Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 45

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 45
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 and financial resources, and may take several years to complete. Data obtained from
preclinical and clinical testing are not always conclusive and may be susceptible to varying interpretations, which could delay, limit,
or prevent regulatory approval. Health Canada may not grant approval of an NDS on a timely basis, or at all. In Canada, NDSs are subject
to user fees and these fees are typically increased annually to reflect inflation.

Even if Health Canada approves
a product candidate, the relevant authority may limit the approved indications for use of the product candidate, require that contraindications,
warnings or precautions be included in the product labeling, including a black box warning, require that post-approval studies, including
Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs
to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management
mechanisms.

Health Canada may prevent or
limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types
of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject
to further testing requirements, notification, and regulatory authority review and approval. Further, should new safety information arise,
additional testing, product labeling or regulatory notification may be required.

European Union Regulation

Regulation in the European Union

The process governing approval
of medicinal products in the EU generally follows the same lines as in the United States. It entails satisfactory completion of pharmaceutical
development, non-clinical studies, and adequate and well-controlled clinical trials to establish the safety and efficacy of the medicinal
product for each proposed indication. It also requires the submission to relevant competent authorities for clinical trials authorization
and to the European Medicines Authority, or EMA, for a marketing authorization application, or MAA, and granting of a marketing authorization
by these authorities before the product can be marketed and sold in the EU.

<div align='center'>S-25</div>

Clinical Trial Approval

Pursuant to the currently applicable
Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on cGCP, a system for the approval of clinical trials in the EU (the
equivalent of the IND process in the United States) has been implemented through national legislation of the EU member states. Under
this system, an applicant must obtain approval from the competent national authority of an