Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 413

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 413
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 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 |

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| 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 the 0.05 and 0.15 mg/animal dose groups, and in 24 days for the 0.5 mg/animal dose group. |     | 2024.09.03 |

DRT -102for Bone Regeneration DRT -102is an investigational product classified as a medical device product by the Ministry of Food and Drug Safety of the Republic of Korea (“MFDS”). DRT -102is composed of freeze -driedAB204 protein, that promotes bone formation, and