Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 33

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 33
---
 testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising,
distribution, post-approval monitoring and reporting, marketing, pricing, export and import of drug products (“Regulated Products”),
such as those we are developing. Generally, before a new Regulated Product can be marketed, considerable data demonstrating its quality,
safety 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.

<div align='center'>S-18</div>

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