Merck and Jiangsu Hengrui Pharmaceuticals announced today they have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a) inhibitor currently in Phase 2 clinical trials in China. The deal represents a significant expansion of Merck's cardiovascular portfolio and addresses a major unmet need in cardiovascular disease management.
Under the terms of the agreement, Merck will pay Hengrui Pharma $200 million upfront and up to $1.77 billion in potential development, regulatory, and commercial milestone payments, plus royalties on net sales if the drug receives approval. Merck gains exclusive rights to develop, manufacture, and commercialize HRS-5346 worldwide, excluding the Greater China region.
Addressing a Significant Cardiovascular Risk Factor
Elevated Lipoprotein(a), or Lp(a), affects approximately one in five adults globally and is recognized as an independent risk factor for atherosclerotic cardiovascular disease. Unlike other cardiovascular risk factors, Lp(a) levels are primarily determined by genetics rather than lifestyle factors.
"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 of 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."
Lp(a) is a type of lipoprotein produced in the liver that carries cholesterol, fats, and proteins in the blood. It can accumulate in blood vessel walls, forming atherosclerotic plaques similar to LDL cholesterol, potentially leading to heart attacks, strokes, and other cardiovascular diseases. Approximately 1.4 billion people worldwide have elevated levels of Lp(a), creating a substantial market opportunity for effective treatments.
Oral Therapy Could Offer Advantages
Current investigational therapies targeting Lp(a) primarily consist of injectable treatments. An oral small molecule inhibitor like HRS-5346 could potentially offer advantages in terms of patient convenience and adherence, potentially expanding treatment options for this widespread cardiovascular risk factor.
Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, expressed optimism about the partnership: "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."
Strategic Fit for Both Companies
For Merck, the acquisition strengthens its cardiovascular portfolio at a time when the company is expanding beyond its oncology and vaccine franchises. The company has been actively seeking external assets to complement its internal pipeline.
Hengrui Pharmaceuticals, founded in 1970, has established itself as an innovative global pharmaceutical company with 14 R&D centers and more than 5,500 R&D professionals worldwide. The company has commercialized 19 new molecular entity drugs and 4 other innovative drugs in China, with therapeutic focus areas including oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience.
Transaction Details and Timeline
The transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. It is expected to close in the second quarter of 2025. Merck anticipates recording 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.
Market Implications
The deal highlights the growing interest in addressing residual cardiovascular risk beyond traditional cholesterol management. While statins and PCSK9 inhibitors have proven effective for managing LDL cholesterol, elevated Lp(a) represents a distinct risk factor that requires targeted approaches.
Industry analysts note that the cardiovascular disease market remains one of the largest pharmaceutical segments globally, with substantial unmet needs despite decades of therapeutic advances. The development of oral therapies targeting novel risk factors like Lp(a) could represent the next wave of innovation in cardiovascular medicine.
As HRS-5346 progresses through clinical development, healthcare providers and patients will be watching closely to see if this oral therapy can effectively reduce Lp(a) levels and, ultimately, cardiovascular events in high-risk populations.
