Core Viewpoint - The recent approval of the novel Bcl-2 selective inhibitor, Lisangtuo (generic name: Lishatoclax), by Ascentage Pharma marks a significant advancement in the treatment of high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients, particularly those with TP53 mutations, who have limited treatment options and a poor prognosis [1][2][4] Group 1: Product and Market Impact - Lisangtuo is the first domestically developed Bcl-2 inhibitor approved in China and the second globally, indicating a milestone in the development of targeted therapies for hematological malignancies [1][2] - The mechanism of Bcl-2 inhibitors involves specifically binding to and inhibiting the Bcl-2 protein, which is overexpressed in certain malignancies, thereby restoring the apoptotic pathway in cancer cells [1][3] - The global incidence of CLL/SLL exceeds 100,000 new cases annually, with an increasing trend in China due to an aging population, despite a lower incidence compared to Western countries [2][3] Group 2: Clinical and Safety Profile - Clinical trial data supporting Lisangtuo's approval demonstrated a favorable safety profile, with no reported cases of tumor lysis syndrome, a serious adverse reaction previously associated with Bcl-2 inhibitors [3][4] - Traditional treatment options for high-risk patients, such as chemotherapy, yield a progression-free survival of only about 12 months, highlighting the need for more effective therapies [2][4] Group 3: Future Directions and Industry Trends - The emergence of new-generation Bcl-2 inhibitors addresses limitations of existing therapies, such as BTK inhibitors, by reducing drug interactions and allowing for potential intermittent dosing, which can alleviate long-term economic burdens and risks of resistance [5] - There are currently 42 Bcl-2 inhibitors in development globally, indicating a growing interest and investment in this therapeutic area [5] - The future goals for blood cancer treatment include moving towards non-chemotherapy approaches and achieving clinical cures in certain patient populations [5]
时隔九年全球第二款Bcl-2抑制剂上市，对慢淋白血病治疗改变多大