Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 411

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 411
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 and cartilage. BMPs have been used clinically in orthopedic procedures but they are typically administered at high, supra -physiologicalconcentrations that have been linked to undesirable local and systemic side effects. BMPs engineered to have enhanced therapeutic potency may circumvent this problem and provide the desired effects of healing bone and cartilage while minimizing the likelihood of adverse events. DRT -101for Cartilage and Joint Recovery DRT -101is a synthetic bio -signalingmolecule that replaces BMPRII -bindingsegments of BMP -7, one of the bone -formingproteins, with high affinity ActRII binding segments of Activin A, a member of the transforming growth factor ß (TGF -ß). In nature, endogenous BMP7 promotes chondrogenesis in damaged cartilage tissue by signaling primarily via the type II receptor BMPRII and to a lesser extent via the activin type II receptor ActRII, which it binds with lower affinity. DRT -101amplifies intracellular regeneration signaling capacity compared to natural BMP -7and allows for regeneration and restoration of mechanically depleted cartilage cells to normal levels. DRT -101pre -clinicalstudy in animals DRT -101was evaluated in Sprague Dawley rats by ChemOn Inc. in 2021 for toxicity measurement. This study was conducted to assess the approximate lethal dose (ALD) and the dose -rangefinding(DRF) of the test substance DRT -101, when administered intravenously. 252

The table below lists the type, species, purpose and results of our completed pre -clinicaltoxicology studies from 2021 -2022. These studies were conducted with the assistance of Chemon Inc., a GLP -licensedthird -partyvendor.

| Type of Study                                                                      |     | Species             |     | Purpose                                                                                                                                                                                           |     | Results                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |     | Period      |
| Single Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley Rats            |     | Sprague Dawley Rats |     | Assess the toxicity of the test substance DRT-101 when administered intravenously to Sprague-Dawley Rats                                                                                          |     | The approximate lethal dose (ALD) was determined to exceed 10mg/kg for both males and females.                                                                                                                                                                                                                                                                                                                                                                                                                  |     | 2021.03.05- 
 2021.05.11  |
| Single Dose Intravenous Toxic