SINTBILO® Received Approval in Macau as the First China-Developed PCSK9 Antibody , Providing a New Option for Patients with Hypercholesterolemia

SAN FRANCISCO, U.S. and SUZHOU, China, June 09, 2025 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of major diseases in oncology, autoimmune, cardiovascular and metabolic disorders, and ophthalmology, today announced that its independently developed anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) monoclonal antibody, SINTBILO® (tafolecimab injection), has been officially approved for marketing by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of China. This approval marks SINTBILO® as the first China-originated PCSK9 monoclonal antibody approved in Macau, representing a significant milestone in domestic innovation and expanding treatment options for patients with primary hypercholesterolemia and mixed dyslipidemia in the region. Innovent’s portfolio of innovative biologics continues to expand globally. Notably, TYVYT® (sintilimab) has been approved in Macau, BYVASDA® (bevacizumab) in Indonesia, and PEMAZYRE® (pemigatinib) in Hong Kong, Macau, and Taiwan. SINTBILO® now joins this growing list in Macau. In addition, several portfolio products are under regulatory review for approval in Brazil, Mexico, Colombia, India, and other regions, with the potential to bring more innovative therapies to patients across Latin America and Southeast Asia. The approval of SINTBILO® in Macau covers adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial forms) and mixed dyslipidemia. The treatment is aimed at reducing low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (ApoB) levels. The approval of this indication is primarily supported by robust clinical data from pivotal trials conducted in China, which demonstrated: Superior lipid-lowering efficacy: SINTBILO® reduced LDL-C by nearly 70% and lipoprotein(a) [Lp(a)] by approximately 50%, surpassing comparable therapies. Up to 93% of patients achieved target lipid levels. Rapid onset and durable effect: Provides early and sustained LDL-C reduction, particularly beneficial for patients at high or very high cardiovascular risk. Favorable safety profile: Across trials involving over 1,200 Chinese patients, SINTBILO® showed a good safety profile. The most common adverse events were mild upper respiratory infections and injection site reactions. No serious safety concerns or withdrawal signals were reported. Guideline-endorsed:The 2024 Chinese Guideline for Lipid Management (Primary Care Edition) recommends SINTBILO® as a preferred treatment for patients inadequately controlled by statin therapy. SINTBILO® is China’s first original PCSK9 monoclonal antibody and the only innovative PCSK9 therapy included in China’s National Reimbursement Drug List (NRDL). With full intellectual property rights, the product is characterized by high binding affinity and potent efficacy. The advanced injection device minimizes discomfort and enhances treatment adherence. Cardiovascular disease remains the leading cause of death in both China and Macau, with dyslipidemia as a major modifiable risk factor. The approval of SINTBILO® brings a powerful, durable, and well-tolerated lipid-lowering therapy to patients in Macau, contributing to improved cardiovascular outcomes and public health. As Innovent continues to pursue its mission of "empowering patients worldwide with affordable, high-quality biopharmaceuticals," the company remains dedicated to bringing cutting-edge therapies to more patients worldwide. About SINTBILO® (Tafolecimab Injection) SINTBILO® (tafolecimab injection) is a fully human IgG2 monoclonal antibody independently developed by Innovent. It selectively binds to PCSK9, inhibiting its interaction with LDL receptors (LDLR) and preventing PCSK9-mediated receptor degradation. This enhances LDLR recycling and promotes greater clearance of LDL-C from the bloodstream. SINTBILO® (tafolecimab injection) is indicated as adjunct to diet, in combination with statins or statins and other lipid-lowering therapies, for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have failed to achieve LDL-C goals by using moderate or higher doses of statins, to reduce LDL-C, TC and ApoB levels. 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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, 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. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. References: Qi L, et al. JACC: Asia, 2023; Huo Y, et al. The Lancet Regional Health–Western Pacific, 2023） * The 26.1-day half-life leads to stable and long-lasting lipid-lowering effects. 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. Innovent 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 Innovent 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 Innovent'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, Innovent's competitive environment and political, economic, legal and social conditions. Contact Media： E-mail：[email protected] Tel：+86 512-69566088 Investors： E-mail：[email protected] Tel：+86 512-69566088

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