Company: OSRH
Filing Date: 2025-06-10
Form Type: S-1/A
Source: 0001213900-25-053114
Chunk: 12

Company: OSR Holdings, Inc.
Filing Date: 2025-06-10
Form: S-1/A
Chunk 12
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 any drug or biological product candidate in humans, the                      
 product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory          
 evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential    
 for adverse events and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is               
 subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. Vaximm will perform preclinical 
 studies to evaluate the safety, immunogenicity, and anti-tumor efficacy of its oral cancer vaccine candidates in line with the            
 GLP regulations that the FDA requires.                                                                                                    |
| 3. | File an Investigational New Drug (IND) application: Upon the successful completion of preclinical                                         
 studies, Vaximm will submit an IND application to regulatory authorities such as the FDA. IND is a request for authorization              
 from the FDA to ship an investigation product and then administer it to humans and must be allowed to proceed by the FDA before human     
 clinical trials may begin. This submission includes all relevant data from preclinical studies and outlines the proposed clinical         
 trial protocols. The IND review period typically takes 30 days, during which the regulatory agency evaluates the submission               
 to ensure the safety of proceeding to human trials.                                                                                       |

| 4. | Initiate clinical trials: Based on the preclinical data and IND approval, the company will design                                
 and conduct additional Phase 1/2 clinical trials to assess the safety, tolerability, and preliminary efficacy of its oral cancer 
 vaccines in other cancer indications.                                                                                            |

| 5. | Conduct Phase 3 clinical trials: Phase 3 trials are large-scale, randomized, controlled                                                        
 studies designed to provide additional supporting evidence of the efficacy and safety of therapeutic candidates. These trials typically        
 involve hundreds to thousands of patients and are conducted at multiple sites worldwide. Vaximm will work closely with clinical investigators, 
 regulatory authorities, and patient advocacy groups to design and execute Phase 3 clinical trials for its oral cancer vaccine                  
 candidates.                                                                                                                                    |

| 6. | Seek regulatory approval: Following the successful completion of Phase 3 clinical trials, the                                   
 result of the pre-clinical studies and clinical trials, together with detailed information relating to the product’s chemistry, 
 manufacture, controls, and proposed labeling, among other things, are submitted to authorities, such as the FDA or EMA. This    
 stage is