Company: OSRH
Filing Date: 2025-06-10
Form Type: S-1/A
Source: 0001213900-25-053114
Chunk: 18

Company: OSR Holdings, Inc.
Filing Date: 2025-06-10
Form: S-1/A
Chunk 18
---
 Darnatein, competition takes two forms: pharmaceutical products (drugs) that address the underlying causes of osteoarthritis, and orthopedic solutions involving bone graft and other products. Several pharmaceutical companies and research institutions are actively working on developing Disease-Modifying Osteoarthritis Drugs (DMOADs) to address the underlying causes of osteoarthritis (current treatments primarily focus on symptom management). There are currently no approved DMOAD treatments for osteoarthritis but the table below identifies drugs under development: The table below summarizes the main competitors we have identified for Darnatein’s DRT-101. Each of these identified competitors are developing therapies for osteoarthritis and have active clinical trials ongoing assessing the safety and efficacy of their product candidates.

| Drug Name    |     | Company                |     | Mechanism                                              |     | Indication     |     | Clinical 
 Phase    |     | NCT         
 Number(s)   |
| Invossa      |     | Kolon TissueGene       |     | Cell and gene therapy (TGF-ß1 expressing chondrocytes) |     | Osteoarthritis |     | Phase 3  |     | NCT03383471 |
| Lorecivivint |     | Biosplice Therapeutics |     | CLK/DYRK1A inhibitor                                   |     | Osteoarthritis |     | Phase 3  |     | NCT03928184 |
| Sprifermin   |     | Merck KGaA/EMD serono  |     | Recombinant human fibroblast growth factor 18          |     | Osteoarthritis |     | Phase 2  |     | NCT01919164 
 NCT01033994 |

The table below summarizes the main competitors we have identified for Darnatein’s DRT-102. Each of these identified competitors are commercialized orthopedic solutions.

| Drug Name         |     | Company    |     | Mechanism                                                                |     | Indication                                             |
| Infuse Bone Graft |     | Medtronic  |     | rhBMP-2 and collagen sponge                                              |     | Spinal fusion, long bone fractures, orthopedic surgery |
| Osteocel Plus     |     | NuVasive   |     | Demineralized bone matrix (DBM) and mesenchymal stem cells (MSC)         |     | Spinal fusion, bone defects                            |