China’s National Medical Products Administration has granted accelerated approval to rocbrutinib in adult patients with relapsed or refractory mantle cell lymphoma. Eligible patients must have received at least two prior systemic therapies, including a bruton tyrosine kinase inhibitor.
As a fourth-generation inhibitor, the drug utilizes a dual covalent and non-covalent mechanism to target resistant mutations and overcome acquired drug resistance, according to a press release by Lupeng Pharmaceutical, the manufacturer of the drug.
The NMPA approval was based on data from the phase 2 ROCK-1 study evaluating rocbrutinib monotherapy in patients with MCL who had relapsed or were refractory after prior treatment with covalent BTK inhibitors. As of June 5, 2025, clinical trial 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.
In April 2026, the Chinese Society of Clinical Oncology Guidelines for the Diagnosis and Treatment of Lymphoma included rocbrutinib as a Category 2 recommendation for the treatment of MCL.
“The successful approval of rocbrutinib is a major milestone in Lupeng Pharmaceutical’s development,” Tan Fenlai, co-founder and CEO of Lupeng Pharmaceutical, stated in the release. “It will bring a new and effective treatment option to MCL patients who have experienced disease progression after earlier-generation BTK inhibitor therapy. Furthermore, it demonstrates Lupeng’s global leadership in advancing BTK-targeted innovation. Going forward, we will continue to advance clinical studies of rocbrutinib in other indications such as diffuse large B-cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma, to help more patients with various hematologic malignancies.”
In January 2026, a global phase 3 trial was initiated to evaluate rocbrutinib against the third-generation.non-covalent BTK inhibitor pirtobrutinib in relapsed or refractory CLL/SLL.
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