连花清瘟获批新适应症!治疗新冠肺炎轻型、普通型患者

2020-04-14 以岭药业 以岭药业

4 月 14 日,以岭药业发布公告,连花清瘟胶囊和连花清瘟颗粒新增适应症申请获国家药监局发布的《药品补充申请批件》。

4 月 14 日,以岭药业发布公告,连花清瘟胶囊和连花清瘟颗粒新增适应症申请获国家药监局发布的《药品补充申请批件》。

审评结论描述如下:根据《中华人民共和国药品管理法》有关规定以及疫情救治临床实践,批准连花清瘟胶囊处方药说明书。

处方药说明书中【功能主治】项除原批准内容外,增加「在新型冠状病毒性肺炎的常规治疗中,可用于轻型、普通型引起的发热、咳嗽、乏力。」,【用法用量】项除原批准内容外,增加「新型冠状病毒肺炎轻型、普通型疗程 7-10 天。」质量标准【功能主治】【用法与用量】项内容以及标签内容与说明书相应内容保持一致。

同时,以岭药业公告表示,连花清瘟胶囊此次新批处方药说明书,批件中未否定原非处方药的定位。

图片来自:网络

对比此前的 OTC 说明书发现,连花清瘟胶囊的主治功能是「清瘟解毒,宣肺泄热」,深究八个字似乎也不像是增加新适应症,本来就是抗病毒药物,用于清热解毒。

在今年 2 月 1 日,以岭药业曾经在中国临床实验注册中心登记2项连花清瘟关于新冠肺炎的临床试验(登记号:ChiCTR2000029433 /34),一项针对新冠肺炎疑似病例、一项针对确诊病例,两项临床研究的计划时间是 2 月 1 日-12 月 1 日;从瑞德西韦的国内临床进展来看,连花清瘟两项临床研究应该还没结束,本次修订药品说明书的依据公告也指出,是疫情救治临床实践

不过连花清瘟已经火爆全球,目前已经作为海外留学生的健康大礼包必备产品之一。国内零售价十几元的连花清瘟,在国外价格已被炒到近 100 块一盒,而且不一定有货源。

据以岭药业公布的 2020 年 1 季度业绩预告显示,预计 1 季度净利润 43,255.16 万元~46,138.84 万元,同比增长 50%-60%。该增长是因为 1 季度连花清瘟产品营业收入较去年同期大幅增长。

本次连花清瘟名正言顺拿下新冠肺炎适应症,公司表示将和北京以岭将积极组织连花清瘟胶囊(颗粒)针对新适应症的市场推广工作。

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    2020-04-14 公卫新人

    新冠肺炎,疫情何时才能消失

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