Efmedaglutide alfa (GX-G6) / Genexine, CSPC Pharma, NovaBridge Biosciences, TJ Biopharma - LARVOL DELTA

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

A Study of TG103 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus