Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 46

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 46
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With respect to Darnatein, competition takes two forms: pharmaceutical
products (drugs) that address the underlying causes of osteoarthritis, and orthopedic solutions involving bone graft and other products.
Several pharmaceutical companies and research institutions are actively working on developing Disease-Modifying Osteoarthritis Drugs
(DMOADs) to address the underlying causes of osteoarthritis (current treatments primarily focus on symptom management). There are currently
no approved DMOAD treatments for osteoarthritis but the table below identifies drugs under development:

The table below summarizes the main competitors we have identified
for Darnatein’s DRT-101. Each of these identified competitors are developing therapies for osteoarthritis and have active clinical
trials ongoing assessing the safety and efficacy of their product candidates.

    Drug Name
     
    Company
     
    Mechanism
     
    Indication
     
    Clinical
Phase
     
    NCT
Number(s)
  
    Invossa
     
    Kolon TissueGene
     
    Cell and gene therapy (TGF-ß1 expressing chondrocytes)
     
    Osteoarthritis
     
    Phase 3
     
    NCT03383471
  
    Lorecivivint
     
    Biosplice Therapeutics
     
    CLK/DYRK1A inhibitor
     
    Osteoarthritis
     
    Phase 3
     
    NCT03928184
  
    Sprifermin
     
    Merck KGaA/EMD serono
     
    Recombinant human fibroblast growth factor 18
     
    Osteoarthritis
     
    Phase 2

    NCT01919164
    NCT01033994

26

The table below summarizes the main competitors we have identified
for Darnatein’s DRT-102. Each of these identified competitors are commercialized orthopedic solutions.

    Drug Name
     
    Company
     
    Mechanism
     
    Indication
  
    Infuse Bone Graft
     
    Medtronic
     
    rhBMP-2 and collagen sponge
     
    Spinal fusion, long bone fractures, orthopedic surgery
  
    Osteocel Plus
     
    NuVasive
     
    Demineralized bone matrix (DB