August 25, 2025 – Hasten Biopharmaceutical Co., Ltd. ("Hasten") announced achieving a new key milestone in the Phase 3 clinical trial of its novel first-in-class, small binding protein, single monthly dose PCSK9 inhibitor Lerodalcibep (HST101) in China.

This study is a key registrational trial for Chinese patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The topline data analysis of the 12-week randomized, double-blind, placebo-controlled treatment period was completed, and met;

• ‌• The primary end point for low-density lipoprotein cholesterol (LDL-C) efficacy at Week 12
• • The secondary efficacy endpoints for other atherogenic lipids and apolipoproteins  
• • The trial demonstrated a favorable safety and tolerability profile versus placebo.‌

It is anticipated that detailed results will be presented in an International Scientific Congress in the near future.

Professor Yong HUO, the leading principal investigator, Chief Cardiology Expert from Peking University First Hospital, stated: "Over the past decades, the prevalence of dyslipidemia, particularly hypercholesterolemia, has risen significantly in China. Extensive studies have confirmed that LDL-C is one of the most critical and modifiable risk factors for atherosclerotic cardiovascular disease (ASCVD). It has been identified as the primary intervention target for ASCVD prevention and treatment in both domestic and international lipid management guidelines, yet the target rate of LDL-C remains suboptimal. The topline of this Phase 3 clinical trial demonstrated that HST101 significantly reduces LDL-C levels in Chinese patients with hypercholesterolemia, meeting the primary efficacy endpoint, which offering a potential new PCSK9 inhibitor option while its small, single monthly dosing and room-temperature stability（up to 6 months below 25℃）could improve patient adherence."

Dr. Lisa LIU, VP and Head of Medical Department from Hasten, added: " These robust Phase 3 clinical trial results position HST101 as a promising therapeutic option for Chinese patients. We are currently expediting comprehensive data analysis for regulatory submissions so as to benefit patients with uncontrolled hypercholesterolemia early. "

Lerodalcibep, a novel third-generation PCSK9 inhibitor, is the first innovator in research introduced by Hasten in 2023. The positive results from its Phase 3 clinical trial in China not only signify a milestone achievement for Hasten in addressing clinical development in chronic diseases area, but also demonstrate the company's R&D capabilities and enduring commitments to its patients.‌ As an emerging innovative biopharmaceutical company, Hasten reaffirms its dedication to delivering superior therapeutic solutions for patients‌ through strategic partnerships and accelerated commercialization pathways.

*HST101 is an investigational product not yet approved in China. Hasten does not recommend the use of any drug that has not been approved.

About the Phase 3 Clinical Trial of HST101 (HST101-301)

The study of HST101-301 enrolled 213 Chinese adult patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD high-risk (including heterozygous familial hypercholesterolemia [HeFH]). During the 12-week randomized, double-blind treatment period, participants were allocated in a 2:1 ratio to receive either HST101 300 mg or placebo via subcutaneous injection every 4 weeks (Q4W; ≤31-day interval).

All subjects maintained stable background therapy with moderate- or high-intensity statins (with or without ezetimibe/ hyzetimibe) yet exhibited suboptimal LDL-C control at baseline. Co-primary efficacy endpoints comprised: (1) the percentage change in LDL-C from baseline to Week 12 versus placebo, and (2) the percentage change in mean LDL-C levels at Weeks 10 and 12. Having completed the double-blind phase, all participants are now entering a 36-week open-label extension receiving HST101 300 mg Q4W, followed by a 4-week safety follow-up period, culminating in a total study duration of 52 weeks.

About Lerodalcibep (HST101):‌

Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed by LIB Therapeutics Inc as a more convenient, once-monthly, single small-volume, subcutaneous injection that will not require refrigeration at home or in travel. These features make Lerodalcibep a unique alternative to approved PCSK9 inhibitors. The anti-PCSK9 binding domain of Lerodalcibep is a 10.4-kDa polypeptide called an adnectin, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life. Lerodalcibep, after completing a large global Phase 3 development program is currently under review for marketing approval by both the USA Food & Drug Administration (FDA) and the European Medicines Agency (EMA).‌

About LIB Therapeutics Inc. 

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in low density lipoprotein cholesterol (LDL-C), despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals.

About Hasten:‌
Hasten Biopharmaceutical Co., Ltd. (Hasten), which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry, particularly around chronic and acute and severe diseases. Through adhering to the principle of patient oriented, Hasten is committed to providing high-quality medicines and solutions to benefit patients via speeding up patient access to premium therapeutics and create social value.