Latest news with #HRS-5346
Reuters
30-03-2025
- Health
- Reuters
Experimental Lilly drug cuts genetic heart disease risk factor by 94% in trial
CHICAGO, March 30 (Reuters) - The highest dose of an experimental drug developed by Eli Lilly (LLY.N), opens new tab significantly reduced levels of a genetically inherited risk factor for heart disease in a midstage trial, according to data presented at a major medical meeting on Sunday. The drug, lepodisiran, reduced levels of lipoprotein(a), or Lp(a), by an average of 93.9% versus placebo over six months after a single 400 milligram dose. There were 72 patients in the 400 mg arm of the study, while 69 received a placebo. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. After a second 400 mg dose given at six months, participants saw an average reduction of nearly 95% over 12 months. No serious adverse events related to the drug were reported. "What we have is a drug that can lower lipoprotein(a) with very infrequent administration," study author Dr. Steven Nissen, a long-time cardiologist at the Cleveland Clinic, said in an interview. Nissen presented the results at the American College of Cardiology meeting in Chicago. They were also published in the New England Journal of Medicine. Lilly's drug is one of several being tested to treat high Lp(a), a risk factor for heart disease that affects an estimated 1.4 billion people worldwide, including 64 million people in the United States. Unlike LDL, the so-called bad cholesterol that can be treated with diet and statins, there are no approved treatments for Lp(a), and few individuals even know they have it. Elevated Lp(a) can significantly increase the risk of heart attack, stroke, narrowing of the aortic valve, and peripheral artery disease, a buildup of fatty plaques in the arteries. Individuals of African ancestry are at highest risk. Lilly has already moved lepodisiran into late-stage clinical trials. While the drug reduced a cardiovascular risk factor, large trials are needed to prove that lowering Lp(a) actually cuts heart attacks and other adverse cardiovascular events, Nissen said. Lilly is conducting a second Phase 3 trial to test whether lowering Lp(a) actually reduces those risks. Nissen said patient enrollment in that trial should be completed this year. Other injectable treatments for Lp(a) in development include Silence Therapeutics' ( opens new tab zerlasiran, Amgen's (AMGN.O), opens new tab olpasiran and pelacarsen from Novartis (NOVN.S), opens new tab. Lilly is also testing muvalaplin, the only oral treatment for LP(a) in clinical trials. Merck (MRK.N), opens new tab last week signed a licensing agreement with Jiangsu Hengrui Pharmaceuticals ( opens new tab to test its experimental Lp(a) pill called HRS-5346.
Yahoo
30-03-2025
- Health
- Yahoo
Experimental Lilly drug cuts genetic heart disease risk factor by 94% in trial
By Julie Steenhuysen CHICAGO (Reuters) -The highest dose of an experimental drug developed by Eli Lilly significantly reduced levels of a genetically inherited risk factor for heart disease in a midstage trial, according to data presented at a major medical meeting on Sunday. The drug, lepodisiran, reduced levels of lipoprotein(a), orLp(a), by an average of 93.9% versus placebo over six months after a single 400 milligram dose. There were 72 patients in the 400 mg arm of the study, while 69 received a placebo. After a second 400 mg dose given at six months, participants saw an average reduction of nearly 95% over 12 months. No serious adverse events related to the drug were reported. "What we have is a drug that can lower lipoprotein(a) with very infrequent administration," study author Dr. Steven Nissen, a long-time cardiologist at the Cleveland Clinic, said in an interview. Nissen presented the results at the American College of Cardiology meeting in Chicago. They were also published in the New England Journal of Medicine. Lilly's drug is one of several being tested to treat high Lp(a), a risk factor for heart disease that affects an estimated 1.4 billion people worldwide, including 64 million people in the United States. Unlike LDL, the so-called bad cholesterol that can be treated with diet and statins, there are no approved treatments for Lp(a), and few individuals even know they have it. Elevated Lp(a) can significantly increase the risk of heartattack, stroke, narrowing of the aortic valve, and peripheralartery disease, a buildup of fatty plaques in the of African ancestry are at highest risk. Lilly has already moved lepodisiran into late-stage clinical trials. While the drug reduced a cardiovascular risk factor, large trials are needed to prove that lowering Lp(a) actually cuts heart attacks and other adverse cardiovascular events, Nissen said. Lilly is conducting a second Phase 3 trial to test whether lowering Lp(a) actually reduces those risks. Nissen said patient enrollment in that trial should be completed this year. Other injectable treatments for Lp(a) in development include Silence Therapeutics' zerlasiran, Amgen's olpasiran and pelacarsen from Novartis. Lilly is also testing muvalaplin, the only oral treatment for LP(a) in clinical trials. Merck last week signed a licensing agreement with Jiangsu Hengrui Pharmaceuticals to test its experimental Lp(a) pill called HRS-5346.
Yahoo
25-03-2025
- Business
- Yahoo
Merck Bets $2B on China's Hengrui for Next Big Heart Drug
Merck (NYSE:MRK) is doubling down on China's biotech boomthis time with a $2 billion licensing deal for a potential blockbuster heart drug from Jiangsu Hengrui Pharmaceuticals. The deal gives Merck global rights (excluding Greater China) to develop and commercialize HRS-5346, an experimental oral treatment targeting lipoprotein(a)a lesser-known but dangerous cardiovascular risk factor. Merck will pay $200 million upfront, with the rest tied to development and commercial milestones. If approved, HRS-5346 could carve out a new lane in the treatment of atherosclerosis-related conditions like heart attacks and strokes. The transaction is expected to close in Q2 2025. Warning! GuruFocus has detected 1 Warning Sign with MRK. This move continues a clear strategy: Merck is tapping China for high-impact science at leaner valuations. Just last year, it cut billion-dollar deals with Hansoh Pharma and LaNova, targeting obesity and early-stage cancer drugs. Now, with HRS-5346 in mid-stage trials, Merck is building out its cardio-metabolic pipeline with speedand precision. It's part of a broader shift where Big Pharma isn't just looking to China for manufacturing scale, but for next-gen drug innovation that's ready to move globally. HRS-5346's targetelevated lipoprotein(a)is a genetically inherited condition impacting roughly 1.4 billion people. It's also underdiagnosed and largely untreated, giving Merck an opening in a space with high unmet need and little direct competition. Merck's president of R&D called it a natural fit for the company's expanding cardiovascular portfolio. And with a global spotlight on metabolic health, this latest deal positions Merck to play offensenot just defensein one of medicine's biggest markets. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
25-03-2025
- Business
- Yahoo
Merck Enters Exclusive License Agreement for HRS-5346, an Investigational Oral Lipoprotein(a) Inhibitor, for Cardiovascular Disease from Jiangsu Hengrui Pharmaceuticals Co., Ltd.
RAHWAY, N.J., March 25, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui Pharma"), a global pharmaceutical company focused on scientific and technological innovation, today announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China. "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, 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." Under the agreement, Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region. Hengrui Pharma will receive an upfront payment of $200 million and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $1.77 billion, as well as royalties on net sales of HRS-5346, if approved. "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," said Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma. Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the second quarter of 2025. Merck expects to record 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. About Lipoprotein(a)Produced in the liver, lipoprotein(a), or Lp(a), is a type of lipoprotein that carries cholesterol, fats and proteins in the blood. Lp(a) can accumulate in blood vessel walls, forming atherosclerotic plaques similar to LDL cholesterol. These plaques can limit blood flow to vital organs and result in conditions such as heart attack, stroke and other cardiovascular diseases. Elevated Lp(a) is a genetically determined condition and an independent risk factor for cardiovascular disease. Approximately 1.4 billion people worldwide have elevated levels of Lp(a). About Hengrui PharmaJiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. With a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. To date, Hengrui has commercialized 19 new molecular entity drugs and 4 other innovative drugs in China. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About MerckAt Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USAThis news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( View source version on Contacts Merck Media Contacts: Robert Josephson(203) 914-2372 Justine Moore(347) 281-3754 Hengrui Media Contacts: Simona Kormanikova(332) 220-2797 Camilla White(332) 345-8318 Merck Investor Contacts: Peter Dannenbaum(732) 594-1579 Steven Graziano(732) 594-1583 Sign in to access your portfolio
Reuters
25-03-2025
- Business
- Reuters
Merck buys rights to heart disease drug in latest China deal
March 25 (Reuters) - Merck (MRK.N), opens new tab has signed a licensing agreement for a heart disease drug with Jiangsu Hengrui Pharmaceuticals ( opens new tab worth up to $2 billion, the latest in a series of deals U.S. drugmakers have recently signed with China-based firms. Large drugmakers including Merck and Eli Lilly (LLY.N), opens new tab have turned to Chinese biotechs for deals that give them access to new drugs for a cheaper investment, analysts have said. here. Most recently, Danish drugmaker Novo Nordisk ( opens new tab bought global rights to China-based United Laboratories International's ( opens new tab weight-loss drug candidate in a deal worth up to $2 billion. Merck (MRK.N), opens new tab last year signed a licensing deal worth up to $2 billion for Chinese biotech Hansoh Pharma's ( opens new tab experimental oral drug to treat obesity. It also bought the rights to an early-stage cancer drug from China's LaNova in an up to $3.3 billion deal. Under the latest deal, announced on Tuesday, Merck will get exclusive rights to develop, manufacture and sell Jiangsu Hengrui Pharmaceuticals' experimental oral heart disease drug, HRS-5346, worldwide, except in the Greater China region. The drug, currently being studied in a mid-stage trial in China, belongs to a class of drugs which prevent formation of cholesterol, fats and proteins in the blood, which can limit the blood flow to vital organs resulting in heart attack, stroke and other cardiovascular diseases. Hengrui Pharma will receive an upfront payment of $200 million and will be eligible for up to $1.77 billion if it meets certain development, regulatory and commercial milestones, as well as royalties on net sales of HRS-5346, if approved. The deal is expected to close in the second quarter of 2025.
