Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 415

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 415
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 the 0.05 and 0.15 mg/animal dose groups, and in 24 days for the 0.5 mg/animal dose group. |     | 2024.09.03 |

DRT -102for Bone Regeneration DRT -102is an investigational product classified as a medical device product by the Ministry of Food and Drug Safety of the Republic of Korea (“MFDS”). DRT -102is composed of freeze -driedAB204 protein, that promotes bone formation, and a synthetic bone graft in granular form. The AB protein (AB204) is a synthetic protein, created by fusing Activin and BMP -2, both members of the BMP (Bone Morphogenetic Protein) family, growth factors by Darnatein’s segmental reassembly technology. AB204 combines BMP’s type II receptor binding with activin A’s high -affinitytype II receptor binding. It induces significantly greater and longer -lastingSmad 1/5/8 phosphorylation in osteoblastic cells compared to BMP2, promoting mineral calcium nodule formation crucial for bone apatite formation. Unlike BMP2, AB204 is unaffected by noggin by design and also inhibits activin signaling, which further enhances its bone formation and is noteworthy since activin antagonism itself can promote bone formation. When used in conjunction with existing synthetic bone grafts, it facilitates the generation of new bone and can aid in fracture healing. The synthetic bone graft uses approved products and is composed of hydroxyapatite and beta -tricalciumphosphate, with internal pores connected in a three -dimensionalstructure. By coating a highly bioactive and absorbable ß -TCPon an HA scaffold that can support structurally for a long period with excellent biocompatibility and slow biodegradation, it enables rapid initial bone bonding and long -termsupport dynamics. DRT -102pre -clinicalstudy for toxicity measurement in animal models The toxicity test of DRT -102was conducted with multiple institutions including KTR (Korea Chemical Corporation), KIT (Korea Institute of Toxicology), and ChemOn. The purpose of this study is to evaluate the potential toxicity and determine the dose levels for a repeated toxicity study of DRT -102, when intravenously administered to rats and Beagles(non -rodents) The table below outlines the type, species, purpose and results of the pre -clinicaltoxicology studies so far.

| Type of study                                                   |     | Species     |