In a significant move into the cardiovascular drug space,
pharmaceutical giant Merck & Co. has secured rights to a promising oral heart medication through a $200 million upfront payment to Chinese drugmaker Jiangsu Hengrui Pharmaceuticals. The deal, announced Tuesday, gives Merck access to an experimental drug known as HRS-5346, which targets lipoprotein(a), a protein particle linked to blood vessel blockages.
The agreement, which excludes the greater China region, could see Jiangsu Hengrui receiving up to $1.77 billion in additional milestone payments plus royalties from future sales. The drug is currently undergoing Phase 2 clinical trials, joining a competitive field of treatments targeting the same mechanism.
This development marks Merck’s latest effort to strengthen its cardiovascular portfolio, an area where the company historically made its mark with cholesterol-lowering statins in the 1980s and 1990s. While Merck’s recent success has largely centered on cancer
immunotherapy, the company has shown renewed interest in heart medications, as evidenced by its successful development of a pulmonary arterial hypertension drug acquired through the Acceleron Pharma purchase.
The race to develop effective Lp(a)-blocking medications has attracted several major pharmaceutical companies. Novartis leads the pack with an RNA-based therapy in Phase 3 trials, with crucial cardiovascular outcomes data expected in 2026. These results will provide important insights into how effectively such drugs improve heart health.
Industry analysts, including Jefferies’ Dennis Ding, note that the sector appears to be shifting toward oral medications. Other companies pursuing oral Lp(a) treatments include Eli Lilly, whose drug muvalaplin has completed Phase 2 trials, and AstraZeneca, which recently invested $100 million in a preclinical Lp(a)-blocking drug from CSPC Pharmaceutical.
The current Phase 2 trial of HRS-5346 in Beijing is evaluating three different dosage levels against a placebo in patients with heart disease or high risk factors. The study, measuring Lp(a) reduction over 12 weeks, is expected to conclude by year-end.
Injectable RNA therapies have set high effectiveness standards, achieving more than 90% reduction in Lp(a) levels during clinical testing. Lilly’s oral drug muvalaplin has shown promising results as well, with up to 85% reduction. However, analysts suggest that effective oral medications could serve both high-risk patients currently targeted by injectable treatments (estimated at 10-15% of the population) and a broader group with moderate Lp(a) levels.
Dean Li, president of Merck Research Laboratories, emphasized the strategic importance of the deal, noting that it “expands and complements our cardio-metabolic pipeline.” The company is also developing an oral PCSK9 inhibitor, currently in Phase 3 testing, further demonstrating its commitment to cardiovascular medicine.
The potential market for Lp(a)-targeting drugs remains largely untapped, as no approved therapies currently exist. This represents a significant opportunity in the cardiovascular disease space, where new treatment options are continually sought to address unmet medical needs.
The licensing agreement highlights the growing trend of major pharmaceutical companies partnering with Chinese firms to expand their drug development pipelines, as well as the increasing importance of oral alternatives to injectable therapies in cardiovascular medicine.