Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 128

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 128
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 related to quality control and assurance. If we are unable to obtain or maintain third-party manufacturing
for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates
successfully. Our or a third-party’s failure to execute on our manufacturing requirements and comply with cGMPs could adversely
affect our business in a number of ways, including:

●an inability to initiate or continue clinical trials of product
candidates under development;

●delay in submitting regulatory applications, or receiving
regulatory approvals, for product candidates;

●loss of the cooperation of an existing or future collaborator;

●subjecting third-party manufacturing facilities or our
manufacturing facilities to additional inspections by regulatory authorities;

66

●requirements to cease distribution or to recall batches of
our product candidates; and

●in the event of approval to market and commercialize a product
candidate, an inability to meet commercial demands for our products.

Changes in methods of product candidate manufacturing or formulation
may result in additional costs or delay.

As product candidates progress through preclinical to late stage clinical
trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing
methods and formulation, are optimized along the way in an effort to improve yield, manufacturing batch size, minimize costs and achieve
consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes
could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials
conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials
or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize
our ability to commercialize our product candidates and generate revenue.

In addition, there are risks associated with large scale manufacturing
for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility,
stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials. Even if we obtain
marketing approval for any of our product candidates, there is no assurance that our manufacturers will be able to manufacture the approved
product to specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities
to meet the requirements for the potential commercial launch of the product or to meet potential future demand.