武田制药(TAK.US)1类新药“奥博雷通片”在中国申报上市

Core Viewpoint - Takeda's investigational oral selective orexin 2 receptor (OX2R) agonist, oveporexton (development code: TAK-861), is positioned for regulatory approval in the second half of 2026, targeting narcolepsy type 1 (NT1) [2] Group 1: Product Development - Ovaporexton has been included in the breakthrough therapy designation by the CDE for the treatment of NT1 [2] - Two pivotal Phase 3 studies for oveporexton have met all primary and secondary endpoints [2] - Takeda has a diversified pipeline of orexin products, with orexin being a key regulator of sleep-wake patterns and involved in attention, mood, metabolism, and respiration [2] Group 2: Regulatory and Market Position - The product is expected to receive regulatory approval from authorities in the United States (FDA) and China (CDE) as a breakthrough therapy for NT1 [2]