Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 146

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 146
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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 our potential
market in the PRC, we have obtained an exclusive license of certain PRC patents directed to certain of the drug candidates that we are
developing and are currently seeking approval of additional patent and other IP filings in the PRC. Seeking IP approval in the PRC subjects
us to some of the rules and practices of the PRC government. Since the Company intends eventually to market its products in the PRC, at
least some of our drug candidates may become subject to regulatory approval and marketing authorization in the PRC.

Permission Required from the PRC Authorities

As of the date of this annual
report, we are not required to obtain approvals from the PRC authorities to operate our business or list on the U. S. exchanges and offer
or continue to offer securities; specifically, we are currently not required to obtain any permission or approval from the CSRC, the CAC
or any other PRC governmental authority to operate our business or to list our securities on a U. S. securities exchange or issue securities
to foreign investors. The laws and regulations of mainland China do not currently have any material impact on our business, financial
condition or results of operations and we are currently not subject to the PRC government’s direct influence or discretion over
the manner in which we conduct our business activities outside of the mainland China.

Nevertheless, we are aware
that recently, the PRC government initiated a series of regulatory actions and statements to regulate business operations in certain areas
in mainland China with little advance notice, including cracking down on illegal activities in the securities market, enhancing supervision
over mainland Chinese companies listed overseas using a VIE structure, adopting new measures to extend the