信达生物(01801.HK)：捷帕力®匹妥布替尼在中国获批复发或难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤适应症

Core Viewpoint - The approval of the non-covalent BTK inhibitor, Pirtobrutinib (捷帕力®), for a new indication in China represents a significant advancement for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have previously undergone treatment with BTK inhibitors [1][2] Group 1: Approval and Indication - Pirtobrutinib has received approval from the National Medical Products Administration (NMPA) in China for the treatment of adult patients with CLL/SLL who have previously received at least one systemic therapy including a BTK inhibitor [1] - The drug was previously approved by the FDA in January 2023 and is indicated for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic therapies, including BTK inhibitors, by October 2024 in China [1] Group 2: Clinical Study Results - The approval is based on the results of the international, multicenter, randomized controlled BRUIN-CLL-321 Phase III study, which included 238 patients previously treated with covalent BTK inhibitors [2] - Pirtobrutinib significantly extended the median progression-free survival (PFS) to 14.0 months compared to 8.7 months for the control group (HR=0.54) and had a lower treatment-related discontinuation rate of 5.2% versus 21.1% [2] Group 3: Market Impact and Strategy - The approval of Pirtobrutinib for CLL/SLL in China is a major breakthrough, allowing local patients to benefit from this global innovation [2] - The company aims to leverage its leading brand and expertise in the oncology field to accelerate the accessibility of this innovative therapy for more patients in need [2]