Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 352

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 352
---
 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
experienced by early-stage companies in rapidly evolving fields. Consequently, we have no meaningful history of drug development
operations experience upon which to evaluate our drug development business, and predictions about its future success or viability may
not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing therapeutic
products.

Our product candidates will, of necessity, be subjected to pre-clinical and
clinical trials prior to commercialization. Delays in those trials, or if the results of the trials raise regulatory issues, may adversely
impact our results of operations and financial condition.

We may experience setbacks that could delay or prevent regulatory approval
of, or our ability to commercialize, our product candidates, including:

●timely completion of our preclinical studies and clinical trials;

●negative or inconclusive results from our preclinical studies
or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct
additional preclinical testing or clinical trials or abandon a program;

●the prevalence, duration and severity of potential product-related side
effects experienced by participants receiving our product candidates in our clinical trials or by individuals using drugs or therapeutics
similar to our product candidates;

●delays in submitting Investigational New Drug (“IND”)
or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial,
or a suspension or termination of a clinical trial once commenced;

●conditions imposed by the FDA