Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 10

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 10
---
 the FDA may accept data from clinical trials conducted outside the U. S. for our
New Drug Application (“ NDA”), acceptance of this data is subject to certain conditions imposed by the FDA. There can be no
assurance the FDA will accept data from any of the clinical trials we conduct outside the U. S. If the FDA does not accept the data from
any of our clinical trials conducted outside the U. S., it would likely result in the need for additional clinical trials in the U. S.,
which would be costly and time-consuming and could delay or prevent the commercialization of any of our drug candidates.

Risks Related to Obtaining Regulatory Approval
for Our Drug Candidates

The regulatory approval processes of the
FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities are lengthy, time-consuming and inherently unpredictable, and
if we are ultimately unable to obtain regulatory approval for our current drug candidates or any future drug candidates we may develop,
our business will be substantially harmed.

We cannot commercialize drug
candidates without first obtaining regulatory approval to market each drug from the FDA, NMPA, EMA, Health Canada or comparable regulatory
authorities. Before obtaining regulatory approvals for the commercial sale of any drug candidate for a target indication, we must demonstrate
in studies in animals and well-controlled clinical trials, and, with respect to approval in the United States and other regulatory agencies,
to the satisfaction of the FDA, NMPA, EMA, Health Canada or comparable regulatory authorities, that the drug candidate is safe and effective
for use for that target indication and that the manufacturing facilities, processes and controls are adequate.

The time required to obtain
approval from the FDA, NMPA, EMA, Health Canada and other comparable regulatory authorities is unpredictable but typically takes many
years following the commencement of studies in animals and clinical trials and depends upon numerous factors, including the substantial
discretion of the regulatory authorities.

In addition, approval policies,
regulations or the type and amount of clinical data necessary to gain approval can differ among regulatory authorities and may change
during the course of the development of a drug candidate. We have not obtained regulatory approval for any drug candidate. It is possible
that neither our existing drug candidates nor any drug candidates we may discover or acquire for development in the future will ever obtain
regulatory approval. Even if we obtain regulatory approval in one jurisdiction, we may not obtain it in other jurisdictions.

Our drug candidates could
fail to receive regulatory approval from any of the FDA,