眾生藥業(002317.SZ)：口服抗新冠藥來瑞特韋片的新藥上市申請獲受理
格隆匯3月16日丨眾生藥業(002317.SZ)公佈，2023年3月15日，公司控股子公司廣東眾生睿創生物科技有限公司(“眾生睿創”)口服抗新型冠狀病毒3CL蛋白酶抑制劑來瑞特韋片(商品名：樂睿靈®，研發代號：RAY1216)的新藥上市申請獲得國家藥品監督管理局(NMPA)受理，並收到《受理通知書》。
來瑞特韋片通過作用於新型冠狀病毒(SARS-Cov-2)的3CL蛋白酶，抑制病毒多聚前體蛋白的切割，進而阻斷病毒複製，達到抗新冠病毒的作用。來瑞特韋片在野生株、阿爾法、貝塔、德爾塔、奧密克戎(包括BA.5、BF.7)等多種新冠病毒感染的細胞模型中，可以有效抑制新冠病毒複製，展現了廣譜抗新冠病毒的能力。
已完成的I期臨牀研究提示來瑞特韋片具有良好安全性和耐受性；一項研究者發起、來瑞特韋片治療新冠感染患者的劑量探索性研究中，提示來瑞特韋片單藥組或聯合利托那韋組均較安慰劑組可快速降低新冠病毒RNA載量和顯著縮短病毒核酸轉陰時間(二者均有統計學顯著性差異)。
2022年11月13日，來瑞特韋片治療輕型和普通型SARS-CoV-2感染患者的隨機、雙盲、安慰劑對照III期臨牀研究完成首例受試者入組和給藥；2022年12月30日，完成在廣東、北京、山東、河南、江蘇、湖北、內蒙古、江西、海南等全國多個省市區的33家臨牀研究中心開展競爭性入組，修訂後方案計劃入組1344例新冠感染患者，實際完成隨機入組1359例。III期臨牀研究入選人羣包括伴或不伴高危因素的輕型和普通型SARS-CoV-2感染患者，給藥方案為來瑞特韋片400mg單藥，連續口服5天，研究主要療效終點指標為新冠感染患者11項臨牀症狀/體徵均持續恢復正常的時間。截至本公吿披露日，來瑞特韋片的臨牀研究已達到方案預設的事件數，數據管理和統計分析結果提示，本研究已達到方案預設的主要療效終點指標，不良事件發生率與安慰劑組相當，安全性良好。
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