Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 47

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 47
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 orphan medicinal products, advanced therapy products and products with a new active substance indicated
for the treatment of certain diseases, including products for the treatment of cancer. For products with a new active substance indicated
for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients,
the centralized procedure may be optional.

Under the centralized procedure,
the Committee for Medicinal Products for Human Use, or the CHMP, established by the EMA is responsible for conducting the assessment of
a product to define its risk/benefit profile. Under the centralized procedure, the maximum timeframe for the evaluation of an MAA is 210 days,
excluding clock stops when additional information or written or oral explanation is to be provided by the applicant in response to questions
of the CHMP. Accelerated evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest
from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation.

If the CHMP accepts such a
request, the time limit of 210 days will be reduced to 150 days, but it is possible that the CHMP may revert to the standard
time limit for the centralized procedure if it determines that it is no longer appropriate to conduct an accelerated assessment.

Periods of Authorization and Renewals

A marketing authorization is
valid for five years, in principle, and it may be renewed after five years on the basis of a reevaluation of the risk benefit
balance by the EMA or by the competent authority of the authorizing Member State. To that end, the marketing authorization holder must
provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety, and efficacy, including
all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases
to be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent
authority decides on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization
that is not followed by the placement of the drug on the EU market (in the case of the centralized procedure) or on the market of the
authorizing Member State within three years after authorization ceases to be valid.

<div align='center'>S-26</div>

Regulatory Requirements after Marketing Authorization

Following approval, the holder
of the marketing authorization is required to comply with a