Biobetter (688759.SH): Injection of Ipinocetam Hydrochloride obtained a drug clinical trial approval letter.

BiBeiTe (688759.SH) announced that recently, the company received the Drug Clinical Trial Approval Notification issued by the National Medical Products Administration (NMPA), allowing the clinical trial of injection of hydrochloride ipinostat (BEBT-908) in combination with the CHOP regimen in patients with newly diagnosed peripheral T-cell lymphoma. The approval for this clinical trial is mainly based on the results of open-label, multicenter Phase II clinical studies of ipinostat monotherapy in the second line or above treatment of relapsed or refractory peripheral T-cell lymphoma, as well as multiple non-clinical research data, fully demonstrating the good anti-tumor activity and controllable safety characteristics of the product in the field of peripheral T-cell lymphoma treatment, laying a solid foundation for the advancement of its combination chemotherapy regimen to first-line treatment clinical research. This approved clinical study is an open-label, multicenter Phase II clinical trial aimed at systematically evaluating the efficacy, safety, and pharmacokinetic characteristics of ipinostat in combination with the CHOP regimen in the treatment of newly diagnosed peripheral T-cell lymphoma, while exploring the correlation between tumor biomarkers and treatment outcomes. It is expected to break through the efficacy bottleneck of traditional chemotherapy and provide a new first-line treatment option for newly diagnosed patients.