Regeneron Pharmaceuticals has entered the competitive obesity market through a strategic licensing agreement with Hansoh Pharmaceuticals Group, acquiring exclusive clinical development and commercial rights to HS-20094, a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. The deal, announced Monday, involves an $80 million upfront payment and potential milestone payments reaching $1.93 billion.
Strategic Entry into GLP-1 Market
The acquisition represents Regeneron's first direct access to a GLP-1 molecule, marking the company's official entry into the rapidly expanding obesity therapeutics space. HS-20094 has been studied in over 1,000 patients as a weekly subcutaneous injection and has demonstrated promising efficacy and safety data suggesting a potentially similar profile to Eli Lilly's Mounjaro, the only FDA-approved GLP-1/GIP receptor agonist.
"Regeneron is committed to advancing better obesity treatments by enhancing quality of weight loss," said George Yancopoulos, co-Chair, President and Chief Scientific Officer of Regeneron. "Despite the transformative impact of recent weight loss therapies, significant unmet needs remain, including the ability to sustain weight loss and maintain muscle mass over time."
Combination Strategy for Enhanced Outcomes
Regeneron plans to leverage HS-20094 in combination studies with its proprietary pipeline candidates to address muscle loss and obesity-related comorbidities. Boaz Hirshberg, Senior Vice President of Clinical Development at Regeneron, explained that the in-licensed asset will enable studies combining it with Regeneron's drugs "in order to holistically address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes and liver conditions."
The company has already demonstrated progress in this approach through its Phase 2 COURAGE study, which investigated adding trevogrumab, a GDF8 antibody, to semaglutide with and without garetosmab, an anti-activin antibody. Results announced simultaneously with the Hansoh deal showed that adding trevogrumab improved muscle preservation by 51.3%, while the three-drug combination improved muscle preservation to 80.9%. The combinations also increased total weight loss to 11.3% and 13.2% respectively, compared to 10.4% with semaglutide alone.
Financial Terms and Development Timeline
Under the licensing agreement, Regeneron will make future royalty payments in the low double digits for global net sales outside of Chinese Mainland, Hong Kong, and Macau. Hansoh retains rights in these territories, where a Phase 3 obesity trial and Phase 2b diabetes study are currently ongoing.
The transaction is subject to customary closing conditions, including regulatory clearances under the Hart-Scott-Rodino Antitrust Improvements Act. Regeneron gains exclusive rights to develop and commercialize HS-20094 in all territories outside of the designated Chinese regions.
Market Context and Unmet Needs
The deal comes as Regeneron seeks to address significant limitations in current obesity treatments. According to the company, while GLP-1 receptor agonists have had revolutionary impact on weight loss, they can cause profound muscle loss and many patients cycle on and off treatment. When patients discontinue treatment, they often regain weight primarily as fat, resulting in negatively altered body composition.
Regeneron's approach focuses on developing a pipeline centered on quality weight reduction, with multiple independent approaches aimed at promoting and preserving muscle during weight loss to increase fat loss, since adiposity is the principal driver of obesity-related comorbidities and metabolic diseases.
Timing Amid Pipeline Challenges
The obesity deal follows recent setbacks for Regeneron, including the failure of itepekimab, its Dupixent follow-up candidate, in a Phase III COPD trial last week. The company's shares declined more than 16% following that announcement, with analysts noting the need for positive developments in Regeneron's pipeline.
The HS-20094 acquisition provides Regeneron with a late-stage asset that complements its existing obesity research programs and positions the company to compete in the growing metabolic disease market through combination approaches targeting both weight loss and muscle preservation.
