新天藥業(002873.SZ):匯倫江蘇藥業獲得“注射用左亞葉酸”藥品註冊證書
格隆匯7月7日丨新天藥業(002873.SZ)公佈,公司參股公司上海匯倫生物科技有限公司(“匯倫生物”)的全資子公司上海匯倫江蘇藥業有限公司(“匯倫江蘇藥業”)近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》(批件號:2021S00764、2021S00765),藥品名稱為注射用左亞葉酸。
左亞葉酸用於使用高劑量甲氨蝶呤後的解救、減少由葉酸拮抗劑過量或甲氨蝶呤消除下降引起的毒性、與氟尿嘧啶聯用治療轉移性結直腸癌。左亞葉酸是亞葉酸的活性異構體,其向細胞轉運的能力優於亞葉酸,能更好的增強5-FU的活性,具有藥效和安全性優勢。其鈉鹽的形式相比鈣鹽可避免藥物沉積,允許聯合輸液,提高5-FU化療效率;亦可防止引起離子代謝紊亂、心率失常及高血鈣綜合症。該產品針對的適應症為:1)葉酸拮抗劑(例如甲氨蝶呤)化療、過量使用時,減輕其毒性、抵消其作用;2)化療中,與氟尿嘧啶類藥物聯合使用,用於治療胃癌和結直腸癌。前述特徵使得左亞葉酸成為亞葉酸類藥物在臨牀腫瘤治療中,更新更優的選擇。
匯倫生物的全資子公司匯倫江蘇藥業此次獲得“注射用左亞葉酸”藥品註冊證書,有利於公司進一步優化產業佈局,加快在小分子化藥領域的業務拓展,包括抗腫瘤、心腦血管、呼吸及消化系統等疾病的仿製藥及創新藥領域,對公司未來發展將產生積極影響,但不會對公司當期經營業績產生重大影響。
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