Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 32

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 32
---
 study, the high dose will be set at 0.5 mg/kg/day
     
    2013.11.25
~
2014.02.13
     
    ChemOn
  
    4-Week Repeated Intravenous Injection with 2-Week Recovery Period for Non-Rodents Following PK Sampling
     
    Beagle dog
     
    To examine the characteristics of DRT-102 when administered intravenously to Beagle dogs repeatedly for 4 weeks, and to assess its recovery potential through a 2-week recovery period
     
    No toxicological changes were observed. Therefore, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was determined to be 0.32 mg/kg/day for both males and females.
     
    2014.02.11
~
2014.07.18
     
    ChemOn
  
    Safety Test – Cardiovascular System
     
    Beagle Dog
     
    To evaluate the effects of a single intravenous administration of DRT-102 to male Beagle dogs on cardiovascular function, including blood pressure, heart rate, and electrocardiogram (ECG), using a telemetry device for remote monitoring.
     
    No adverse effect on cardiovascular function, including blood pressure, heart rate, and electrocardiogram (ECG) was observed.
     
    2014.07.17
~
2014.08.07
     
    KIT (Korea Institute of Toxicology)
  
    Safety Test – Respiratory System
     
    Sprague-
Dawley Rats
     
    To evaluate the effects of a single intravenous administration of the test substance AB204 on the respiratory system by measuring the respiratory rate and volume in Sprague-Dawley rats.
     
    When DRT-102 is administered as a single intravenous dose of 0.8 mg/kg or lower, the test substance does not affect the respiratory system.
     
    2014.07.17
~
2014.08.07
     
    ChemOn

16

    Type of study
     
    Species
     
    Purpose
     
    Results
     
    Date
     
    Institution

    Safety Test – Central Nervous System
     
    ICR Mouse
     
    To evaluate the effects of a single intr