Chinese clinical-stage company Lupeng Pharmaceutical Ltd announced on Thursday that China's National Medical Products Administration (NMPA) has granted accelerated approval to rocbrutinib (development code: LP-168) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have received at least two prior systemic therapies, including BTK inhibitors.

Independently developed by Lupeng Pharmaceutical, rocbrutinib is a fourth-generation BTK inhibitor with dual covalent (irreversible) and non-covalent (reversible) mechanism. The approval of rocbrutinib will provide a new breakthrough treatment option for R/R MCL patients following failure of earlier-generation BTK inhibitor therapy.

The NMPA approval of rocbrutinib for the treatment of R/R MCL is primarily based on positive results from a nationwide, multi-centre, open-label, single-arm Phase II registration clinical trial involving 41 centres across China. The study was designed to evaluate the efficacy and safety of rocbrutinib monotherapy in MCL patients who had relapsed or were refractory after prior treatment with covalent BTK inhibitors. As of 5 June 2025, the data showed an objective response rate of 63.9%, a complete response rate of 23%, and a median duration of response of 16.5 months. All enrolled patients had previously received at least a covalent BTK inhibitor; more than one-third of them had received two or more cBTK inhibitors. Baseline characteristics of the patient group were generally difficult to treat and had poor prognosis.

In terms of safety, no atrial fibrillation/flutter or other cardiac events occurred, and no patient permanently discontinued treatment due to adverse events. The incidence of BTK inhibitor–associated toxicity was relatively low.

The recommendation provides authoritative and standardised clinical guidance for physicians and offers a new treatment opportunity for patients with R/R MCL.