Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 242

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 242
---
, the level of payment may not be sufficient to allow a company to sell its products at a
profit.

The U.S. government and
state legislatures have shown significant interest in implementing cost containment programs to limit the growth of government-paid health
care costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded
prescription drugs. Adoption of government controls and measures, and tightening of restrictive policies in jurisdictions with existing
controls and measures, could limit payments for pharmaceuticals.

Even if favorable coverage
and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies
and reimbursement rates may be implemented in the future. Unfavorable coverage or reimbursement policies regarding any of the Company’s
products would have a material adverse impact on the value of that product.

Other Healthcare Laws and Compliance Requirements

If we obtain regulatory approval
of our products, we may be subject to various federal and state laws targeting fraud and abuse in the healthcare industry. These laws
may impact, among other things, our proposed sales, marketing and education programs. In addition, we may be subject to patient privacy
regulation by both the federal government and the states in which we conduct our business.

Patient Protection and the Affordable Care Act

The Affordable Care Act, enacted
in March 2010, includes measures that have or will significantly change the way health care is financed in the United States
by both governmental and private insurers. Among the provisions of the Affordable Care Act of greatest importance to the pharmaceutical
industry are the following:

| ● | The Medicaid Drug Rebate Program requires pharmaceutical manufacturers                                                                        
 to enter into and have in effect a national rebate agreement with the Secretary of the Department of Health and Human Services as a condition 
 for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid patients. The Affordable           
 Care Act increased pharmaceutical manufacturers’ rebate liability on most branded prescription drugs from 15.1% of the average                
 manufacturer price to 23.1% of the average manufacturer price, added a new rebate calculation for line extensions of solid oral dosage        
 forms of branded products, and modified the statutory definition of average manufacturer price. The Affordable Care Act also expanded         
 the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers to pay rebates on Medicaid managed     
 care utilization and expanding the population potentially eligible for Medicaid drug benefits.                                                |

| ● | In order for a pharmaceutical product to receive federal reimbursement                                                                 
 under the Medicare Part B and Medicaid programs or to