Xianyida (ecnoglutide SC) / Sciwind Biosci, Korea Kolmar, Pfizer - LARVOL DELTA

The novel cAMP biased GLP-1 analog ecnoglutide in Chinese adolescents with obesity: a Phase 1b-randomised, placebo-controlled trial (EASD 2026) - P1 | "Participants were randomly assigned 1:1:1:1 to once-weekly subcutaneous ecnoglutide (1.2, 1.8, or 2.4 mg) or placebo for 20 weeks... Ecnoglutide exhibited a safety and tolerability profile in adolescents with obesity consistent with adults, with no unexpected safety signals. These results support the suitability of the adult dosing regimen for weight management in adolescents."

Clinical • Late-breaking abstract • P1 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Ecnoglutide: First Approvals. (PubMed, Drugs) - "In January 2026, subcutaneous ecnoglutide received its first approval, in China, for use in glycaemic control in adults with T2DM...An oral tablet formulation of ecnoglutide is in clinical development. This article summarises the milestones in the development of ecnoglutide leading to these first approvals for T2DM and long-term weight management."

Journal • Diabetes • Genetic Disorders • Immunology • Metabolic Disorders • Obesity • Osteoarthritis • Pain • Respiratory Diseases • Rheumatology • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

Pfizer, Innovent GLP-1 drugs clear China insurance hurdle (Reuters) - "Pfizer's ecnoglutide and Innovent's mazdutide, approved in China as treatments for weight management and type II diabetes....Results of price negotiations with the National Healthcare Security Administration would ⁠be disclosed ​before the end of the year, though if ​negotiations for a drug failed, it would not be reimbursed in the following year, Shu said."

Reimbursement • Obesity • Type 2 Diabetes Mellitus

Effect of a Novel GLP-1 Analogue Ecnoglutide on the Pharmacokinetics of Rosuvastatin and Digoxin in Healthy Participants. (PubMed, Diabetes Obes Metab) - "Based on the PK and safety evaluations, ecnoglutide does not cause clinically significant PK interactions with rosuvastatin or digoxin. Consequently, no dose adjustments for rosuvastatin or digoxin are required when ecnoglutide is co-administered. However, close clinical and plasma monitoring is advised during the coadministration of digoxin, especially in patients with renal impairment."

Journal • PK/PD data • Genetic Disorders • Renal Disease

Hangzhou Sciwind Biosciences…announced that key data from a head-to-head study (SLIMMER-UP-SWITCH) evaluating ecnoglutide versus semaglutide was presented as a Late-Breaking abstract at the 86th Scientific Sessions of the American Diabetes Association (ADA) 2026 (PRNewswire) - "Study data showed that at week 20, the least-squares mean percentage change in body weight from baseline was -12.8% in the ecnoglutide group and -9.5% in the semaglutide group (P<0.0001). The proportion of participants achieving ≥5% weight loss was 99% in the ecnoglutide group versus 86% in the semaglutide group (P<0.01). The proportion achieving ≥10% weight loss was 74% in the ecnoglutide group versus 40% in the semaglutide group (P<0.001)....Study data showed that at week 20, the mean reduction in waist circumference from baseline was 10.5 cm in the ecnoglutide group and 8.7 cm in the semaglutide group (P<0.05), representing a 20% greater reduction for ecnoglutide."

Late-breaking abstract • P2 data • Obesity

A Study of XW003 Injection in Chinese Adolescents With Obesity (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Apr 2026

Trial completion • Trial completion date • Genetic Disorders • Obesity

No dose adjustment required for warfarin or metformin when coadministered with the novel GLP-1 receptor agonist ecnoglutide: an open-label, fixed-sequence, crossover study. (PubMed, Front Pharmacol) - "The findings demonstrate the absence of a clinically significant interaction between XW003 and either metformin or warfarin. This supports the concomitant use of XW003 with these medications without dose adjustment, providing crucial evidence for its safe application in real-world clinical practice where polypharmacy is common."

Journal

Pfizer challenges Novo and Lilly: GLP-1 drug available for pre-order in China (The News International) - "According to a listing on JD.com, a 1.2 ml Xianweiying injector pen shipping on April 27 costs 489 yuan ($72). Pfizer is strengthening its position in the rapidly growing weight-loss sector by licensing Xianweiying ecnoglutide from the Hangzhou-based biotech firm Sciwind."

Commercial • Obesity

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Study to Compare XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity (SLIMMER-UP-SWITCH) (clinicaltrials.gov) - P2 | N=163 | Active, not recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Study of XW003 Injection in Chinese Adolescents With Obesity (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

USE OF ECNOGLUTIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS - A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIAL (ACC 2026) - "The use of glucagon-like peptide-1 receptor agonists, such as ecnoglutide, has an impact on reduction of glycated hemoglobin (HbA1c) and weight, with cardiovascular protection...Three trials, with 904 patients and median follow-up of 32 weeks, assessed ecnoglutide (0.6 mg or 1.2 mg weekly) in comparison with placebo or dulaglutide...Ecnoglutide reduces HbA1c, FPG, weight, and waist circumference in T2DM patients. More RCTs should be performed to corroborate these data."

Retrospective data • Review • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hangzhou Sciwind Biosciences…announced today that China's National Medical Products Administration (NMPA) has approved Ecnoglutide injection for chronic weight management in Chinese adults with overweight or obesity (PRNewswire) - "Ecnoglutide injection is the world's first approved cAMP-biased GLP-1RA for weight management. Through its unique biased mechanism, it achieves highly effective weight reduction in the Chinese population, with an average 15.1% placebo-adjusted weight loss, and 92.8% of patients reaching clinical meaningful weight loss....The approval of Ecnoglutide injection for weight management is supported by the Phase 3 clinical trial (SLIMMER) conducted in Chinese adults with overweight or obesity."

China approval • Obesity

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy (clinicaltrials.gov) - P3 | N=140 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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

Pfizer strikes $495 Mn weight-loss drug deal with China’s Sciwind Biosciences (The Economic Times)

Licensing / partnership • Obesity • Type 2 Diabetes Mellitus

A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy (clinicaltrials.gov) - P3 | N=140 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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

HK inno.N completes enrollment for phase 3 study of once-weekly obesity drug (Korea Biomedical Review) - "Upon completion of recruitment, HK inno.N plans to complete the 40-week dosing period within the year and then proceeded with a regulatory approval application...After initiating enrollment of the first subject in September of the same year, it recruited 313 participants over the next four months....The phase 3 trial is being conducted at 24 medical institutions, including Kangbuk Samsung Hospital, and targets Korean adult patients who are obese or overweight without diabetes."

Enrollment closed • Obesity

HK inno.N said on the 22nd that it completed enrollment for a domestic phase 3 clinical trial of the GLP-1 receptor agonist obesity treatment IN-B00009 (ingredient name: ecnoglutide). (Chosun Biz) - "According to the company, as of the 20th, enrollment of a total of 313 trial participants was completed. HK inno.N plans to complete approximately 40 weeks of dosing within the year and then begin the regulatory filing process."

Enrollment closed • Obesity

Sciwind Biosciences’ type 2 diabetes treatment Xianyida was approved for use in ‌China, the company said on Friday, adding another participant to a hot sector in the ⁠world’s second-largest pharmaceutical market. (Devdiscourse)

China approval • Type 2 Diabetes Mellitus

Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone (clinicaltrials.gov) - P3 | N=110 | Not yet recruiting | Sponsor: HK inno.N Corporation

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

Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: HK inno.N Corporation

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A Study of XW003 Injection in Chinese Adolescents With Obesity (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

VRB-101 is a potent oral GLP-1 tablet with once-weekly dosing potential (EASD 2025) - P1 | "These exposures are nearing or exceeding the weekly exposure achieved by 2.4 mg subcutaneous semaglutide or 2.4 mg subcutaneous ecnoglutide. This data supports the rationale for VRB-101 to be a QW oral GLP-1 treatment... This data supports the rationale for VRB-101 to be a QW oral GLP-1 treatment. Compared with subcutaneous injections, oral QW 90 mg and 120 mg VRB-101 are projected to match or exceed the weekly exposures of subcutaneous GLP-1 injections. VRB-101 is expected to exert potent weight lowering while improving adherence via a more patient-friendly dosing regimen."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial. (PubMed, Lancet Diabetes Endocrinol) - P3 | "Once-weekly ecnoglutide 0·6 mg and 1·2 mg were non-inferior to dulaglutide 1·5 mg in reducing HbA1c in adults with type 2 diabetes and elevated glucose concentrations on metformin monotherapy. Although the 1·2 mg dose showed statistically significantly greater reductions in HbA1c from baseline to week 32 than dulaglutide 1·5 mg, the difference was not considered clinically relevant. Both doses of ecnoglutide were well tolerated. These results suggest that ecnoglutide might offer a new treatment option for type 2 diabetes."

Head-to-Head • Journal • Monotherapy • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus