武田制药(TAK.US)1类新药“奥博雷通片”在中国申报上市

智通财经
Jan 16

智通财经APP获悉,1月16日,中国国家药监局药品审评中心(CDE)官网最新公示显示,武田制药(TAK.US)申报的1类新药奥博雷通片上市申请获得受理。

公开资料显示,奥博雷通片是武田研发的口服选择性食欲素2型受体(OX2R)激动剂oveporexton(研发代号:TAK-861)。该产品此前已经被CDE纳入突破性治疗品种,针对1型发作性睡病(NT1)适应症。其针对NT1适应症的两项3期关键性研究已经达到所有主要和次要终点。在刚刚结束的2026年JPM大会上,武田披露该产品预计于2026年下半年获监管机构批准上市。

据公开资料介绍,武田拥有多元化食欲素产品管线。食欲素是睡眠与觉醒模式的关键调节因子,同时还参与调节注意力、情绪、代谢和呼吸等重要功能。Oveporexton是武田食欲素产品线中主要的在研OX2R激动剂,拟用于1型发作性睡病的治疗,针对该适应症已被美国FDA与中国CDE授予突破性治疗。

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