Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 413

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 413
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 01 ~ 2014. 
 10.31      |     | Pharmalegacy (China)               |

258

| 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 -102for 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 -102includes both exploratory and confirmatory phases. The patient selection criteria for both studies are as follows: Inclusion Criteria: (1)Age between 30 -80years old. (2)Patients requiring one -levelposterior 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 -energyX -rayabsorptiometry (DEXA), (2)History of cancer, (3)Patient unable to discontinue anticoagulation therapy, (4)Female patients of childbearing potential, (5)Patients testing positive for DRT -102antibody, (6)Specific conditions, including psychological problems. Patients were regularly followed up at2,12, 24 and 48 weeks postoperatively. Patients were divided into two groups: TLIF (Transforaminal Lumbar Interbody Fusion) performed with or without the use of