Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 356

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 356
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 the approval of a New Drug
Application (“NDA”), a Biologic License Application (“BLA”) or similar application. The FDA may
also find that the benefits of any product candidate in any applicable indication do not outweigh its risks in a manner sufficient to
grant regulatory approval or may find that our proposed development program is not sufficient to support a marketing authorization application,
or that the proposed indication is considered to be too broad. Moreover, the FDA or other regulatory authorities may also refuse or impose
certain restrictions on our reliance on data supporting our marketing authorization application should such data originate from studies
outside of the relevant jurisdiction. In each case, this could delay the clinical development timeline for a given product candidate.

Our principal investigators for our clinical trials may also
serve as scientific advisors or consultants to our subsidiaries and investments, which may raise regulatory issues with the FDA or other
regulatory authorities.

Principal investigators for our clinical trials may serve as scientific
advisors or consultants to us from time to time and 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