众生药业(002317.SZ)：口服抗新冠药来瑞特韦片的新药上市申请获受理
格隆汇3月16日丨众生药业(002317.SZ)公布，2023年3月15日，公司控股子公司广东众生睿创生物科技有限公司(“众生睿创”)口服抗新型冠状病毒3CL蛋白酶抑制剂来瑞特韦片(商品名：乐睿灵®，研发代号：RAY1216)的新药上市申请获得国家药品监督管理局(NMPA)受理，并收到《受理通知书》。
来瑞特韦片通过作用于新型冠状病毒(SARS-Cov-2)的3CL蛋白酶，抑制病毒多聚前体蛋白的切割，进而阻断病毒复制，达到抗新冠病毒的作用。来瑞特韦片在野生株、阿尔法、贝塔、德尔塔、奥密克戎(包括BA.5、BF.7)等多种新冠病毒感染的细胞模型中，可以有效抑制新冠病毒复制，展现了广谱抗新冠病毒的能力。
已完成的I期临床研究提示来瑞特韦片具有良好安全性和耐受性；一项研究者发起、来瑞特韦片治疗新冠感染患者的剂量探索性研究中，提示来瑞特韦片单药组或联合利托那韦组均较安慰剂组可快速降低新冠病毒RNA载量和显著缩短病毒核酸转阴时间(二者均有统计学显著性差异)。
2022年11月13日，来瑞特韦片治疗轻型和普通型SARS-CoV-2感染患者的随机、双盲、安慰剂对照III期临床研究完成首例受试者入组和给药；2022年12月30日，完成在广东、北京、山东、河南、江苏、湖北、内蒙古、江西、海南等全国多个省市区的33家临床研究中心开展竞争性入组，修订后方案计划入组1344例新冠感染患者，实际完成随机入组1359例。III期临床研究入选人群包括伴或不伴高危因素的轻型和普通型SARS-CoV-2感染患者，给药方案为来瑞特韦片400mg单药，连续口服5天，研究主要疗效终点指标为新冠感染患者11项临床症状/体征均持续恢复正常的时间。截至本公吿披露日，来瑞特韦片的临床研究已达到方案预设的事件数，数据管理和统计分析结果提示，本研究已达到方案预设的主要疗效终点指标，不良事件发生率与安慰剂组相当，安全性良好。
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