Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 110

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 110
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okinetic of a drug candidate are assessed in animal models.  

  IND Preparation and Submission: Preparation of a package of documents for different sections such as CMC, clinical, nonclinical, etc. and getting them reviewed, approved and final checked and f...  

Human clinical trials are
typically conducted in three sequential phases that may overlap or be combined:

  Phase 1. Phase 1 includes the initial introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients but are usually conducted in ...  
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  Phase 2. Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients...  

  Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2, and ar...  
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Our non-therapeutics projects
can be sub-divided into the following stages:

  Development and Experimentation: Early development work for proof-of-concept.  

  Product Optimization: The practice of making changes or adjustments to a product to make it more desirable.  
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  Clinical Validation: Confirming the performance of a technology using clinical/patient samples.  

  Pre-commercialization preparation: The logistics that need to be accomplished before commercialization.  

  Formulation: Preparation of a marketed dosage form from active ingredients and excipients/additives.  

  Commercialization: The process of introducing a new product or production method into commerce—making it available on the market.  

ALS-4: Small molecule for the treatment of
bacterial infections caused by Staphylococcus aureus including but not limited to Methicillin-resistant Staphylococcus aureus (“ MRSA”)

Just as certain strains of
viruses, such as human immunodeficiency virus (“ HIV”) and influenza have developed resistance to drugs developed to treat
them, certain bacteria such as Staphylococcus aureus, Mycobacterium tuberculosisand Pseudomonas
aeruginosahave become “superbugs”, having developed resistance