Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 84

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 84
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 relating to the manufacture
of our drug candidates may occur in the future. Additionally, our manufacturers may experience manufacturing difficulties due to resource
constraints, or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these
difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide our drug candidate to patients in
clinical trials would be jeopardized. Any delay or interruption in the manufacturing of clinical trial supplies could delay the completion
of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require
us to begin new clinical trials with additional costs or terminate clinical trials completely.

Review of changes in the manufacturing process of our drug candidates could cause delays resulting from the need for additional regulatory approvals.

Changes in a process or procedure
for manufacturing one of our drug candidates, including a change in the location where the drug candidate is manufactured or a change
of a contract manufacturer, could require prior review by the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities
and approval of the manufacturing process and procedures in accordance with the FDA, NMPA, EMA, or Health Canada’s regulations,
or comparable requirements. This review may be costly and time-consuming and could delay or prevent the launch of a product. The new facility
will also be subject to pre-approval inspection. In addition, we would have to demonstrate that the product made at the new facility is
equivalent to the product made at the former facility by physical and chemical methods, which are costly and time-consuming. It is also
possible that the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities may require clinical testing as a way to prove
equivalency, which would result in additional costs and delay.

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Risks Related to Our Industry, Business and Operation

If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

Our research and development
operations involve the use of hazardous materials, chemicals and various radioactive compounds/radiation. Our R&D Center may maintain
quantities of various flammable and toxic chemicals in our facilities that are required for our research, development and manufacturing
activities. We are subject to local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous
materials and of medical waste at the jurisdictions where we operate our research facilities, which are currently