Madrigal And CSPC Partner To Advance Oral GLP-1 Therapy, Clinical Trials To Initiate In 2026

Madrigal Pharmaceuticals, Inc. has entered a global licensing agreement with CSPC Pharmaceutical Group (HKEX: 1093) for SYH2086, an oral, preclinical glucagon-like peptide-1 (GLP-1) receptor agonist and derivative of orforglipron. Madrigal intends to begin clinical development of SYH2086 in the first half of 2026.

“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,” said Bill Sibold, Chief Executive Officer of Madrigal. 

The agreement grants Madrigal worldwide rights to develop, manufacture, and commercialize SYH2086. CSPC will receive an upfront payment of $120 million and is eligible for up to $2 billion in milestone-based payments tied to clinical, regulatory, and commercial achievements. Additionally, CSPC will earn royalties on net sales of the product.

David Soergel, M.D., Chief Medical Officer of Madrigal, added, “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.”

CSPC retains conditional rights to develop and market other oral GLP-1 agonists in China. The transaction is expected to close in Q4 2025, pending regulatory approvals. The partnership strengthens Madrigal’s presence in the metabolic and endocrine disease space by expanding into the GLP-1 therapeutic class. 

“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,” said Dongchen Cai, Chairman of the Board, CSPC.