BEBT-908 is a globally pioneering (First-in-Class) small molecule dual-target inhibitor designed against PI3K/HDAC, which has entered critical clinical stages. Preclinical and clinical research results indicate that BEBT-908 demonstrates remarkable anti-tumor effects, significantly inhibiting the growth of lymphoma, multiple myeloma, and solid tumors, even leading to tumor regression. The BEBT-908 project has been included in the "Thirteenth Five-Year Plan" National Key New Drug Development Major Science and Technology Special Project and has passed its acceptance review. A pivotal phase II clinical study targeting relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) has been successfully completed. Based on outstanding IIa clinical data, BEBT-908 was granted "Breakthrough Therapy Drug" qualification by the China Drug Evaluation (CDE) in October 2021. It is expected to submit a New Drug Application (NDA) in Spet 2023, potentially becoming the first domestically approved small molecule targeted innovative drug for the third-line or above treatment of r/r DLBCL. DLBCL is the most common aggressive subtype of NHL, accounting for 45.8% of all NHL cases and 40.1% of all lymphomas in China. In addition to r/r DLBCL, BEBT-908 also demonstrates promising therapeutic potential in other types of hematologic malignancies. It is being evaluated in Phase II clinical trials for indications including relapsed or refractory peripheral T-cell lymphoma (r/r PTCL), relapsed or refractory follicular lymphoma (r/r FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL), and marginal zone lymphoma (r/r MZL). Moreover, BEBT-908 is undergoing Phase Ib/II clinical trials as monotherapy for late-stage solid tumors with PIK3CA mutations, in combination with fulvestrant for ER+/HER2- metastatic breast cancer, and in combination with PD-1/PD-L1 monoclonal antibodies for advanced solid tumors.
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