China CDE has accepted the IND application for BPI-221351, an IDH1/2 inhibitor developed by Betta Pharma . BPI-221351 is potentially developed specifically for patients with glioma. As reported , BPI-221351 demonstrates excellent blood-brain-barrier penetration, resulting in a higher drug concentration in the brain compared to the plasma. In an IDH-mutant xenograft model, BPI-221351 reduced 2-HG to baseline level up to 24 h after a single oral dose administration. In 2022, Betta Pharma applied for a patent (WO/2023/174235) claiming an IDH1/2 inhibitor for use in glioma. The reference compound is Vorasidenib (AG-881), an orally administered brain-penetration inhibitor. In August 2023, Servier reported the results of the phase 3 trial of Vorasidenib in patients with residual or recurrent grade 2 IDH-mutant glioma. " Progression-free survival was significantly improved in the vorasidenib group as compared with the placebo group (median progression-free survival, ...
China Biotech XYZ Shares Updates Related to New Drug Development in China