Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 161

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 161
---
 clinical data and the magnitude of unmet
need, we may also pursue:

| ● | Accelerated Assessment, reducing           
 EMA review timelines from 210 to 150 days; |

| ● | Conditional                                                                                                                        
 Marketing Authorization, particularly if robust efficacy and safety data can be demonstrated in Phase 2 studies and the product is 
 addressing a life-threatening or seriously debilitating condition;                                                                 |

| ● | Future                                                                                              
 inclusion under Europe’s AMR-focused regulatory and incentive frameworks, currently under revision. |

China

We intend to pursue regulatory approval for Nano-Mupirocin
in China through the National Medical Products Administration (NMPA) under the classification of a Class 1 New Chemical Drug, due to
its novel liposomal formulation enabling systemic (parenteral) use of mupirocin, which is currently approved in China only as a topical
agent.

Given the escalating burden of antimicrobial
resistance in China and the urgent need for systemically active antibiotics targeting multidrug-resistant pathogens, Nano-Mupirocin may
qualify for Breakthrough Therapy designation or Priority Review, especially if supported by compelling Phase 2/3 data. We will also evaluate
eligibility for inclusion in China’s Urgently Needed Imported Drug List, which can provide a fast-track review pathway if initial
clinical trials are conducted overseas and meet China’s public health priorities.

The development pathway may include:

| ● | Pre-IND                                                                                                                           
 consultation with CDE to align on the need for bridging studies, acceptance of overseas data, and specific technical requirements 
 for liposomal formulations.                                                                                                       |

| ● | Submission                                                                                                                       
 of a clinical trial application (CTA) in China, which must be approved before initiating local clinical trials unless exemptions 
 apply.                                                                                                                           |

| ● | A possible                                                                                                              
 requirement for local Phase 1 or bridging PK studies, depending on the origin and scope of the global clinical package. |

<div align='center'>101</div>

| ● | Full New                                                                                                                           
 Drug Application (NDA) submission following successful completion of clinical development, CMC review, and local site inspections. |

| ● | To support                                                                                                                         
 regulatory success, we will ensure early alignment on CMC requirements specific to liposomal products, including characterization, 
 release specifications, and stability, in accordance with ICH and Chinese Pharmacopoeia standards.                                 |

Japan

In Japan, we intend to file through the Pharmaceuticals
and Medical Devices Agency (PMDA) and anticipate applying under the Sak