Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 28

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 28
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 Rats
     
    Sprague Dawley Rats
     
    Assess the toxicity of the test substance DRT-101 when administered intravenously to Sprague-Dawley Rats
     
    The approximate lethal dose (ALD) was determined to exceed 10mg/kg for both males and females.
     
    2021.03.05-
2021.05.11
  
    Single Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley Rats
     
    Sprague Dawley Rats
     
    Investigate the toxicity and histopathological changes at the administration route
     
    The approximate lethal dose exceeded 0.625 mg/kg for both males and females, and toxicologically adverse changes including dysplasia and hypertrophy of cartilage at the injection area were observed.
     
    2021.04.29-
2021.11.01
  
    Two-Week Repeated Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley Rats
     
    Sprague Dawley Rats
     
    Investigate the toxicity of DRT-101 when administered intravenously to Sprague-Dawley rats repeatedly for two weeks, with the aim of determining dosage for subsequent intravenous toxicity tests
     
    DRT-101 was injected at dose of 0.069, 0.208, and 0.625 mg/kg/day. Swelling at the administration area (tail) was observed in male and female rats in dose groups above 0.208 mg/kg/day. Induration at the administration area was observed in all test substance groups of both sexes. The induration is speculated to be dysplasia and hypertrophy of cartilage in the tail. Accordingly, it is recommended to set 0.069 mg/kg/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-101 is 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-articular injection to rats and Beagles(non-rodents)

The table below outlines the type, species, purpose and results of