Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 425

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 425
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 products, as well as diagnostics. Generally, before a new drug, biologic or diagnostic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved, authorized, or cleared by the applicable regulatory authority. United States Government Regulation of Drug and Biological Products In the United States, the FDA regulates drugs and biologics primarily under the Federal Food, Drug, and Cosmetic Act, or “ FD&C Act,” the Public Health Service Act, or “ PHSA,” regulations implementing the FD&C Act and PHSA, and other federal statutes and regulations. These laws and regulations govern areas such as the safety and efficacy of drugs and biologics, approvals, pre -clinicalstudies and clinical trials, advertising and promotion, quality control, storage, manufacturing, labeling, distribution, post -marketsafety surveillance and reporting, and record keeping. Both drugs and biologics also 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