Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 59

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 59
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 and could significantly harm
our business, results of operations and prospects.

Even if we receive regulatory approval for our drug candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drug candidates.

If our drug candidates or
any future drug candidates we develop are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling,
packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy,
and other post-market information, including both federal and state requirements in the United States and requirements of comparable regulatory
authorities outside of the United States.

Manufacturers and manufacturers’
facilities are required to comply with extensive requirements from the FDA, NMPA, EMA, Health Canada and comparable regulatory authorities,
including, in the United States, ensuring that quality control and manufacturing procedures conform to cGMP regulations. As such, our
contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments
made in any NDA, other marketing application, and previous responses to inspection observations. Accordingly, we and others with whom
we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and
quality control.

Any regulatory approvals that
we receive for our drug candidates may be subject to limitations on the approved indicated uses for which the drug may be marketed or
to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials
and surveillance to monitor the safety and efficacy of the drug candidate. The regulatory authorities may also require risk management
plans or programs as a condition of approval of our drug candidates (such as REMS of the FDA and risk-management plan of the EMA), which
could entail requirements for long-term patient follow-up, a medication guide, physician communication plans or additional elements to
ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA,
NMPA, EMA, Health Canada or a comparable regulatory authority approves our drug candidates, we will have to comply with requirements including,
for example, submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with
cGCP and cGMP, for any clinical trials that we