UBT251 / United Laboratories, Novo Nordisk - LARVOL DELTA

UBT251 Injection Phase II Clinical Study (CKD) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Active, not recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Genetic Disorders • Nephrology • Obesity • Renal Disease

Pharmacokinetic Study of UBT251 Injection in Subjects with Normal Renal Function and Renal Insufficiency (ChiCTR) - P=N/A | N=24 | Not yet recruiting | Sponsor: The Third Xiangya Hospital of Central South University; Third Xiangya Hospital, Central South University

New trial • Nephrology • Renal Disease

A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus (ChiCTR) - P2 | N=210 | Completed | Sponsor: The Second Xiangya Hospital of Central South University; Federal Biotechnology (Zhuhai Hengqin) Co., LTD

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

UBT251 Injection Phase II Study (Overweight or Obesity) (clinicaltrials.gov) - P2 | N=205 | Active, not recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

T2DM: UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study (clinicaltrials.gov) - P2 | N=211 | Active, not recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) (clinicaltrials.gov) - P2 | N=156 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

UBT251 Injection Phase II Clinical Study (CKD) (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

New P2 trial • Chronic Kidney Disease • Genetic Disorders • Nephrology • Obesity • Renal Disease

A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of UBT251 injection in obese/overweight chronic kidney disease (CKD) population (ChiCTR) - P2 | N=180 | Not yet recruiting | Sponsor: Peking University First Hospital; Federal Biotechnology (Zhuhai Hengqin) Co., Ltd

New P2 trial • Chronic Kidney Disease • Nephrology • Obesity • Renal Disease

New hope! UBT251 injection starts clinical trial in the treatment of obese chronic kidney disease [Google translation] (Sohu.com) - "According to the latest clinical trial progress, UBT251 injection of United Biotech (Zhuhai Hengqin) Co., Ltd. is committed to bringing new treatment options to patients with chronic kidney disease who are overweight or obese...The Phase II clinical trial of UBT251 injection was launched on July 14, 2025. The main purpose is to evaluate the efficacy and safety of different doses of UBT251 in obese/overweight chronic kidney disease patients. The drug is injected subcutaneously once a week for 24 weeks and is expected to provide treatment for 180 patients."

Trial status • Chronic Kidney Disease • Obesity

United Pharmaceuticals receives upfront payment from Novo Nordisk for exclusive license agreement for UBT251 [Google translation] (Sina Corp) - "Federal Pharma...announced that on June 20, 2025, Federal Biotech had received an advance payment of US$180 million (after deducting Danish withholding tax) from Novo Nordisk....Under the exclusive license agreement and subject to the terms and conditions thereof, Commonwealth Biotech will be eligible to receive further potential milestone payments of up to $1.8 billion, contingent upon the achievement of certain development and sales milestones, as well as tiered royalties based on annual net sales in the region."

Financing • Obesity

The United Laboratories and Novo Nordisk announce exclusive license agreement for UBT251, a GLP-1/GIP/glucagon triple receptor agonist (GlobeNewswire) - "The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), have entered into an exclusive license agreement 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....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 200 million US dollars and potential milestone payments of up to 1.8 billion dollars from Novo Nordisk, as well as tiered royalties on net sales outside of Chinese mainland, Hong Kong, Macau, and Taiwan."

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

UBT251 injection developed by United Laboratories (03933) for CKD indication has been approved by the US FDA for new drug clinical trials [Google translation] (Sina Corp) - "United Pharmaceutical....announced that recently, the UBT251 injection, a Class 1 innovative drug independently developed by the company's wholly-owned subsidiary United Biotech (Zhuhai Hengqin) Co., Ltd., has been approved by the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial for the indication of chronic kidney disease (CKD)."

New P2 trial • Chronic Kidney Disease

United Lab (03933): UBT251 injection for chronic kidney disease indication received implicit approval for clinical trials [Google translation] (Zhitong Finance) - "According to the Zhitong Finance APP, Federal Pharmaceutical...announced that on January 20, 2025, the company's wholly-owned subsidiary Federal Biotech (Zhuhai Hengqin) Co., Ltd.'s independently developed Class 1 innovative drug UBT251 injection for the indication of chronic kidney disease received implicit clinical trial approval from the China National Medical Products Administration, with acceptance number CXHL2401227."

New trial • Chronic Kidney Disease

Hong Kong Stocks Move | United Laboratories (03933) rose more than 5%. Recently, UBT251 injection for chronic kidney disease indications received implicit approval for clinical trials [Google translation] (163.com) - "On the news front, Federal Pharmaceutical announced that on January 20, 2025, the registration application for the Phase II clinical trial of UBT251 injection, a Class 1 innovative drug independently developed by the company's wholly-owned subsidiary Federal Biotech (Zhuhai Hengqin) Co., Ltd., for the indication of chronic kidney disease was granted implicit clinical trial approval by the China National Medical Products Administration."

New P2 trial • Chronic Kidney Disease