Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 414

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 414
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/day as the high-dose group for the next repeated intravenous toxicity studies. |     | 2021.12.07- 
 2022.02.10  |

Currently, the toxicity test of DRT -101is ongoing with BiotoxTech. The purpose of this study is to evaluate the potential toxicity and determine the dose levels for a repeated toxicity study of DRT -101, when given Intra -articularinjection to rats and Beagles(non -rodents) The table below outlines the type, species, purpose and results of the pre -clinicaltoxicology studies so far conducted with the assistance of BiotoxTech

| Type of study                                                                     |     | Species     |     | Purpose                                                                                                                                                                     |     | Results                                                                                                                                                              |     | Date of    
 Completion |
| 30-Day Repeated Intraarticular Injection (total 2 times) Dose Range Finding Study |     | Sprague-    
 Dawley Rats |     | To evaluate the potential toxicity and determine the dose levels for a repeated toxicity study of DRT-101, when given Intra-articular injection to the Sprague-Dawley rats. |     | There were no DRT-101-related effects on body weight, food consumption, clinical pathology, or organ weight.                                                         
 In external and macroscopic evaluations, thickening in the injection site was observed in both sexes of the 3, 9 and 30 µg/animal groups in a dose-dependent manner. 
 p-values < 0.05 (Anova&Dunnett)                                                                                                                                      |     | 2024.09.13 |

253

| Type of study                                                                     |     | Species     |     | Purpose                                                                                                                                                                                                                  |     | Results                                                                                                                                                                                                                                                                                                                                                                                                      |     | Date of    
 Completion |
| 30-Day Repeated Intraarticular Injection (total 2 times) Dose Range Finding Study |     | Beagle dogs |     | To evaluate the potential toxicity of DRT-101 when administered via intra-articular injection to Beagle dogs 2 times with an interval of 4 weeks, and to determine the dose levels for a 6-week repeated toxicity study. |     | No deaths occurred during the course of the study. In clinical observations, all animals in DRT-101 dosing groups exhibited edemas at injection sites and abnormal gait after dosing. Edemas were exhibited in a broad area around the injection site, the right stifle joint, gradually recovering in 10 days for