遠大醫藥(00512.HK)：全球創新眼科藥物GPN00136的中國II期臨牀試驗申請獲藥監局默示許可
格隆匯4月18日丨遠大醫藥(00512.HK)公吿，集團用於治療乾眼症的小分子多肽藥物GPN00136 (BRM421)的II期臨牀試驗申請，近日已獲得中華人民共和國國家藥品監督管理局臨牀試驗默示許可，是集團在眼科疾病治療領域的又一項重要研發進展。
GPN00136(BRM421)為全球創新的小分子多肽滴眼液產品，通過加速角膜緣幹細胞的分裂增殖，促進眼表修復以治療乾眼症。此次臨牀研究是一項單臂、開放標籤的II期臨牀研究，擬入組不超過40例的中重度乾眼症患者，旨在評估BRM421治療中重度乾眼症患者的有效性和安全性。此外，該產品的海外研究已進入III期臨牀階段，並於今年2月完成首例患者入組。
集團作為中國主要的眼科藥研發、生產及銷售綜合企業之一，眼科在售產品近30款，主要聚焦於乾眼症、眼底出血、青光眼、白內障、抗炎、近視相關等主流適應症，覆蓋了化學制劑、中藥製劑及眼用健康產品，包含處方藥、OTC、器械、消費品等幾大類別打造集"預防+治療+保健"為一體的"大眾護眼生態圈"。
創新研發方面，儲備了治療"近視"、"乾眼症"、"翼狀胬肉"和"眼科術後抗炎鎮痛"的多款全球創新產品，其中治療翼狀胬肉的創新產品CBT-001和用於抗炎鎮痛的激素納米混懸滴眼液GPN00833分別於今年3月和4月獲批在中國開展III期臨牀研究。
此外，GPN00833海外II期臨牀研究和兩項III期臨牀研究均已成功達到臨牀終點，根據臨牀結果顯示，該產品在治療眼科術後抗炎和鎮痛方面有着顯著的有效性，且安全性良好，該產品的上市許可申請(NDA)預計今年上半年向美國食品藥品監督管理局(Foodand Drug Administration，FDA)遞交。未來該板塊將秉持"以重磅創新藥械為引領，以大眾護眼生態圈產品為基礎"的發展戰略，不斷強化行業影響力，實現業務領域新突破。
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