GUANGZHOU, June 4 (Xinhua) -- Rocbrutinib, a new targeted anti-cancer drug, received marketing approval on Thursday from China's National Medical Products Administration (NMPA). This revolutionary drug offers new treatment opportunities for lymphoma patients who have developed resistance to other drugs.
Developed by clinical-stage drugmaker Lupeng Pharmaceutical based in Guangzhou, south China's Guangdong Province, this oral drug can block the survival switch of cancer cells and induce cancer cell death by binding to and inhibiting the target protein named BTK in cancer cells through two different modes.
In particular, on the one hand, the drug can firmly bind to the normal target in an irreversible manner; on the other hand, even when the target has undergone multiple resistance-related mutations, the drug can still bind to and inhibit it, remaining effective for patients who have developed resistance.
The approval is expected to offer a new option for lymphoma patients who have developed resistance to earlier treatments and have few effective treatment options.
The drug had been included in the NMPA's list of Breakthrough Therapy Designations (BTD). Results from its Phase II clinical trial showed an objective response rate of 63.9 percent, a complete response rate of 23 percent, and a median duration of response of 16.5 months.
In other words, for every 100 patients with lymphoma that had become resistant to other drugs and had few remaining treatment options, about 64 saw significant tumor shrinkage, 23 had complete tumor disappearance on imaging, and in about half of the responders the clinical benefit lasted beyond 16.5 months.
In 2025, a total of 76 innovative drugs were approved in China, setting a new record.
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