Regeneron Pharmaceuticals is to enter an in-licensing agreement with Hansoh Pharmaceuticals to secure exclusive rights for HS-20094.

The agreement will involve the clinical development and commercialisation of the dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist outside the Chinese mainland, Macau and Hong Kong.

Regeneron will pay Hansoh $80m upfront, with additional milestone payments that could reach $1.93bn contingent upon development, regulatory and sales targets being met.

The company will also pay royalties in low double digits on global net sales outside the designated territories.

With this strategic agreement, Regeneron is expanding its clinical-stage obesity portfolio. 

The deal is subject to standard closing conditions, including clearances from regulatory agencies under the US 1976 Hart-Scott-Rodino Antitrust Improvements Act.

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The therapy, currently in Phase III trial, has been tested in more than 1,000 subjects.

Delivered through a weekly subcutaneous injection, its safety and efficacy data in trials were encouraging, indicating a potential to match the profile of the only US Food and Drug Administration (FDA)-approved GLP-1/GIP receptor agonist.

Ongoing studies include a Phase III trial for obesity in China and a Phase IIb trial for diabetes.

Regeneron Pharmaceuticals president, co-chair and chief scientific officer George Yancopoulos stated: “Regeneron is committed to advancing better obesity treatments by enhancing the 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 programs for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits.”

The in-licensing agreement follows the announcement of Sanofi and Regeneron’s Phase III AERIFY-1 trial of the fully human monoclonal antibody itepekimab, which met its primary goal in treating former smokers with inadequately controlled chronic obstructive pulmonary disease.

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