Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 249

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 249
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 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 -tenthof 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 -establishedsafety 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 -stagetrials. 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 (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 Rescue. Retrieved from https://www.pharmoutsourcing.com/Featured -Articles /345076 -Accelerating-Drug-Development-Through-Repurposing-Repositioning-and-Rescue / ) •Cost -saving: Along with time -saving, money -savingis also a key benefit. The cost to relaunch a repositioned drug averages $8.4 million, whereas