Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 121

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 121
---
im data and final data could significantly harm our business prospects.

We may not be able to file INDs or IND amendments or comparable
applications to commence clinical trials on the timelines we expect, and even if we are able to, the FDA or other regulatory authorities
may not permit us to proceed.

We may not be able to file Investigational New Drug (“IND”)
applications or other comparable applications for our product candidates on the timelines we expect. For example, we or our third party
collaborators may experience manufacturing delays or other delays with IND-enabling studies or FDA or other regulatory authorities
may require additional preclinical studies that we did not anticipate. Moreover, we cannot be sure that submission of an IND or other
comparable application will result in the FDA or other regulatory authorities allowing clinical trials to begin, or that, once begun,
issues will not arise that result in a decision by us, by institutional review boards or independent ethics committees, or by the FDA
or other regulatory authorities to suspend or terminate clinical trials, including as a result of a clinical hold. Additionally, even
if FDA or other regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or comparable
application, we cannot guarantee that they will not change their requirements or expectations in the future. These considerations also
apply to new clinical trials we may submit as amendments to existing INDs or to a new IND or other comparable application. Any failure
to file INDs or other comparable applications on the timelines we expect or to obtain regulatory approvals for our trials may prevent
us from completing our clinical trials or commercializing our products on a timely basis, if at all.

We may in the future seek orphan drug designation for our product
candidates, but we may be unable to obtain orphan drug designation and, even if we obtain such designation, we may not be able to realize
or maintain the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.

Regulatory authorities in some jurisdictions, including the United States
and other major markets, may designate products intended to treat conditions or diseases affecting relatively small patient populations
as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a drug or biologic product candidate as an orphan
drug if it is intended to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000
individuals in the United States, or a patient population greater than