Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 31

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 31
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 of DRT-102, when intravenously injected to the Sprague-Dawley rats.
     
    No deaths were observed. A slight dose-dependent increase in the absolute and relative weights of the spleen and liver was noted in female rats administered 0.25 and 0.5 mg/kg/day. Therefore, it was determined to set the high dose for the 4-week repeated intravenous toxicity study at 0.5 mg/kg/day
     
    2013.11.11
~
2014.05.07
     
    ChemOn

15

    Type of study
     
    Species
     
    Purpose
     
    Results
     
    Date
     
    Institution
  
    Single Intravenous Injection
     
    Sprague-
Dawley Rats
     
    To evaluate the potential toxicity of DRT-102 when administered intravenously single time
     
    The approximate lethal dose (ALD) of AB204 was determined to exceed 10 mg/kg (400 times the clinically intended dose) for both males and females.
     
    2012.02.02
~
2012.04.09
     
    ChemOn
  
    4-Week Repeated Intravenous Injection with 2-Week Recovery Period for Rodents
     
    Sprague-
Dawley Rats
     
    To evaluate the characteristics of DRT-102 when administered intravenously to Sprague-Dawley rats repeatedly for 4 weeks and to assess its recovery potential through a 2-week recovery period.
     
    No deaths were observed, and no toxicologically adverse changes were detected. Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) of the test substance DRT-102 in rats was determined to be 0.32 mg/kg/day.
     
    2014.01.02
~
2014.06.16
     
    ChemOn
  
    Dose Range Finding Study: 2-Week Repeated Intravenous Injection for Non-Rodents
     
    Beagle dog
     
    To evaluate the characteristics of DRT-102 when administered intravenously to Beagle dog repeatedly for 2 weeks.
     
    No changes attributable to the test substance were observed. Therefore, in the upcoming 4-week repeated intravenous toxicity