Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 114

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 114
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 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.

59

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 biologics
are still in early-stage development and may not be able to obtain regulatory approval. Neither OSR nor any of its subsidiaries have
(1) manufactured any product on a commercial scale, (2) contracted with a third party to produce any product on a commercial
scale (we have contracted with a third party for limited quantities of our products necessary for testing and clinical trials), or (3) conducted
sales and marketing activities for approved therapeutic products (RMC does conduct sales and marketing activities for medical devices
designed and manufactured by third parties).

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