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Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

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  • China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitors
  • Approval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved ORR
  • Lisaftoclax is being evaluated in 4 P-III trials incl. an FDA-cleared GLORA trial for CLL/SLL pts with >12mos. of suboptimal response to BTK inhibitors, GLORA-2 for newly diagnosed CLL/SLL, GLORA-3 for newly diagnosed, elderly & unfit AML as well as GLORA-4 for newly diagnosed high-risk MDS

Ref: GlobeNewswire | Image: Ascentage Pharma| Press Release

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