Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 41

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 41
---
 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 the regulatory agency evaluates the submission to ensure the safety of proceeding to human trials.

4. Initiate clinical trials:
Based on the preclinical data, Darnatein will design and conduct additional Phase 1 clinical trials to assess the safety, tolerability,
and preliminary efficacy of its regeneration of those new tissue candidates.

5. Conduct Phase 2
and Phase 3 clinical trials: Phase 2 trials are designed to determine if the new treatment has sufficiently promising efficacy
to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety. These studies
usually involve a few hundred patients. Phase 2 trials also generate insights on adverse events and their management, the diseases
in which the treatment is effective, and the best regimen for future use in a later phase, depending on the trial design.

Phase 3 trials are large-scale, randomized, controlled
studies designed to provide additional supporting evidence of the efficacy and safety of therapeutic candidates. These trials typically
involve hundreds to thousands of patients and are typically conducted at multiple hospital sites worldwide.

Darnatein will work closely with clinical investigators, regulatory
authorities, and patient advocacy groups to design and execute initially Phase 2 and seek to continue with Phase 3 clinical
trials based on evaluation of Phase 2 studies for its tissue targets.

6. Seek regulatory approval:
Following the successful completion of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials,
together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other
things, are submitted to authorities, such as the FDA or EMA. This stage is known as the New Drug Application (NDA) review.

23

Based on these steps and the timeline for regulatory approvals, Darnate