Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 137

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 137
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 may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly
referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent
term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining
term of a patent beyond a total of 14 years from the product’s approval date.

In addition, the FDCA provides
a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for
a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active
moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not
accept for review an abbreviated new drug application (“ ANDA”) or a 505(b)(2) Application submitted by another company for
another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.

In the future, if appropriate,
we intend to apply for restorations of patent term and/or marketing exclusivity for some of our products; however, there can be no assurance
that any such extension or exclusivity will be granted to us.

Disclosure of Clinical Trial Information

Sponsors of clinical trials
of the FDA-regulated products, including drugs are required to register and disclose certain clinical trial information, which is publicly
available at www. clinicaltrials. gov. Information related to the product, patient population, phase of investigation, study sites and investigators,
and other aspects of the clinical trial is then made public as part of the registration. Sponsors are also obligated to disclose the results
of their clinical trials after completion. Disclosure of the results of these trials can be delayed until the new product or new indication
being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development
programs.

Pharmaceutical Coverage, Pricing and Reimbursement

Much of the revenue generated
by new Regulated Products depends on the willingness of third-party payors to reimburse the price of the product. Significant uncertainty
exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. In the United States,
sales of any products for which we may receive regulatory