綠葉製藥(02186.HK):抗抑鬱1類創新藥若欣林在中國澳門獲批上市
格隆匯4月7日丨綠葉製藥(02186.HK)公告,集團自主研發的1類創新藥若欣林(鹽酸託魯地文拉法辛緩釋片)正式獲得中國澳門藥物監督管理局的上市批準,用於治療抑鬱症。
若欣林是中國首個自主研發並擁有自主知識產權、用於治療抑鬱症的化藥1類創新藥。臨牀前研究顯示,若欣林對於5-羥色胺(5-HT)、去甲腎上腺素(NE)和多巴胺(DA)均具有再攝取抑制作用;另有PET/CT研究證實若欣林可與大鼠和健康受試者腦內DA轉運體結合,爲其三重再攝取抑制作用再添強證。
若欣林的3期臨牀研究結果證實其能夠全面、穩定的治療抑鬱症,顯著改善患者焦慮狀態、阻滯╱疲勞症狀、快感缺失和認知能力,促進社會功能恢復,而且具有良好的安全性和耐受性,不引起嗜睡,不影響性功能、體重和脂代謝。
若欣林自2022年11月在中國內地獲批上市以來,療效和安全性不斷獲得臨牀認可,已成爲近年來中國內地增長最快的抗抑鬱新藥之一,當前累計服務超過3萬名患者。2024年底,若欣林通過談判首次納入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2024年)》,有望提升創新可及、造福更多患者。此外,若欣林用於治療廣泛性焦慮障礙的3期臨牀試驗也在進行中。
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