Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 16

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 16
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 uses for which the drug may be marketed or
to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials
and surveillance to monitor the safety and efficacy of the drug candidate. The regulatory authorities may also require risk management
plans or programs as a condition of approval of our drug candidates (such as REMS of the FDA and risk-management plan of the EMA), which
could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to
ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA,
NMPA, EMA, Health Canada or a comparable regulatory authority approves our drug candidates, we will have to comply with requirements including,
for example, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with
cGCP and cGMP, for any clinical trials that we conduct post-approval.

The FDA may impose consent
decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the
drug reaches the market. Later discovery of previously unknown problems with our drug candidates, including adverse events of unanticipated
severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements,
may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies
to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences
include, among other things:

  restrictions on the marketing or manufacturing of our drug candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;  
  fines, untitled or warning letters, or holds on clinical trials;                                                                                              
  refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;      
  product seizure or detention, or refusal to permit the import or export of our drug candidates; and                                                           
  injunctions or the imposition of civil or criminal penalties.                                                                                                 

The FDA strictly regulates
marketing, labeling, advertising and promotion of products that are placed on the market. Companies may promote drugs only for the approved
indications and in accordance with the provisions of the approved label and may not promote drugs for any off-label use, such as uses
that are not described in the product’s labeling and that differ