Lerodalcibep

Shanghai, China – March 24, 2026 – Everest Medicines (HKEX 1952.HK, “Everest”, or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that 2 presentations on Lerodalcibep (LEROCHOL®) , a novel, monthly, small dose third-generation PCSK9 inhibitor, will be presented at 2026 American College of Cardiology Annual Scientific Session (ACC.26). This marks the first presentation of Phase 3 clinical data from China for Lerodalcibep. ACC.26 will be held on March 28–29, 2026, in New Orleans, U.S. The two presentations report results from Lerodalcibep’s key registrational Phase 3 trial for Chinese patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), and a 72-week open-label extension study in subjects who completed the Phase 3 studies. ‌Lerodalcibep is expected to be submitted for a Biologics License Application (BLA) in China in the first half of 2026, with potential approval in 2027. The U.S. Food and Drug Administration (FDA) has approved LEROCHOL® (lerodalcibep-liga) injection from LIB Therapeutics, for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH) on December 12, 2025. Lerodalcibep is currently under regulatory review by the European Medicines Agency (EMA). Abstracts 01 Abstracts Number: A8397 Title: Efficacy and Safety of Lerodalcibep in Chinese Patients with Hypercholesterolemia：A Randomized, Double-blind, Placebo-Controlled Phase 3 Trial (LIBerate-CN) Principal author and affiliation: Yong Huo, Peking University First Hospital, Beijing, China. Abstract: The study is to evaluate the efficacy and safety of Lerodalcibep in Chinese patients with, or at very-high or high risk for, ASCVD, on statin therapy requiring additional LDL-C reduction. Session Title: Evolving Non Statin Lipid Therapies Session Date and Time: Sunday Mar 29 2026 9:30 PM - 10:30 PM 02 Abstracts Number: 16905 Title: Long-term Efficacy and Safety of Lerodalcibep, a Novel, Third Generation PCSK9 Inhibitor in the Open-Label 72-Week Extension Study of Subjects Completing the Phase 3 Studies Principal author and affiliation: Dr David Kallend, LIB Therapeutics Inc. Abstract: An open-label 72-week extension study is to evaluate the long-term efficacy and safety of Lerodalcibep in participants completing the Phase 3 studies. Session Title: Next-Generation Lipid Treatment Options Session Date and Time: Saturday Mar 28 2026 3:30 PM - 4:30 PM About the Phase 3 Clinical Trial of Lerodalcibep The Phase 3 Clinical Trial of Lerodalcibep enrolled 213 Chinese adult patients with, or at very-high or high risk for, atherosclerotic cardiovascular disease (ASCVD), including heterozygous familial hypercholesterolemia (HeFH). Participants were randomized in a 2:1 ratio to receive either lerodalcibep mg or placebo via subcutaneous injection every 4 weeks (Q4W; ≤31-day interval). After 12-week double-blind treatment period, participants will enter 36-week open-label treatment period, receiving lerodalcibep 300 mg Q4W, followed by a 4-week follow-up period. The duration of study will be 52 weeks. All subjects were on stable background therapy with moderate- or high-intensity statins (with or without ezetimibe/ hyzetimibe) yet achieving suboptimal LDL-C target at baseline. Co-primary efficacy endpoints are, compared to placebo: (1) the percentage change in LDL-C from baseline at Week 12, and (2) the mean percentage change in LDL-C at Weeks 10 and 12. All participants have completed the study. About LEROCHOL®(lerodalcibep-liga) Lerodalcibep (LEROCHOL®) received marketing approval by FDA on December 12, 2025 and is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Lerodalcibep’s Marketing Authorization Application to the European Medicines Agency is currently under regulatory review. LEROCHOL® is a novel, third-generation small recombinant fusion protein therapeutic agent comprised of a proprotein convertase subtilisin/kexin type 9 (PCSK9)-binding domain (Adnectin) and human serum albumin (HSA) with an approximate molecular weight of 77 kDa and binds PCSK9 with picomolar affinity. The recommended dosage of LEROCHOL® is 300 mg (1.2mL) administered subcutaneously once monthly. LEROCHOL® may be kept at room temperature up to 25°C (77°F) for up to 3 months prior to use. These features make lerodalcibep a unique alternative to other PCSK9 inhibitors. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal, autoimmune, critical care, cardiovascular, and ophthalmic diseases. For more information, please visit its website at www.everestmedicines.com. About LIB Therapeutics, Inc. LIB Therapeutics is a privately held, commercial-stage biopharmaceutical company dedicated to bringing novel, highly effective, and safe therapies to help the millions of people with cardiovascular disease and familial hypercholesterolemia finally achieve their LDL-C goals. For more information, please visit: www.libtherapeutics.com. 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