射液獲得藥品註冊批件
格隆匯10月20日丨通化東寶(600867.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的門冬胰島素注射液《藥品註冊證書》。
截至2021年9月30日,公司在該相關研發項目(含門冬胰島素、門冬胰島素注射液、門冬胰島素30注射液、門冬胰島素50注射液)中已累計投入1.988億元。
門冬胰島素是一種速效的胰島素類似物,其降血糖作用是通過與肌肉和脂肪細胞上的胰島素受體結合後,促進細胞對葡萄糖吸收利用,同時抑制肝臟葡萄糖的輸出來實現的。由於其特點,主要作為餐時胰島素使用,患者在使用時依從性比較好,使用效果也明顯,對其它治療效果不好的患者,治療效果顯著;經濟成本相對人胰島素及其它胰島素類似物也不高,是一種有效的,值得推廣的胰島素類似物。
公司門冬胰島素原料藥及注射液生產車間已通過藥品GMP符合性檢查,公司投資建設的門冬胰島素生產基地項目設計生產能力為年產門冬胰島素原料藥1000公斤,年產門冬胰島素注射液5000萬支。
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