四環醫藥(00460.HK):創新藥安奈拉唑鈉用於反流性食管炎的新適應症III期臨牀完成首例受試者入組
格隆匯7月30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科技股份有限公司(“軒竹生物”)自主研發的1類創新藥安奈拉唑鈉腸溶片(商品名:安久衞®)用於治療反流性食管炎的III期臨牀研究完成首例受試者入組(“該研究”),是安奈拉唑鈉腸溶片拓展的第二個適應症。
該研究是一項評價安奈拉唑鈉腸溶片用於反流性食管炎患者的多中心、隨機、雙盲、陽性藥物對照的III期臨牀研究,研究由上海長海醫院牽頭,李兆申院士和杜奕奇教授共同擔任Leading PI,並聯合北京協和醫院、上海交通大學附屬瑞金醫院、山東齊魯醫院等32家權威機構的消化科共同開展。旨在全面評估安奈拉唑鈉腸溶片治療反流性食管炎的療效和長期安全性,為該適應症的獲批提供關鍵數據支持。
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