The Center for Drug Evaluation (CDE) website indicates that Advenchen Lab’s AL8326 and Hengrui Pharmaceuticals’ (SHA: 600276) SHR-A1811 have been awarded separate breakthrough therapy designations (BTDs). This recognition highlights the potential of both drugs to significantly improve the treatment of cancer patients.
Advenchen’s AL8326: A Promising TKI Inhibitor
Advenchen’s drug candidate AL8326 is a Category 1.1 tyrosine kinase inhibitor (TKI) that exerts anti-tumor effects by inhibiting tyrosine kinase FGF family receptors, VEGF family receptors, and Aurora-B of the Aurora kinase family. The BTD is awarded for its potential as a third-line treatment for small-cell lung cancer, indicating its potential to provide a new treatment option for patients who have not responded to previous therapies.
Hengrui’s SHR-A1811: An Innovative HER2-Targeting ADC
Hengrui’s SHR-A1811 is an in-house developed antibody-drug conjugate (ADC) targeting HER2. It is undergoing multiple clinical studies in solid tumors with HER2 expression or mutation. The recent BTD reflects its potential against advanced non-small cell lung cancer with HER2 mutations in patients who have previously failed platinum-containing chemotherapy. SHR-A1811 was previously granted BTD status for the treatment of breast cancer with positive HER2 or low HER2 expression, further validating its broad therapeutic potential.-Fineline Info & Tech
