Home Merck and Hengrui Pharma Enter into Exclusive License Agreement for Oral Lp(a) Inhibitor HRS-5346 in Cardiovascular Disease

Merck and Hengrui Pharma Enter into Exclusive License Agreement for Oral Lp(a) Inhibitor HRS-5346 in Cardiovascular Disease

Mar 25, 2025 19:05 CST Updated 19:05
Hengrui Pharma

Innovative and High-Quality Pharmaceutical Developer

MSD

Pharmaceutical R&D and Manufacturer

      Rahway, New Jersey, USA, March 25, 2025 — MSD (NYSE: MRK, MSD is the corporate name of Merck & Co., Inc. in Rahway, New Jersey, USA) and Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui Pharma"), an international pharmaceutical company focused on technological innovation, today announced that they have entered into an exclusive licensing agreement for HRS-5346, an investigational oral small-molecule lipoprotein(a), or Lp(a), inhibitor currently being evaluated in Phase II clinical trials in China.

      Dr. Dean Y. Li, President of Merck & Co., Inc. Laboratories, stated: "Elevated Lp(a) serum concentration is a well-documented risk factor for atherosclerotic cardiovascular disease, affecting one in five adults worldwide. HRS-5346, an investigational oral small-molecule Lp(a) inhibitor, will significantly expand and complement our research and development pipeline in the field of cardiometabolic diseases."

      According to the agreement, Hengrui Pharma has granted MSD exclusive rights to develop, manufacture, and commercialize HRS-5346 globally, excluding Greater China. Hengrui Pharma will receive an upfront payment of $200 million and is eligible to obtain milestone payments of up to $1.77 billion based on specific development, registration, and commercialization milestones. Additionally, if HRS-5346 is approved, Hengrui Pharma will be entitled to royalties based on its net sales.

      Dr. Jiang Ningjun, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, stated: "We are very pleased to collaborate with MSD, a global leader in the cardiovascular field. We believe that MSD's excellent clinical research and development capabilities and global presence will accelerate the development process of HRS-5346, which is expected to provide more patients with a new treatment option to reduce the risk of atherosclerosis in the future."

      The proposed transaction is subject to approval under the U.S. Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions before completion. The transaction is expected to close in the second quarter of 2025. Merck & Co., Inc. anticipates incurring a pre-tax charge of $200 million (or approximately $0.06 per share), which will be recorded in both GAAP and non-GAAP financial results in the quarter when the transaction is completed.

About Lipoprotein(a)

      Lipoprotein(a), also known as Lp(a), is a lipoprotein generated in the liver that transports cholesterol, fats, and proteins in the blood. Lp(a) can accumulate on the walls of blood vessels, forming atherosclerotic plaques similar to low-density lipoprotein cholesterol (LDL), which may restrict blood flow to vital organs, leading to heart disease, stroke, and other cardiovascular conditions. Elevated Lp(a) levels are hereditary and represent an independent risk factor for cardiovascular diseases. Globally, approximately 1.4 billion people have elevated Lp(a) concentrations.

About Hengrui Pharma

      Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an innovative international pharmaceutical company dedicated to the research, production, and promotion of high-quality drugs, aiming to address unmet clinical needs. Hengrui Pharma has established 14 research and development centers globally, with a global R&D team of over 5,500 people. Its business spans multiple fields including oncology, metabolism and cardiovascular diseases, immunology and respiratory diseases, as well as neuroscience. Currently, Hengrui Pharma has received approval in China for the market launch of 19 new molecular entity drugs and four other innovative drugs. Founded in 1970, Hengrui Pharma has always adhered to its original mission of being "patient-centered," committing to leveraging the power of science and technology to overcome diseases, improve and extend life, serving human health through scientific innovation.

About MSD

      At MSD (the corporate name of Merck & Co., Inc. in the United States, based in Rahway, New Jersey), we are united in our pursuit of a shared mission: harnessing the power of leading-edge science to save and improve lives around the world. For over 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We strive to be a top-tier research-intensive biopharmaceutical company — today, we stand at the forefront of innovation, delivering transformative solutions to advance the prevention and treatment of diseases in both humans and animals. We have built a diverse and inclusive global workforce, conducting ourselves responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and follow us on X (formerly Twitter), LinkedIn, and YouTube.

MSD Forward-Looking Statements

      MSD is the trade name of Merck & Co., Inc., located in Rahway, New Jersey, USA (hereinafter referred to as "the Company"). This press release contains "forward-looking statements" made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The content herein is based on the current views and expectations of the Company's management and is subject to significant risks and uncertainties. MSD does not guarantee that its products under development will receive the necessary regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties arise, actual results may differ materially from those anticipated in the forward-looking statements.

      Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors (including interest rate and currency fluctuations), the impact of pharmaceutical industry regulations and healthcare policies in the United States and other countries, global trends toward healthcare cost containment, technological advances, new products and patents attained by competitors, inherent challenges in new product development (including obtaining regulatory approval), MSD's ability to accurately predict future market conditions, difficulties or delays in production, unstable international economic and financial conditions and sovereign risks, reliance on the effectiveness of MSD’s patent and other innovative product protections, and the risk of patent litigation and/or regulatory actions against the company.

      MSD has no obligation to publicly update any forward-looking statements due to new information, future events, or other reasons. Other factors may cause actual results to materially differ from forward-looking statements; see MSD's 2024 Annual Report (as of December 31, 2024), Form 10-K, and other documents filed by the company with the U.S. Securities Exchange Commission (available at www.sec.gov).