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Natural Exosome Therapeutics Platform
Function-Defined MSC-Derived Exosome Products for Inflammatory and Regenerative Diseases

Natural MSC-derived exosomes

Function-Defined Exosome Subpopulations

P.S.K Biosciences has established a function-defined natural exosome therapeutics platform based on MSC-derived exosome subtyping. Instead of developing heterogeneous mixed MSC exosomes, the platform uses a proprietary TFF and SEC-based purification workflow to reproducibly separate MSC-derived exosomes into functionally defined subpopulations.

This strategy transforms exosome drug development from mixed vesicle products into defined therapeutic candidates with clearer biological identity, indication-specific potency characterization, and improved CMC controllability.

S1 & S2 Subpopulations

Two distinct function-defined MSC-derived exosome subpopulations powering differentiated therapeutic programs.

PSK-S1 Subpopulation

Anti-Inflammatory Function

A function-defined exosome subpopulation with anti-inflammatory, anti-fibrotic, and immunomodulatory potential.

  • Proprietary SEC-based S1-subpopulation separation technology
  • Completed RP-ILD IIT study with improved survival and oxygenation signals
  • Demonstrated anti-fibrotic and inflammation-modulating effects in pulmonary diseases
  • Suitable for nebulized inhalation delivery
  • Completed FDA DMF Type II filing and INCI listing
PSK-S2 Subpopulation

Regeneration and Tissue Repair

A function-defined exosome subpopulation with potential in cell proliferation, vascular regeneration, and tissue repair.

  • Proprietary SEC-based S2-subpopulation separation technology
  • Translational evidence across AE-COPD, stroke, heart failure, and neurodegenerative diseases
  • Compatible with nebulized inhalation and intranasal administration
  • Completed FDA DMF Type II filing and INCI listing

A Function-Defined Drug Portfolio

The platform supports a function-defined natural exosome drug portfolio:

S1 subpopulation

Inflammation & Immunomodulation

RP-ILD, AE-COPD, IBD

S2 subpopulation

Regeneration & Repair

Stroke, heart failure, Alzheimer’s disease, Parkinson’s disease

RP-ILD Clinical Translation Evidence

S1 has demonstrated encouraging clinical signals in an investigator-initiated RP-ILD study, including oxygenation and survival improvement. These data provide early human translational evidence supporting the therapeutic potential of PSK’s function-defined anti-inflammatory exosome platform.

Positive human signals in RP-ILD / severe inflammation

  • Nebulized, 14-day treatment course
  • Historical mortality: 50–90%
  • PSK-treated cohort: 10% mortality within 3 months (10 patients)
Positive human signals in RP-ILD

Positive human signals in RP-ILD

RP-ILD CT comparison

RP-ILD CT comparison

AE-COPD Clinical Translation Evidence

  • Drug profile:
  • Acute anti-inflammatory biologic
  • Nebulized, non-invasive administration
  • 14-day treatment course
  • High unmet need, strong market potential
  • Superior patient compliance vs IV or inpatient therapies

Before treatment

Before treatment

After treatment

After treatment

Patient profile: Male, 10-year COPD history

Pulmonary findings: Bronchial wall thickening in both lungs with scattered emphysema

Together with translational and preclinical data in AE-COPD, stroke, heart failure, and neurodegenerative diseases, the platform supports both inflammation modulation and tissue repair/regeneration potential.

Standardization & Regulatory Compliance

Building trust through transparent documentation and international regulatory engagement.

2024
Liu et al. J Extracell Vesicles

First peer-reviewed characterization of S1-sEVs and S2-sEVs from HucMSCs.

2025
FDA DMF Type II

S1 (041763) and S2 (041762) filings completed by P.S.K Biosciences.

2025
INCI Filing

Listed as "Human Umbilical Mesenchymal Stem Cell Extracellular Vesicles" (INCI 40148).

2026
Clinical Translation

Continued clinical evaluation in RP-ILD, AE-COPD, and regenerative indications.