Shanmeining (efmedaglutide alfa) / Genexine, CSPC Pharma, NovaBridge Biosciences, TJ Biopharma - LARVOL DELTA

Efficacy and safety of TG103 versus dulaglutide as an add-on to metformin in patients with type 2 diabetes: a randomised Phase III trial (EASD 2026) - P3 | "TG103 15 mg was noninferior to DULA in glycemic control with T2D on metformin. TG103 showed sustained glycemic improvement, with marked efficacy evident at week 8, stabilized at week 12, and maintained to week 52, as well as improvement trend in cardiometabolic markers and an overall favorable safety profile over 52 weeks. These findings suggest that TG103 15 mg is a promising add-on treatment option for this patient population."

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

China’s National Medical Products Administration has accepted a second marketing authorization application for its once-weekly Efmedaglutide Alfa (Shanmeining) injection, this time for glycaemic control in adults with type 2 diabetes (TipRanks) - "The latest application is backed by two pivotal Phase III trials in Chinese type 2 diabetes patients, showing rapid and durable reductions in HbA1c of more than 1% by week 8 and up to over 2% in those with higher baseline levels, along with weight loss and improved lipid, blood pressure and other metabolic parameters."

China filing • Type 2 Diabetes Mellitus

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=632 | Completed | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ Feb 2026

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

SYSA1803-010: A Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=465 | Completed | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ Jan 2026

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

NEW DRUG APPLICATION FOR EFMEDAGLUTIDE ALFA INJECTION ACCEPTED BY THE NMPA (CSPC Press Release) - "The Product has been applied as a Class 1 therapeutic biological product, and its indication is for the long-term weight management in overweight or obese adults in combination with diet control and increased physical activity....This new drug application is primarily based on a pivotal Phase III clinical trial that enrolled obese or overweight adult patients with at least one weight-related comorbid condition."

China filing • Obesity

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=632 | Active, not recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

SYSA1803-010: A Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=465 | Active, not recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of TG103 Injection in Non-diabetic Overweight or Obesity (clinicaltrials.gov) - P3 | N=675 | Completed | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity (clinicaltrials.gov) - P2 | N=314 | Completed | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Oct 2024 | Trial primary completion date: Dec 2024 ➔ Sep 2024

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study. (PubMed, BMC Med) - P1 | "In this trial, all three doses of once-weekly TG103 were well tolerated with an acceptable safety profile. TG103 demonstrated preliminary 12-week body weight loss without lifestyle interventions, thus showing great potential for the treatment of overweight and obesity."

Clinical • Journal • P1 data • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Phase 3 Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

Phase 3 Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=618 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

A Study of TG103 Injection in Non-diabetic Overweight or Obesity (clinicaltrials.gov) - P3 | N=675 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study of TG103 Injection in Non-diabetic Overweight or Obesity (clinicaltrials.gov) - P3 | N=675 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Obesity

A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: May 2022 ➔ Jan 2023 | Trial primary completion date: Mar 2022 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Obesity

Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects. (PubMed, Eur J Pharm Sci) - P1 | "TG103 offers a potential option for hypoglycemic therapy with good tolerability and safety."

Journal • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • B2M

A Study of TG103 Injection in Overweight or Obesity (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of TG103 Injection in Type 2 Diabetes Subjects (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

A Study of TG103 Injection in Overweight or Obesity (clinicaltrials.gov) - P2 | N=195 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion

A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes (clinicaltrials.gov) - P2; N=208; Not yet recruiting; Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

A Study of TG103 Injection in Overweight/Obese Subjects Without Diabetes (clinicaltrials.gov) - P1; N=48; Not yet recruiting; Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Clinical • New P1 trial • Diabetes • Metabolic Disorders • Obesity

A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P1 trial