Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 192

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 192
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, pharmaceutical
development consists of preclinical and clinical phases. The preclinical phase can further sub-divided into the following stages:

| ● | Target                                                                                                                                  
 Identification & Selection: The target is the naturally existing cellular or modular structure that appears to have an important        
 role in a particular disease pathway and will be targeted by the drug that will subsequently be developed. Target validation techniques 
 for different disease areas can be very different but typically include from in vitro and in silico methods through to the use of whole 
 animal models.                                                                                                                          |

| ● | Lead                                                                                                                                  
 Discovery: Following “Target Identification & Selection,” compound screening assays are developed as part of the                      
 Lead Discovery. ‘Lead’ molecules can mean slightly different things to different researchers or companies, but in this document,      
 we refer to Lead Discovery as the process of identifying one or more small molecules with the desired activity against the identified 
 targets. Leads can be identified through one or more approaches, which can depend on the target and what, if any, previous knowledge  
 exists.                                                                                                                               |

| ● | Lead Optimization: In this stage of the drug discovery process, the aim is to produce a preclinical drug candidate by maintaining the desired and favorable properties in the lead compounds, while repairing or reducing deficiencies in their structures. For example, to optimize the chemical structures to improve, among others, efficacy, reduce toxicity, improve metabolism, absorption and pharmacokinetic properties. |

| ● | CTA-Enabling Studies: Includes all the essential studies such as GLP toxicology studies, pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are used for CTA submission. |

| ● | IND-Enabling Studies: Includes all the essential studies such as GLP toxicology studies, pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are used for IND submission. |

| ● | In vitro validation: At this stage, the efficacy and safety of a drug candidate are assessed at cellular levels. |

| ● | In vivo validation: At this stage, the efficacy, safety and pharmacokinetic 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 followed by submission to regulatory agencies. |

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