SBP GROUP(01177.HK): NDA for BCL‑2 Inhibitor TQB3909 Accepted, for Treatment of CLL/SLL

NewTimeSpace News: Sino Biopharmaceutical Limited (01177.HK) released a voluntary announcement on 4 August 2026. The New Drug Application for TQB3909 Tablets, a Class‑1 innovative BCL‑2 inhibitor self‑developed by group subsidiary Chia‑Tai Tianqing, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). It is intended for adult chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one prior systemic therapy containing a BTK inhibitor.

TQB3909 induces apoptosis by binding to the BCL‑2 protein. This NDA is supported by a single‑arm, open‑label, multi‑centre phase II registrational clinical study, which demonstrated meaningful clinical efficacy and manageable safety profile in relapsed‑refractory CLL/SLL patients. The drug was included in the priority review and approval procedure in July 2026. CLL/SLL predominantly affects middle‑aged and elderly populations, with very limited therapeutic options for patients with resistance or intolerance after prior BTK‑inhibitor treatment. The Group stated it will continue to focus on precision oncology therapy.

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