Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 164

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 164
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-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. |

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| ● | 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 Sakigake designation. This program offers expedited review for innovative
therapies and is broadly comparable to the FDA’s Fast Track designation in the United States.

Novel ARB Combination Therapy Regulatory Strategy

United States

We may seek FDA approval for Nano-Candesartan
under the 505(b)(2) pathway, which is subject to FDA discretion, and there can be no assurance that this pathway will be available or
sufficient for approval. This approach could potentially allow us to reference existing safety and pharmacology data from the reference
product, Candesartan, as well as the regulatory precedent for the liposomal delivery platform used in FDA-approved products such as Doxil.
Nano-Candesartan is a PEGylated liposomal formulation of candesartan, a widely used angiotensin II receptor blocker (ARB) currently approved
for hypertension and heart failure (e.g., Atacand). Our novel formulation introduces a new route of administration and a potential therapeutic
use in oncology, while relying on components with demonstrated safety and prior regulatory acceptance. While this pathway may provide
a more efficient development route compared to traditional approaches, there can be no assurance that the FDA will approve it.

While the cardiovascular indications of candesartan
are well established, emerging evidence has demonstrated its potential in oncology, particularly through modulation of the tumor microenvironment