Sino Biopharm Innovation "TQ-B3525" included in CDE's list of Breakthrough Therapy Drugs
Release time：2022-04-08
On April 8, Sino Biopharm announced that the Group's self-developed innovative drug "TQ-B3525" has been included in the list of breakthrough therapeutics by the China Center for Drug Evaluation (CDE) of the State Drug Administration for relapsed/refractory follicular lymphoma that has failed at least second-line therapy.
TQ-B3525 is a novel, selective oral PI3K (phosphatidylinositol 3-kinase) α/δ inhibitor. TQ-B3525 is a dual PI3K catalytic subunit α/δ inhibitor, which can overcome the drug resistance problem caused by upregulation of PI3Kα subunit activity when PI3Kδ subunit is inhibited alone, while significantly reducing the toxic side effects compared with PI3K pan-inhibitors. The Group has initiated several clinical studies of TQ-B3525 in China, mainly for hematological tumors, and some of them have already entered the phase II clinical stage.
The CDE established the breakthrough therapy drug program to encourage research and creation of new drugs to meet clinical needs and to accelerate the review and approval of innovative drug species. Innovative drugs that are included in the breakthrough therapeutic drug program can follow the accelerated procedure for follow-up communication and review and approval.
