Boehringer Ingelheim. (7/1/19). "Press Release: Boehringer Ingelheim Expands Nonalcoholic Steatohepatitis (NASH) R&D Pipeline with New First-in-Class Compound from Yuhan Corporation". Ingelheim & Seoul.

	Organisation	Boehringer Ingelheim (Group)
	Organisation 2	Yuhan Corporation (Yu Han) (000100:KS)
	Product	FGF21 (GLP1R/FGF21R agonist) (Yuhan Corp / Boehringer)
	Product 2	drug development
	Index term	Boehringer–Yuhan: GLP1R/FGF21R agonist, 201907– collab + license agreem for FGF21 $40m upfront + $830m milestones + royalties
	Person	Pairet, Michel (Boehringer 201009 head Boehringer Ingelheim Venture Fund)
	Person 2	Lee, Jung Hee (Yuhan 201907 CEO of Yuhan Corp)

> Boehringer Ingelheim focuses on the development of next generation NASH treatments that target all three key drivers of the disease - steatosis, inflammation and fibrosis

> Collaboration aims to develop first-in-class dual agonist (GLP1R/FGF21R agonist) for NASH

> Yuhan Corporation to receive up to USD 870 million in upfront and success-based development and commercialization milestones, excluding royalties

Boehringer Ingelheim and Yuhan Corporation today announced a collaboration and license agreement for the development of a first-in-class dual agonist for the treatment of NASH and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. The collaboration brings together Yuhan Corporation’s expertise in FGF21 biology, obesity and NASH with Boehringer Ingelheim’s pharmaceutical expertise and commitment to bringing innovative medicines to patients with cardiometabolic diseases.

NASH 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. It has an especially high prevalence among obese and diabetic patients and is an area of high-unmet medical need with no treatments currently available. Boehringer Ingelheim believes that in many cases approaches targeting one of the features of NASH will not be able to achieve the desired resolution of NASH in patients with advanced stages of the disease. Thus Boehringer Ingelheim has built a comprehensive program to develop next generation therapy approaches targeting all three key drivers of the disease - steatosis, inflammation and fibrosis.

Preclinical evidence suggests high efficacy, when combining the gut-derived hormone GLP-1 with FGF21. The dual agonist (GLP1R/FGF21R agonist) is expected to reduce liver cell injury and hepatic inflammation by resolution of steatohepatitis as well as having direct antifibrotic effects and complements Boehringer Ingelheim’s R&D portfolio in NASH adding another potential first-in-class opportunity.

“We are excited about this new opportunity which adds to our longstanding and successful partnership with Yuhan Corporation,” says Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the Innovation Unit. “This partnership brings us closer to next generation treatments for patients with NASH,” adds Pairet.

”We look forward to working jointly with Boehringer Ingelheim, with its strong track record of bringing new treatments to patients with cardiometabolic disease. Boehringer Ingelheim’s clinical expertise will now be applied to the development of this drug which has the potential to make a real difference for patients with NASH,” says Jung Hee Lee, CEO and President at Yuhan Corporation. “This molecule, which is a fusion protein utilizing the long-acting (HyFc) technology of Genexine, has been developed in-house by Yuhan Corporation. Not only is our collaboration with Boehringer Ingelheim on this molecule Yuhan’s first external partnership with biologics, it is also the very first out-licensing of biologics targeting NASH from Korea,” adds Mr. Lee.

Boehringer Ingelheim has a long history of excellence in the discovery and development of medicines for patients with cardiometabolic diseases. It has established a broad portfolio of marketed products for thromboembolic diseases, type 2 diabetes, acute myocardial infarction, hypertension, and cardio-renal risk reduction. The cardiometabolic diseases pipeline extends beyond type 2 diabetes and anticoagulation with a focus on innovative drugs for the treatment of the devastating consequences of diabetes as well as contributing factors like obesity.

Yuhan Corporation has over many years been a commercial partner for selected Boehringer Ingelheim cardiovascular and metabolic products in Korea. Under the terms of the agreement Yuhan Corporation will receive an upfront and near term payments of USD 40 million and is eligible to receive up to USD 830 million in potential milestone payments plus tiered royalties on future net sales.

Boehringer Ingelheim

Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Yuhan Corporation

Yuhan Corporation is a South Korea-based healthcare company founded in 1926. The company has positioned itself as one of the top pharmaceutical companies in terms of market cap and sales revenue in Korea. The core business consists of primary & specialty care, dietary supplements, household & animal care, and contract manufacturing of active pharmaceutical ingredients. It has a number of subsidiaries and a global presence in the form of joint ventures with the Clorox Company (USA) and Kimberly-Clark Corporation (USA). Yuhan Corporation (000100:KS) is a publicly-listed company traded on the Korea Stock Exchange.

Media Contacts:

Boehringer Ingelheim

Dr. Reinhard Malin
Head of Communications Innovation Unit
Boehringer Ingelheim Corporate Center GmbH
Media + PR
P: +49 6132 77-90815
press@boehringer-ingelheim.com

Linda Ruckel
Associate Director, Media and Corporate Reputation
Boehringer Ingelheim U.S.
Media + PR
P: + 203-791-6672
linda.ruckel@boehringer-ingelheim.com

Yuhan Corporation

Investors:
Jaehong Park
Head of Investor Relations Team
+82 2-828-0265

Media:
Jongwon Kim
Manager, Public Relations Team
+82 2-828-0036

Record changed: 2023-06-05