Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 245

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 245
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, as discussed above in similar context to government regulation
in the United States.

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The manufacture of investigational
drugs for the conduct of human clinical trials is subject to current Good Manufacturing Practice, or cGMP, requirements. Investigational
drugs and active pharmaceutical ingredients imported into Canada are also subject to regulation by Health Canada relating to their labeling
and distribution. Post authorization requirements include reporting of serious adverse events and clinical trial site inspection program.
Phase 1, Phase 2 and Phase 3 clinical trials are subject to a clinical trial application (CTA) for each phase of study.
Furthermore, in Canada, Health Canada or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including
a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an REB can suspend or terminate approval
of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the REB’s requirements or
if the drug has been associated with unexpected serious harm to subjects. Additionally, some clinical trials are overseen by an independent
group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group regularly
reviews accumulated data and advises the study sponsor regarding the continuing safety of trial subjects, potential trial subjects and
the continuing validity and scientific merit of the clinical trial. We may also suspend or terminate a clinical trial based on evolving
business objectives or competitive climate.

New Drug Submission (NDS)

Upon successful completion
of Phase 3 clinical trials, in Canada the company sponsoring a new drug then assembles all the preclinical and clinical data and
other testing relating to the product’s pharmacology, chemistry, manufacture, and controls, and submits it to Health Canada as part
of a New Drug Submission, or NDS. The NDS is then reviewed by Health Canada for approval to market the drug.

As part of the approval process,
an additional application for a Drug Establishment License (DEL) 90 days prior the NDS submission to Health Canada to initiate review
and inspection of the facility or the facilities at which the drug is manufactured are compliant with GMP requirements. Health Canada
will not approve the product unless compliance with cGMP — a quality system regulating manufacturing — is
satisfactory and the NDS contains data that provide substantial evidence that the drug is safe and effective in the indication studied.
In addition, before approving an NDS, Health Canada will typically