Clinical Development Status of Lead Programs

Successful commercialization of allogeneic umbilical cord blood-derived mesenchymal stem cells products

MEDIPOST has successfully launched World’s First Regulatory-Approved allogeneic umbilical cord blood-derived mesenchymal stem cells product CARTISTEM® in Korea. In addition, clinical trials for the preventive treatment of bronchopulmonary dysplasia(BPD) and fro patients suffereingg from Alzheimer’s disease are in progress.

1st Generation of Stem Cell Products

CARTISTEM®
Treatment of repetitive and/or traumatic cartilage degeneration including Degenerative Osteoarthritis(OA) without age limit.
· Biologics License Application(BLA) Market-Approval by Ministry of Food and Drug Safety(MFDS), Korea in January 2012
· Completed US FDA Phase 1/2a Clinical Trial
· Approved Japan PMDA & MHLW Phase 2 Clinical Trial

Market Approval by MFDS in January 2012100%
100%
Completion of US FDA phase 1/2a clinical trial60%
60%
Approval of Phase 2 clinical trial by PMDA & MHLW, Japan67%
67%

PNEUMOSTEM®
Preventive Treatment for Bronchopulmonary Dysplasia(BPD)
· Phase 2 clinical trial ongoing in Korea
· Completed US FDA Phase 1/2 clinical trial
· Orphan Drug Designation by US FDA & EMA
· Fast-Track Designation by US FDA

Phase 2 clinical trial ongoing in Korea67%
67%
Completion of US FDA phase 1/2 clinical trial67%
67%

NEUROSTEM®
Treatment and Prevention of Alzheimer’s disease(AD)
· Completed Phase 1/2a clinical trial in Korea
· Cleared US FDA Phase I/2 IND

Phase 1/2a clinical trial completed in Korea60%
60%
Cleared US FDA Phase I/2 IND42%
42%

2nd Generation of Stem Cell Products

SMUP-IA-01
Intra-articular injectable for the treatment of osteoarthritis
· Phase 1 clinical trial ongoing in Korea

Phase 1 clinical trial by MFDS approved53%
53%

SMUP-IV-01
Intra-venous infusion for the treatment of diabetic nephropathy
· Phase 1 IND submission in Korea is scheduled in 2020

Scheduled to apply for approval of the domestic clinical trial (Phase 1)27%
27%
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