Pharmaceutical giant Merck & Co. announced a significant licensing agreement on Tuesday, committing $200 million upfront to acquire rights for a novel oral heart medication from Chinese pharmaceutical company Jiangsu Hengrui Pharmaceuticals. The deal excludes the greater China region and could result in additional payments of up to $1.77 billion, plus royalties, if certain milestones are achieved.
The experimental drug, HRS-5346, targets lipoprotein(a), a protein particle linked to blood vessel blockages. Currently undergoing Phase 2 clinical trials in Beijing, the medication represents Merck’s latest venture into cardiovascular therapeutics, an area where the company historically made its mark with cholesterol-lowering statins in the 1980s and 1990s.
The agreement positions Merck alongside other pharmaceutical companies developing treatments targeting Lp(a), including Novartis, which leads the field with an RNA-based injectable medicine in Phase 3 trials. Cardiovascular outcomes data for Novartis’s drug is anticipated in 2026, potentially setting industry standards for Lp(a)-targeting therapeutics.
Dean Li, who heads Merck Research Laboratories, emphasized the strategic importance of the deal, noting that it strengthens and diversifies the company’s cardiovascular pipeline. While Merck’s revenue now primarily stems from cancer immunotherapy, the company has been actively rebuilding its presence in cardiovascular medicine, as evidenced by its successful development of a pulmonary arterial hypertension drug acquired through Acceleron Pharma.
The Beijing-based Phase 2 trial of HRS-5346 is testing three different dosage levels against a placebo in patients with heart disease or high risk factors. The study aims to measure Lp(a) reduction over a 12-week period and is expected to conclude by year-end.
Industry analysts, including Jefferies’ Dennis Ding, suggest this deal reflects a broader shift toward oral medications in the Lp(a) space. While injectable RNA therapies have demonstrated impressive results with over 90% Lp(a) reduction, and Eli Lilly’s oral drug muvalaplin has achieved up to 85% reduction, the market potential remains substantial for effective oral treatments.
The development of oral medications could particularly benefit patients with moderately elevated Lp(a) levels who might not qualify for injectable therapies. Market analysts predict oral drugs could serve both high-risk patients currently targeted by injectable treatments (estimated at 10-15% of the population) and a broader patient base with lower Lp(a) levels.
This deal follows similar industry movements, such as AstraZeneca’s $100 million agreement with CSPC Pharmaceutical for an Lp(a)-blocking drug still in preclinical development. Merck’s latest investment also complements its ongoing development of an oral PCSK9 inhibitor currently in Phase 3 trials.
The competition in this therapeutic space is intensifying, with various pharmaceutical companies pursuing different technological approaches to address elevated Lp(a) levels. Notable contenders include Amgen, which is also developing an oligonucleotide therapy, adding to the growing roster of companies seeking to establish a presence in this untapped market.
This licensing agreement underscores the pharmaceutical industry’s growing interest in addressing cardiovascular disease through novel mechanisms, particularly in a market segment currently lacking approved therapies. The development of oral medications targeting Lp(a) could potentially transform treatment options for patients at risk of cardiovascular disease, representing a significant opportunity in what analysts describe as “pharma white space.”