Takeda Pharmaceutical Co. Ltd. Sponsored ADR (TAK.US) has applied for market approval for a new drug called "Obleiton tablets" in China.

On January 16, the latest announcement on the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) showed that the application for the market approval of a new drug, Oveporexton tablets sponsored by Takeda Pharmaceutical Co. Ltd. Sponsored ADR (TAK.US), has been accepted. Public information shows that Oveporexton tablets are an oral selective orexin 2 receptor (OX2R) agonist developed by Takeda (research code: TAK-861). This product has been previously classified by CDE as a breakthrough therapy for the treatment of type 1 narcolepsy (NT1). Two key phase 3 studies targeting NT1 have already achieved all primary and secondary endpoints. At the recent 2026 JPM conference, Takeda disclosed that the product is expected to receive regulatory approval for market launch in the second half of 2026. According to public information, Takeda has a diversified pipeline of orexin products. Orexins are key regulators of sleep and wake patterns and are also involved in regulating important functions such as attention, emotions, metabolism, and respiration. Oveporexton is the main investigational OX2R agonist in Takeda's orexin product line, intended for the treatment of type 1 narcolepsy, and has been granted breakthrough therapy designation by the FDA in the United States and CDE in China for this indication.