Diabegone (efsubaglutide alfa) / Innogen Pharmaceutical Technology - LARVOL DELTA

Innogen Pharmaceuticals Receives PIC/S GMP Certificatation, Accelerating Global Expansion of Efsubaglutide Alfa (The Manila Times) - "This milestone represents a significant recognition of Innogen Pharmaceuticals' quality systems by an international regulatory authority, confirming that the Company's manufacturing site has achieved PIC/S GMP international standards. It will further accelerate the registration, market access, and commercial partnerships for Efsubaglutide alfa in Brazil and other emerging markets that recognize the PIC/S GMP framework, providing a critical quality assurance foundation for the product's internationalization. With Brazil as a key strategic hub, the Company will further expand into South American and other PIC/S member markets, laying a solid groundwork for the global development and overseas registration of additional indications of Efsubaglutide Alfa, and continuously strengthening Innogen's global footprint."

Commercial • Obesity • Type 2 Diabetes Mellitus

Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

40-Week Repeat-Dose Toxicity, Toxicokinetics, and Immunogenicity of Efsubaglutide Alfa Following Subcutaneous Administration in Cynomolgus Monkeys. (PubMed, Regul Toxicol Pharmacol) - "Anti-drug antibodies occurred at low incidence and were not associated with clinically meaningful changes in safety parameters or TK. The NOAEL was 3 mg/kg under the conditions of this study, supporting further clinical development of efsubaglutide alfa."

Journal • Diabetes • Hematological Disorders • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

Guangzhou Innogen Pharmaceutical Group has received regulatory clearance from China’s National Medical Products Administration to begin a Phase Ib clinical trial of Efsubaglutide Alfa for treating obesity in adolescents. (TipRanks) - "The company plans to start the trial in July 2026, enrolling about 36 participants..."

New P1 trial • Obesity

Efsubaglutide Alfa in Overweight or Obesity: Phase 2b ENLIGHT Study (ADA 2026) - P2/3 | "ENLIGHT regimens (QW and Q2W) produced clinically meaningful weight loss with a favorable safety profile, supporting progression to the Phase 3 stage."

P2b data • Metabolic Disorders • Obesity

Innogen to Present Phase IIb ENLIGHT Study Results for Efsubaglutide Alfa at the 2026 ADA Scientific Sessions (The Manila Times) - "Innogen's proprietary Efsubaglutide α met the primary endpoint of the Phase IIb ENLIGHT study conducted in Chinese overweight and obese adults. This randomized, double-blind, placebo-controlled, multicenter study enrolled 200 overweight and obese adults without diabetes to evaluate the efficacy and safety of Efsubaglutide α at doses ranging from 5 to 20 mg for 18 weeks. Results showed that all dose groups experienced significant weight loss from baseline, superior to the placebo group, and the weight loss was positively correlated with the dose. During treatment, patients in the Efsubaglutide α group showed a continuous weight loss trend without a plateau....Results showed that after 18 weeks of treatment including titration and maintenance, Efsubaglutide α significantly reduced the weight of participants, with reductions of 10.58% and 9.70% in the QW and Q2W groups, respectively."

P2b data • Obesity

Efsubaglutide alfa added to metformin improves glycaemia with β-cell functional responses in type 2 diabetes: a randomised, double-blind, placebo-controlled, two-stage adaptive phase 2b/3 trial (SUPER 2). (PubMed, Nat Commun) - P2/3 | "Adverse events were predominantly mild to moderate gastrointestinal events. Trial registration: ClinicalTrials.gov NCT04998032."

Journal • P2/3 data • P2b data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Sensitive RP-LC Method Enabling PTM-Specific Quality Control and MS-Compatible Characterization of Fc-Containing GLP-1 Therapeutics. (PubMed, J Am Soc Mass Spectrom) - "Using dulaglutide (IgG4-Fc) as a model, critical parameters─including mobile-phase additives, acid concentration, and shallow gradients─were optimized to resolve PTM variants (e.g., hydroxylation, N-terminal truncation, disulfide reduction, glycosylation) within 40 min. The method was further demonstrated on the IgG2-subtype GLP-1-Fc-fusion (supaglutide), showing applicability across the two Fc subtypes examined without additional optimization. This robust, MS-compatible RP-LC platform provides a rapid, accurate, and comprehensive (RAC) means of conducting PTM-specific QC for Fc-GLP-1 therapeutics, supporting PAT implementation and accelerating biosimilar and next-generation drug development."

Journal

Future development and outlook for 2026 (HKEXnews) - "Subject to Phase III data readout and regulatory progress, the Group plans to initiate pre-launch preparation for the weight management indication. Following the readout of Phase III clinical data, the Group will evaluate product positioning, target patient population, patient education and commercialisation planning for the indication....In addition, the Group will also continue to advance its T1D and AD programs. Both programs are currently in the IND-enabling stage and are expected to progress toward IND submission in 2026, subject to development progress and regulatory approval."

Commercial • IND • Alzheimer's Disease • Obesity • Type 1 Diabetes Mellitus

Efsubaglutide alfa for obesity and overweight (HKEXnews) - "The Group continued to advance the Phase III clinical development of Efsubaglutide Alfa for the treatment of obesity and overweight in Chinese Mainland during the Reporting Period...Topline data from the trial is expected to be read out by the end of 2026...Enrolment for the Phase II clinical trial in Australia was completed in November 2025, and the trial is expected to be completed in 2026."."

P3 data: top line • Trial completion date • Obesity

Effect of Efsubaglutide Alfa combined with dietary fiber intervention on body weight in overweight/obese patients with polycystic ovary syndrome (PCOS), A multi-center randomized controlled study (ChiCTR) - P=N/A | N=60 | Sponsor: Shanghai General Hospital; Shanghai General Hospital

New trial • Genetic Disorders • Obesity • Polycystic Ovary Syndrome

BRIDGE-BR: A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

New P1 trial

Efsubaglutide alfa in adults with overweight or obesity: Protocol for a seamless, adaptive phase 2b/3 randomized, double-blind, placebo-controlled trial (LIGHT 2). (PubMed, Diabetes Obes Metab) - "LIGHT 2 is designed to efficiently identify and confirm an efsubaglutide alfa regimen with clinically meaningful weight-loss efficacy and an acceptable safety profile, while generating evidence relevant to real-world implementation."

Clinical • Journal • P2/3 data • P2b data • Genetic Disorders • Obesity

The Efficacy and Safety of Efsubaglutide Alfa Injection in Overweight and Obese Subjects (ENLIGHT) (clinicaltrials.gov) - P2/3 | N=1003 | Active, not recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Efsubaglutide Alfa attenuates metabolic dysfunction-associated steatohepatitis in mice with improvements in second harmonic generation-derived fibrosis features. (PubMed, Diabetes Obes Metab) - "Efsubaglutide Alfa reduced liver steatosis and improved SHG/TPEF-derived perisinusoidal collagen features, which supported further evaluation of Efsubaglutide Alfa for MASH, particularly for steatosis improvement and suggests potential effects on fibrosis-related features that warrant confirmation in longer duration studies."

Journal • Preclinical • Fibrosis • Genetic Disorders • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Diabetes Remission in Drug-Naïve Patients with Type 2 Diabetes After Efsubaglutide Alfa Treatment. (PubMed, Adv Ther) - P | "Efsubaglutide alfa demonstrated efficacy in achieving stable glycemic control and drug-free diabetes remission. Enhanced β-cell function emerged as a key factor contributing to long-term remission."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy, tolerability, and safety of Efsubaglutide Alfa in participants with obesity or overweight (LIGHT 1): A randomized, double-blind, placebo-controlled, ascending-dose phase 2a trial. (PubMed, Diabetes Obes Metab) - "Efsubaglutide Alfa demonstrated significant weight-loss efficacy, metabolic improvements, and a preferable tolerability and safety profile, supporting further clinical development for obesity and related metabolic disorders."

Clinical • Journal • P2a data • Genetic Disorders • Metabolic Disorders • Obesity

Long-acting management of diabetes and associated complications using an injectable thermosensitive hydrogel incorporating IgG-conjugated GLP-1RA. (PubMed, Theranostics) - "Herein, we developed a sustained-release hydrogel-based delivery system for Efsubaglutide Alfa (Suba), an IgG-conjugated GLP-1RA, designed to alleviate treatment burden and enhance patient adherence...Additionally, this system ameliorated diabetes-related complications by improving lipid metabolism, reversing hepatic steatosis and enhancing nerve fiber density. The Suba@T-gel system represents a promising strategy for long-acting management of diabetes and substantial improvement in patient compliance."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE） (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Metabolic Drug, Electrophysiological Savior: Unmasking GLP-1RA's Novel Therapeutic Target in Sinoatrial Node Dysfunction (AHA 2025) - "This study identifies Supaglutide as the first GLP-1RA capable of restoring SAN electrophysiology via oxidative and calcium signaling regulation, beyond glucose control. These findings not only uncover a novel function of GLP-1RA beyond metabolic regulation but also suggest that targeting SAN-specific mechanisms may represent a broader therapeutic strategy for arrhythmogenic cardiac diseases, especially those associated with metabolic disorders."

Late-breaking abstract • Cardiovascular • Diabetes • Fibrosis • Heart Failure • Immunology • Inflammation • Metabolic Disorders • CAMK2D • CD86 • RYR2 • SIRT3 • TNFA

Efficacy and safety of efsubaglutide alfa in individuals with type 2 diabetes (SUPER1): a randomised, double-blind, placebo-controlled, Phase IIb/III trial. (PubMed, Diabetologia) - P2/3 | "Efsubaglutide alfa significantly improved glycaemic management and promoted weight loss in drug-naive individuals with type 2 diabetes, with a favourable safety profile. These results establish efsubaglutide alfa as a promising therapeutic option for type 2 diabetes and related metabolic disorders."

Journal • P2/3 data • P2b data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Biweekly dosing of efsubaglutide alfa maintains glycaemic and continuous glucose monitoring control in type 2 diabetes: A randomised multicentre trial. (PubMed, Diabetes Obes Metab) - "Over 12 weeks, efsubaglutide alfa 3 mg Q2W provided glycaemic and CGM benefits comparable to 1 mg QW with favourable tolerability. These findings support the feasibility of a biweekly regimen as an alternative to weekly dosing; larger, longer-duration confirmatory trials in more diverse populations are warranted."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Mellitus. (PubMed, Clin Pharmacokinet) - P2/3 | "Efsubaglutide alfa demonstrates a strong E-R relationship for glycemic control and weight reduction in drug-naïve participants with T2DM. The extended half-life and favorable safety profile of efsubaglutide alfa make it well-suited for once weekly or biweekly monotherapy in patients with newly diagnosed T2DM."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Treated with Metformin. (PubMed, Clin Pharmacokinet) - P2/3 | "Efsubaglutide alfa, combined with metformin, significantly improves glycemic control and weight management, with an acceptable safety profile. This E-R model provides insights for dose optimization and trial design, and supports its use as an effective add-on therapy for patients with T2D, as indicated in the drug specification."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus