News & Events
On May 28, 2025, the New Drug Application (NDA) for Rocbrutinib, the 4th generation Bruton's tyrosine kinase (BTK) inhibitor, independently developed by Lupeng Pharmaceutical, was formally accepted by the Center for Drug Evaluation (CDE) in China for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL) in adult patients who have previously received other BTK inhibitor therapies. If approved, Rocbrutinib is expected to become China’s first domestically developed BTK inhibitor used to treat this disease.
The NDA submission is based on study results from a pivotal Phase II registration clinical study (CTR20230100) conducted in China. The study focused on evaluating the efficacy and safety of Rocbrutinib monotherapy in patients with R/R MCL. It was led by Professor Zhu Jun and Professor Song Yuqin from Peking University Cancer Hospital and had participation from over 40 research centers nationwide. The study results will be officially presented at the Chinese Society of Clinical Oncology (CSCO) Annual Meeting later this year in September.
The pivotal Phase II registration clinical study (CTR20230100) was granted by NMPA in September 2023, following the release of interim data (cut-off date: May 31, 2023) from the Rocbrutinib Phase I clinical study (CTR20211173) in patients with R/R MCL. The Phase I study results, presented at the American Society of Hematology (ASH) Annual Meeting in 2023, demonstrated that Rocbrutinib has a favorable safety profile and outstanding efficacy in R/R MCL patients previously treated with BTK inhibitors. The objective response rate (ORR) reached levels as high as 70.6% (12/17), and the complete metabolic remission/complete response rate also reached 35.3% (6/17), indicating the therapeutic potential of Rocbrutinib in R/R MCL patients with drug resistances induced by previous BTK inhibitor treatments.
Additionally, clinical studies evaluating Rocbrutinib monotherapy or combination regimens for various B-cell lymphomas are ongoing concurrently in China and the United States.
Dr. Tan Fenlai, Chairman, CEO, and CMO of Lupeng Pharmaceutical, stated: "The acceptance of the NDA for Rocbrutinib is a significant milestone for Lupeng. We extend our utmost gratitude to the investigators, patients, investors, and relevant authorities for their trust, support, and assistance, and to all employees for their persistent efforts. We remain committed to innovation-driven development, focusing on clinical needs to develop more and better innovative drugs for the benefit of patients."