Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 360

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 360
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 condition.

63

We may seek orphan drug designation for some of our future product
candidates in which there is a medically plausible basis for the use of these products. We may be unable to obtain and maintain orphan
drug designation and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential
marketing exclusivity of our product candidates, if approved.

Even if we obtain orphan drug exclusivity for a product candidate,
that exclusivity may not effectively protect the product candidate from competition because different drugs can be approved for the same
condition in the United States. Even after an orphan drug is approved, the FDA may subsequently approve another drug for the same
condition if the FDA concludes that the latter drug is not the same drug or is clinically superior in that it is shown to be safer, more
effective or makes a major contribution to patient care.

We face substantial competition, which may result in others discovering,
developing or commercializing products before or more successfully than us.

The development and commercialization of new drug products is highly
competitive. We may face competition with respect to any product candidates that we seek to develop or commercialize in the future from
major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Potential competitors also
include academic institutions, venture capital firms, hedge funds, government agencies, and other public and private research organizations
that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and
commercialization.

There are a number of large pharmaceutical and biotechnology companies
that are currently pursuing the development of products, or already have products in the market, for the diseases in oncology and immunology.
Although we believe that our approaches are or will be unique, there is no assurance that they will demonstrate advantages or even parity
against competitive products from other companies.

Many of our current or potential competitors, either alone or with
their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical
testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology industries
may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies
may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These
competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial
sites and patient registration for