A newly developed cancer drug from Guangzhou, Guangdong, is expected to bring new hope to patients with a tough-to-treat type of lymphoma. China's National Medical Products Administration has recently approved Rocbrutinib, a first-in-class fourth-generation BTK inhibitor, for adults with relapsed or refractory mantle cell lymphoma who have received at least two prior systemic therapies, including BTK inhibitors.
This marks the world's first approved BTK inhibitor to act through both covalent and non-covalent mechanisms, offering a breakthrough option for patients who have exhausted effective treatments after failing earlier-generation BTK inhibitors.
The approval is based on positive results from a nationwide, multi-center, open-label, single-arm Phase II registration trial. 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. On the safety front, no cardiac events, such as atrial fibrillation or flutter, were reported, and no patients discontinued treatment due to adverse reactions.
The drug was independently developed by Lupeng Pharmaceutical. The company received financial support through Guangzhou's biomedical industry subsidies, which played a key role in funding the pivotal registration clinical study.
Guangzhou's innovation subsidy policy covers multiple areas, including new drug clinical research, medical device registration, institutional certification, R&D services, and clinical trial services. Individual project grants range from 500,000 to 30 million yuan, provided as "post-subsidies," allowing companies to use the funds flexibly.
A representative from the Guangzhou Municipal Science and Technology Bureau said that the city will continue to deepen its business environment reforms, improve its science and technology innovation policy system, and attract more high-level talent and quality projects.
Reporter | Chen Jinxia
Photo | Lupeng Pharmaceutical
