Merck and Hengrui Pharma Partner on Investigational Cardiovascular Drug HRS-5346

  • Merck and Hengrui Pharma have signed an exclusive licensing agreement for HRS-5346, an investigational oral small molecule inhibitor targeting Lipoprotein(a) (Lp(a)).
  • The deal includes a $200 million upfront payment, potential milestone payments of up to $1.77 billion, and royalties on future sales, with the transaction expected to close in Q2 2025.

Merck, also known as MSD outside the U.S. and Canada, has entered into an exclusive licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) for the global development, manufacturing, and commercialization of HRS-5346, an investigational oral small molecule Lipoprotein(a) (Lp(a)) inhibitor. The drug is currently being evaluated in a Phase 2 clinical trial in China.

Under the terms of the agreement, Hengrui Pharma will receive an upfront payment of $200 million. The company is also eligible for milestone payments tied to development, regulatory, and commercial achievements, which could total up to $1.77 billion. Additionally, Hengrui Pharma will receive royalties on net sales of HRS-5346 if the drug is approved. The agreement grants Merck exclusive global rights, excluding the Greater China region.

Lp(a) is a known risk factor for atherosclerotic cardiovascular disease, affecting approximately 20% of adults worldwide. Dr. Dean Y. Li, president of Merck Research Laboratories, stated, “HRS-5346, an investigational oral small molecule inhibitor of Lp(a) formation, is an important addition that expands and complements our cardio-metabolic pipeline.”

The completion of the transaction is subject to regulatory approvals, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary conditions. Merck expects the transaction to close in the second quarter of 2025, at which point it will record a pre-tax charge of $200 million, or approximately $0.06 per share, in its financial results.

Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, emphasized the importance of the collaboration, stating, “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.”

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