JW THERAP-B(02126): BeiNoda has been granted breakthrough therapy designation in China for the treatment of second-line recurrent or refractory adult large B-cell lymphoma.

JW THERAP-B (02126) announced that the China National Medical Products Administration (NMPA) Drug Evaluation Center has granted breakthrough therapy designation for Beinoda (Rojicorlinzolam injection) for the second-line treatment of relapsed or refractory adult large B-cell lymphoma (r/r LBCL). Beinoda is a CAR-T cell immunotherapy product developed independently by Pharmaron. The breakthrough therapy designation is based on clinical data from a study evaluating the efficacy and safety of Beinoda in adult r/r LBCL patients who are not suitable for autologous stem cell transplantation after first-line treatment failure. This is the first time that clinical trial data based on Chinese patients have been obtained. Large B-cell lymphoma is a highly aggressive subtype of non-Hodgkin lymphoma and the most common lymphoma subtype in adults. LBCL is a potentially curable disease, but 30-40% of patients experience refractory or relapse after treatment. Patients with first-line treatment failure have a poor prognosis, and although high-dose chemotherapy followed by autologous stem cell transplantation (HDCT/ASCT) is the standard treatment, over half of the patients are not suitable for ASCT due to reasons such as old age or comorbidities. There is currently no standard treatment available, leading to a poor prognosis and significant unmet clinical needs. There is an urgent need to develop new and safe treatment options for r/r LBCL.