Innovent Biologics, Inc., a premier biopharmaceutical enterprise focused on the development, production, and distribution of top-tier medications for oncology, cardiovascular, autoimmune, ophthalmology, and other significant health conditions, has announced that the 2024 National Reimbursement Drug List (NRDL) will now feature Sintbilo (tafolecimab injection, an anti-PCSK9 monoclonal antibody) for the initial time, along with a new use for olverembatinib (a BCR-ABL inhibitor). The revised NRDL is set to take effect on January 1, 2025.
In the latest iteration of the NRDL, Sintbilo has been newly added for treating adult patients with primary hypercholesterolemia (including both heterozygous familial and non-familial forms) and mixed dyslipidemia. Sintbilo (tafolecimab injection) represents Innovent’s venture into the cardiovascular sector, presenting a variety of dosing solutions: 150mg every two weeks, 450mg every four weeks, and 600mg every six weeks. These treatment courses have been shown to decrease low-density lipoprotein cholesterol (LDL-C) by approximately 70% and reduce lipoprotein a [Lp(a)] by about 50%. As the inaugural domestic PCSK9 inhibitor featured in the NRDL, Sintbilo introduces a vital new option for cholesterol regulation within China, vastly improving life quality for a wide array of patients with hypercholesterolemia.
Concerning olverembatinib, the initial use has been renewed while introducing an additional use in the updated NRDL through a straightforward contract renewal process. The NRDL encompasses olverembatinib for adult patients with chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) possessing the T315I mutation, as well as adult patients with CML-CP who exhibit resistance or intolerance to first and second-generation tyrosine kinase inhibitors (TKIs). Olverembatinib stands as China’s first third-generation BCR-ABL inhibitor framed by the National Medical Products Administration (NMPA). Innovent and Ascentage Pharma are decisively driving the commercialization of olverembatinib within the Chinese market.
Dr. Michael Yu, Innovent’s founder, chairman, and CEO, remarked, “We are thrilled with Sintbilo’s inclusion in the NRDL, which will significantly increase access to and affordability of this groundbreaking therapy, marking a significant accomplishment for both Innovent and individuals with hypercholesterolemia. We are equally delighted by the new indication of olverembatinib in the NRDL, which will advantage a broader spectrum of CML patients. Our organization remains dedicated to our mission of supplying patients globally with affordable, superior biopharmaceuticals, continually advancing frontline treatments in critical areas—oncology, cardiovascular and metabolic (CVM), autoimmune, and ophthalmology—where there is substantial societal demand. We remain committed to enhancing patient access, leveraging our drug expertise, and furthering drug affordability and availability, with the ultimate goal of benefitting more patients and families promptly. We take pride in contributing to enhanced patient care.”
Sintbilo (tafolecimab injection), independently created by Innovent, is a fully human lgG2 monoclonal antibody specializing in PCSK9 binding, lowering LDL-C levels by blocking PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis and boosting LDL-C clearance.
Recognized and included in the NRDL, Sintbilo is intended for treating adults with primary hypercholesterolemia (both heterozygous familial and non-familial) and mixed dyslipidaemia.
Olverembatinib is an orally accessible third-generation tyrosine kinase inhibitor (TKI) and the first third-generation BCR-ABL inhibitor sanctioned in China capable of effectively targeting BCR-ABL and a variety of BCR-ABL mutants, inclusive of the T315I mutation.
Currently, olverembatinib is endorsed and featured in the NRDL for treating adult patients with chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) with the T315I mutation; and adult patients with CML-CP resistant and/or unable to tolerate primary and secondary generation TKIs.
In July 2021, Innovent and Ascentage Pharma forged an agreement for the united development and marketing of olverembatinib in China.
Established in 2011, Innovent is a preeminent biopharmaceutical company driving the mission to empower patients globally with reasonably priced, high-quality biopharmaceuticals. The company is committed to discovering, developing, manufacturing, and marketing innovative medicines targeting some of the most relentless diseases.