Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 15

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 15
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 and may harm our reputation, business, financial condition and
business prospects significantly.

Additionally, if any of our
current or future drug candidates receives regulatory approval, and we or others later identify undesirable side effects caused by such
drugs, a number of potentially significant negative consequences could result, including but not limited to:

  suspending the marketing of the drug;                                                                                                                                                                 
  having regulatory authorities withdraw approvals of the drug;                                                                                                                                         
  adding warnings on the label;                                                                                                                                                                         
  developing a REMS for the drug or, if a REMS is already in place, incorporating additional requirements under the REMS, or to develop a similar strategy as required by a comparable regulatory a...  
  conducting post-market studies;                                                                                                                                                                       
  being sued and held liable for harm caused to subjects or patients; and                                                                                                                               
  damage to our reputation.                                                                                                                                                                             

Any of these events could
prevent us from achieving or maintaining market acceptance of the particular drug candidate, if approved, and could significantly harm
our business, results of operations and prospects.

Even if we receive regulatory approval for
our drug candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant
additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems
with our drug candidates.

If our drug candidates or
any future drug candidates we develop are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling,
packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy,
and other post-market information, including both federal and state requirements in the United States and requirements of comparable regulatory
authorities outside of the United States.

Manufacturers and manufacturers’
facilities are required to comply with extensive requirements from the FDA, NMPA, EMA, Health Canada and comparable regulatory authorities,
including, in the United States, ensuring that quality control and manufacturing procedures conform to cGMP regulations. As such, our
contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments
made in any NDA, other marketing application, and previous responses to inspection observations. Accordingly, we and others with whom
we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and
quality control.

Any regulatory approvals that
we receive for our drug candidates may be subject to limitations on the approved indicated