CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd.

辛辛那提--（商业新闻短讯）--LIB Therapeutics，Inc.（LIB），一家私营的晚期生物制药公司，今天宣布其在中国的区域合作伙伴Hasten Biopharmaceuticals Co，Ltd。宣布推出Lerodalcibep，一种潜在的一流PCSK9抑制剂，用于治疗和预防心血管疾病（CVD）。

(Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China..

（Hasten）已收到中国国家医药产品管理局（NMPA）药物评估中心（CDE）接受乐罗达昔布临床试验申请的通知。。

In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories. The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten..

2023年9月，LIB宣布已签署协议，授予Hasten在大中华区（中国大陆、香港、澳门和台湾）开发和商业化Lerodalcibep的权利，并将负责这些地区的临床开发和监管批准。NMPA接受Lerodalcibep临床试验申请是基于LIB提供的综合数据档案，包括CMC，在美国，欧洲和世界其他地区完成的非临床和临床研究，以及Hasten提出的中国临床发展计划。。

“We are excited for Hasten to begin the bridging studies necessary to seek approval and to bring Lerodalcibep to a large and growing population in China with CVD who need substantial additional LDL-C reductions, despite being on statin therapy,” said David Cory, Chief Executive Officer of LIB. “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA.

LIB首席执行官大卫·科里（DavidCory）表示：“我们很高兴能尽快开始必要的桥接研究，以寻求批准，并将Lerodalcibep带给中国越来越多的心血管疾病患者，尽管他们正在接受他汀类药物治疗，但仍需大幅降低LDL-C。”。“我们正在准备我们自己的Lerodalcibep BLA提交给FDA，然后将MAA提交给EMA。

Lerodalcibep has a potential best in class LDL-C lowering profile and will be differentiated as a more patient-friendly, once-monthly, small-volume, single subcutaneous injection that will not require refrigeration at home or in travel.”.

Lerodalcibep具有潜在的同类最佳低密度脂蛋白胆固醇降低特性，将被区分为更具患者友好性，每月一次，小容量，单次皮下注射，不需要在家或旅行中冷藏。”。

About Lerodalcibep

关于Lerodalcibep

Lerodalcibep is a potential best in class, novel, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly dose in a small injection volume and with long-ambient stability. Combined with sustained LDL-C reductions demonstrated in clinical trials, Lerodalcibep is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH)..

Lerodalcibep是一种潜在的同类最佳，新型，小结合蛋白，第三代PCSK9抑制剂，已被开发为一种更方便，每月一次的剂量，注射量小，环境稳定性长。结合临床试验证明的LDL-C持续降低，Lerodalcibep有望为全球数百万动脉粥样硬化性心血管疾病（ASCVD）患者以及ASCVD高危人群（包括3000万遗传性高胆固醇血症（FH））扩大治疗选择。。

The global Phase 3 LIBerate program with over 2,700 patients enrolled a diverse population of patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (FH). Key registration placebo-controlled trials included Lerodalcibep once-monthly for up to 52 weeks, and over 2,400 patients continued in the 72-week open-label extension trial.

全球第三阶段解放计划有2700多名患者，招募了不同人群的心血管疾病患者，这些患者没有心血管疾病，心血管疾病的风险非常高，包括杂合性和纯合性家族性高胆固醇血症（FH）。关键注册安慰剂对照试验包括Lerodalcibep，每月一次，长达52周，超过2400名患者继续进行72周的开放标签延长试验。

LIB is preparing a biologics license application (BLA) for submission to the Food and Drug Administration followed by a marketing authorization application (MAA) for submission to the European Medicines Agency..

LIB正在准备生物制品许可证申请（BLA）提交给食品和药物管理局，然后是上市授权申请（MAA）提交给欧洲药品管理局。。

About Hasten Biopharmaceutical Company, Ltd.

关于哈森生物制药有限公司。

Hasten Biopharmaceutical Co., Ltd., 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. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value..

哈斯腾生物制药有限公司成立于2020年，是一家集研发、生产、商业推广为一体，覆盖整个产业链的公司。Hasten致力于成为医疗行业的领导者。通过与相关政府机构、医疗卫生专业人员和行业合作伙伴等利益相关者携手合作，Hasten提供优质药品和解决方案，造福患者，创造社会价值。。

About LIB Therapeutics, Inc.

关于LIB Therapeutics，Inc。

LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents..

LIB Therapeutics是一家私营的晚期生物制药公司，致力于为数百万心血管疾病患者和3000万家族性高胆固醇血症（FH）患者提供新型、安全、方便的皮下和口服PCSK9抑制剂，这些患者需要进一步大幅度降低低密度脂蛋白胆固醇（LDL-C）尽管他汀类药物和其他降脂药物的耐受性最高。。

For more information, please visit: www.libtherapeutics.com.

有关更多信息，请访问：www.libtherapeutics.com。