Efinopegdutide

Merck & Co – known as MSD outside the US and Canada – will be gaining exclusive global rights to Hansoh Pharma’s preclinical GLP-1 candidate in a deal worth over $2bn. The agreement gives Merck a global licence to develop, manufacture and commercialise the investigational oral small molecule GLP-1 receptor agonist, HS-10535. The company will aim to evaluate the drug and its “potential to provide additional cardiometabolic benefits beyond weight reduction,” according to Dean Li, president of Merck Research Laboratories. In exchange, Hansoh will receive an upfront payment of $112m and will be eligible for up to $1.9bn in milestone payments, as well as royalties on sales. Hansoh may also co-promote or solely commercialise HS-10535 in China, subject to certain conditions. Eliza Sun, executive director of the board at Hansoh Pharma, said: “We are pleased to announce the in-licence of our oral GLP-1 by Merck… we see Merck’s expertise and capabilities as key to accelerating the development of this promising asset for patients worldwide.” GLP-1 receptor agonists are a relatively new class of drugs that can be used to treat type 2 diabetes, promote weight loss and reduce the risk of cardiovascular events. They work by mimicking the hormone GLP-1, which is produced in the small intestine. Merck’s pipeline already includes efinopegdutide, an investigational GLP-1/glucagon receptor co-agonist that has demonstrated promising results in nonalcoholic fatty liver disease, a progressive condition in which fat builds up in the liver. The company shared positive results from a phase 2a open-label study evaluating the candidate against Novo Nordisk’s GLP-1 drug semaglutide last year and outlined that the drug has already been granted fast track designation from the US Food and Drug Administration as a potential treatment for patients with nonalcoholic steatohepatitis. Merck’s latest announcement comes just one month after it entered into an exclusive global licensing agreement worth over $3.2bn to advance LaNova Medicines’ investigational PD-1/VEGF bispecific antibody. A phase 1 clinical trial of LM-299 in advanced solid tumours is currently enrolling patients in China following promising preclinical results demonstrating strong inhibition of tumour growth and a well tolerated safety profile.

Merck is finally making a move in obesity by licensing an oral GLP-1 candidate, though it’s happening years after some of its big pharma peers. Like AstraZeneca did a year ago with Eccogene, Merck went to China to find a preclinical obesity asset. The New Jersey pharma giant is now teaming up with Hansoh Pharma, one of the largest biopharma companies in China, for a candidate known as HS-10535. Merck will dish out $112 million upfront and up to $1.9 billion in biobucks, the companies said Wednesday. In China, Hansoh will co-promote or solely commercialize the drug. The move adds to a busy year of dealmaking for Merck in China. The drugmaker, which is preparing to fill an eventual revenue gap when its $25 billion Keytruda franchise loses patent protection, has signed multiple deals with Chinese companies, including in the hot PD-1xVEGF space and burgeoning bispecific field . Merck has been open about its ability to do multibillion-dollar deals , and CEO Rob Davis has emphasized the importance of combination approaches , particularly in obesity. “If you think of what you have today with the injectable peptides, largely Novo and Lilly today, that’s not an area where we believe the primary opportunity resides,” Davis said Dec. 5 at the Citi Global Healthcare Conference, according to an AlphaSense transcript. At that conference, he also hinted at the potential of oral small molecules. “We are more focused in second- and third-generation oral small molecule opportunities where you can do combinations of a GLP-1 with other agents focusing on outcomes as well as just obesity and the comorbidities that exist,” Davis said then. The drugmaker already has a GLP-1/glucagon receptor co-agonist, dubbed efinopegdutide , in Phase 2 testing in metabolic dysfunction-associated steatohepatitis, or MASH. “We think we have best-in-class liver fat reductions,” Davis said at the Citi conference, describing “Ozempic-like types of weight reductions.” With its hands on a preclinical asset, Merck is still behind multiple other drugmakers in the field. That includes Pfizer, AstraZeneca, Viking, Structure and Roche , which made the last major obesity acquisition when it bought Carmot Therapeutics for $2.7 billion last December. Despite the hype around Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, other large pharmas like GSK and AbbVie have largely steered clear of obesity. Viking, an obesity drug developer that analysts have speculated could be acquired by Merck, saw its shares $VKTX drop about 9% on Wednesday morning. “Viking shares will understandably sell off today,” William Blair’s Andy Hsieh told investors. “However, we do not believe the licensing agreement with Hansoh will preclude Merck from expanding its presence in obesity through further external business development activities.” About 15 years ago, Merck was working on a CB1 asset called taranabant for obesity. The drugmaker and others scrapped their drugs after side effects sidelined the class.