Nuvation Bio (NUVB) said Monday that China's National Medical Products Administration approved taletrectinib to treat adult patients with advanced ROS1-positive non-small cell lung cancer.
Under an exclusive license agreement, Innovent Biologics will market taletrectinib in China under the brand name Dovbleron.
The approval was based on data from the phase 2 study, which showed the drug's effectiveness in Chinese patients, including those who had and had not been previously treated with ROS1 tyrosine kinase inhibitors.
Taletrectinib previously received breakthrough therapy designation and priority review from China's NMPA, as well as orphan drug designation and breakthrough therapy designation from the US FDA for treating patients with advanced ROS1-positive NSCLC.
Shares of Nuvation Bio were down 0.2% in recent trading.
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。