Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 29

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 29
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the pre-clinical toxicology 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

14

    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-102 for Bone Regeneration

DRT-102 is an investigational product classified as a medical
device product by the Ministry of Food and Drug Safety of the Republic of Korea (“MFDS”). DRT-102 is