Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 119

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 119
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 receive compensation in connection with such services. Under certain circumstances,
we may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities
may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected
the integrity of the study. The FDA or other regulatory authority may therefore question the integrity of the data generated at the applicable
clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection,
of our marketing applications by the FDA or other regulatory authority, as the case may be, and may ultimately lead to the denial of marketing
approval of any of our product candidates.

Negative results or safety signals in our clinical trials may
make it difficult or impossible to recruit and retain patients in our clinical trials.

Any negative results or new safety signals we may report in clinical
trials of our product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting.
Similarly, negative results reported by our competitors about their drug candidates may negatively affect patient recruitment in our clinical
trials. Also, marketing authorization of competitors in this same class of drugs may impair our ability to enroll patients into our clinical
trials, delaying or potentially preventing us from completing recruitment of one or more of our trials. Delays or failures in planned
patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability
to develop our product candidates, or could render further development impossible.

The results of our clinical trials may not support our proposed
claims for our product candidates, or regulatory approvals on a timely basis or at all, and the results of earlier studies and trials
may not be predictive of future trial results.

The results of pre-clinical studies and early clinical trials
of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stages
of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical and
initial clinical trials. In addition, results from clinical trials or pre-clinical studies may require further evaluation,
delaying the next stage of development or submission of an NDA/BLA or similar application. A future failure of a clinical trial to meet
its pre-specified endpoints would likely cause us to abandon our product candidates. Any delay in,