四環醫藥(00460.HK):安納拉唑鈉新適應症獲國家藥監局批准開展II期臨牀試驗
格隆匯7月19日丨四環醫藥(00460.HK)發佈公吿,集團旗下非全資附屬公司軒竹生物自主研發的安納拉唑鈉腸溶片的新適應症成人反流性食管炎(RE)的治療及其相關症狀(反酸、燒心、胸骨後疼痛或不適、噯氣反流等)控制的II期臨牀試驗申請(IND)已獲得中國國家藥品監督管理局批准。
安納拉唑鈉是新一代國內唯一一個自主研發的質子泵抑制劑(“PPI”),首個適應症用於治療十二指腸潰瘍已經於2021年遞交新藥上市申請(NDA)。安納拉唑鈉經多酶和非酶代謝,藥物間相互作用的風險低。臨牀數據顯示,集團研發的安納拉唑鈉的安全性及症狀緩解均為同類產品最佳(Best-in-class)。
據IQVIA數據,2021年PPI藥物中國市場規模超過人民幣200億元,其中口服制劑達到人民幣100億元。反流性食管炎是消化系統的常見疾病,在中國普通人羣中的發病率高達6.4%,臨牀上常採用PPI治療反流性食管炎,治療效果顯著,有效改善患者疼痛、反酸及燒心等症狀,具有非常顯着的臨牀應用價值。
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