Madrigal Pharmaceuticals has entered into a global licensing agreement with CSPC Pharmaceutical Group for SYH2086, an oral GLP-1 receptor agonist.

The move aligns with Madrigal’s strategy to develop innovative treatments for MASH, anchored by its foundational therapy, Rezdiffra.

The combination of Rezdiffra and SYH2086 promises a potential once-daily, well-tolerated MASH treatment.

Under the agreement, Madrigal obtains exclusive rights to develop, manufacture, and commercialise SYH2086 globally.

CSPC will receive an upfront payment of $120m and could earn up to $2bn in milestone payments, alongside royalties on net sales.

CSPC retains the right to develop other oral GLP-1 agonists in China, subject to conditions.

The transaction is expected to close in the fourth quarter of 2025, pending regulatory clearance.

Madrigal CEO Bill Sibold said: “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.”

SYH2086, developed by CSPC with complete global intellectual property rights, is a novel oral small-molecule GLP-1 receptor agonist.

GLP-1 receptor agonists are used in managing type 2 diabetes and obesity, offering benefits such as enhanced insulin secretion and weight loss.

Preclinical data show SYH2086’s strong in vitro and in vivo effects, with a linear pharmacokinetic profile and no significant safety risks observed.

Madrigal plans to initiate clinical development of SYH2086 in the first half of 2026.

The agreement supports Madrigal’s pipeline strategy to develop combination treatments for MASH, leveraging the potential of SYH2086 alongside Rezdiffra.

Madrigal chief medical officer David Soergel said: “The clinical rationale for developing a combination therapy with Rezdiffra and an oral GLP-1 is clear: we want to optimise 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.”