Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 132

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 132
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 to administrative or judicial sanctions or lead to voluntary product recalls.
Administrative or judicial sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval,
a clinical hold, untitled or warning letters, product seizures, total or partial suspension of production or distribution, injunctions,
fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before
a drug may be marketed in the United States generally involves the following:

  completion of non-clinical laboratory tests, preclinical studies according to cGLP and manufacturing of clinical supplies according to cGMP;  

  submission to the FDA of an IND, which must become effective before human clinical trials may begin;  
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  approval by an independent IRB, at each clinical site before each trial may be initiated;  
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  performance of adequate and well-controlled human clinical trials according to cGCP, to establish the safety and efficacy of the proposed product for its intended use;  
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  preparation and submission to the FDA of an NDA, for a drug;  

  satisfactory completion of an FDA advisory committee review, if applicable;  

  satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP; and  

  payment of user fees and the FDA review and approval of the NDA.  

The testing and approval process
requires substantial time, effort and financial resources and we cannot be certain that any approvals for our drug candidates, or any
future drug candidates we may develop, will be granted on a timely basis, if at all.

Once a drug candidate is identified
for development, it enters the non-clinical testing stage. Non-clinical tests include laboratory evaluations of product chemistry, toxicity,
formulation and stability, as well as preclinical studies. An IND sponsor must submit the results of the non-clinical tests, together
with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND prior to
commencing any testing in humans. An IND sponsor must also include a protocol detailing, among other things, the objectives of the clinical
trial, dosing