Merck has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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.

“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. HRS-5346, an investigational oral small molecule inhibitor of Lp(a) formation, is an important addition that expands and complements our cardio-metabolic pipeline,” said Dr. Dean Y. Li, president, Merck Research Laboratories.

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 USD 200 million and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to USD 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 USD 200 million, or approximately USD 0.06 per share, to be included in GAAP and non-GAAP results in the quarter the transaction closes.