Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 7

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 7
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 NDA review. The
review team issues a recommendation, and a senior official makes a decision.

NDA Approval

In cases where FDA or EMA determines that a drug has been shown to
be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information.
This is referred to as “labeling.” Labeling accurately and objectively describes the basis for approval and how best to use
the drug.

5

FDA Advisory Committees

Often, the NDA contains sufficient data for FDA or EMA to determine
the safety and effectiveness of a drug. Sometimes, though, questions arise that require additional consideration. In these cases, FDA
or EMA may organize a meeting of one of its Advisory Committees to get independent, expert advice and to permit the public to make comments.
These Advisory Committees include a Patient Representative that provides input from the patient perspective.

The estimated timeframe for this process is as follows:

●Antigen discovery and vaccine formulation: 1-2 years

●Preclinical studies: 1-2 years

●IND filing and review: 1 month

●Phase 1/2 clinical trials: 2-3 years

●Phase 3 clinical trials: 2-3 years

●Regulatory approval (including NDA review): 1 year

Based on this timeline, Vaximm anticipates that its first oral cancer
vaccine candidate beyond VXM01 could enter clinical trials within the next 3-5 years, with potential regulatory approval in
the next 7-9 years.

Clinical Trials

Overview of VXM01 clinical trial

A phase1 clinical trial of VXM01 in Glioblastoma was initiated in May 2016
(ClinicalTrials.gov ID: NCT02718443). The trial was conducted at the Neurology Clinic and National Center for Tumor Diseases in Heidelberg,
Germany, and the principal investigator is Dr. Wolfgang Wick, MD, who is a professor at the Neurology Clinic and National Center
for Tumor Diseases.

The phase I clinical trial was evaluated for 14 patients with
recurrent glioblastoma who had progressed after standard treatment and were candidates for reoperation. The primary objective of the study
was to examine the safety and tolerability of the investigational VEGFR2 DNA vaccine VXM01 after four vaccinations in glioblastoma patients.
The secondary objective was to examine the immune and biom