Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 213

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 213
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 and efficacy must be obtained, organized to address the requirements of and in the format specific to each regulatory authority,
submitted for review and approved by the regulatory authority. This process is very lengthy and expensive, and success is uncertain.

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Regulated Products are also
subject to other federal, state and local statutes and regulations in the United States and other countries, as applicable. The process
of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations
require the expenditure of substantial time and financial resources. Failure to comply with the applicable regulatory requirements at
any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial
sanctions. These sanctions could include, among other actions, the regulatory authority’s refusal to approve pending applications,
withdrawal of an approval, clinical holds, untitled or warning letters, voluntary product recalls or withdrawals from the market, product
seizures, total or partial suspension of production or distribution, injunctions, disbarment, fines, refusals of government contracts,
restitution, disgorgement, or civil or criminal penalties. Any such administrative or judicial enforcement action could have a material
adverse effect on us.

As part of the Company’s
principal place of business is in Hong Kong, the Company is subject to various Hong Kong laws and regulation covering its business activities
there, described in further detail below. Also, the Company anticipates that, if it obtains marketing approval for any of its drug candidates,
it intends to focus its marketing and sales efforts primarily in three regions: the United States, Canada, Europe and PRC. The regulatory
framework for each of these regions is described below.

U.S. Drug Development Process

The process of obtaining regulatory
approvals and maintaining compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial
time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process,
approval process, or after approval, may subject an applicant to administrative or judicial sanctions or lead to voluntary product recalls.
Administrative or judicial sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval,
a clinical hold, untitled or warning letters, product seizures, total or partial suspension of production or distribution, injunctions,
fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before
a