Innovent Announces First-Time Inclusion of SINTBILO® and New Indication for Olverembatinib in China's National Reimbursement Drug List

Rhea-AI Summary

Innovent Biologics announces two significant updates to China's 2024 National Reimbursement Drug List (NRDL), effective January 1, 2025. SINTBILO® (tafolecimab injection), their first cardiovascular drug, is newly listed for treating adult primary hypercholesterolemia and mixed dyslipidemia. The anti-PCSK9 antibody reduces LDL-C by ~70% and Lp(a) by ~50%. Additionally, olverembatinib, their BCR-ABL inhibitor, has both renewed its existing indication and added a new one for chronic myeloid leukemia (CML) treatment. These NRDL inclusions aim to improve drug accessibility and affordability for Chinese patients.

Positive

• SINTBILO® inclusion in NRDL will increase market access and affordability
• SINTBILO® shows strong efficacy with ~70% LDL-C and ~50% Lp(a) reduction
• Expanded market opportunity with olverembatinib's new indication in NRDL
• First domestic PCSK9 inhibitor to enter NRDL, gaining competitive advantage

Negative

• None.

SAN FRANCISCO and SUZHOU, China, Nov. 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), 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 leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring 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."

About SINTBILO® (Tafolecimab Injection)

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 dyslipidemia.

About Olverembatinib

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 leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring 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 (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

About Innovent

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. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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SOURCE Innovent Biologics

FAQ

When will SINTBILO® and olverembatinib's new indication be effective on China's NRDL?

Both updates to China's National Reimbursement Drug List will be effective from January 1, 2025.

What conditions is SINTBILO® approved to treat under the NRDL?

SINTBILO® is approved for adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) and mixed dyslipidemia.

What are the dosing options available for SINTBILO®?

SINTBILO® offers multiple dosing options: 150mg every 2 weeks, 450mg every 4 weeks, and 600mg every 6 weeks.

What are the efficacy results of SINTBILO® in reducing cholesterol levels?

SINTBILO® reduces low-density lipoprotein cholesterol (LDL-C) levels by nearly 70% and lowers lipoprotein a [Lp(a)] by nearly 50%.