Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1 anti-tumor drug, TQ-B3525, a phosphatidylinositol3-kinase (PI3-K) α/δ inhibitor. The filing has been accepted for review by China’s Center for Drug Evaluation (CDE), with the intended indication being the treatment of recurrent/refractory follicular lymphoma (FL) as a third-line or later treatment option.
Follicular Lymphoma and Current Treatment Landscape
Follicular lymphoma (FL) is the second most common type of non-Hodgkin’s lymphoma (NHL), with approximately 80% of patients diagnosed in the advanced stages (III/IV) of the disease. Despite being classified as an indolent lymphoma, the majority of FL patients will experience multiple relapses and progression, leading to invasive diseases and potentially fatal outcomes within 1-2 years. Currently, FL is not curable, and treatment options for patients with recurrent/refractory (R/R) FL in China are limited, highlighting unmet clinical needs.
TQ-B3525: A Dual Inhibitor Addressing Drug Resistance
TQ-B3525 is designed as a PI3K catalytic subunit α/δ dual inhibitor, aiming to overcome drug resistance caused by the up-regulation of 3K subunits due to the inhibition of a single PI3K subunit. This innovative approach significantly reduces toxic side effects compared to pan-PI3K inhibitors. Previous studies have confirmed TQ-B3525’s outstanding efficacy in R/R FL and other advanced malignant tumors. The drug obtained breakthrough therapy designation from CDE in July 2021, underlining its potential impact on the treatment landscape for FL.-Fineline Info & Tech
