泰诺麦博(688806.SH):芮特韦拜单抗注射液获批上市

智通财经
Sep 03

智通财经APP讯,泰诺麦博(688806.SH)发布公告,公司收到国家药品监督管理局通知,通过优先审评审批程序批准公司自主研发的1类儿童专用创新药芮特韦拜单抗注射液(商品名:新多妥®,研发代号:TNM001)上市。该产品适用于即将进入或出生在第一个呼吸道合胞病毒(RSV)流行季的新生儿和婴儿预防RSV所致的下呼吸道感染。

据悉,芮特韦拜单抗注射液是公司自主研发的重组长效抗呼吸道合胞病毒(RSV)全人源单克隆抗体,通过靶向RSV病毒融合前构象(Pre-F)蛋白的保守表位,介导RSV中和并阻止病毒与宿主细胞的融合,从而阻止病毒进入细胞,发挥被动免疫预防作用。作为公司完全自主研发的1类创新药,芮特韦拜单抗注射液项目获国家科技重大专项立项支持。该药品此次获批,标志着公司第二款自主研发的全人源单克隆抗体创新药物成功上市,是公司经营发展的重要里程碑,进一步扩充了公司商业化产品矩阵,提升了公司的市场竞争力。

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