ASCENTAGE-B (06855) opened up over 4%. As of press time, it rose 4.53% to HK$90, hitting a record high with a trading volume of HK$16.893 million.

On the news front, ASCENTAGE PHARMA GROUP announced that the global registration Phase III clinical study (GLORA-4) of its independently developed Bcl-2 selective inhibitor lisaftoclax (trade name: Lisaftoclax; development code: APG-2575) in combination with azacitidine (AZA) as first-line treatment for newly diagnosed intermediate-to-high risk myelodysplastic syndrome (HR-MDS) patients has received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

As the second global Phase III study of Lisaftoclax approved by regulatory authorities in Europe and the United States, GLORA-4 will simultaneously enroll patients across multiple countries and centers, accelerating the drug's market approval process.

Lisaftoclax is a novel oral Bcl-2 selective inhibitor independently developed by ASCENTAGE PHARMA GROUP. It works by selectively inhibiting the Bcl-2 protein, restoring the normal apoptosis process of cancer cells, thereby achieving the purpose of treating tumors.

Currently, this product has been approved for marketing in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic treatment including Bruton's tyrosine kinase (BTK) inhibitors. Lisaftoclax is China's first domestically developed original Bcl-2 inhibitor approved for market.

As of the announcement date, Lisaftoclax is also the only Bcl-2 inhibitor internationally advancing a registration Phase III clinical trial for intermediate-to-high risk MDS.