On November 4, according to the official website of CDE, Suzhou Ascentage Pharmaceuticals Co., Ltd. (hereinafter referred to as "Ascentage Pharmaceuticals") proposed a priority review for the Class 1 new drug APG-2575 tablets, which is intended for patients with refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma.
APG-2575 is a Bcl-2 selective inhibitor independently developed by Ascentage Pharmaceuticals. It can restore the normal apoptosis process of cancer cells by selectively inhibiting Bcl-2 protein, thereby achieving the purpose of treating tumors. It is understood that APG-2575 is the first locally developed Bcl-2 inhibitor to enter the clinical stage in China. It is also the second in the world and the first in China to see clear efficacy and enter the key registration clinical stage. At present, the drug has broad potential for single-drug and combination therapy in the treatment of various blood tumors and solid tumors.
To date, APG-2575 has received five orphan drug designations (ODDs) from the U.S. FDA for the treatment of Waldenstrom's macroglobulinemia (WM), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), acute myeloid leukemia (AML), and follicular lymphoma (FL).

At the 2023 ASH Annual Meeting, Ascent Pharmaceuticals presented a study result: APG-2575 had an overall response rate (ORR) of 73.3% in the treatment of R/R CLL; the complete remission/complete remission with incomplete blood cell recovery (CR/CRi) rate was 24.4%, and the CR/CRi rate increased with increasing doses; in terms of safety, the incidence of tumor lysis syndrome (TLS) was maintained at a low level comparable to previous study results.

This time, APG-2575 has been granted priority review by the CDE, which is expected to further accelerate its marketing process and bring new treatment options to relevant patients.

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