The NMPA Conditionally Approves the Marketing of 索托克拉片

2026.1.7 Recently, the National Medical Products Administration (NMPA) has conditionally approved the marketing of 索托克拉片(商品名：百悦达), a Class 1 innovative drug filed by BeiGene (Suzhou) Bio-Tech Co., Ltd., through the priority review and approval process. This drug is indicated for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor, as well as adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy (including a Bruton's tyrosine kinase [BTK] inhibitor). It provides a new treatment option for clinical practice