Merck & Co. has agreed to license the oral small molecule Lipoprotein(a) [Lp(a)] inhibitor HRS-5346 from Jiangsu Hengrui Pharmaceuticals, through a licensing agreement that could generate up to $2 billion plus for the Chinese drug developer.
Hengrui Pharma has granted Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 worldwide, except in Greater China where Hengrui will retain rights. At China’s Peking University Third Hospital, HRS-5346 is under study in a Phase II trial (NCT06816264) designed to assess the drug’s efficacy and safety in adults with elevated Lp(a) at high risk for cardiovascular events.
Dean Y. Li, MD, PhD, president, Merck Research Laboratories, hailed HRS-5346 in a statement as “an important addition that expands and complements our cardiometabolic pipeline.”
“Elevated blood concentrations of Lp(a) provide a well-documented risk factor for atherosclerotic cardiovascular disease, affecting as many as 1 in 5 adults globally,” Li stated.
Merck agreed to pay Hengrui $200 million upfront and up to $1.77 billion in payments tied to achieving development, regulatory, and commercial milestones, plus royalties on net sales of HRS-5346, if approved.
The collaboration agreement positions Merck to challenge two other pharma giants that aim to treat cardiovascular diseases by inhibiting Lp(a), a form of low-density lipoprotein (LDL) that plays a key role in the transport of cholesterol in the bloodstream.
Last November, Eli Lilly announced positive Phase II data showing three dosages of its oral, once daily muvalaplin (10 mg, 60 mg, and 240 mg) to have met the primary endpoint of a Phase II trial (NCT05565742) by showing significant reductions in Lp(a) levels vs placebo. Reductions were 47.6% (10 mg), 81.7% (60 mg), and 85.8% (240 mg) with an intact Lp(a) assay, and 40.4% (10 mg), 70.0% (60 mg), and 68.9% (240 mg) with an apolipoprotein A [apo(a)] assay.
$2B+ dyslipidemia partnership
And last October, AstraZeneca inked a potentially $2 billion-plus collaboration deal of its own to advance the development of YS2302018, a small molecule Lp(a) inhibitor designed to treat dyslipidemia. The pharma giant exclusively licensed rights to the preclinical candidate from Chinese-based CSPC Pharmaceutical Group. Under the companies’ agreement, AstraZeneca agreed to pay CSPC $100 million upfront, up to $1.92 billion tied to achieving development and commercialization milestones, plus tiered royalties.
Other pharmas targeting Lp(a) within their pipelines include Amgen and Novartis.
As for Merck and Hengrui, their collaboration deal is expected to close in the second quarter, subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Merck said it expected 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 during which the transaction will close.
Investors reacted to news of the deal by sending Hengrui shares on the Shanghai Stock Exchange up 1.17%, to CNY 44.87 ($6.18) at the close of trading today. Merck shares on the New York Stock Exchange nearly 5% from yesterday’s close of $92.31, to $88.03 as of 1:11 p.m. ET.
“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,” added Frank Jiang, MD, PhD, Hengrui’s executive vice president and chief strategy officer.