Takeda’s Adzynma, BeiGene’s Sonrotoclax, and Avistone’s Andatinib Set for Priority Review in China

Takeda's Adzynma, BeiGene's Sonrotoclax, and Avistone's Andatinib Set for Priority Review in China

The website of China’s Center for Drug Evaluation (CDE) indicates that Takeda’s (TYO: 4502) Adzynma (apadamtase alfa), BeiGene, Ltd.’s (NASDAQ: ONC, HKG: 6160, SHA: 688235) sonrotoclax, and Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd’s andatinib are on course to obtain priority review statuses. This development highlights the potential of these therapies to address significant unmet medical needs.

Adzynma: Recombinant ADAMTS13 Protein
Adzynma is a recombinant ADAMTS13 protein designed for on-demand or prophylactic enzyme replacement therapy (ERT) in children and adults with congenital thrombotic thrombocytopenic purpura (cTTP). Its priority review status reflects the urgent need for effective treatments for this rare and life-threatening condition.

Sonrotoclax: BCL2 Inhibitor
Sonrotoclax, a BCL2 inhibitor, is intended for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received anti-CD20 and BTKi therapy. It is also indicated for adult patients with previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The priority review status underscores its potential to improve outcomes in these challenging hematological malignancies.

Andatinib: EGFR Inhibitor
Andatinib is an epidermal growth factor receptor (EGFR) inhibitor being developed for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). It is specifically targeted at patients who have undergone platinum-based chemotherapy and/or PD-1/PD-L1 immunotherapy, or who have experienced disease progression or intolerance after treatment, and have been confirmed to have an EGFR exon 20 insertion mutation. This priority review status highlights its importance in the treatment landscape for advanced NSCLC with EGFR mutations.-Fineline Info & Tech