Company
Business
Stem Cell Therapy
Organoid
CDMO Business
IR Resource Center
Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Selection of global consulting project
13
2025.06
Kangstem Biotech has been selected as an implementing organization for the “2025 Advanced Consulting Support Program for Global Expansion in the Pharmaceutical Industry,” organized by the Korea Health Industry Development Institute(KHIDI).
Kangstem Biotech has been selected as an implementing organization for the “2025 Advanced Consulting Support Program for Global Expansion in the Pharmaceutical Industry,” organized by the Korea Health Industry Development Institute(KHIDI).
Through this initiative, the company plans to advance FDA pre-IND review and apply for expedited programs for its knee osteoarthritis treatment candidate “OSCA,” aiming to enhance the asset’s global out-licensing value.
This government-backed program is designed to support domestic pharmaceutical and biotech companies in strategically entering global markets by offering expert consulting on global new drug development planning. Kangstem Biotech was selected as a final recipient. Notably, knee osteoarthritis is a condition with rapidly increasing prevalence due to population aging, yet there is no fundamental cure currently available.
OSCA, administered via a single intra-articular injection without surgery, has demonstrated fundamental therapeutic potential in preclinical and Phase 1 trials, including symptomatic relief, functional improvement, and structural regeneration of cartilage and subchondral bone. Its competitiveness as a novel drug candidate led to its selection for this program.
With this support, Kangstem Biotech intends to initiate pre-IND discussions with the U.S. Food and Drug Administration (FDA) and pursue applications for expedited review programs such as RMAT (Regenerative Medicine Advanced Therapy) and BTD (Breakthrough Therapy Designation), which are designed for therapies targeting areas of high unmet medical need.
These designations can allow for accelerated or conditional approval based on surrogate endpoints or interim results, rather than final clinical trial outcomes, thereby expediting time to market.
One of the key criteria for such expedited programs is evidence of therapeutic potential in early-stage clinical trials. In the case of OSCA, Phase 1 trials conducted in Korea demonstrated statistically significant improvements across all key indicators including 50–100% pain relief, enhanced joint function, and improved mobility. Moreover, the therapeutic effect was sustained or even improved at 12 months post-injection, a level of efficacy not observed in existing treatments. These results support OSCA’s strong candidacy for fast-track designation.
As the lead organization for this project, Kangstem Biotech will collaborate with its U.S. partner to implement a global drug development strategy that includes FDA pre-IND procedures and applications for RMAT and BTD. The company aims to accelerate its entry into overseas markets and further enhance the global licensing value of OSCA through strengthened technological competitiveness.