Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 228

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 228
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 mandatory, must also be conducted in strict compliance with the EMA’s
cGMP requirements and comparable requirements of other regulatory bodies in the EU, which mandate the methods, facilities and controls
used in manufacturing, processing and packing of drugs to assure their safety and identity. Finally, the marketing and promotion of authorized
products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the
general public, are strictly regulated in the EU under Directive 2001/83EC, as amended.

Orphan Drug Designation and Exclusivity

Regulation (EC) No. 141/2000
and Regulation (EC) No. 847/2000 provide that a product can be designated as an orphan drug by the European Commission if its sponsor
can establish: that the product is intended for the diagnosis, prevention or treatment of (1) a life-threatening or chronically debilitating
condition affecting not more than five in ten thousand persons in the EU when the application is made, or (2) a life-threatening, seriously
debilitating or serious and chronic condition in the EU and that without incentives it is unlikely that the marketing of the drug in the
EU would generate sufficient return to justify the necessary investment. For either of these conditions, the applicant must demonstrate
that there exists no satisfactory method of diagnosis, prevention, or treatment of the condition in question that has been authorized
in the EU or, if such method exists, the drug has to be of significant benefit compared to products available for the condition.

An orphan drug designation
provides a number of benefits, including fee reductions, regulatory assistance and the possibility to apply for a centralized EU marketing
authorization. Marketing authorization for an orphan drug leads to a ten-year period of market exclusivity. During this market exclusivity
period, neither the EMA nor the European Commission or the EU member states can accept an application or grant a marketing authorization
for a “similar medicinal product.” A “similar medicinal product” is defined as a medicinal product containing
a similar active substance or substances as contained in an authorized orphan medicinal product, and which is intended for the same therapeutic
indication. The market exclusivity period for the authorized therapeutic indication may, however, be reduced to six years if, at the end
of the fifth year, it is established that the product no longer meets the criteria for orphan drug designation because, for example, the
product is sufficiently profitable not to justify market exclusivity.

PRC Regulation

In order to protect