Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 200

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 200
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 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).

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In summary, drug repurposing
offers the following 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. Since safety accounts for approximately 30% of drug failures in clinical       
 trials, this is a key advantage that repositioned drugs can harness to great effect. (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 (NCE) can take 10 to 17 years, depending on indications. (Roin, B. N. Solving the Problem  
 of New Uses, 2013). For a drug repositioning company, the development process from compound identification to launch can be around 3     
 to 8 years. (Walker, N. (2017, December 07). Accelerating Drug Development Through Repurposing, Repositioning and