Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 43

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 43
---
 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 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.

<div align='center'>S-24</div>

The manufacture of investig