Paidakang (visepegenatide) / PegBio, PDC - LARVOL DELTA

VOLUNTARY ANNOUNCEMENT CHINA NMPA GRANTED APPROVAL OF NDA FOR PB-119 (HKEXnews)

China approval • Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects (clinicaltrials.gov) - P1/2 | N=32 | Completed | Sponsor: PegBio Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Dec 2024

Trial completion • Trial completion date • Genetic Disorders • Obesity

PROPOSED GRANT OF AN EXCLUSIVE LICENSE FOR VISEPEGENATIDE (PB-119) IN THE MIDDLE EAST AND AFRICA (HKEXnews) - "The Company...has entered into a non-binding term sheet with PDC FZ-LLC ('PDC') of the United Arab Emirates in relation to an exclusive license (the 'License') for the Company’s product, Visepegenatide (PB-119), a subcutaneous injectable GLP-1 agonist for the treatment of Type II Diabetes Mellitus and Obesity Management (the 'Product'). Under the proposed terms, PDC will be granted an exclusive license to develop, distribute, market, and commercialize the Product in the Middle East and Africa region (the 'Territory')."

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of incretin co-agonists: Transformative advances in cardiometabolic healthcare. (PubMed, World J Cardiol) - "The GLP-1 receptor agonists (GLP-1RAs), namely liraglutide, dulaglutide, albiglutide, exenatide, and semaglutide, have been found to have beneficial effects on glycated hemoglobin, weight, lipid profile, and liver fat and thereby improving cardiometabolic health. Other drugs of the same group in development include Orforglipron, which has a high weight loss efficacy (-15% weight reduction). Long-acting GLP-1RAs in trials are Ecnoglutide, Efpeglenatide, TG103, and Visepegenatide...Retatrutide and Efocipegtrutide belong to this novel group of drugs. The newer drugs in the broad category of incretin co-agonists include the GLP-1/amylin receptor agonist like CagriSema and Amycretin, oral GLP-1 agonists other than semaglutide, and the peptide YY/GLP-1 receptor dual agonists. The profound biochemical and weight loss outcomes associated with incretin co-/poly-agonists are expected to translate into outstanding cardiometabolic benefits, the theme of this evidence review."

Journal • Review • Cardiovascular • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial. (PubMed, Lancet Reg Health West Pac) - P3 | "Visepegenatide (PB-119) is a once a week, subcutaneous, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection without the requirement of dose titration that has shown glycaemic control and safety profile in two phase 2 studies conducted in China and the United States, respectively...Visepegenatide would provide an optimal treatment approach with its high benefit and low-risk balance. PegBio Co., Ltd."

Journal • Monotherapy • P3 data • Diabetes • Gastrointestinal Disorder • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 1b/2a Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of PB-718, a GLP-1R/GCGR Dual Agonist in Subjects with Obesity (ADA 2024) - P1/2 | "Introduction: PB-718 is a fixed dose combination of PB-119 (GLP-1 receptor agonist) and PB-722 (glucagon receptor agonist in clinical development. PB-718 was safe, had predicted PK profile, and led to greater reductions in BW, HbA1c, blood lipids, uric acid, liver fat content and visceral fat mass. These data highlight the potential for PB-718 to provide additional benefit, and support the development of PB-718 as a promising treatment for obesity and NASH."

Clinical • P1/2 data • PK/PD data • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects (clinicaltrials.gov) - P1/2 | N=32 | Active, not recruiting | Sponsor: PegBio Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects (clinicaltrials.gov) - P1/2 | N=32 | Enrolling by invitation | Sponsor: PegBio Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: PegBio Co., Ltd.

New P1/2 trial • Genetic Disorders • Obesity

A phase 3, randomised, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of once-weekly PB-119 as add-on to metformin in patients with type 2 diabetes in China (EASD 2023) - P3 | "Once-weekly PB-119 significantly improves glycemic control and beta-cell function in patients with T2DM, and is well tolerated. Dose titration is not needed."

Clinical • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy (clinicaltrials.gov) - P3 | N=620 | Completed | Sponsor: PegBio Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Apr 2023 ➔ Sep 2022

Combination therapy • Monotherapy • Trial completion • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PB119: Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects (clinicaltrials.gov) - P3 | N=273 | Completed | Sponsor: PegBio Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Nov 2022

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: PegBio Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

PB119: Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects (clinicaltrials.gov) - P3; N=260; Recruiting; Sponsor: PegBio Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy (clinicaltrials.gov) - P3; N=600; Recruiting; Sponsor: PegBio Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy (clinicaltrials.gov) - P3; N=600; Not yet recruiting; Sponsor: PegBio Co., Ltd.

Clinical • Combination therapy • Monotherapy • New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PB119: Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects (clinicaltrials.gov) - P3; N=260; Not yet recruiting; Sponsor: PegBio Co., Ltd.

Clinical • New P3 trial • Type 2 Diabetes Mellitus

[VIRTUAL] A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of 12 Once-Weekly Subcutaneous Doses of PB-119 to Patients with Type 2 Diabetes Mellitus as Monotherapy (ADA 2020) - P2 | "Background: PB119 (polyethylene glycol exenatide) which is a novel once-weekly subcutaneous GLP-1RA, has good pharmacokinetic properties. Significant reductions in TC and TG were observed in 150ug and 200ug groups (P<0.05), while the reductions in body weight and LDL-C were significant in 200ug group (P<0.05). There were no reports of drug-related serious adverse events or severe hypoglycemia."

Clinical • Monotherapy • P2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Clinical trial for PB-119 in healthy subjects (phase I) (clinicaltrials.gov) - P1, N=70; Sponsor: PegBio; Recruiting; New P1 trial.

New P1 trial • Diabetes

THE EVALUATION OF OXIDATIVE STRESS IN PATIENTS WITH ESSENTIAL THROMBOCYTHEMIA AND VASCULAR EVENTS (EHA 2018) - "...abstract n. PB2119.5... In our study group, ET patients had a lower antioxidant capacity than healthy controls. The history of vascular in ET patients was associated with a lower antioxidant capacity than ET patients with no previous vascular events or healthy controls. We may hypothesize that, via a decreased antioxidant capacity, oxidative stress is related to vascular events in ET in addition to the JAK2V617F status."

Clinical • Hematological Malignancies • Leukemia • Oncology

Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2; N=214; Completed; Sponsor: PegBio Co., Ltd.; Recruiting ➔ Completed; Trial primary completion date: Apr 2019 ➔ Jul 2019

Clinical • Monotherapy • Trial completion • Trial primary completion date

Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects (clinicaltrials.gov) - P2; N=251; Completed; Sponsor: PegBio Co., Ltd.; Recruiting ➔ Completed; Trial primary completion date: Mar 2019 ➔ Jul 2019

Clinical • Trial completion • Trial primary completion date