Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 422

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 422
---
irus                   |     | Recurrent glioblastoma                     |     | Phase 2   |     | NCT03178032              |
| Ofranergene obadenovec (VB-111)   |     | VBL Therapeutics     |     | Dual-targeted gene therapy             |     | Recurrent glioblastoma                     |     | Phase 3   |     | NCT02511405              |
| AV-GBM-1                          |     | Aivita Biomedical    |     | Personalized dendritic cell vaccine    |     | Newly diagnosed glioblastoma               |     | Phase 2   |     | NCT03400917              |
| VAL-083                           |     | Kintara Therapeutics |     | DNA-targeting agent                    |     | Recurrent and newly diagnosed glioblastoma |     | Phase 2/3 |     | NCT02717962, NCT03050736 |

With respect to 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 -ModifyingOsteoarthritis 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   |     |