Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 141

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 141
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 investigational new drug to human subjects under
the supervision of qualified investigators in accordance with current Good Clinical Practices, or cGCP, requirements, which include review
and approval by REBs. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the trial
procedures, the parameters to be used in monitoring safety and the efficacy criteria to be evaluated and a statistical analysis plan.
Human clinical trials are typically conducted in three sequential phases, as discussed above in similar context to government regulation
in the United States.

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