China-based Lupeng Pharmaceutical has secured approval from local regulator the National Medical Products Administration (NMPA) for rocbrutinib, a novel fourth‑generation BTK inhibitor indicated for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received a BTK inhibitor. The company positions the drug as a global first, featuring a hybrid covalent/non‑covalent binding mechanism designed to overcome resistance to earlier‑generation therapies.

Clinical data from the pivotal rock‑1 study showed an objective response rate (ORR) of 63.9% and a complete response (CR) rate of 23.0% in this heavily pre‑treated population. The median progression‑free survival (PFS) was 7.39 months, while the median duration of response (DOR) was 16.46 months. In a significant prior deal, compatriot Hansoh Pharmaceutical secured the rights to develop rocbrutinib for non‑oncological indications in China, in a transaction valued at up to RMB 729 million (USD 108 million).

PharmCube's NextBiopharm® database shows that rocbrutinib is the second drug approved that can bypass the BTK C481S mutation. Click here to request a free trial for NextBiopharm®.