Ascentage Pharma’s Olverembatinib Granted Breakthrough Therapy Designation in China for First-Line Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Rockville, MD and Suzhou, China, March 05, 2025 – Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a leading global biopharmaceutical company dedicated to discovering, developing, and commercializing therapies to address unmet medical needs, particularly in hematological malignancies, has announced that its investigational drug, olverembatinib, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This designation is for the combination of olverembatinib with low-intensity chemotherapy in the first-line treatment of patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
What is Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)?
Ph+ ALL is a type of cancer that affects the white blood cells, specifically a type called lymphocytes. The Philadelphia chromosome is a genetic abnormality that causes the production of an abnormal protein called BCR-ABL, which drives the growth and spread of leukemia cells. This condition is responsible for approximately 25-30% of all ALL cases, making it a significant health concern.
About Olverembatinib
Olverembatinib is an oral, potent and selective BCR-ABL tyrosine kinase inhibitor. It is designed to target the BCR-ABL protein, which is overexpressed in Ph+ ALL, and inhibit its function, thereby preventing the growth and spread of leukemia cells. Olverembatinib has shown promising results in clinical trials, demonstrating significant efficacy and a favorable safety profile.
Impact on Patients
The BTD designation signifies that olverembatinib, in combination with low-intensity chemotherapy, may demonstrate substantial improvement over existing therapies for the treatment of Ph+ ALL. This could potentially lead to more effective treatments with fewer side effects for patients, improving their quality of life and increasing their chances of long-term survival. Furthermore, the earlier administration of such an effective treatment could help prevent complications and reduce the overall burden of the disease.
Impact on the World
According to the World Health Organization, leukemia is the most common type of cancer among children, accounting for approximately 30% of all childhood cancers. Ph+ ALL is a particularly aggressive subtype, and effective treatments are crucial for improving patient outcomes. The BTD designation for olverembatinib represents a significant step forward in the development of new, more effective treatments for this disease. Not only will it benefit patients in China, but it could also pave the way for regulatory approvals in other regions, ultimately making this life-saving therapy available to a larger population of patients worldwide.
Conclusion
The granting of a Breakthrough Therapy Designation to olverembatinib by the NMPA is a testament to its potential to significantly improve the lives of patients with Ph+ ALL. This designation underscores the importance of continued investment in research and development of innovative therapies, particularly in the field of hematological malignancies. The potential benefits of olverembatinib extend beyond China, as it could lead to regulatory approvals in other regions and ultimately provide a more effective and less burdensome treatment option for patients worldwide.
- Ascentage Pharma’s olverembatinib granted BTD for first-line Ph+ ALL treatment in China
- BTD designation signifies substantial improvement over existing therapies
- Olverembatinib could lead to more effective treatments with fewer side effects
- Potential benefits extend beyond China, with global implications
