君實生物(01877.HK):氫溴酸氘瑞米德韋片獲得國家藥品監督管理局常規批准
格隆匯1月10日丨君實生物(01877.HK)公吿,公司控股子公司上海旺實生物醫藥科技有限公司收到中國國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,氫溴酸氘瑞米德韋片(商品名:民得維,產品代號:VV116/JT001)用於治療輕中度新型冠狀病毒感染(COVID-19)的成年患者的適應症獲得國家藥監局同意,由附條件批准轉為常規批准。
本次民得維常規批准基於多項臨牀及非臨牀研究,包括JT001-015研究及一項納入近8,000例患者的真實世界研究。研究結果顯示,在輕、中度COVID-19患者中,民得維可顯著加速症狀緩解和消失、縮短病程,加快病毒轉陰,降低重症COVID-19或全因死亡發生率,對老年和高風險患者效果更顯着。在輕中度肝腎功能不全的患者中,民得維表現出良好的安全性和耐受性,患者在服藥過程中無需或僅需少量調整用藥劑量。同時,藥理研究顯示民得維基本無藥物間相互作用,大大減少了用藥禁忌,有效保障患者的合併用藥,為特殊人羣提供了更安全、更有效的選擇。
民得維是一款口服核苷類抗病毒藥物,可抑制SARS-CoV-2複製。相關研究顯示,民得維對包括奧密克戎XBB.1.16、EG.5、JN.1在內的SARS-CoV-2原始株和突變株表現出顯著的抗病毒作用,且無遺傳毒性。民得維由中國科學院上海藥物研究所、中國科學院武漢病毒研究所、中國科學院新疆理化技術研究所、中國科學院中亞藥物研發中心╱中烏醫藥科技城(科技部「一帶一路」聯合實驗室)、臨港實驗室、蘇州旺山旺水生物醫藥有限公司和本公司共同研發。民得維於2023年1月起臨時性納入醫保支付範圍,2024年1月起納入正式國家醫保目錄。
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