A major pharmaceutical deal was announced Tuesday as Merck & Co. agreed to pay $200 million upfront to Chinese drugmaker Jiangsu Hengrui Pharmaceuticals for the rights to develop and commercialize a novel oral heart disease treatment outside of greater China.
The experimental drug, known as HRS-5346, targets lipoprotein(a), or Lp(a), a protein particle linked to blood vessel blockages. Under the agreement terms, Jiangsu Hengrui could receive up to an additional $1.77 billion in milestone payments plus royalties if the drug meets certain development, regulatory and commercial targets.
The deal positions Merck in an increasingly competitive field of companies developing Lp(a)-targeting therapies. Currently, Novartis leads the pack with an RNA-based injectable treatment in Phase 3 trials, with crucial cardiovascular outcomes data expected in 2026. These results are anticipated to provide key insights into how effectively these drugs improve heart health.
For Merck, which pioneered statin medications in the 1980s and 1990s, this agreement marks a renewed push into cardiovascular medicine. While the company’s recent success has largely come from cancer immunotherapy, it has shown increasing interest in heart treatments. This is evidenced by its successful development of a pulmonary arterial hypertension drug acquired through Acceleron Pharma, and its ongoing Phase 3 trials of an oral PCSK9 inhibitor.
HRS-5346 is currently undergoing Phase 2 clinical trials in Beijing, where researchers are evaluating 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 12 weeks and should conclude by year’s end.
Industry analysts note that while injectable RNA therapies have demonstrated impressive results, showing more than 90% reduction in Lp(a) levels, oral medications could capture a significant market share. Eli Lilly’s oral drug muvalaplin has achieved up to 85% reduction in clinical testing. Jefferies analyst Dennis Ding suggests that effective oral treatments could serve both high-risk patients who might otherwise receive injectables (estimated at 10-15% of the population) and a broader group with moderate Lp(a) levels who wouldn’t qualify for injectable therapy.
The race to develop Lp(a)-blocking treatments has attracted other major players. AstraZeneca recently invested $100 million in a preclinical Lp(a) drug from CSPC Pharmaceutical, another Chinese company, indicating growing industry interest in oral alternatives to injectable therapies.
“This represents an important addition that expands and complements our cardio-metabolic pipeline,” stated Dean Li, president of Merck Research Laboratories, regarding the licensing agreement.
The deal highlights a broader trend in pharmaceutical development, with companies increasingly pursuing oral medications for targets traditionally addressed by injectable treatments. The Lp(a) market presents a particularly attractive opportunity as there are currently no approved therapies specifically targeting this risk factor.
This latest move by Merck demonstrates the company’s strategic focus on expanding its cardiovascular portfolio while leveraging external innovation through partnerships. The development of an oral
Lp(a)-lowering drug could potentially offer patients a more convenient treatment option compared to injectable alternatives, while addressing an unmet medical need in cardiovascular disease management.