Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 208

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 208
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 viewed as a lower-cost method for drug commercialization, as it is based on already-approved drugs (which has been proven to be safe for human use by the respective governing regulatory agency) and explores new target indications. (Ashburn, T. T. & Thor, K. B. Drug repositioning: identifying and developing new uses for existing drugs. Nat. Rev. Drug Discov. 3, 673 – 683, 2004). One of the advantages of drug repurposing is a lower development risk due to safety and toxicity, as well as other properties related to water solubility, absorption, distribution and metabolism, as the safety and CMC profiles of marketed drugs are usually well-established. Due to the same reason, the development time is also shortened because there is no need to repeat the whole spectrum of the safety assessment. As a result, the drug repurposing approach appears to be attractive due to its superior risk management, smaller capital investment and quicker financial return. (Sudeep Pushpakom, et. al. Drug repurposing: progress, challenges and recommendations. Nat. Rev. Drug Discov. 18, 41-58, 2019) The cost of bringing a repurposed drug is estimated to be around US$300 million, which is only one-tenth of the development cost for a new drug. (Nosengo, N. Can you teach old drugs new tricks? Nature. 534, 314-316, 2016). In summary, drug repurposing may offer the following potential advantages:

| ● | Well-established safety profiles: The development risk for new indications can be substantially                                    
 reduced by applying existing drugs that are approved or have been shown to be safe in large scale late-stage trials. While safety  
 and efficacy determinations for any new indication are ultimately made by the FDA or alternative foreign regulators through their  
 formal approval processes, existing safety data may provide a foundation for regulatory submissions. Since safety accounts for     
 approximately 30% of drug failures in clinical trials, this represents a potential advantage for repositioned drugs. (The benefits 
 of drug repositioning. (n.d.). Retrieved from https://www.ddw-online.com/the-benefits-of-drug-repositioning-1779-201104/)          |

| ● | Time-saving: As repositioned drugs can rely on existing data,                                                                                                                                                                      
 including efficacy and toxicity studies, the process is usually faster than de novo development. Developing a new chemical entity (N