bofanglutide (GZR18) / Gan & Lee Pharma, Lupin, JW Pharma, Menarini - LARVOL DELTA

Pharmacokinetic and pharmacodynamic profiles of GZR102, a novel once-weekly fixed-ratio combination of insulin GZR4 and GLP-1 receptor agonist bofanglutide (EASD 2026) - "This contrasts with the PK profile of IcoSema, which exhibited significant drug-drug interactions on C max and T max . The combination of GZR4 and GZR18 in GZR102 did not affect the PK of the individual components compared with mono- component treatments. GZR102 demonstrated greater improvements in glycemic control, body weight reduction, and lipid metabolism compared with mono-component treatments. These findings support the further clinical development of GZR102 as a once-weekly FRC targeting both insulin and GLP-1 receptor pathways simultaneously."

PK/PD data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Gan & Lee and Menarini Group Partner to Advance Bofanglutide in Europe (PRNewswire) - "Under the agreement, the parties will collaborate on the registration and commercialization of Gan & Lee's independently developed glucagon-like peptide-1 receptor agonist (GLP-1 RA), bofanglutide (development code: GZR18), under development for the treatment of adults with obesity or overweight, administered once every two weeks....Under the agreement, Gan & Lee is eligible to receive an upfront payment of EUR 62million, milestone payments totaling up to EUR 664million, and double-digit royalties on net sales in the licensed territory. The aggregate potential deal value is up to EUR 726million, excluding royalties."

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

JW Pharmaceutical has filed an investigational new drug application with the Ministry of Food and Drug Safety to conduct a domestic Phase 3 clinical trial of bofanglutide, its obesity treatment candidate (The Herald Business - Herald Corp) - "The Phase 3 trial will enroll 300 adults with obesity or overweight across multiple domestic sites in a placebo-controlled design, the company said Tuesday. JW Pharmaceutical plans to begin enrollment in December and evaluate the drug's weight-loss superiority over placebo, as well as its safety profile, through March 2029."

New P3 trial • Obesity

Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants (clinicaltrials.gov) - P2 | N=326 | Completed | Sponsor: Gan and Lee Pharmaceuticals, USA | Trial completion date: Jun 2026 ➔ Feb 2026 | Not yet recruiting ➔ Completed

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

Safety, tolerability, relative bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of the novel oral bofanglutide in healthy Chinese participants. (PubMed, Diabetes Res Clin Pract) - "Oral bofanglutide was safe and well tolerated. The PK/PD profiles support further investigation of once-daily oral bofanglutide for type 2 diabetes and overweight/obesity."

Journal • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Safety and efficacy of GZR18, a long-acting GLP-1 analog, in Chinese patients with type 2 diabetes: A randomized, double-blind, phase 1b/2a trial. (PubMed, Cell Rep Med) - P1/2 | "These findings support further development of GZR18 in larger, longer-term trials. The trial is registered at ClinicalTrials.gov (NCT06256523)."

Clinical • Journal • P1/2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Meanwhile, a Phase 2 clinical trial evaluating the efficacy and safety of bofanglutide injection in overweight and obese participants in the United States has also met its primary endpoint. (PRNewswire) - "After 36 weeks of treatment, among participants with overweight/obesity without type 2 diabetes, the 48 mg bofanglutide injection group achieved an average weight loss of 15.18%, with no weight loss plateau observed; the 15 mg tirzepatide injection group achieved a mean weight reduction of 16.93%. Bofanglutide injection also demonstrated significant improvements in cardiovascular and metabolic parameters, including blood pressure, waist circumference, and serum uric acid levels. The most common adverse events were gastrointestinal in nature, including nausea, vomiting, and diarrhea; these events were generally mild and transient, and no new safety signals were identified."

P2 data • Obesity

Bofanglutide injection: Key Phase 3 Study in China Meets Primary Endpoint (PRNewswire) - "The results showed that after 52 weeks of treatment, participants receiving bofanglutide injection 24 mg and 48 mg achieved mean body weight reductions of 15.12% and 18.54%, respectively, compared with 1.11% in the placebo group. In addition, 91.8% and 98.1% of participants in the bofanglutide injection 24 mg and 48 mg groups, respectively, achieved at least 5% weight loss from baseline...In addition, bofanglutide injection also showed comprehensive improvements in cardiovascular and metabolic parameters, including waist circumference, blood pressure, triglycerides, and serum uric acid...Regarding safety, bofanglutide injection was generally well tolerated in both the 24 mg and 48 mg groups....Detailed results from these two studies are scheduled to be presented at future scientific conferences and published in international academic journals."

P3 data: top line • Obesity

Safety, Tolerability, and Pharmacokinetic Characteristics of GZR102 Injection Compared with GZR4 or Bofanglutide (ADA 2026) - "The combination of GZR4 and GZR18 in GZR102 had no significant effect on GZR4 PK or GZR18 total exposure, but did slightly increase the Cmax of GZR18. GZR102 showed favorable safety and tolerability."

Clinical • PK/PD data • Metabolic Disorders

Pharmacokinetic and Pharmacodynamic Profiles of GZR102 Injection, a Novel Once-Weekly Fixed-Ratio Combination of Insulin GZR4 and GLP-1 Analog Bofanglutide (ADA 2026) - "The combination of GZR4 and GZR18 in GZR102 did not affect the PK of the individual components. GZR102 demonstrated complementary glycemic control and metabolic benefits including weight reduction and lipid metabolism. These findings support the further clinical development of GZR102 as a once-weekly FRC."

PK/PD data • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=374 | Not yet recruiting | Sponsor: Carnot Laboratories

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or Obesity (clinicaltrials.gov) - P3 | N=352 | Not yet recruiting | Sponsor: Carnot Laboratories

New P3 trial • Genetic Disorders • Obesity

Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy (clinicaltrials.gov) - P3 | N=140 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy (clinicaltrials.gov) - P3 | N=140 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

GZR18, a GLP-1 analog with once-weekly or bi-weekly dosing for body weight management: A randomized, placebo-controlled, phase 1b/2a trial. (PubMed, Cell Rep Med) - P1/2 | "These findings warrant larger and longer trials of GZR18 for body weight management. The trial is registered at ClinicalTrials.gov (NCT06256536)."

Journal • P1/2 data • Genetic Disorders • Obesity

The company said on Apr. 9 that it signed an exclusive domestic licensing agreement with China's Gan & Lee Pharmaceuticals for the GLP-1 drug candidate 'bofanglutide' (Chosun Biz) - "With this agreement, JW Pharmaceutical secured exclusive rights in Korea for the development, approval, marketing, and commercialization of bofanglutide. Gan & Lee will provide regulatory data required for investigational new drug (IND) approval and marketing authorization and support related procedures....The total value of the agreement is $81.10 million (120.1 billion won). JW Pharmaceutical will pay $5 million (7.4 billion won) upfront and up to $76.10 million (112.7 billion won) in milestone payments....JW Pharmaceutical plans to pursue a domestic phase 3 trial in the second half of this year for obesity and type 2 diabetes indications."

Licensing / partnership • New P3 trial • Obesity • Type 2 Diabetes Mellitus

GZR18-BWM-303: Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Efficacy and safety of bofanglutide, a GLP-1 receptor agonist, in Chinese adults with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial (Nature) - "Overall, 286 participants (84.1%) completed the trial. The mean percentage change in body weight from baseline to week 30 ranged from −9.75% to −16.69% with bofanglutide, compared with −1.15% with placebo (all p < 0.001 versus placebo). Adverse events occurred in 98.9% (271/274) of the bofanglutide group versus 86.4% (57/66) of the placebo group and were mostly grade 1–2 gastrointestinal events (83.9% [230/274] with bofanglutide and 33.3% [22/66] with placebo). Bofanglutide is generally well tolerated and has a robust ability to reduce body weight."

P2b data • Obesity

GYG1 as a Dual Biomarker of Glucagon-Like Peptide-1 Receptor Agonist Weight-Loss Response: Findings from an Integrative Multi-Omics Substudy of a Phase II Trial. (PubMed, Endocrinol Metab (Seoul)) - "We investigated circulating multi-omics signatures for predicting and monitoring glucagon-like peptide-1 receptor agonist (GLP-1RA) (GZR18) response, addressing gaps in personalized obesity therapy...This study establishes GYG1 as a clinically actionable, dual-function biomarker for GLP-1RA therapy in obesity, linking baseline prediction and real-time monitoring of treatment response through integrated multi-omics profiling. Our findings highlight convergent metabolic pathways driving therapeutic efficacy and provide a precision-medicine framework for optimizing obesity pharmacotherapy through blood-based molecular signatures."

Biomarker • Journal • P2 data • Genetic Disorders • Obesity • IGFBP2

Bioequivalence Study of GZR18 Injection Before and After CMC Change (clinicaltrials.gov) - P1 | N=138 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P1 trial • Genetic Disorders • Obesity

Lupin announced that it has entered into an exclusive license, supply, and distribution agreement with China-based Gan & Lee Pharmaceuticals for Bofanglutide, a novel fortnightly GLP-1 receptor agonist. (Business Standard)

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

GZR18-BWM-303: Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Genetic Disorders • Obesity

Once-Monthly GLP-1 RA | Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management (PRNewswire) - "In this study, bofanglutide injection will be administered subcutaneously once every four weeks (once-monthly) to explore its potential to maintain the achieved weight loss and improved long-term adherence....This phase 3 study (Chinadrugtrials.org.cn: CTR20254659) is designed to evaluate the efficacy and safety of once-monthly bofanglutide injection on body weight after 24 weeks of continuous treatment."

Trial status • Obesity

Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Optimum 2: A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=1100 | Active, not recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2026 ➔ Dec 2026

Enrollment closed • Monotherapy • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus