Merck Secures Exclusive License for HRS-5346 Cardiovascular Drug from Jiangsu Hengrui

28 March 2025
RAHWAY, NJ, USA, March 25, 2025 – Merck, known globally as MSD outside the United States and Canada, has announced a new partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. The companies have entered an exclusive licensing agreement for HRS-5346, a promising oral small molecule Lipoprotein(a) inhibitor currently being tested in Phase 2 clinical trials in China.

Lipoprotein(a), or Lp(a), is a type of lipoprotein produced in the liver. It plays a significant role in carrying cholesterol, fats, and proteins in the blood. High concentrations of Lp(a) are linked to an increased risk of atherosclerotic cardiovascular disease, a condition affecting one in five adults worldwide. The condition is genetically inherited and acts as an independent risk factor for cardiovascular diseases, including heart attacks and strokes, due to its ability to form atherosclerotic plaques in blood vessels.

HRS-5346 represents an innovative approach to tackling this serious health issue. According to Dr. Dean Y. Li, president of Merck Research Laboratories, this investigational drug is a crucial addition to Merck’s cardio-metabolic pipeline, given its potential to inhibit Lp(a) formation effectively.

Under the terms of the agreement, Merck has obtained exclusive global rights to develop, manufacture, and commercialize HRS-5346, except in the Greater China region. In return, Hengrui Pharma will receive an initial payment of $200 million and is eligible for additional payments tied to developmental, regulatory, and commercial milestones, potentially totaling up to $1.77 billion. Additionally, if HRS-5346 is approved, Hengrui Pharma will receive royalties based on net sales.

Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, expressed optimism about the collaboration. He believes that Merck’s extensive clinical expertise and global reach will accelerate the development of HRS-5346, offering patients a new option to lower their risk of atherosclerosis.

The completion of this transaction is contingent upon approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, with an expected closure date in the second quarter of 2025. Financially, Merck anticipates recording a pre-tax charge of $200 million, which equates to around $0.06 per share, in the quarter the transaction finalizes.

Hengrui Pharma, founded in 1970, is a leading pharmaceutical company dedicated to developing high-quality medications to meet unmet clinical needs. With a robust global research and development team, the company focuses on therapeutic areas such as oncology, cardiovascular, metabolic diseases, immunology, respiratory diseases, and neuroscience. Hengrui has a strong track record of innovation, having commercialized multiple new molecular entity drugs in China.

Merck, with a legacy spanning over 130 years, is committed to using cutting-edge science to improve and save lives globally. As a leading research-intensive biopharmaceutical company, Merck is at the forefront of developing innovative health solutions for disease prevention and treatment across the world.

This strategic partnership between Merck and Hengrui Pharma aims to harness their combined expertise to bring a promising new treatment to the global market, addressing a critical need in cardiovascular health management.

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