北京泰德制药 I 类新药「TDI01」获批抗新冠肺炎临床试验
2022-10-16 · Beijing Tide Pharmaceutical Co., Ltd · original tidepharm.com ↗
2022年9月23日，中国生物制药宣布，集团附属公司北京泰德制药股份有限公司自主研发的 I 类创新药「TDI01」已于2022年9月23日获得中国国家药品监督管理局批准开展新型冠状病毒肺炎的临床试验。TDI01 是全球率先通过高选择性地抑制 ROCK2 激酶来抑制新型冠状病毒对宿主细胞的侵染，从而实现显著抗击新型冠状病毒作用的小分子创新药。TDI01 此前已在中、美获批开展特发性肺纤维化的临床试验，在中国获批开展尘肺病临床试验。新冠肺炎为其第三个获批开展临床试验的适应症，集团还将继续探索 TDI01 在更多适应症领域的应用 TDI01 作用机理是通过高选择性地抑制 ROCK2 靶点来抑制病毒侵袭和复制来实现抗病毒作用，这是一种全新的抗病毒机制，在体外实验及动物体内试验中具有显著的抑制新冠病毒的效果；同时具有抗炎、抗纤维化的作用。TDI01 区别于目前全球和国内在研的传统抗新冠病毒药物，是一款全新机制、全新靶点、全新结构的I类小分子口服新冠治疗药物。TDI01 目前已在美国完成了I期临床试验，安全性良好，目前在国内已完成临床I期的人种桥接试验。 TDI01 在新冠肺炎适应临床试验的获批，为全球抗击新冠肺炎带来了一种全新机制的潜在治疗方案，TDI01 在呼吸领域三大适应症临床试验的获批，将进一步增加中国生物制药在呼吸领域原创新药的产品管线，为广大的呼吸疾病患者带来全新的治疗选择。 $(function () { var contentWidth = parseInt($('#smv_tem_26_24').css("width")); ///长图自适应屏幕 $('#smv_tem_26_24 table').each(function () { $(this).removeAttr("width"); if ($(this).width() > contentWidth) { $(this).css("width", "100%"); } }); var splitLength = $('#tem_26_24_txt').find("div").html().split("_ueditor_page_break_tag_"); if (splitLength.length > 1) { pagination('tem_26_24_txt', "首页", "末页", "上一页", "下一页", function (hisHeight) { if (typeof hisHeight == 'undefined') { $('#smv_tem_26_24').smrecompute(); 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