Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 359

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 359
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 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 200,000 in the United States where there is no reasonable
expectation that the cost of developing the product will be recovered from sales in the United States. Orphan drug designation must
be requested before submitting a marketing application. In the United States, orphan drug designation entitles a party to financial
incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. After the FDA
grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the
FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

Generally, if a product candidate with an orphan drug designation
receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing
exclusivity, which precludes the FDA or foreign regulatory authorities from approving another marketing application for a product that
constitutes the same drug treating the same indication for a period of seven (7) years, except in limited circumstances, such as
a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient
product quantity. Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially
defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease
or