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Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab injection, an anti-PCSK9 monoclonal antibody) for the first time, along with a new indication of olverembatinib (a BCR-ABL inhibitor) on the list. The updated NRDL will be officially effective from January 1, 2025.
In the updated NRDL, Sintbilo is newly listed for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) and mixed dyslipidemia. Sintbilo (tafolecimab injection) is Innovent’s first entry into the cardiovascular field, offering multiple dosing options: 150mg Q2W, 450mg Q4W, and 600mg Q6W. These regimens significantly reduce low-density lipoprotein cholesterol (LDL-C) levels by nearly 70% and lower lipoprotein a [Lp(a)] by nearly 50%. As the first domestic PCSK9 inhibitor in the NRDL, Sintbilo provides an important new treatment option for cholesterol management in China, improving quality of life for a broad population of patients with hypercholesterolemia.
As for olverembatinib, its first indication was renewed and the new indication was also included in the updated NRDL through the simple contract renewal process. The NRDL coverage of olverembatinib includes: for the treatment of adult patients with chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) harbouring the T315I mutation; and for the treatment of adult patients with CML-CP resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs). Olverembatinib is the first third-generation BCR-ABL inhibitor approved by China’s National Medical Products Administration (NMPA). Innovent and Ascentage Pharma are mutually committed to the commercialization of olverembatinib in the Chinese market.
Dr. Michael Yu, founder, chairman and CEO of Innovent, stated: “We are pleased with the inclusion of Sintbilo in the NRDL, which will significantly increase the accessibility and affordability of this innovative therapy and marks a significant achievement for both Innovent and patients with hypercholesterolemia. We are also encouraged by the inclusion of the new indication of olverembatinib in the NRDL, which will benefit a broader range of CML patients. As a company with the mission of ‘empowering patients worldwide with affordable, high-quality biopharmaceuticals’, Innovent continues to invest in pioneering treatments across key areas—oncology, cardiovascular and metabolic (CVM), autoimmune and ophthalmology—where there is substantial societal need. We look forward to building on our patient-centered approach, leveraging our product strengths, and further improving drug affordability and accessibility, so that high-quality drugs can benefit more patients and their families as soon as possible. We are proud to contribute to the better care of our patients.”
Sintbilo (tafolecimab injection), developed independently by Innovent, is a fully human lgG2 monoclonal antibody that can specifically bind to PCSK9, reducing LDL-C levels by inhibiting PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis and enhancing LDL-C clearance.
Sintbilo is indicated and included in the NRDL for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) and mixed dyslipidaemia.
Olverembatinib is an orally-available third-generation tyrosine kinase inhibitor (TKI), and the first China-approved third-generation BCR-ABL inhibitor that can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation.
At present, olverembatinib has been approved and included in the NRDL in China for the treatment of adult patients with chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) harbouring the T315I mutation; and adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs.
In July 2021, Innovent and Ascentage Pharma reached the agreement regarding the joint development and commercialization of olverembatinib in China.
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases.
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