Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 425

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 425
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 are subject to other federal, state and local statutes and regulations, such as those related to competition. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the product development, approval, or post -approvalprocesses may subject an applicant to administrative actions or judicial sanctions. These actions and sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, license revocation, a clinical hold, untitled or warning letters, voluntary or mandatory product recalls 268 or market withdrawals, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and civil or criminal fines or penalties. Any agency or judicial enforcement action could have a material adverse effect on our business, the market acceptance of our products and our reputation. Our pharmaceutical product candidates must be approved by the FDA through either a NDA or a BLA before they may be legally marketed in the United States. Prior to filing for regulatory review and approval of any pharmaceutical product candidate, clinical trials must be conducted in escalating numbers of patients to demonstrate efficacy and safety. Although our clinical stage pharmaceutical product candidates have completed early clinical trials, we have not yet advanced any of these pharmaceutical product candidates to later stage clinical trials. Accordingly, none of our product candidates have received FDA approval, nor have we advanced any product candidate to a stage where we’ve been eligible to apply for approval. The regulatory approval process, in the US, generally involves the following: •completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements; •submission to the FDA of an IND application, which must become effective before human clinical trials may begin; •approval by an Institutional Review Board, or IRB, or independent ethics committee at each clinical trial site before each human trial may be initiated; •performance of adequate and well -controlledhuman clinical trials in accordance with IRB approved clinical trial protocols, applicable IND regulations, Good Clinical Practices (“ GCP”) requirements and other clinical trial -relatedregulations to establish the safety, efficacy and quality of the investigational product for each intended indication; •preparation and submission to the FDA of an NDA or BLA; •a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review; •satisfactory completion of