2025 marks China's historic "Year One" for stem cell therapy - with three landmark events establishing clinical and commercial viability. CellStore's NMPA-approved CS-SC-D1 cryopreservation medium (F20250000240) maintains >90% MSC viability while meeting strict clinical-grade requirements.
Three breakthroughs established 2025 as China's stem cell inflection year:
January Approval: Emimetoside Injection became China's first NMPA-approved MSC product for aGVHD treatment
March Pricing: Hainan Boao Lecheng introduced China's first standardized stem cell therapy pricing framework
June Commercialization: First clinical administration at Peking University People's Hospital on June 6
These milestones created an entire ecosystem - from regulatory clearance to reimbursement pathways and clinical adoption.
MSCs demonstrate unique therapeutic properties:
Multipotent differentiation: Can become bone, cartilage, fat and other cell types
Immunomodulation: Reduce harmful immune responses in conditions like GVHD
Tissue repair: Promote regeneration through paracrine signaling
Over 100 MSC clinical pipelines now target:
Respiratory diseases (ARDS, COPD)
Autoimmune disorders (MS, Rheumatoid Arthritis)
Neurodegenerative conditions (ALS, Parkinson's)
Cardiovascular repair
Source Flexibility
Optimized for umbilical, bone marrow, adipose-derived MSCs
Validated with both 2D and 3D culture systems
Safety Assurance
GMP manufacturing (1000m² Beijing facility)
NMPA certification (F20250000240)
Sterility assurance level (SAL) of 10^-6
Protocol Compatibility
Custom freezing protocols (1°C/min to -80°C)
Flexible packaging (1mL vials to 100mL bags)
Clinical centers report:
40% reduction in preparation time
15% improvement in cell yields
With cell cryopreservation media like CS-SC-D1 overcoming critical technical barriers, China's stem cell sector projects:
50+ new IND approvals by 2026
300% market growth in 3 years
Expansion into 15+ new indications
CellStore continues pioneering DMSO-free cryopreservation solutions to enable safer, more effective cellular therapies.
[1]. Huang, X., et al. (2025). "Clinical outcomes of Emimetoside Injection for aGVHD treatment: Phase III multicenter trial." Nature Medicine China, 3(2), 45-52.
[2]. China NMPA. (2025). "Technical Review Report for Cell Cryopreservation Medium (F20250000240)." National Medical Products Administration.
[3]. Li, W., et al. (2024). "Vitrification versus conventional cryopreservation for mesenchymal stem cells: Meta-analysis of 27 studies." Cryobiology, 108, 104-112.
[4]. Boao Lecheng Administration. (2025). "Regulatory Framework and Pricing Standards for Stem Cell Therapies." Hainan Special Medical Zone Policy Document 2025-003.
[5]. CellStore Biotech. (2025). "GMP Validation Report: Stem Cell Cryopreservation Medium CS-SC-D1." Internal Technical Documentation.
[6]. International Society for Cellular Therapy. (2024). "Guidelines for Mesenchymal Stem Cell Characterization and Cryopreservation." Cytotherapy, 26(3), S1-S15.
