Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 26

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 26
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    12/01/2021 
    17791282 

    20230121528 
    12/01/2041 
    under examination

12

Darnatein

Corporate Overview

Darnatein is developing design-augmented (DA) biologics for age-related and
other degenerative diseases, such as osteoarthritis and spine and joint disorders. Darnatein’s lead DA biologics are intended to
be injected directly into pathological tissues to promote regeneration of target tissues such as bone or cartilage cells. Leveraging these
innovative DA biologics to regenerate bone and cartilage has the potential to restore functionality and reduce pain across several degenerative
conditions.

Darnatein has identified and advanced two therapeutic candidates, DRT-102,
a clinical-stage asset for spinal fusion, and DRT-101, a pre-clinical stage asset for osteoarthritis. A small exploratory, clinical
trial of 15 patients with DRT-102 indicated potential efficacy compared to a placebo, with no serious adverse events reported. Safety
and efficacy evaluation will be determined following review of all safety data by relevant regulatory agencies. Larger clinical trials
will be required to provide more extensive and accurate data on the safety and effectiveness of DRT102. A pre-clinical (non-human)
trial of DRT-101 demonstrated cartilage regeneration and joint healing in animals, with no serious adverse events reported. Based
on these preliminary results, Darnatein intends to continue the development and testing of DRT-101 and, when additional resources
are available, DRT-102. Darnatein has not previously advanced any therapeutic candidates into late-stage clinical trials nor received
regulatory and marketing approvals for any commercial sales of its products.

Opportunity

Age-related degeneration, such as osteoarthritis and spine disorders,
is a naturally occurring process that may be accelerated due to chronic and cumulative impact over time. Limited therapeutic options exist
and only offer limited and temporary symptomatic relief with no cure currently available.

Beyond therapeutic options, invasive surgical procedures may be available
for spine and joint disorders but are not readily accessible and may not be a curative, pain-free, long-term solution. Additionally,
neither symptomatic therapies nor invasive and costly surgical procedures address the underlying cause of chronic and age-related degenerative
diseases. Darnatein