Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 418

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 418
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 the difference in success rates between the control and test groups. Finally, in the largest sample size of 60 patients, the p -valuereaches 0.002, demonstrating a statistically significant difference. Throughout the analysis, the test group outperformed the control group in success rates. Development plans for DRT-101 and DRT-102 Based on preliminary tests of DRT -101and DRT -102, Darnatein intends to expand the potential application of DRT -101to other cartilage regeneration targets, including spinal cartilage in the treatment of lower back pain. Darnatein may, depending upon securing additional financial resources and other opportunities requiring investment, expand the potential application of DRT -102to other bone regeneration targets, including non -fusionbone fracture in the treatment of deformed bone tissue. Darnatein’s strategy generally involves the following key steps: 1.Identify novel drug candidate for cartilage- and bone -degenerativedisorders: Darnatein will leverage its expert knowledge and experience in tissue regenerative medicine to identify new cartilage- and bone -degenerativedisorders that can be targeted by Darnatein’s DRT -101and DRT -102platforms. 2.Conduct preclinical studies with the FDA’s good laboratory practice (“GLP”) regulations: Before testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre -clinicaltesting. The pre -clinicaldevelopmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the

262 potential for adverse events and, in some cases, to establish a rationale for therapeutic use. The conduct of pre -clinicalstudies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. Darnatein will first perform preclinical studies to evaluate the safety, immunogenicity, and efficacy of regenerating the new target tissue candidates. 3.File an Investigational New Drug (IND) application: Upon the successful completion of preclinical studies, Darnatein will submit an IND application to regulatory authorities such as the FDA. IND is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to proceed by the FDA before human clinical trials may begin. This submission includes all relevant data from preclinical studies and outlines the proposed clinical trial protocols. The IND review period typically takes 30 days, during which