Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 166

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 166
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 we may provide:

| ● | Justification that pancreatic cancer affects fewer than 5 in 10,000 individuals in the EU. |

| ● | Evidence of the product’s potential significant benefit over existing treatments, such as FOLFIRINOX or gemcitabine/nab-paclitaxel, particularly when used in combination regimens. |

| ● | Data supporting the drug’s unique mechanism of action, involving tumor microenvironment normalization and improved drug penetration. |

| ● | Upon designation, we will benefit from a range of regulatory incentives, including: |

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

| ● | Protocol assistance from the EMA, including scientific advice specifically 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. |

| ●