Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 351

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 351
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 selling certain products and product candidates outside of the United States,
which could limit our growth potential and increase our development costs.

The failure to comply with laws governing international business practices
may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend
or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

Risks Related to the Development of the Company’s Product
Candidates

The following risk factors reference the risks and uncertainties
relating to the development of product candidates by OSR, which, following the closing of the Business Combination, will be the development of
product candidates by the Company. References in this section to “we,” “us,” and “our” refer to OSR
prior to the closing of the Business Combination and to the Company after closing.

Our business includes subsidiaries that are developing oral immunotherapies
for the treatment of cancer and design-augmented biologics. These companies have a limited operating history, and their programs
are in early stages of development. This may make it difficult to evaluate our prospects and likelihood of success.

Our business includes subsidiaries that are (i) developing oral
immunotherapies for the treatment of cancer, and (ii) developing design-augmented biologics for age-related and other degenerative
diseases. Each of these subsidiaries is an early-stage company with a limited operating history, has no pharmaceutical products approved
for commercial sale and has not generated any revenue from sales of its products. Our approach to the discovery and development of any
therapeutic product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value. These
product candidates will require substantial additional development and clinical research time and resources before we would be able to
apply for or receive regulatory approvals and begin generating revenue from product sales. We do not yet have substantial experience progressing
therapeutic product candidates through clinical trials. We may be unable to demonstrate safety and efficacy in clinical trials, obtain
regulatory approval, manufacture at a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing
activities necessary for successful product commercialization of any of our product candidates.

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We have not yet demonstrated the ability to progress any therapeutic
product candidate through clinical trials to regulatory approval. Our oral immunotherapy candidates and design-augmented