News & Events
From April 24 to 25, 2026, the Chinese Society of Clinical Oncology (CSCO) Guidelines Conference was held in Harbin, where a series of updated CSCO clinical practice guidelines were released. Rocbrutinib, an innovative drug independently developed by Lupeng Pharmaceutical, was included in the CSCO Guidelines for the Diagnosis and Treatment of Lymphoma for the first time, receiving a recommendation as a second-line treatment for mantle cell lymphoma (MCL). This marks a milestone for Lupeng Pharmaceutical in bringing this innovative product to truly benefit patients.
As the world's first and only dual covalent and non-covalent fourth-generation BTK inhibitor, Rocbrutinib was designed to bind covalently to wild-type BTK and non-covalently to C481-mutated BTK. This enables it to inhibit wild-type BTK activity while overcoming multiple resistance mutations arising from first-, second-, and third-generation BTK inhibitor therapy, such as C481X, T474X, and L528W. The ROCK-1 study, a nationwide, multicenter, open-label, single-arm registration clinical trial led by Professor Zhu Jun and Professor Song Yuqin of Peking University Cancer Hospital, demonstrated that Rocbrutinib exhibited excellent safety and efficacy in patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who had previously received BTK inhibitor therapy. The study achieved an overall response rate (ORR) of 63.9%, a complete response rate (CR) of 23%, and a 1-year progression-free survival (PFS) rate of 45.7%, offering the potential to break the resistance deadlock that may occur following treatment with prior-generation BTK inhibitors. The relevant findings were presented at the CSCO Annual Meeting in September and the American Society of Hematology (ASH) Annual Meeting in December 2025. As a recommended second-line treatment for MCL in the CSCO guidelines, Rocbrutinib will provide a valuable therapeutic option and renew the hope for advance-staged patients with limited treatment alternatives.
Beyond its favorable efficacy in R/R MCL, Rocbrutinib has also demonstrated therapeutic potential across other B-cell malignancies. In May 2024, Rocbrutinib was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) for the treatment of relapsed or refractory non-germinal center B-cell-like diffuse large B-cell lymphoma (R/R non-GCB DLBCL); the corresponding pivotal clinical study, ROCK-2, was initiated at the end of 2025. In May 2025, the New Drug Application (NDA) for Rocbrutinib in BTK inhibitor-pretreated R/R MCL was accepted by the CDE and granted priority review. In January 2026, the global Phase III head-to-head clinical trial comparing Rocbrutinib versus Pirtobrutinib for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), the ROCKET-CLL study, was also initiated, marking the first step in Rocbrutinib's global development.
Forward-Looking Statements
This press release contains forward-looking statements, including those regarding clinical development timelines, regulatory progress, and the potential therapeutic benefits of Rocbrutinib. These statements are subject to risks and uncertainties that could cause actual results to differ materially.