Evergreen Medicines announced that China's National Medical Products Administration (NMPA) has formally accepted the Biologics License Application (BLA) for LEROCHOL® for the treatment of adult hypercholesterolemia.

Shanghai, China – June 26, 2026 – Evergreen Medicines (HKEX: 1952.HK, the 'Company'), a biopharmaceutical company dedicated to the research and development, clinical development, manufacturing, and commercialization of innovative medicines, today announced that China’s National Medical Products Administration (NMPA) has formally accepted the Biologics License Application (BLA) for LEROCHOL® (lerodalcibep), a third-generation PCSK9 inhibitor, as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) levels in adult patients with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). This timely acceptance, achieved as scheduled, further demonstrates the Company’s efficient execution of its established clinical development and regulatory strategy and marks steady progress toward delivering key R&D milestones for 2026.

LEROCHOL® is a novel, third-generation recombinant fusion protein therapeutic with a relatively low molecular weight, composed of a PCSK9-binding domain (Adnectin) and human serum albumin (HSA), with a molecular weight of approximately 77 kDa. It binds to PCSK9 with picomolar affinity. The recommended dose of LEROCHOL® is 300 mg administered via subcutaneous injection once monthly. Prior to use, LEROCHOL® can be stored at room temperature up to 25°C for up to three months. These attributes position it to differentiate from currently approved PCSK9 inhibitors and offer best-in-class potential.

Huo Yong, Chief Expert in the Department of Cardiology at Peking University First Hospitalstated: 'The NMPA’s acceptance of the Biologics License Application for LEROCHOL® brings new hope to a broad patient population. Extensive research has confirmed that LDL-C is one of the most important and modifiable pathogenic risk factors for atherosclerotic cardiovascular disease (ASCVD), and it has been established by both domestic and international lipid management guidelines as the primary therapeutic target for preventing and treating this condition. Despite existing lipid-lowering therapies, the majority of patients with cardiovascular disease or those at high risk—including those with familial hypercholesterolemia—still fail to achieve the LDL-C control targets recommended in the latest guidelines. There is an urgent clinical need for more effective, innovative therapies.'

Results from the Phase III clinical trial in China demonstrated that LEROCHOL® significantly reduced LDL-C levels in Chinese patients with hypercholesterolemia during treatment, with a favorable safety and tolerability profile. Combined with its convenient once-monthly, low-volume, single-dose subcutaneous administration and its stability at room temperature for up to three months, LEROCHOL® offers patients a more effective and user-friendly treatment option for long-term lipid management at home or while traveling. We look forward to its early approval to benefit more patients.”

Mr. Luo Yongqing, Chief Executive Officer of Evergreen Medicines,stated: 'The NMPA’s acceptance of this BLA represents a significant step forward in the commercialization of LEROCHOL® in China.'

Cardiovascular disease remains the leading cause of death globally and in China. Approximately 400 million people in China have dyslipidemia, yet only about 14% receive lipid-lowering treatment, reflecting low treatment penetration and significant unmet medical needs.

As a potential best-in-class PCSK9 inhibitor, LEROCHOL® offers superior efficacy in lowering lipids, a favorable safety profile, and convenient dosing, better addressing patients’ long-term at-home lipid management needs and providing a new therapeutic option. LEROCHOL® is expected to be approved and launched in mainland China by 2027. We will continue advancing its accessibility across Greater China to benefit more patients as soon as possible.

This application for LEROCHOL® is based on results from multiple large global clinical trials and a pivotal Phase III registration trial conducted in China. Across several global Phase III trials enrolling over 2,900 patients in total, LEROCHOL® demonstrated sustained LDL-C reductions of ≥60% in patients with cardiovascular disease (CVD) or those at very high/high risk, and a 59% reduction in patients with more severe LDL-C elevations, including those with HeFH. In the Chinese Phase III trial, LEROCHOL® 300 mg administered once monthly via subcutaneous injection significantly lowered LDL-C levels, achieving a 65.9% reduction versus placebo at Week 12 and an average reduction of 67.0% at Weeks 10 and 12. Additionally, over 95% of patients successfully reached the LDL-C target recommended by Chinese lipid management guidelines.

Previously, the Biologics License Application (BLA) for LEROCHOL® received approval from the U.S. Food and Drug Administration (FDA), and a Marketing Authorization Application has been submitted to the European Medicines Agency (EMA).

About LEROCHOL® (LEROCHOL®, lerodalcibep)

Lerodalcibep® is a novel third-generation smaller molecular weight recombinant fusion protein therapeutic composed of a PCSK9-binding domain (Adnectin) and human serum albumin (HSA), with a molecular weight of approximately 77 kDa and picomolar affinity for PCSK9. The recommended dose of Lerodalcibep® is a 300 mg (1.2 mL) subcutaneous injection once per month. Prior to use, Lerodalcibep® can be stored at room temperature not exceeding 25°C (77°F) for up to three months. These features position it to achieve differentiation among currently approved PCSK9 inhibitors and possess best-in-class potential.

The Biologics License Application for lerodalcibep was approved by the U.S. Food and Drug Administration (FDA) on December 12, 2025. As a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, it is indicated—alongside diet and exercise—for reducing low-density lipoprotein cholesterol (LDL-C) levels in adult patients with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). Marketing authorization applications for lerodalcibep have been submitted to both the European Medicines Agency (EMA) and China’s National Medical Products Administration (NMPA) and are currently under review.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on the research and development, clinical development, manufacturing, and commercialization of innovative medicines to address unmet medical needs in global markets. The company’s management team possesses deep expertise and extensive experience from leading pharmaceutical companies in China and globally. Everest Medicines operates a commercial-scale global manufacturing facility in Jiashan, Zhejiang Province, and has established a comprehensive GMP quality management system aligned with standards from China, the United States, and the European Union.

The company focuses on therapeutic areas including autoimmune diseases, ophthalmology, acute and critical care, and CKM (cardiovascular, kidney, and metabolic) disorders. It has built an integrated commercial platform combining an omnichannel commercialization system with full lifecycle drug commercialization capabilities. Leveraging its proprietary mRNA platform with global rights, Everest Medicines is advancing its existing pipeline, including in vivo mRNA CAR-T and mRNA cancer vaccines. Simultaneously, through strategic partnerships and ecosystem-driven incubation of promising platforms, the company is expanding its R&D capabilities and reinforcing its global footprint to accelerate international growth. For more information, please visit the company’s official website:www.everestmedicines.com。

About LIB Therapeutics Inc.
LIB Therapeutics is a privately held, commercial-stage biopharmaceutical company dedicated to developing and delivering innovative, effective, and safe therapies to help millions of patients with cardiovascular disease and familial hypercholesterolemia achieve their low-density lipoprotein cholesterol (LDL-C) control goals. For more information, please visit:www.libtherapeutics.com。

Forward-Looking Statements

This press release may contain certain forward-looking statements based on the company’s or management’s current views, beliefs, and expectations regarding the company’s business operations and financial condition at the time such statements are made. These statements may be identified by words such as “will,” “expect,” “forecast,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “confident,” and similar expressions. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the company’s control and are difficult to predict. Accordingly, actual results may differ materially from those indicated in the forward-looking statements due to various factors and assumptions, including future changes and developments in our business, competitive environment, political, economic, legal, and social conditions. Neither the company nor any of its subsidiaries, directors, officers, advisors, or agents undertakes any obligation to update the forward-looking statements contained herein to reflect subsequent events, new information, or future circumstances after the date of this press release, except as required by law.

References

1. China Cardiovascular Health and Disease Report 2022–2024

2. Chen, B., Pei, Z., Huang, Z., et al. 26-A-8397-ACC Efficacy and Safety of Lerodalcibep in Chinese Patients with Hypercholesterolemia: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. JACC. April 2026, 87(13_Supplement): A166.

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