RAY1225 / Guangdong Zhongsheng Pharma - LARVOL DELTA

Zhongsheng Pharmaceutical's innovative drug RAY1225 injection enters first phase III clinical trial [Google translation] (Eastmoney.com) - "On June 19, Zhongsheng Pharmaceutical...announced that a class of innovative drugs developed by its holding subsidiary Zhongsheng Ruichuang. The Phase III clinical trial of RAY1225 injection for obesity/overweight has completed the enrollment of the first participant."

Enrollment open • Obesity

Zhongsheng Pharmaceutical: There is uncertainty in the progress of clinical trials of the RAY1225 injection product under development [Google translation] (MSN News) - "At present, the Phase III clinical trial of RAY1225 injection for the treatment of overweight/obese patients and two Phase III clinical trials for patients with type 2 diabetes have obtained clinical trial ethics approval. There is a certain degree of uncertainty in the progress of clinical trials of RAY1225 injection, the results of review and approval, and the future product market competition landscape. There is uncertainty as to whether the drug can be approved for marketing, the time of approval for marketing, and the production and sales after marketing."

Clinical • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of RAY1225 Once Every Two Weeks in Chinese Adults with Type 2 Diabetes (SHINING-1) (ADA 2025) - "Chinese T2DM adults naive or uncontrolled on Metformin, alpha-glucosidase or SGLT-2 inhibitors with a 7.0% ≤ HbA1c ≤11.0% were randomized. This study showed RAY1225 once every two weeks subcutaneous injection was generally well tolerated and demonstrated superior reduction in HbA1c in Chinese adults with T2DM."

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

Efficacy and Safety of RAY1225 Once Every Two Weeks in Chinese Adults with Obesity or Overweight (REBUILDING-1) (ADA 2025) - "This study showed RAY1225 once every two weeks subcutaneous injection was safe and achieved robust body weight reduction in Chinese adults with overweight or obesity."

Clinical • Metabolic Disorders • Obesity

Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight (clinicaltrials.gov) - P3 | N=640 | Not yet recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P3 trial • Genetic Disorders • Obesity

A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed

Trial completion

A Study of RAY1225 in Participants With Impaired Liver Function (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Trial completion date: Mar 2025 ➔ Nov 2025 | Trial primary completion date: Dec 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Hepatology

RAY1225-23-02: A Study of RAY1225 in Participants With Obesity (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

Zhongsheng Pharmaceutical: Recently obtained the ethics approval of the lead unit of the Phase III clinical trial of RAY1225 injection for the treatment of overweight/obese participants [Google translation] (163.com) - "Zhongsheng Pharmaceutical (002317.SZ) said on the investor interaction platform on March 10 that the clinical trial of RAY1225 injection is progressing smoothly and has recently obtained the ethics approval of the lead unit of the Phase III clinical trial of RAY1225 injection for the treatment of overweight/obese participants. Zhongsheng Ruichuang will, under the leadership of the main researchers nationwide, promote the Phase III clinical trial with high quality, acceleration, and scientific norms in accordance with relevant requirements."

New P3 trial • Obesity

A Study of RAY1225 in Participants With Impaired Kidney Function (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed

Trial completion • Renal Disease

RAY1225-23-03: A Study of RAY1225 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Trial completion date: Feb 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

Zhongsheng Pharmaceutical Holdings' subsidiary receives FDA approval to conduct clinical trials of RAY1225 injection [Google translation] (Eastmoney.com) - "Caizhong News Agency, February 7th, Zhongsheng Pharmaceutical(002317) announced that its holding subsidiary Zhongsheng Ruichuang successfully obtained the approval notice for clinical trial of RAY1225 injection issued by the US FDA, allowing it to conduct Phase II clinical trials for overweight or obesity indications in the United States."

New P2 trial • Obesity

A Study of RAY1225 in Participants With Impaired Kidney Function (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial • Renal Disease

A Study of RAY1225 at Different Injection Sites in Participants With Different Body Sizes (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial

A Study of RAY1225 in Participants With Impaired Liver Function (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial • Hepatology

The Safety, Tolerability and Pharmacokinetic Study of RAY1225 (clinicaltrials.gov) - P1 | N=68 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed | N=130 ➔ 68

Enrollment change • Trial completion • Obesity

RAY1225-23-03: A Study of RAY1225 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

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

RAY1225-23-02: A Study of RAY1225 in Participants With Obesity (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of RAY1225 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

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

A Study of RAY1225 in Participants With Obesity (clinicaltrials.gov) - P2 | N=270 | Not yet recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P2 trial • Genetic Disorders • Obesity

The Safety, Tolerability and Pharmacokinetic Study of RAY1225 (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Obesity

The Safety, Tolerability and Pharmacokinetic Study of RAY1225 (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial • Obesity