Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 140

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 140
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product candidates and our research and development activities are primarily regulated by the Food and Drugs Actand
the rules and regulations thereunder, which are enforced by Health Canada. Health Canada regulates, among other things, the research,
development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, post-approval monitoring,
marketing and import and export of pharmaceutical products. Drug approval laws require licensing of manufacturing facilities, carefully
controlled research and testing of products, government review and approval of experimental results prior to giving approval to sell drug
products. Regulators also typically require that rigorous and specific standards such as Good Manufacturing Practices (GMP), Good Laboratory
Practices, or GLP, and Good Clinical Practices, or GCP, are followed in the manufacture, testing and clinical development, respectively,
of any drug product. The processes for obtaining regulatory approvals in Canada, along with subsequent compliance with applicable statutes
and regulations, require the expenditure of substantial time and financial resources.

The principal steps required for drug
approval in Canada is as follows:

Preclinical Toxicology Studies

Non-clinical studies
are conducted in vitroand in animals to evaluate pharmacokinetics, metabolism and possible toxic effects to provide
evidence of the safety of the drug candidate prior to its administration to humans in clinical studies and throughout development. Such
studies are conducted in accordance with applicable laws and GLP.

Initiation of Human Testing

In Canada, the process of
conducting clinical trials with a new drug cannot begin until we have received a NOL (No objection Letter) from Health Canada, typically
within 30 days (during Covid the 30 days extended to 45 days) of a CTA submission. Similar regulations apply in Canada to a CTA as to
an IND in the United States. Once approved, two key factors influencing the rate of progression of clinical trials are the rate at which
patients can be enrolled to participate in the research program and whether effective treatments are currently available for the disease
that the drug is intended to treat. Patient enrollment is largely dependent upon the incidence and severity of the disease, the treatments
available and the potential side effects of the drug to be tested and any restrictions for enrollment that may be imposed by regulatory
agencies.

Clinical Trials

Similar regulations apply
in Canada regarding clinical trials as in the United States. In Canada, Research Ethics Boards, or REBs, instead of IRBs, are used to
review and approve clinical trial plans. Clinical trials involve the administration of an