2026 Year-Opening Success! RAY1225 Injection Efficiently Completes Enrollment Target in Phase III Clinical Trial for Monotherapy in Type 2 Diabetes

Following the achievement of enrollment targets in the Phase III study of RAY1225 combination therapy (previously treated) for diabetes by the end of 2025, Guangdong Raynovent Biotech Co., Ltd.'s R&D front has delivered another breakthrough victory: the pivotal Phase III clinical trial of RAY1225 monotherapy for type 2 diabetes (treatment-naïve) has efficiently achieved full enrollment targets at the beginning of the new year!

Within just half a month, two pivotal studies have consecutively achieved success, not only realizing a "year-opening success" in the 2026 R&D journey but also demonstrating the project team's exceptional execution capability and collaborative spirit in the more challenging treatment-naïve patient population. This milestone lays a decisive foundation for this globally first dual-target biweekly innovative drug to become a first-line treatment option.

Dual-Track Advancement, Efficient Breakthrough

Compared to previously treated type 2 diabetes populations, enrollment and screening criteria for treatment-naïve populations are more stringent, with higher requirements for participant baseline characteristics, presenting significantly increased difficulty and challenges. Under the outstanding guidance of Leading PI Professor Linong Ji and the efficient collaboration of 70 participating centers nationwide, the research team demonstrated extraordinary execution capability and coordinated combat effectiveness. The two projects advanced in parallel, achieving breakthroughs efficiently, with both the first enrollment and completion of target enrollment timelines nearly simultaneously reaching their predetermined goals.

Dual-Target Synergy: Targeting a New First-Line Treatment Option for Treatment-Naïve Populations

This study aims to evaluate the efficacy and safety of RAY1225 Injection as monotherapy in patients with type 2 diabetes whose blood glucose control remains inadequate after diet and exercise interventions. As a globally innovative GLP-1/GIP dual receptor agonist, RAY1225's dual mechanism not only provides potent and stable glycemic control but also demonstrates comprehensive potential in weight reduction and improvement of cardiovascular metabolic indicators. The advancement of this study aims to explore RAY1225's outstanding performance as an initial first-line treatment, potentially providing a novel, highly effective, and more convenient (biweekly dosing) first-line treatment option for the vast population of newly diagnosed or early-stage type 2 diabetes patients, reshaping new standards for disease management.

Riding Forward with Momentum, Embarking on a New Journey

We once again extend our heartfelt gratitude to Professor Linong Ji for his professional leadership, to all participating centers nationwide for their hard work, to all partners for their sincere collaboration, and to all participants for their trust. The rapid completion of enrollment in these two pivotal Phase III studies represents a phased victory and, more importantly, the starting point of a new journey. In the new year, we will keep in mind President Xi Jinping's New Year message, muster the courage to ride forward with vigor, stimulate the vitality of galloping forward, maintain the drive of continuous progress, continue to uphold the highest reverence for science and quality, go all out to complete subsequent clinical studies with high quality, and repay every ounce of trust with conclusive efficacy and safety evidence, contributing solid innovative strength to fulfill the mission of "Healthy China."