智通财经APP获悉，1月22日，中国国家药监局药品审评中心(CDE)官网最新公示，梯瓦制药(TEVA.US)申报的3.1类新药瑞玛奈珠单抗注射液上市申请已获得受理。公开资料显示，瑞玛奈珠单抗(fremanezumab)是一种人源化单克隆抗体(mAb)，可选择性结合降钙素基因相关肽(CGRP)配体。 该产品适用于成年患者偏头痛的预防性治疗。

截图来源：CDE官网

CGRP信号通路是治疗偏头痛的热门靶点，全球范围内已经有多款CGRP受体或CGRP本身的抗体类疗法获批上市，用于偏头痛的预防治疗。瑞玛奈珠单抗即是一种人源化CGRP单克隆抗体，它可选择性结合CGRP配体，并阻断两种CGRP亚型(α-和β-CGRP)与受体结合。既往多项研究显示，瑞玛奈珠单抗可显著减少慢性偏头痛(CM)和发作性偏头痛(EM)患者的头痛天数，且安全性良好 。

值得一提的是，瑞玛奈珠单抗还有望用于预防6~17岁儿童和青少年患者发作性偏头痛。梯瓦公司于2024年12月公布了一项新的3期临床研究结果。该研究评估了瑞玛奈珠单抗预防6~17岁儿童和青少年患者发作性偏头痛的有效性和安全性。结果显示，与安慰剂相比，瑞玛奈珠单抗在12周内的疗效在统计学上显著优于安慰剂，在12周的时间内显著减少了每月偏头痛天数(MMD)和每月头痛天数(MHD)，其良好的安全性与在成人人群中观察到的结果一致。

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