Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 310

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 310
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adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. In addition, as a business
with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown
factors and risks frequently experienced by early-stage drug development companies in rapidly evolving fields.

Our product candidates will require substantial development time — including
extensive clinical, and in many cases pre-clinical, research and development — and resources before we would
be able to apply for or receive applicable regulatory approvals and begin generating revenue from product sales. Because of the numerous
risks and uncertainties associated with drug development, we are unable to predict precisely the timing or amount of increased expenses,
or when we will be able to generate any meaningful revenue or achieve or maintain profitability, if ever.

38

If we obtain regulatory approval for any of our product candidates,
we still may never achieve profitability.

If we do successfully obtain regulatory approval to market product
candidates, our revenue will be dependent upon, in part and among other things, the size of the markets in the geographic areas for which
we gain regulatory approval, the number of competitors in such markets, the accepted price for product candidates and whether we own the
commercial rights for those territories. If the indication approved by regulatory authorities is narrower than expected, or the treatment
population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of
our product candidates, even if approved (especially for products receiving orphan drug designations). We cannot assure you that we will
be profitable even if we successfully commercialize our product candidates.

Even if a product candidate we develop receives regulatory approval,
it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical
community necessary for commercial success.

Even if a product candidate we own or develop receives regulatory approval,
it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, such as Medicare and Medicaid
programs and managed care organizations, and others in the medical community. In addition, the availability of coverage by third-party payors
may be affected by existing and future health care reform measures designed to reduce the cost of health care. If the product candidates
we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable.

The degree of market acceptance of any product candidate, if approved