Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 6

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 6
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 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 conducted at multiple sites worldwide. Vaximm will
work closely with clinical investigators, regulatory authorities, and patient advocacy groups to design and execute Phase 3 clinical
trials for its oral cancer vaccine candidates.

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.

Regulatory Steps

New Drug Application

A New Drug Application (NDA) tells the full story of a drug. Its purpose
is to demonstrate that a drug is safe and effective for its intended use in the population studied.

A drug developer must include everything about a drug — from
preclinical data to Phase 3 trial data — in an NDA. Developers must include reports on all studies, data, and
analyses. Along with clinical results, developers must include proposed labeling, safety updates, drug abuse information, patent information,
any data from studies that may have been conducted in other countries, institutional review board compliance information and directions
for use

NDA Review

Once each authority such as FDA or EMA receives an NDA, the review
team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review
team has 6 to 10 months to make a decision on whether to approve the drug. The process includes the following:

●Each member of the review team conducts a full review of his
or her section of the application. For example, the medical officer and the statistician review clinical data, while a pharmacologist
reviews the data from animal studies. Within each technical discipline represented on the team, there is also a supervisory review.

●FDA or EMA inspectors travel to clinical study sites to conduct
a routine inspection. The Agency looks for evidence of fabrication, manipulation, or withholding of data.

●The project manager assembles all individual reviews and other
documents, such as the inspection report, into an “action package.” This document becomes the record for