Merck Enters Exclusive License Agreement for HRS-5346, an Investigational Oral Lipoprotein(a) Inhibitor, for Cardiovascular Disease from Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui Pharma"), a global pharmaceutical company focused on scientific and technological innovation, today announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China.
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"Elevated blood concentrations of Lp(a) provides a well-documented risk factor for atherosclerotic cardiovascular disease, affecting as many as 1 in 5 adults globally," said Dr. Dean Y. Li, president, Merck Research Laboratories. "HRS-5346, an investigational oral small molecule inhibitor of Lp(a) formation, is an important addition that expands and complements our cardio-metabolic pipeline."
Under the agreement, Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region. Hengrui Pharma will receive an upfront payment of $200 million and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $1.77 billion, as well as royalties on net sales of HRS-5346, if approved.
"We are pleased to partner with Merck, a global leader in cardiovascular care. We believe Merck's clinical expertise and global scale will help accelerate the development of HRS-5346 and potentially provide more patients with an additional option to reduce their risk of atherosclerosis," said Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma.
Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the second quarter of 2025. Merck expects to record a pre-tax charge of $200 million, or approximately $0.06 per share, to be included in GAAP and non-GAAP results in the quarter the transaction closes.
About Lipoprotein(a)
Produced in the liver, lipoprotein(a), or Lp(a), is a type of lipoprotein that carries cholesterol, fats and proteins in the blood. Lp(a) can accumulate in blood vessel walls, forming atherosclerotic plaques similar to LDL cholesterol. These plaques can limit blood flow to vital organs and result in conditions such as heart attack, stroke and other cardiovascular diseases. Elevated Lp(a) is a genetically determined condition and an independent risk factor for cardiovascular disease. Approximately 1.4 billion people worldwide have elevated levels of Lp(a).
About Hengrui Pharma
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. With a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. To date, Hengrui has commercialized 19 new molecular entity drugs and 4 other innovative drugs in China. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
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Merck Media Contacts:
Robert Josephson
(203) 914-2372
Justine Moore
(347) 281-3754
Hengrui Media Contacts:
Simona Kormanikova
(332) 220-2797
Camilla White
(332) 345-8318
Merck Investor Contacts:
Peter Dannenbaum
(732) 594-1579
Steven Graziano
(732) 594-1583