Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 33

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 33
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avenous administration of DRT-102 on the central nervous system by observing the animals’ body temperature and systemic behaviors in ICR mice.
     
    When DRT-102 was administered as a single intravenous dose of 0.8 mg/kg or lower to ICR mice, no changes in body temperature or systemic behaviors were observed.
     
    2014.03.25
~
2014.04.29
     
    ChemOn

    Biological Safety Tests
     
    — 
     
    Cytotoxicity test (Elution method)
     
    Grade 2 (mildly cytotoxic)
     
    2014.0924
~
2014.10.28
     
    KTR (Korea Chemical Corporation)

    NZW rabbits
     
    Intracutaneous reactivity
     
    No signs of erythema or edema.

    Dunkin Hartley guinea pigs
     
    Skin Irritation test
     
    No skin reactions after sensitization, indicating weak skin sensitization.

    ICR mice
     
    Acute toxicity test
     
    No systemic toxicity changes observed within 72 hours after administration

    NZW rabbits
     
    Fever test
     
    No body temperature increase of 0.5°C or higher.

    — 
     
    Genotoxicity Test
(Microbial Reversion Mutation)
     
    Negative

    — 
     
    Genotoxicity Test (Mammalian Chromosome)
     
    Negative

Pre-clinical study of DRT-102 for efficacy measurement
in animal models

Efficacy test of DRT-102 was conducted with multiple institution
including Joint Center for Bioscience, Inha University Hospital, Seoul Borame Medical Center, and Pharmalegacy (China). The purpose of
this study is to evaluate the potential efficacy of DRT-102, when intravenously administered.

17

The table below outlines the type, species, purpose and results of
the pre-clinical efficacy studies so far.

    Type of study
     
    Species
     
    Purpose
     
    Results
     
    Date
     
    Institution
  
    Beagle dog spinal fusion
     
    Beagle dog
     
    To evaluate the efficacy of DRT-102 by tibial bone Fusion

    – Test group implanted with DRT-