SBP GROUP (01177): The new drug application for TQB3909 (BCL-2 inhibitor) has been accepted.

SBP GROUP (01177) announced that its subsidiary, Chengdu TIANQING Pharmaceutical Group Co., Ltd. (Tianqing), has submitted a New Drug Application (NDA) for the nationally classified innovative drug TQB3909 tablets (BCL-2 inhibitor) to the Drug Evaluation Center (CDE) of the National Medical Products Administration of China and has received acceptance. The drug is intended for the treatment of adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously undergone at least one systemic therapy, including a BTK inhibitor. TQB3909 is a BCL-2 inhibitor developed independently by the group. It induces apoptosis by binding to the BCL-2 protein, which releases pro-apoptotic proteins such as BAK, BAX, and BAD, promoting the release of cytochrome c from mitochondria, facilitating phosphatidylserine externalization, and stimulating caspase 3/7 activity as well as caspase 3/9 cleavage. This NDA is based on a single-arm, open-label, multicenter Phase II registration clinical study aimed at evaluating the efficacy and safety of TQB3909 in patients with refractory relapsed CLL/SLL. The study results indicate that TQB3909 demonstrates significant efficacy and controllable safety in patients who have previously undergone systemic treatment that included a BTK inhibitor. Compared to existing treatment options in China, TQB3909 is expected to bring significant clinical benefits. CLL/SLL is a clonal proliferative tumor of mature B lymphocytes commonly found in middle-aged and elderly populations, characterized by a specific immunophenotypic trait. The median survival time for this disease is approximately 10 years, but patient prognosis shows high heterogeneity. For patients with refractory relapsed CLL/SLL, especially those who have developed resistance or intolerance after treatment with BTK inhibitors, current therapeutic options are extremely limited, significantly shortening both overall survival (OS) and progression-free survival (PFS). TQB3909 has been included in the priority review and approval process by the CDE as of July 2026. The steady advancement of this NDA is expected to provide better treatment options for patients with relapsed/refractory CLL/SLL. In the future, the group will continue to deeply engage in the field of precision oncology, increase investment in original innovation, and commit to providing innovative drugs with better efficacy and higher quality for clinical use, benefiting a wide range of patients.