遠大醫藥(00512.HK)全球創新藥Ryaltris複方鼻噴劑獲NMPA III期臨牀批件
格隆匯10月20日丨遠大醫藥(00512.HK)發佈公吿,集團的全球創新藥Ryaltris複方鼻噴劑於2021年8月向中國國家藥品監督管理局(“NMPA”)遞交新藥臨牀試驗申請並獲得受理以來,於近日取得NMPA核准簽發的“藥物臨牀試驗批准通知書”,同意產品開展用於治療12歲及以上患者的過敏性鼻炎和鼻結膜炎症狀的III期臨牀試驗。
Ryaltris是一種新型的抗組胺藥和皮質類固醇的複方鼻噴劑,主要成分為鹽酸奧洛他定和糠酸莫米松,用於治療成人和青少年的季節性過敏性鼻炎(“SAR”)。Ryaltris複方鼻噴劑已完成在海外的III期臨牀研究,並於2021年7月向美國食品藥品管理局(FDA)提交新藥上市申請,該申請目前在審核中。Ryaltris複方鼻噴劑目前已在澳洲、韓國、俄羅斯和歐盟等國家和地區獲批上市。此次於中國獲批開展的III期臨牀試驗,將在超過500名中國成人和青少年SAR患者中評估產品的有效性、安全性、耐受性及藥代動力學,為產品在中國上市提供依據。
集團一直高度重視創新產品和先進技術的研發,以患者需求為核心,以科技創新為驅動,針對尚未滿足的臨牀需求,加大對全球創新產品和先進技術的投入,豐富和完善產品管線及產業佈局,採用“全球化運營佈局,雙循環經營發展”策略,形成國內國際雙循環聯動發展並相互促進的新格局,充分發揮集團的產業優勢和研發實力,快速將科技創新產品落地上市,為全球患者提供更先進更多樣的治療方案。
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