On May 9, 2026, Regend Therapeutics convened the launch meeting for the Phase III clinical trial of REGEND001, an autologous cell therapy for chronic obstructive pulmonary disease (COPD), at Jin Mao Tower in Lujiazui, Shanghai. The meeting was organized by Regend Therapeutics and co-hosted by Chinese Society for Cell and Gene Therapy.

The meeting was jointly chaired by Prof. Shiyue Li, Vice Chair of the Respiratory Disease Branch of the Chinese Medical Association, and Dr. Ting Zhang, Chief Scientist of China’s National Key R&D Program. Leading investigators from more than ten clinical research centers across China gathered to finalize the study strategy and implementation framework.

With the official launch ceremony, the REGEND001 Phase III clinical trial formally entered the execution stage, marking a critical milestone in the program's transition into confirmatory clinical development. REGEND001 has the potential to become the world’s first approved autologous regenerative therapy for the lung. The study is sponsored by Shanghai Jirui Medical Technology Co., Ltd., a wholly owned subsidiary of Regend Therapeutics.

I. Leading Experts Gather to Advance a New Era in COPD Treatment

The launch meeting brought together many of China’s leading respiratory medicine experts for a high-level scientific exchange focused on regenerative approaches for COPD.

Attendees included Prof. Shiyue Li from The First Affiliated Hospital of Guangzhou Medical University; Prof. Yuanlin Song from Zhongshan Hospital, Fudan University; Prof. Qiang Li from Shanghai East Hospital, Tongji University; Prof. Min Zhou from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Prof. Jungang Xie from Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology; Prof. Ran Li from Peking University People’s Hospital; Prof. Nan Zhang from the Emergency General Hospital; Prof. Ying Liang from Peking University Third Hospital; Associate Chief Physician Ke Huang from China-Japan Friendship Hospital; Associate Professor Junhong Jiang from the Fourth Affiliated Hospital of Soochow University; Associate Professor Jinmi Yang from Inner Mongolia People's Hospital; and Dr. Haiqin Guo from the First Affiliated Hospital of Army Medical University, among others.

During the closed-door discussions, experts conducted in-depth reviews of key scientific and operational aspects of the Phase III study and reached multiple important consensus recommendations, laying a strong academic foundation for the successful execution of the trial.

Figure 1. REGEND001 Phase III Trial Launch Meeting

 

II. Focus on Core Scientific Questions: In-Depth Discussion of the COPD Phase III Study Design

The meeting centered on the key scientific and clinical questions surrounding REGEND001 for COPD, including study design optimization, endpoint selection, procedural standardization, and consistency of efficacy assessments.

REGEND001 is designed to regenerate damaged alveolar structures and restore pulmonary gas exchange function, aiming to fundamentally address the underlying pathology of emphysema-predominant COPD. The therapy represents a potential shift in COPD management from symptomatic control toward structural lung repair and regeneration.

Key outcomes from the meeting included:

• Refinement of target patient population: Experts further optimized the primary endpoint strategy for the Phase III study to better identify patients with greater disease burden, higher unmet medical need, and greater responsiveness to regenerative therapy.
• Standardization of procedural operations: Given the unique characteristics of lung progenitor cell therapy, the expert panel conducted dedicated discussions on bronchoscopic cell collection and precision delivery procedures. Comprehensive standardized operating protocols were established to ensure accurate cell administration and maximize therapeutic consistency.
• Strengthening of risk management systems: The meeting also established broad consensus on the standardization of clinical assessments, as well as monitoring and management strategies for intercurrent clinical events, reinforcing end-to-end quality control throughout the trial.

 

III. Looking Ahead: Accelerating the Clinical Translation of Regenerative Medicine

The successful convening of the launch meeting not only provided critical guidance for the design and implementation of the REGEND001 COPD Phase III study, but also demonstrated China’s growing leadership in translating cutting-edge regenerative medicine research into advanced clinical development.

Participating experts expressed strong optimism regarding the potential of stem cell-based therapies to address major unmet needs in severe respiratory diseases and highlighted the importance of generating robust confirmatory clinical evidence to bring transformative new treatment options to patients with COPD.

Regend Therapeutics is a biotechnology company focused on developing innovative regenerative therapies for lung diseases. The Company is dedicated to advancing cell and gene therapies designed to repair, regenerate, and enhance human tissues and organs, with the mission of translating frontier stem cell science into transformative clinical solutions.

As the world’s first autologous regenerative lung therapy, REGEND001 has initiated a series of clinical studies targeting major pulmonary injury-related diseases. Phase II clinical studies in COPD have demonstrated statistically significant improvements versus control across key efficacy endpoints. In addition to improvements in pulmonary function and quality of life, REGEND001 has shown unprecedented potential in repairing structural lung damage, including clinically meaningful increases in lung volume measuring several hundred milliliters in treated patients.