Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 155

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 155
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, 
 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 intend to submit Nano-Candesartan
to the FDA under the 505(b)(2) pathway, leveraging existing safety and pharmacology data from the reference product, Candesartan, and
the well-established regulatory precedent for the liposomal delivery platform used in other 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 novel route of administration and new therapeutic
use in oncology, while relying on components with demonstrated safety and regulatory acceptance, making 505(b)(2) the appropriate and
efficient pathway for development.

While the cardiovascular indications
of candesartan are well established, emerging evidence has demonstrated its potential in oncology, particularly through modulation of
the tumor microenvironment (TME). Candesartan has been shown to reduce tumor-associated fibrosis, lower interstitial pressure, and normalize
abnormal tumor vasculature—mechanisms that enhance the intratumoral delivery and efficacy of co-administered therapies such as
chemotherapy and immune checkpoint inhibitors.

Encapsulation of candesartan in nano-liposomes
enables targeted delivery to tumor tissue, prolongs circulation time, and significantly reduces systemic exposure and side effects, such
as hypotension. This targeted approach enhances the drug’s therapeutic index and supports its repurposing for oncology indications,
including hard-to-treat cancers like pancreatic adenocarcinoma.

The 505(b)(2) pathway is scientifically
and strategically appropriate for this product, as it permits reliance on established safety and pharmacology data from the reference
listed drug (Atacand), while allowing us to