Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 118

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 118
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 approvals. We do not know whether any of our clinical trials will
begin as planned, will need to be restructured or will be completed on schedule, or at all. If we do not achieve our product development
goals in the time frames we announce and expect, the approval and commercialization of our product candidates may be delayed or prevented
entirely. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize
our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully
commercialize our product candidates and harming our business and results of operations. Any delays in our clinical development programs
may harm our business, financial condition and results of operations significantly.

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Clinical trials and pre-clinical studies are very expensive, time-consuming,
and difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not
be able to conduct or complete clinical trials or pre-clinical studies on the expected timelines, if at all.

Clinical trials and pre-clinical studies are very expensive,
time-consuming and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The FDA,
an IRB or other regulatory authorities may not agree with the proposed analysis plans or trial design for the clinical trials of our product
candidates, and during any such review, may identify unexpected efficacy or safety concerns, which may delay 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