Updated in 2026.03
- Pre-Clinical
- Investigator-Initiated Clinical Trial
- IND enabling
- Phase Ⅰ
- Phase Ⅱ
- Phase Ⅲ
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REGEND001 (Aeriotemcel)
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Autologous Lung Progenitor Cell (BC)
Lung regeneration
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- COPD (Emphysema)
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Phase Ⅱ Completed
- China Phase Ⅲ Initiation: 2026 H1
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- IPF
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Phase Ⅱ Completed
- China Phase Ⅲ Initiation: 2026 H2
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FDA-ODD Granted（2）
- Planning for Clinical Trial
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- ILD
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llT Completed
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- Bronchiectasis
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llT Completed
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- BO
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- IND Submission: 2028
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REGEND002
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Autologous Lung Progenitor Cell (Rejuvenated BC)
Lung regeneration
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- COPD, ILD, Bronchiectasis, etc
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- IIT Initiation: 2026H2
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REGEND007
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Universal Lung Progenitor Cell
Secretion of lung repairing factors
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- COPD, ILD, etc
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- IND Submission: 2028
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REGEND003
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Autologous Kidney Progenitor Cell
Kidney regeneration
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- CKD
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- Phase I Completion: 2027
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REGEND008
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Universal Kidney Progenitor Cell
Secretion of kidney repairing factors
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- CKD
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- IND Submission: 2026H2
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REJUVE101
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Engineered Stem Cell Exosome
Tissue rejuvenation
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- Multi-Organ Aging-Associated Diseases
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- IND Submission: 2028
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REJUVE109
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Exosomes Carrying Reprogramming Chemicals
Tissue rejuvenation
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- Multi-Organ Aging-Associated Pathologies, Including Cancer
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- IND Submission: 2028
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★ Core Product
Abbreviations: BC = airway basal stem cell; BO = bronchiolitis obliterans; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; EV = extracellular vesicle; H1 = first half; H2 = second half; IIT = investigator-initiated trial; ILD = interstitial lung disease; IND = investigational new drug; IPF= idiopathic pulmonary fibrosis; ODD = orphan drug designation.
Notes:
(1) Pursuant to the "Regulations on Promoting Biomedical New Technologies in the Bo'ao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port" (《海南自由贸易港博鳌乐城国际医疗旅游先行区生物医学新技术促进规定》)， upon approval from local government in the Hainan Pilot Zone and under its oversight, we are authorized to conduct translational application of the designated drug candidate(s) at the designated medical institution(s). In the beginning of 2025, the relevant medical regulatory authorities in Hainan initiated a series of meetings with us regarding the inclusion of REGEND001 in the biomedical new technology program. Following their comprehensive assessment of the safety and efficacy data of REGEND001 obtained from the Phase Ⅰ, Phase Ⅱ and IIT clinical trials, it was approved for the treatment of patients with COPD, ILD (INCLUDING IPF) and bronchiectasis in the Hainan Pilot Zone.
(2) Except the Orphan Drug Designation of REGEND001 for the treatment of IPF patients granted by the FDA, all of the drug candidates above are regulated by the NMPA.