Takeda Pharmaceutical's (TAK.US) New Class 1 Drug "Oboletong Tablets" Files for Market Approval in China

Stock News
01/16

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.

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10