Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 42

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 42
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 The Affordable Care Act expanded the types of entities 
 eligible to receive discounted 340B pricing.                                                                                           |

The Affordable Care Act imposed a requirement on manufacturers of branded drugs to provide a 50% discount off the negotiated price of branded drugs dispensed to Medicare Part D patients in the coverage gap (i.e., the “donut hole”).

| ● | The Affordable Care Act imposed an annual, non-deductible                                                                                  
 fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their     
 market share in certain government healthcare programs, although this fee does not apply to sales of certain products approved exclusively 
 for orphan indications.                                                                                                                    |

<div align='center'>S-23</div>

In addition to these provisions,
the Affordable Care Act established a number of bodies whose work may have a future impact on the market for certain pharmaceutical products.
These include the Patient-Centered Outcomes Research Institute, established to oversee, identify priorities in, and conduct comparative
clinical effectiveness research, the Independent Payment Advisory Board, which has authority to recommend certain changes to the Medicare
program to reduce expenditures by the program, and the Center for Medicare and Medicaid Innovation within the Centers for Medicare and
Medicaid Services, to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

These and other laws may result
in additional reductions in healthcare funding, which could have a material adverse effect on customers for our product candidates, if
we gain approval for any of them. Although we cannot predict the full effect on our business of the implementation of existing legislation
or the enactment of additional legislation pursuant to healthcare and other legislative reform, we believe that legislation or regulations
that would reduce reimbursement for, or restrict coverage of, our products could adversely affect how much or under what circumstances
healthcare providers will use our product candidates if we gain approval for any of them.

Canadian Regulation

In Canada, our pharmaceutical
product candidates and our research and development activities are primarily regulated by the Food and Drugs Actand the rules
and regulations thereunder, which are enforced by Health Canada. Health Canada regulates, among other things, the research, development,
testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, post-approval monitoring, marketing
and import and export of pharmaceutical products. Drug approval laws require licensing of manufacturing facilities, carefully controlled
research and testing of products, government review and approval of experimental results prior to giving approval to sell drug products.
Regulators also typically require that rigorous