Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 36

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 36
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mg BMP-2/DBM treatment.
     
    2014.06.
01 ~ 2014.
10.31
     
    Pharmalegacy (China)

18

    Type of study
     
    Species
     
    Purpose
     
    Results
     
    Date
     
    Institution

    Mouse Calvaria Defect
     
    C3H mouse
     
    To evaluate the bone healing property of DRT-102 on Calvaria and Tibia osteotomy compared to rhBMP-2 in mouse.

    – No animals died due to surgery
     
    – No individuals showed abnormal changes in body weight.
     
    – Bone remodeling was observed in X-ray images after
    2 months post-surgery
     
    – The volume of new bone and the area of osteoid forming the
    new bone were more prominent than control group
     
    2014.08 ~
2014.10.15
     
    JCB (joint center for biosciences)

Clinical trial of DRT-102

Darnatein is conducting a single-blind, active-controlled, randomized,
multicenter confirmatory trial to evaluate the efficacy of DRT-102 for the treatment of Lumbar Spinal Fusion. The trial is being
conducted at Boramae Medical Center of Seoul National University, Inha University Hospital, and Soonchunhyang University Seoul Hospital.

The clinical trial of DRT-102 includes both exploratory and confirmatory
phases. The patient selection criteria for both studies are as follows:

Inclusion Criteria:

(1) Age between 30-80 years
old.

(2) Patients requiring one-level posterior
decompression and fusion between L1 and S1 due to severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis.

Exclusion Criteria:

(1) Average spine T-score< -2.5
on dual-energy X-ray absorptiometry (DEXA),

(2) History of cancer,

(3) Patient unable to discontinue anticoagulation
therapy,

19

(4) Female patients of childbearing
potential,

(5) Patients testing positive for DRT-102 antibody,

(6) Specific conditions, including
psychological problems.

Patients