Regeneron Pharmaceuticals has signed a licensing deal worth up to nearly $2bn with China-based Hansoh Pharmaceuticals for the latter’s obesity drug candidate, HS-20094.
The deal grants Regeneron Pharmaceuticals exclusive rights to develop and market the dual GLP-1/GIP receptor agonist outside of Mainland China, Hong Kong, and Macau.
HS-20094 is undergoing Phase 3 trials and is intended to be administered as a weekly subcutaneous injection.
This therapeutic candidate is said to have been tested in over 1,000 patients and shows potential effectiveness and safety comparable to the only US Food and Drug Administration (FDA)-approved GLP-1/GIP receptor agonist.
Ongoing trials include a Phase 3 study for obesity in China and a Phase 2b trial for diabetes.
Regeneron Pharmaceuticals co-chair, president, and chief scientific officer George Yancopoulos said: “Regeneron is committed to advancing better obesity treatments by enhancing quality of weight loss.
“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.
“Securing access to a GLP-1/GIP receptor agonist will increase the versatility of our clinical programmes for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits.”
As part of the agreement, Regeneron Pharmaceuticals will provide Hansoh Pharmaceuticals with an initial payment of $80m. There are also provisions for up to $1.93bn in additional payments tied to developmental, regulatory, and sales milestones.
Furthermore, there are potential royalties in low double digits on global net sales outside the specified regions.
The agreement’s completion is contingent upon regulatory approvals under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the US.
Separately, Regeneron Pharmaceuticals has released interim findings from the Phase 2 COURAGE trial, which is examining new combinations for treating obesity. This trial evaluates semaglutide, a GLP-1 receptor agonist, in combination with trevogrumab, an anti-GDF8/anti-myostatin agent, and optionally with garetosmab, an anti-activin A therapy.
The data indicated that about 35% of weight loss attributed to semaglutide resulted in a reduction of lean mass. Additionally, mixing semaglutide with trevogrumab, with or without garetosmab, aided in maintaining lean mass while enhancing fat mass reduction.
These interim results were assessed when 50% of participants reached the 26-week mark.
The dual combination of semaglutide and trevogrumab was generally well-tolerated. However, the triplet combination including both antibodies experienced a higher rate of discontinuations due to tolerability challenges and other adverse events, aligning with previous safety observations associated with garetosmab alone.
