佐力藥業(300181.SZ):聚卡波非鈣片獲批上市
格隆匯12月9日丨佐力藥業(300181.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的聚卡波非鈣片《藥品註冊證書》(受理號:CYHS1700537;證書編號:2021S01220)。
聚卡波非鈣片中的活性成分聚卡波非鈣具有極為獨特的生物化學性質,在酸性環境下可迅速脱鈣,形成聚卡波非,在小腸或大腸的中性環境下顯示了高度的吸水性,膨脹成為凝膠,保持消化道內水分,調節消化道內容物的輸送,從而對便祕發揮治療作用。
聚卡波非鈣片用於緩解腸易激綜合徵(便祕型)患者的便祕症狀。聚卡波非鈣本身是一種惰性的、體內無吸收的高分子聚合物,長期的毒性實驗未發現明顯不良反應,臨牀應用中不良反應的發生率較低。聚卡波菲鈣片在美國、歐洲及日本得到廣泛應用,具有很大的市場潛力。近期頒佈的《國家醫保目錄》(2021年版)聚卡波非鈣片再次被納入其中。
聚卡波菲鈣片的獲批進一步豐富了公司的品種線,其與烏靈膠囊在消化科的應用有一定的協同效應。公司將按照相關法律法規的規定,積極開展該產品的生產銷售工作。
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