Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 224

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 224
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 2016). In summary, drug repurposing offers the following 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. 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 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 to relaunch a new formulation of an existing drug in its original indication costs an average $41.3 million. Given that the average cost of launching a new chemical entity (NCE) is more than $1.3 billion, successfully bringing a repositioned drug to market seems to cost approximately 160 times less than the current standard of NCE development. Even if this differential is off by a hundred times or more, from the purely financial perspective, repositioning is in a completely different league of investment needed to create a new drug product in the market.
( https: // www. ddw -online .com /the -benefits - of-drug -repositioning-1779-201104 /) •Potential for out -licensing: Pharmaceutical companies are said to be exploring new models to out -licensesome