Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 27

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 27
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’s novel Design Augmented (DA) approach has the potential to overcome these limitations of spine and joint disorders
and osteoarthritis with a regenerative therapy to overcome degeneration in bone and cartilage.

Design-Augmented Biologics Program

In recent years, scientists have studied the role of bone morphogenetic
proteins (BMPs) in healing bone and cartilage. BMPs have been used clinically in orthopedic procedures but they are typically administered
at high, supra-physiological concentrations that have been linked to undesirable local and systemic side effects. BMPs engineered
to have enhanced therapeutic potency may circumvent this problem and provide the desired effects of healing bone and cartilage while minimizing
the likelihood of adverse events.

DRT-101 for Cartilage and Joint Recovery

DRT-101 is a synthetic bio-signaling molecule that replaces
BMPRII-binding segments of BMP-7, one of the bone-forming proteins, with high affinity ActRII binding segments of Activin A,
a member of the transforming growth factor ß (TGF-ß). In nature, endogenous BMP7 promotes chondrogenesis in damaged cartilage
tissue by signaling primarily via the type II receptor BMPRII and to a lesser extent via the activin type II receptor ActRII,
which it binds with lower affinity. DRT-101 amplifies intracellular regeneration signaling capacity compared to natural BMP-7 and
allows for regeneration and restoration of mechanically depleted cartilage cells to normal levels.

DRT-101 pre-clinical study in animals

DRT-101 was evaluated in Sprague Dawley rats by ChemOn Inc. in
2021 for toxicity measurement. This study was conducted to assess the approximate lethal dose (ALD) and the dose-range finding(DRF)
of the test substance DRT-101, when administered intravenously.

The table below lists the type, species, purpose and results of our
completed pre-clinical toxicology studies from 2021-2022. These studies were conducted with the assistance of Chemon Inc., a
GLP-licensed third-party vendor.

13

    Type of Study
     
    Species
     
    Purpose
     
    Results
     
    Period
  
    Single Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley