Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 30

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 30
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 composed of freeze-dried AB204
protein, that promotes bone formation, and a synthetic bone graft in granular form.

The AB protein (AB204) is a synthetic protein, created by fusing Activin
and BMP-2, both members of the BMP (Bone Morphogenetic Protein) family, growth factors by Darnatein’s segmental reassembly technology.
AB204 combines BMP’s type II receptor binding with activin A’s high-affinity type II receptor binding. It induces
significantly greater and longer-lasting Smad 1/5/8 phosphorylation in osteoblastic cells compared to BMP2, promoting mineral calcium
nodule formation crucial for bone apatite formation. Unlike BMP2, AB204 is unaffected by noggin by design and also inhibits activin signaling,
which further enhances its bone formation and is noteworthy since activin antagonism itself can promote bone formation. When used in conjunction
with existing synthetic bone grafts, it facilitates the generation of new bone and can aid in fracture healing.

The synthetic bone graft uses approved products and is composed of
hydroxyapatite and beta-tricalcium phosphate, with internal pores connected in a three-dimensional structure. By coating a highly
bioactive and absorbable ß -TCP on an HA scaffold that can support structurally for a long period with excellent biocompatibility
and slow biodegradation, it enables rapid initial bone bonding and long-term support dynamics.

DRT-102 pre-clinical study for toxicity measurement in animal
models

The toxicity test of DRT-102 was conducted with multiple institutions
including KTR (Korea Chemical Corporation), KIT (Korea Institute of Toxicology), and ChemOn. The purpose of this study is to evaluate
the potential toxicity and determine the dose levels for a repeated toxicity study of DRT-102, when intravenously administered to rats
and Beagles(non-rodents)

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

    Type of study
     
    Species
     
    Purpose
     
    Results
     
    Date
     
    Institution

    Dose Range Finding Study: 2-Week Repeated Intravenous Injection
     
    Sprague-
Dawley Rats
     
    To evaluate the potential toxicity and determine the dose levels for a repeated toxicity study