Olverembatinib Included into the China 2022 NRDL
January 18, 2023
Ascentage Pharma and Innovent Biologics today announced that the novel drug olverembatinib has been included into the China 2022 National Reimbursement Drug List（NRDL), for the treatment of T315I-mutant chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase CML (CML-AP). The new version of the NRDL will take effect on Mar 1st, 2023.
Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, olverembatinib is the first and only approved third-generation BCR-ABL inhibitor in China. It is, also the only approved therapy for CML harboring the T315I mutation, with clear global best-in-class potential. Olverembatinib was approved in China in November 2021 and is being jointly commercialized in China by Ascentage Pharma and Innovent. At present, clinical studies of olverembatinib are being conducted in the US to fast track the drug’s journey to market in the country and allow more patients from around the world to benefit from it.This inclusion into the NRDL in China is another milestone validating olverembatinib as an effective and safe innovative therapy addressing an urgent unmet medical need. The inclusion will bolster the accessibility of olverembatinib, allowing more patients with CML to easily and affordably access a novel therapeutic that can help to extend patients’ lives and enable them to live a more fulfilling life with their families and communities.
CML is a malignancy caused by the clonal proliferation of hematopoietic stem cell in the bone marrow. It is one of the most common subtypes of chronic leukemia, accounting for 15% of all leukemia cases in adults1-2. According to epidemiology data, the median age of onset of CML in Chinese patients is 45-50 years old, about 20 years younger than that of the Western patients3, which are among the prime years for many who have families to support.The introduction of BCR-ABL-targeted TKIs has brought marked improvement to the clinical treatment of CML in recent years, allowing treatment-compliant patients to achieve long-term survival and the ability to live a normal and productive live. However, acquired resistance to TKIs remains a major challenge in the treatment of CML, and many patients resistant to both first- and second-generation BCR-ABL inhibitors due to their T315I mutations have long lacked an effective alternative treatment. As the first and only approved third-generation BCR-ABL inhibitor in China and the only therapy for CML harboring the T315I mutation, olverembatinib fulfills the treatment gap in T315I-mutant CML and opens the era of precision medicine for the treatment of CML in China.
In July 2022, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) accepted and granted Priority Review designation to a New Drug Application (NDA) that will support the full approval of olverembatinib in patients with CML-CP who are resistant and/or intolerant of first- and second-generation TKIs. The potential approval of this NDA could allow olverembatinib to benefit a broader population of patients with CML in China.
“Approval by the National Healthcare Security Administration for inclusion in the NRDL will help both patients as well as China’s Healthcare System,” said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. “the NRDL inclusion will drastically improve the accessibility of olverembatinib, allowing many more Chinese patients to affordably access a novel therapy that can help restore normalcy to their lives. Remaining steadfastly committed to our mission of addressing unmet clinical needs in China and around the world for the benefit of more patients, we will continue to explore olverembatinib’s efficacy and safety in other indications with the hope of benefiting more patients.”
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: “We are glad that olverembatinib is successfully included in the NRDL, which will further alleviate the financial burden for CML patients. Innovent has always been devoted to the national health care reform, and working toward improving drug accessibility and affordability to patients. Innovent has established a well-diversified novel pipeline and a professional commercial team in hematology area, and we will proactively support the work of the government departments for the implementation of medical insurance policies to let olverembatinib benefits more Chinese patients and their families as soon as possible.”