Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 163

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 163
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 rare infectious disease indications. To qualify, we will demonstrate that:

| ● | The target condition has a prevalence of fewer than 5 in 10,000 individuals in the EU; |

| ● | Nano-Mupirocin offers significant benefit over existing therapies, such as improved systemic activity or a novel mechanism of action; |

| ● | There is a plausible scientific rationale for its clinical effect in the proposed indication. |

| ● | Upon OMPD approval, the product will benefit from: |

| ● | 10 years of market exclusivity in the orphan indication; |

| ● | Protocol assistance (free or reduced-cost scientific advice); |

| ● | Fee reductions for various regulatory activities. |

As part of our development strategy, we also
intend to submit a Pediatric Investigation Plan (PIP), as required under EU regulation for all new marketing authorization applications,
including 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 plan to 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