In a significant pharmaceutical industry development, Merck & Co. has secured rights to an experimental oral medication targeting heart disease through a $200 million upfront payment to Chinese
pharmaceutical company Jiangsu Hengrui Pharmaceuticals. The agreement, announced Tuesday, positions Merck to compete in the developing market for drugs that target lipoprotein(a), a protein particle linked to blood vessel blockages.
The licensing agreement grants Merck rights to commercialize HRS-5346, currently undergoing Phase 2 clinical trials, in all territories outside greater China. The deal structure includes potential additional payments of up to $1.77 billion tied to development, regulatory and commercial achievements, along with sales royalties.
This move represents Merck’s latest effort to strengthen its cardiovascular medicine 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, this deal signals continued interest in cardiovascular treatments.
The development of Lp(a)-blocking medications has attracted
significant industry attention, with several companies pursuing different approaches. Novartis leads the pack with an RNA-based treatment in Phase 3 trials, with crucial cardiovascular outcomes data expected in 2026. This data will provide important insights into how effectively these drugs improve heart health.
Merck’s acquisition adds to its growing cardiovascular pipeline, which includes a recently approved pulmonary arterial hypertension treatment obtained through the Acceleron Pharma acquisition, and an oral PCSK9 inhibitor in Phase 3 testing.
The oral medication approach distinguishes Merck’s strategy from competitors using injectable RNA therapies. Other pharmaceutical companies are also exploring oral alternatives, including Eli Lilly’s muvalaplin, which has completed Phase 2 trials, and AstraZeneca’s recent $100 million investment in a preclinical Lp(a)-blocking drug from CSPC Pharmaceutical.
Industry analyst Dennis Ding of Jefferies noted that this deal reflects a broader industry shift toward oral treatments. The current Phase 2 trial of HRS-5346, being conducted in Beijing, is evaluating three different dosage levels against a placebo in patients with heart disease or high risk factors. The study aims to measure Lp(a) level reduction over 12 weeks and is expected to conclude by year-end.
The effectiveness bar has been set high by injectable RNA therapies, which have demonstrated over 90% reduction in Lp(a) levels during clinical testing. Lilly’s oral drug muvalaplin has shown promising results with up to 85% reduction.
Market potential for these treatments appears substantial, with oral medications potentially serving both high-risk patients who might otherwise receive injectable treatments (estimated at 10-15% of the population) and a broader group with moderate Lp(a) levels. The absence of currently approved therapies specifically targeting Lp(a) creates significant market opportunity.
The deal terms maintain Jiangsu Hengrui’s rights in the greater China region while providing Merck with global rights elsewhere. This strategic partnership could potentially address an unmet medical need in cardiovascular disease treatment, an area where Merck aims to reclaim its historical leadership position.
For Merck, this investment represents both a return to its
cardiovascular roots and an expansion of its current therapeutic portfolio, which has been dominated by its cancer immunotherapy success. The development of an oral Lp(a)-blocking medication could provide a significant advancement in cardiovascular disease treatment options, particularly for patients who might prefer oral
administration over injectable therapies.