Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 239

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 239
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 a hearing.

If after such review a product
receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may
otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications,
warnings or precautions be included in the product labeling. Any products for which we receive the FDA approval would be subject to continuing
regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product,
providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain
electronic records and signature requirements and complying with the FDA promotion and advertising requirements. In addition, the FDA
may require post-approval studies, including Phase 4 clinical trials, to further assess a product’s safety and effectiveness
after NDA approval and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.
The FDA also may conclude that an NDA may only be approved with a Risk Evaluation and Mitigation Strategy designed to mitigate risks through,
for example, a medication guide, physician communication plan, or other elements to assure safe use, such as restricted distribution methods,
patient registries and other risk minimization tools.

Post-Approval Requirements

Any products for which we receive
the FDA approval are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting
of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution
requirements, complying with certain electronic records and signature requirements and complying with the FDA promotion and advertising
requirements. The FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on
the market. Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. Further,
manufacturers must continue to comply with cGMP requirements, which are extensive and require considerable time, resources and ongoing
investment to ensure compliance. In addition, changes to the manufacturing process generally require prior the FDA approval before being
implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also
subject to further the FDA review and approval.

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The FDA may withdraw a product
approval if compliance with regulatory requirements is not maintained or if problems occur after the product reaches the market. Later
discovery of previously