Boehringer Ingelheim and Yuhan Corp.

In US$ 870m NASH deal.

Boehringer Ingelheim has licenced a preclinical fusion protein from Korean Yuhan Corp. that activates both GLP-1R and FGF21R to treat Nonalcoholic Steatohepatitis (NASH). Boehringer Ingelheim will pay $40m upfront and in near-term payments to acquire the commercialisation rights to the compound.

Under the agreement, Yuhan Corp. is eligible to receive up to USD 830 million in potential milestone payments plus tiered royalties on future net sales.

NASH, which has a high prevalence in the growing patient population of diabetics and obese people, often starts with the accumulation of fat in the liver, giving rise to inflammation and finally leading in many patients to liver fibrosis and cirrhosis which requires liver transplantation. With the deal Boehringer Ingelheim complements its programmes targeting the drivers of NASH – steatosis, inflammation and fibrosis.

Preclinical evidence suggests high efficacy of Yuhan’s drug candidate YH25724. The dual GLP1R/FGF21R agonist is expected to reduce liver cell injury and hepatic inflammation by resolution of steatohepatitis as well as having a direct antifibrotic effect.

Analysts expect an addressable market of US$35bn for treatments of NASH, progressive fibrotic chronic liver inflammation caused by the buildup of fat, which affects at least 2% to 5% of US-Americans. Several companies race for approval of the very first NASH therapy, including FGF21 analogues such as 89Bio’s BIO89-100 (TEV-47948), or /Bristol-Myers Squibb’s NASH lead BMS-986036, Novo Nordisk’s GLP-1 analogue semaglutide or Gilead Sciences FXR agonist cilofexor.

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