Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 164

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 164
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 tailored for orphan development |

| ● | Fee reductions for regulatory                                                  
 procedures (e.g., scientific advice, inspections, and marketing authorization) |

If interim or early clinical data demonstrate
compelling activity or address a critical unmet need, we will also evaluate eligibility for:

| ● | Conditional Marketing Authorization,                                                                                                        
 allowing approval based on less comprehensive data if the benefit-risk balance is positive and further data will be provided post-approval. |

| ● | Accelerated Assessment,                                    
 which shortens the EMA review period from 210 to 150 days. |

We may engage with the Committee for Orphan Medicinal
Products (COMP) during development to discuss potential designation, and we may also seek scientific advice regarding pivotal trial design,
comparator selection, and endpoints. The content, timing, and outcome of such interactions remain subject to regulatory discretion, and
there can be no assurance of acceptance.

China

We may seek regulatory approval for our novel
formulation of Liposomal-ARB in China through the National Medical Products Administration (NMPA) as a Class 1 New Drug, based on its
novel liposomal formulation and intended use in oncology. While candesartan is an approved antihypertensive agent in China, our liposomal
formulation represents a new route of administration (intravenous) and a distinct therapeutic indication (cancer treatment), qualifying
it as a new drug under NMPA’s classification system.

Given the novel mechanism of action in oncology,
through tumor microenvironment (TME) modulation, and its potential synergy with chemotherapy and immunotherapy, Liposomal-ARB may be
eligible for the following expedited programs:

| ● | Breakthrough Therapy Designation                                                                                       
 (BTD), if early clinical data in China or abroad demonstrate significant clinical advantages over existing treatments. |

| ● | Priority Review which regulators                                                                            
 may consider in cases of significant unmet medical need in solid tumors such as pancreatic or liver cancer. |

| ● | China’s                                                                                                                           
 Urgently Needed Overseas Drugs Pathway, which may be considered if supported by compelling clinical data and recognition in major 
 regulatory jurisdictions (e.g., FDA or EMA)..                                                                                     |

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Development Pathway:

| ● | Pre-IND                                                                                                                               
 Consultation with CDE: We plan to initiate communication with the Center for Drug Evaluation (CDE) to confirm clinical development    
 expectations, including the acceptability of foreign clinical data, bridging study requirements, and