Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 309

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 309
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RW 4.38 billion and KRW 4.81 billion in the years ending December 31, 2023 and 2024, respectively, none of our other subsidiaries
have generated any revenues from product sales because none of their current product candidates have received marketing or other required
regulatory approvals anywhere in the world. We may never generate product revenue from the commercial sales of our pharmaceutical product
candidates or achieve profitability.

Our business is dependent on the success of our product candidates
that we advance into clinical trials and ultimately commercial distribution, which will require managing complex scientific, regulatory,
management, sales, licensing and other issues.

Our ability to execute on our business model and generate revenues
depends on a number of factors including our ability to:

●successfully develop new product candidates through our drug
development strategy and advance those product candidates into pre-clinical studies and clinical trials;

●successfully complete ongoing pre-clinical studies
and clinical trials and obtain regulatory approvals for our current and future product candidates;

●attract and retain experienced management and advisory teams;

●add operational, financial and management information systems
and personnel, including personnel to support clinical, pre-clinical manufacturing and planned future commercialization efforts
and operations;

●achieve market acceptance of product candidates in the medical
community and with third-party payors and consumers; and

●maintain, expand and protect our intellectual property portfolio.

If we cannot successfully execute any one of the foregoing, our business
may not succeed and the price of our common shares and warrants may be negatively impacted.

If one or more of our product candidates encounters safety or efficacy
problems, development delays, regulatory issues or other problems, our development plans and business could be significantly harmed. Before
we can generate any revenue from sales of any of our product candidates, we must undergo additional preclinical and clinical development,
regulatory review and approval in one or more jurisdictions. In addition, if one or more of our product candidates are approved, we must
ensure access to sufficient commercial manufacturing capacity and conduct significant marketing efforts in connection with any commercial
launch. These efforts will require substantial investment, and we may not have the financial resources to continue development of our
product candidates.

Drug development is a highly speculative business requiring substantial
investments that may not ever generate operating cash flow.

Investment in drug development is highly speculative because it entails
substantial upfront capital and operating expenditures and significant risk that any potential product candidate will fail to demonstrate