The United Laboratories International Holdings Limited’s (TUL) wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), has entered into an exclusive license agreement with Novo Nordisk for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early-stage clinical development for the treatment of obesity, type 2 diabetes and other diseases.
UBT251 is a long-acting synthetic peptide triple agonist targeting the receptors for GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide) and glucagon. It has demonstrated potent activity on all three receptors in a preclinical setting.
UBT251 is categorised as a Class 1 innovative drug in China, being developed by United Biotechnology for multiple indications. To date, UBT251 has been approved for clinical trials in China in adult type 2 diabetes, overweight or obesity, metabolic dysfunction-associated fatty liver disease and chronic kidney disease, and for clinical trials in the United States in adult type 2 diabetes, overweight or obesity and CKD.
Under the license agreement, Novo Nordisk will obtain exclusive worldwide rights (excluding Chinese mainland, Hong Kong, Macau and Taiwan) to develop, manufacture, and commercialise UBT251. United Biotechnology will retain the rights for UBT251 in Chinese mainland, Hong Kong, Macau and Taiwan. United Biotechnology is eligible to receive an upfront payment of US$200 million and potential milestone payments of up to US$1.8 billion dollars from Novo Nordisk, as well as tiered royalties on net sales outside of Chinese mainland, Hong Kong, Macau and Taiwan.
“The addition of a candidate targeting glucagon, as well as GLP-1 and GIP, will add important optionality to our clinical pipeline, as we look to develop a broad portfolio of differentiated treatment options that cater to the diverse needs of people living with these highly prevalent diseases,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We look forward to building on United Biotechnology’s scientific work and further exploring the potential best-in-class properties of UBT251 across cardiometabolic disease indications.”
United Biotechnology recently completed a randomised, double-blind, placebo-controlled phase 1b trial in China designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of UBT251 in people with overweight or obesity.
A total of 36 patients were enrolled in three different dose groups (1mg, 1mg/3mg, 1mg/3mg/6mg). Each group adopted a dose titration method, with subcutaneous injection once a week for 12 consecutive weeks.
The safety profile of UBT251 was consistent with incretin-based therapies. The most common adverse events were gastrointestinal and the vast majority were mild to moderate in severity. In the highest dose group, the average weight of the people who completed the trial decreased by 15.1% from baseline, while the average weight of people in the placebo group increased by 1.5% from baseline.
United Biotechnology recently initiated a phase 2 trial for UBT251 in people with overweight or obesity in China.
The closing of this transaction is subject to applicable regulatory clearance and other customary closing conditions.
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