Ascentage Pharma's Lisaftoclax: A Promising Bcl-2 Inhibitor in the China Market

Ascentage Pharma, a global biopharmaceutical company, has received a significant boost with the acceptance of its New Drug Application (NDA) for lisaftoclax and the recommendation for Priority Review Designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This marks a crucial milestone for the company and the Bcl-2 inhibitor market, both in China and globally.

Lisaftoclax, a novel Bcl-2 inhibitor, has shown promising efficacy and safety in treating Waldenström macroglobulinemia (WM), a rare blood cancer. In a Phase Ib/II study, lisaftoclax demonstrated an objective response rate (ORR) of 90.9% in combination with ibrutinib in treatment-naïve WM patients, with manageable adverse events (AEs) and a low risk of tumor lysis syndrome (TLS). These results position lisaftoclax as a strong competitor in the Bcl-2 inhibitor market, alongside established drugs like AbbVie's venetoclax and Roche's ventoclax.

The priority review designation granted to lisaftoclax by the CDE of China NMPA is a testament to the drug's potential to address an unmet medical need. The CDE recognized lisaftoclax's strong therapeutic potential, both as a monotherapy and in combinations, for the treatment of hematologic malignancies. The drug's manageable safety profile and low risk of TLS also contributed to this decision.

The priority review process is expected to accelerate the approval timeline for lisaftoclax, enabling Ascentage Pharma to launch the drug in China earlier. This could significantly impact the company's market position and revenue growth. A faster approval process allows lisaftoclax to reach patients more quickly, potentially increasing market access and revenue for Ascentage Pharma.

Moreover, the CDE's decision to accept Ascentage Pharma's NDA for lisaftoclax and grant it Priority Review Designation is a significant milestone that could positively influence investor sentiment and stock performance. This move signals the NMPA's recognition of the drug's potential and the company's robust clinical data, which demonstrated lisaftoclax's promising efficacy and safety in treating WM. Investors may view this as a validation of Ascentage Pharma's research and development capabilities, potentially leading to increased confidence in the company's future prospects and a boost in its stock price.



In conclusion, Ascentage Pharma's lisaftoclax has the potential to become a significant player in the global cancer therapeutics market, with a focus on hematologic malignancies. The drug's promising clinical data, priority review designation, and the growing demand for targeted therapies position it well for success in the China market and beyond. Ascentage Pharma's commitment to advancing the clinical development of lisaftoclax could allow more patients to benefit from the drug as soon as possible, addressing an unmet medical need and potentially driving revenue growth for the company.