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WHAT IS THE REGEND001?
REGEND001, also called Aeriotemcel, is an innovative autologous lung progenitor cell therapy for the treatment of a range of chronic and progressive pulmonary diseases, including COPD, IPF, ILD, bronchiectasis, and BO.
REGEND001 represents a new generation of regenerative therapy that utilizes the intrinsic regenerative capacity of patients’ own stem cells to treat disease. It exerts directly regenerating lung structure by giving rise to new air sac units (alveoli) to replace damaged architecture and therefore restore lung function.
The transformative potential of REGEND001 has been recognized by the scientific community, with related research achievements highlighted as an annual key advancement by the European Respiratory Society (ERS) and published in the top-tier journal Science Translational Medicine.
Mechanism of Action: Epithelial Barrier Restoration and Gas Transfer Regeneration via Lung Progenitor Cells.
The pathogenesis of chronic lung diseases such as COPD and IPF is characterized by persistent epithelial structure injuries and impaired lung function. In damaged regions, effective epithelial regeneration is often absent. Instead, these areas are infiltrated by proliferating fibroblasts and inflammatory cells, leading to abnormal tissue remodeling and progressive, irreversible decline of lung function. REGEND001 consists of lung progenitor cells with robust regenerative and reparative potential. These cells achieve functional regeneration of the lung mainly through two coordinated mechanisms: (1) re-establishing epithelial barrier; and (2) regenerating structures for gas transfer. Moreover, lung progenitor cells also secret multiple cytokines and extracellular vesicles to favor lung repair.
Market Opportunity: Significant Unmet Needs in Chronic Lung Diseases
COPD is a devastating, progressive pulmonary disease characterized by irreversible damage of airway (chronic bronchitis-dominant type) or alveolar tissue (emphysema-dominant type), which threatens the life of millions of people annually and continues to impose one of the largest chronic disease burdens in China. For emphysema-dominant type COPD, no effective pharmacological treatment is currently available to repair alveolar damage or improve lung gas transfer capacity.
IPF is a highly fatal pulmonary disease characterized by irreversible damage of alveolar structure and progressive fibrotic remodeling of lung parenchyma. According to Frost & Sullivan, the incidence of IPF in China was 185.2 thousand in 2024 and is projected to rise to 502.6 thousand in 2035. Current therapies cannot prevent alveolar damage or repair damaged alveoli.
ILD is a heterogeneous group of diseases primarily characterized by interstitial inflammation and fibrosis in the lungs. According to Frost & Sullivan, the prevalence of ILD in China was approximately 809.2 thousand in 2024 and is projected to 969.0 thousand by 2035. No approved therapy reverses established fibrosis or restores alveolar architecture.
Bronchiectasis is a chronic respiratory condition characterized by abnormal and usually irreversible dilatation of the bronchi. According to Frost & Sullivan, the incidence of bronchiectasis in China was from approximately 26.8 million in 2024 and is projected to 35.0 million in 2035. Existing therapies do not reverse airway damage.
Clinical Evidence: REGEND001 is expected to become the first effective drug treatment option for emphysema-dominant type COPD and IPF.
REGEND001 obtained IND approval for IPF and COPD from NMPA in 2020 and 2021. Phase II clinical trials for COPD and IPF have been completed.
In our Phase II clinical trial in COPD, patients treated with REGEND001 demonstrated statistically significant improvements in key efficacy endpoints including DLCO (indicator for lung gas transfer capacity) and alveolar volume (VA) at both Week 24 and Week 52 post-treatment compared to those in the placebo control group. Furthermore, subjects with improved CAT (indicator for quality of life) meeting minimally clinical important difference (MCID) in the REGEND001 group were significantly more than those in the placebo control group.
Patients with idiopathic pulmonary fibrosis (IPF) treated with REGEND001 achieved statistically significant improvements on DLCO, total lung capacity (TLC), FVC, high-resolution CT (HRCT) imaged lung structures at Week 12 or Week 24 post-treatment.