China's First Homegrown Bcl-2 Inhibitor Lisaftoclax Added to Updated National Medical Insurance List, Ascentage Pharma (06855) Advances Dual-Engine Strategy Alongside Global Development

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According to a report, Ascentage Pharma (06855) announced today that two of its original Class 1 innovative drugs have been successfully included in the 2026 National Medical Insurance Drug List. Among them, Lisaftoclax® (lisaftoclax) was included for the first time through negotiation, while Olverembatinib® (olverembatinib) successfully renewed its listing through renegotiation. As of now, all approved indications for both products have been included in the National Medical Insurance Drug List.

Lisaftoclax® is China's first domestically developed and marketed Bcl-2 inhibitor, the world's second Bcl-2 inhibitor to be approved, and the world's first Bcl-2 inhibitor for monotherapy treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have been previously treated with Bruton's tyrosine kinase (BTK) inhibitors. Olverembatinib® is China's first approved third-generation BCR-ABL inhibitor. With both of Ascentage Pharma's major hematology oncology drugs now entering the National Medical Insurance Drug List, the company's commercial "dual-engine" synergy is expected to be further unleashed.

In terms of global clinical development, Lisaftoclax® has four global registrational Phase III clinical studies underway, covering CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with two of them already cleared by the U.S. FDA and the European EMA. Among them, the GLORA-4 study is a global registrational Phase III trial evaluating Lisaftoclax® in combination with azacitidine (AZA) for patients with newly diagnosed MDS. It is noted that no new targeted therapies have emerged for intermediate- to high-risk MDS in nearly two decades, and Lisaftoclax® is currently the only Bcl-2 inhibitor internationally advancing a registrational Phase III study in intermediate- to high-risk MDS, which is expected to break the long-standing clinical gap in this field.

Olverembatinib® has three global registrational Phase III studies underway, covering Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), chronic myeloid leukemia (CML), and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), with two of them cleared by the U.S. FDA and the European EMA. From tackling highly challenging targets to expanding global development, Ascentage Pharma is driving China's original innovative drugs to the international forefront through sustained source innovation.

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