Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 71

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 71
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 approved indicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post -marketingtesting, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the drug candidate. The regulatory authorities may also require risk management plans or programs as a condition of approval of Aptorum’s drug candidates (such as REMS of the FDA and risk -managementplan of the EMA), which could entail requirements for long -termpatient follow -up, a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA, NMPA, EMA, Health Canada or a comparable regulatory authority approves Aptorum’s drug candidates, we will have to comply with requirements including, for example, submissions of safety and other post -marketinginformation and reports, registration, as well as continued compliance with cGCP and cGMP, for any clinical trials that we conduct post -approval. The FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the drug reaches the market. Later discovery of previously unknown problems with Aptorum’s drug candidates, including adverse events of unanticipated severity or frequency, or with our third -partymanufacturers or manufacturing processes, or failure to comply with regulatory requirements, 27 may result in revisions to the approved labeling to add new safety information; imposition of post -marketstudies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things: •restrictions on the marketing or manufacturing of Aptorum’s drug candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls; •fines, untitled or warning letters, or holds on clinical trials; •refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals; •product seizure or detention, or refusal to permit the import or export of Aptorum’s drug candidates; and •injunctions or the imposition of civil or criminal penalties. The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Companies may promote drugs only for the approved indications and in accordance with the provisions of the approved label and may not promote drugs for any off -labeluse, such as uses that are not described in the product’s labeling and