China approves new targeted anticancer drug for lymphoma patients

Rocbrutinib, a new targeted anticancer drug for lymphoma patients, received marketing approval on Thursday from China’s National Medical Products Administration (NMPA). The revolutionary drug offers new treatment opportunities for lymphoma patients who have developed resistance to other drugs. Developed by Guangzhou-based clinical-stage pharmaceutical company Lupeng Pharmaceutical in Guangdong Province, southern China, the oral drug is able to inhibit cancer cell survival mechanisms and cause cancer cell death by binding to cancer cells and preventing a target protein called BTK inside the cells through two different pathways. Specifically, on one hand, the drug can bind strongly to normal targets irreversibly. Even when the target has undergone several resistance-related mutations, the drug remains able to bind to and inhibit the target, thus remaining effective for patients experiencing resistance. The approval is expected to provide a new option for lymphoma patients who are resistant to previous treatments and have few effective treatment options. The drug has been included in the NMPA’s Breakthrough Therapy Designations (BTD) list. Results from the 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 lymphoma patients resistant to other drugs with few remaining treatment options, around 64 experience significant tumour shrinkage, 23 experience total disappearance of the tumour based on imaging results, and about half experience clinical benefits lasting more than 16.5 months. In 2025, a total of 76 innovative drugs have received approval in China, setting a new record for the country’s pharmaceutical industry.