Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 426

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 426
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 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 one or more FDA pre -approvalor pre -licenseinspections of the manufacturing facility or facilities where the drug or biologic will be produced to assess compliance with Current Good Manufacturing Practices, or cGMP, requirements to assure that the facilities, methods and controls are adequate to preserve the drug or biologic’s identity, strength, quality and purity; •potential FDA audit of the clinical trial sites that generated the data in support of the NDA or BLA; •payment of user fees for FDA review of the NDA or BLA; and •FDA review and approval of the NDA or BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug or biologic in the United States. The preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and the regulatory scheme for drugs and biologics is evolving and subject to change at any time. We cannot be certain that any approvals for our product candidates will be granted on a timely basis, or at all. Preclinical Studies Before testing any drug or biologic product candidate in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluation of product chemistry, stability and formulation, as well as in vitroand in vivoanimal studies to assess safety and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulations and requirements, including GLP regulations for safety/toxicology studies. 269 An IND sponsor must submit the results of the preclinical studies,