On January 16, the latest official announcement from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration revealed that the market application for the new Class 1 drug Oboletong Tablets, submitted by Takeda Pharmaceutical Co Ltd (TAK.US), has been accepted. Public information indicates that Oboletong Tablets are Takeda's orally administered, selective orexin type 2 receptor (OX2R) agonist, oveporexton (R&D code: TAK-861). The product had previously been included by the CDE in the Breakthrough Therapy Designation list, targeting the indication for Type 1 Narcolepsy (NT1). Two pivotal Phase 3 studies for its NT1 indication have successfully met all primary and secondary endpoints. At the recently concluded JPM conference in 2026, Takeda disclosed that the product is expected to receive regulatory approval for market launch in the second half of 2026. According to publicly available information, Takeda possesses a diversified pipeline of orexin-targeting products. Orexins are key regulators of sleep-wake patterns and are also involved in modulating critical functions such as attention, mood, metabolism, and respiration. Oveporexton is the primary investigational OX2R agonist in Takeda's orexin product portfolio, intended for the treatment of Type 1 Narcolepsy, and has been granted Breakthrough Therapy Designation for this indication by both the U.S. FDA and China's CDE.
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