Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 60

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 60
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 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.                                       |

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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 from those approved by the regulatory authorities. However, physicians
may prescribe drug products for off-label uses and such off-label uses are common across some medical specialties. Thus, they may, unbeknownst
to us, use our product for an “off label” indication for a specific treatment recipient. The FDA, NMPA, EMA, Health Canada
and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and if we are
found to be out of compliance with the requirements and restrictions imposed on us under those laws and restrictions, we may be subject
to significant liability, including civil and administrative remedies as well as criminal sanctions, and the off-label use of our products
may increase the risk of product liability claims. In addition, management’s attention could be diverted from our business operations
and our reputation could be damaged.

The policies of the FDA, NMP