Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 220

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 220
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 be delayed until the new product or new indication
being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development
programs.

Pharmaceutical Coverage, Pricing and Reimbursement

Much of the revenue generated
by new Regulated Products depends on the willingness of third-party payors to reimburse the price of the product. Significant uncertainty
exists as to the coverage and reimbursement status of any products for which we may obtain regulatory approval. In the United States,
sales of any products for which we may receive regulatory approval for commercial sale will depend in part on the availability of coverage
and reimbursement from third-party payors. Third-party payors include government authorities, managed care providers, private health insurers
and other organizations. The process for determining whether a payor will provide coverage for a product may be separate from the process
for setting the reimbursement rate that the payor will pay for the product. Third-party payors may limit coverage to specific products
on an approved list, or formulary, which is not required to include all of the FDA-approved products for a particular indication. Moreover,
a payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate
third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our
investment in product development.

Third-party payors are increasingly
challenging the price and examining the medical necessity and cost- effectiveness of medical products and services, in addition to their
safety and efficacy. To obtain coverage and reimbursement for any product that might be approved for sale, we may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of any products, in addition to the costs
required to obtain regulatory approvals. Our product candidates may not be considered medically necessary or cost-effective. If third-party
payors do not consider a product to be cost-effective compared to other available therapies, they may not cover the product after approval
as a benefit under their plans or, if they do, 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