Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 154

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 154
---

orphan drugs. Given the increasing incidence of multidrug-resistant infections in pediatric populations—especially in neonatal
and pediatric intensive care settings—Nano-Mupirocin may offer an important pediatric therapeutic alternative. We will engage early
with EMA’s Pediatric Committee (PDCO) to define an age-appropriate development plan or, where justified, request a waiver or deferral
based on disease prevalence and clinical feasibility.

Depending on the strength of 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 will 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.                                                      |

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| ● | Full                                                                                           
 New Drug Application (NDA) submission following successful completion of clinical development