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On February 18, CDE's official website showed that Baoyuan Medicine's AB-106 capsules (taletrectinib, talatinib) are planned to be included in breakthrough therapy varieties for the treatment of non-small cells that carry ROS1 fusion gene and have not been treated with ROS1-TKI.
Talatinib is a new generation of ROS1 and NTRK highly selective and potent tyrosine kinase inhibitors under investigation, which can cross the blood-brain barrier
In June 2021, Innovent Bio obtained the rights to jointly develop and commercialize the drug with Baoyuan Pharma in Greater China (including mainland China, Hong Kong, Macau and Taiwan) for a total amount of US$189 million
On September 27, 2021, Baoyuan Medicine and Innovent Bio announced the interim Phase II clinical data of taletrectinib in ROS1-positive non-small cell lung cancer at the 2021 CSCO Conference
In November 2021, the global Phase II clinical trial (TRUST-II) of taletrectinib in the treatment of ROS1 fusion-positive lung cancer completed the dosing of the first patient
ROS1 gene rearrangement is an oncogenic driver gene of non-small cell lung cancer, occurring in 2% to 3% of patients with advanced non-small cell lung cancer; NTRK gene fusion is an oncogenic driver gene of various solid tumors, occurring in 0.