Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 348

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 348
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 may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize
their full market potential.

In order to market any products outside of the United States,
we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Clinical
trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country
does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries and can involve
additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approvals could result
in significant delays, difficulties and costs for us and may require additional preclinical studies or clinical trials which would be
costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction
of our products in those countries. Satisfying these and other regulatory requirements is costly, time-consuming, uncertain and subject
to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negative effects on the
process for regulatory approval in other countries. We do not have any product candidates approved for sale in any jurisdiction, including
international markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply with
regulatory requirements in international markets or to obtain and maintain required approvals, our ability to realize the full market
potential of our products will be harmed.

EU drug marketing and reimbursement regulations may materially
affect our ability to market and receive coverage for our products in the European member states.

We intend to seek approval to market our product candidates in both
the United States and in selected foreign jurisdictions, where we will become subject to rules and regulations in those jurisdictions.
In some foreign countries, particularly those in the EU, the pricing of drugs is subject to governmental control and other market regulations
which could put pressure on the pricing and usage of our product candidates. In these countries, pricing negotiations with governmental
authorities can take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and sales
of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors
for our product candidates and may be affected by existing and future health care reform measures. There can be no assurance that any
country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing
arrangements for any of our products.

The