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Madrigal Pharmaceuticals secures global rights to SYH2086, aiming to enhance MASH treatment with innovative combination therapies for better patient outcomes.
The the exclusive licensing agreement for SYH2086 will allow for Madrigal to initiate clinical developments early in 2026.
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Madrigal Pharmaceuticals has agreed to enter into a global license agreement with CSPC Pharmaceutical Group Limited for its preclinical oral small molecule glucagon-like-peptide-1 (GLP-1) receptor agonist SYH2086. Alongside SYH2086, Madrigal also got the exclusive global license for CSPC’s orforglipron derivative and plans to commence clinical developments staring in the first half of 2026.
Bill Sibold, chief executive officer of Madrigal, made note of what the agreement means for Madrigal and its future, saying, “We’ve made remarkable progress this year advancing our strategic priorities–from the continued successful launch of Rezdiffra, to securing new IP protection through 2044, to laying the groundwork for Rezdiffra’s next stages of growth in F4c and Europe. This agreement to acquire global rights to SYH2086 aligns perfectly with our long-term goal to extend our leadership in MASH by building a pipeline anchored by Rezdiffra. We believe a combination of Rezdiffra and SYH2086 has the potential to deliver a best-in-class oral treatment for patients with MASH.”1
Metabolic dysfunction-associated steatohepatitis (MASH) is a serious liver disease progressing cirrhosis, liver failure, liver cancer, liver transplant necessity, and can lead to premature fatality. MASH is the leading cause of liver transplants in women, while also being the second leading cause of liver transplants across the U.S. Patients diagnosed with MASH can progress to moderate or advanced liver fibrosis, which raises the risk of severe liver outcomes and highlights the need to treat MASH in a timely and effective manner.
Dongchen Cai, chairman of the board at CSPC touched further on the topic saying, “We are pleased to announce the in-license of our oral GLP-1 by Madrigal, an innovative company that pioneered the first approved treatment for MASH. We believe Madrigal’s strong clinical development and commercial capabilities will help unlock the full potential of SYH2086 to benefit patients.”1
All eyes are on CSPC’s SYH2086, the small molecule GLP-1 receptor agonist, which exerts its effects through GLP-1 receptors and is employed to treat and manage type 2 diabetes as well as obesity. SYH2086 functions by enhancing insulin secretion, suppressing glucagon release, delaying gastric emptying, and reduces appetite, offering glycemic control, and weight loss. SYH2086 has demonstrated excellence in vitro agonistic activity, vivo glucose-lowering, and weight loss effects, and has achieved a linear pharmacokinetic profile with a wide dose range expanding over a vase array of animal species.
David Soergel, M.D., chief medical officer of Madrigal spoke on the advancements of SYH2086, saying, “The clinical rationale for developing a combination therapy with Rezdiffra and an oral GLP-1 is clear: we want to optimize efficacy and tolerability in MASH by balancing the weight loss from a GLP-1 with the fibrosis and lipid reduction of Rezdiffra in a once-a-day pill. In the pivotal Phase 3 MAESTRO-NASH trial, even modest weight loss of five percent or more enhanced Rezdiffra’s antifibrotic benefit, so we are confident that combination therapy with SYH2086 has the potential to provide increased efficacy for patients with MASH.”1
CSPC is expected to receive an upfront payment of $120 million for the exclusive licensing agreement from Madrigal, accompanied with the eligibility of upwards of $2 billion in milestone payments based on specific developmental, regulatory, and commercial milestone achievements. CSPC is also entitled to royalties on net sales of SYH2086 and may develop and commercialize additional GLP-1 agonists in China subject to certain conditions.
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