Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, today announced that the new indication – adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs) – of its novel drug, olverembatinib (HQP1351), has been included into the China 2024 National Reimbursement Drug List (NRDL), effective January 1, 2025. This indication was added to the NRDL through the simple contract renewal process. The previously included indication of adult patients with CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation will maintain its reimbursable status on the NRDL.
Olverembatinib is a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development Program in China and the first third-generation BCR-ABL inhibitor approved by the China National Medical Products Administration (NMPA). As a novel drug, olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. In November 2021, olverembatinib received its first approval in China, thus became the first therapy approved for the treatment of T315I mutant CML in the country. In November 2023, olverembatinib was approved for the treatment of adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.
CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the management of CML. However, TKI resistance is still a global challenge for CML treatment. 20%-40% of patients fail to achieve desired treatment outcome due to resistance or intolerance to TKIs1-3, thus leading to disease progression or even death. The successful renewal and the inclusion of additional indication of olverembatinib in the NRDL is expected to greatly improve the drug’s accessibility, bringing benefit to more and a broader population of patients with CML in China.
“We are glad that the new indication of olverembatinib has been included into the NRDL through the simple contract renewal process,” said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. “This decision reaffirms the importance of olverembatinib as an innovative drug that has the potential to fulfill the urgent unmet needs and treatment gaps in CML. With its new indication included into the NRDL at the third anniversary of the initial approval in China, olverembatinib is positioned to bring renewed hope to more patients with CML, thereby helping countless families and communities. Moving forward, we will work actively to ensure the rapid rollout of the expanded insurance coverage. We are confident these efforts will make olverembatinib more accessible and affordable, ultimately allowing more patients and their families to benefit from this novel therapeutic as soon as possible.”
References
- O’Brien SG, Guilhot F, Larson R, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. Engl J Med. 2003 Mar 13;348(11):994-1004.
- Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2014 update on diagnosis, monitoring, and management. Am J Hematol. 2014 May;89(5):547-56.
- Larson R, Hochhaus A, Hughes T, et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012 Oct;26(10):2197-203.
* Olverembatinib is an investigational drug that has not been approved for any indication outside China.
