ASCENTAGE-B (06855): The application for the marketing of the new drug APG-2575 has been accepted by the China National Medical Products Administration Drug Evaluation Center, and has been recommended for priority review.

ASCENTAGE-B (06855) announced that the new drug application (NDA) for the new selective Bcl-2 inhibitor APG-2575 (proposed Chinese generic name: Lisheng Kelapian) developed independently by the company has been accepted by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) and recommended to be included in the priority review program for the treatment of refractory or relapsed (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first domestically developed Bcl-2 inhibitor to submit an NDA in China and is expected to become the second Bcl-2 inhibitor to be marketed globally. APG-2575 is a novel oral Bcl-2 selective inhibitor developed independently by Ascentage Pharmaceuticals, which restores the normal apoptosis process of tumor cells by selectively inhibiting the Bcl-2 protein, thereby achieving the goal of tumor treatment. APG-2575 is the second Bcl-2 inhibitor globally and the first in China to demonstrate clear efficacy and enter key registration clinical stages. It has broad therapeutic prospects in the treatment of various hematologic malignancies and solid tumors, especially in CLL/SLL patients, with potential for monotherapy and combination therapy. APG-2575 has the best-in-class potential at a global level and is expected to become a safer, more effective, and convenient treatment option. Additionally, APG-2575 is currently undergoing multiple Phase III clinical trials, including a global Phase III clinical trial for the treatment of refractory CLL/SLL patients in combination with BTK inhibitors (licensed by the US FDA); a global Phase III clinical study for the first-line treatment of CLL/SLL patients in combination with acalabrutinib; a global Phase III clinical trial for the first-line treatment of newly diagnosed elderly or intolerant patients with standard chemotherapy for acute myeloid leukemia (AML) in combination with azacitidine (AZA); and a global Phase III clinical trial for the first-line treatment of newly diagnosed patients with high-risk myelodysplastic syndrome (MDS) in combination with AZA.