Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 157

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 157
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 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 will engage with the Committee for Orphan
Medicinal Products (COMP) early in development to secure designation, followed by Scientific Advice to align on pivotal trial design,
comparator selection, and endpoints suitable for regulatory approval in the orphan oncology setting.

China

We plan to 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.                                                |

| ● | Priority                                                                                       
 Review status, based on unmet medical need in solid tumors such as pancreatic or liver cancer. |

| ● | Urgently                                                                                     
 Needed Overseas Drugs Pathway, which may apply if the product shows strong clinical efficacy 
 and is approved or in late-stage development in major regulatory jurisdictions (e.g., FDA    
 or EMA), and if the indication addresses a critical unmet need in China.                     |

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Development Pathway:

| ● | Pre-IND                                                                                       
 Consultation with CDE: We plan to initiate communication with the Center for Drug Evaluation  
 (CDE) to confirm clinical development expectations, including the acceptability of foreign    
 clinical data, bridging study requirements, and technical data for the liposomal formulation. |

| ● | Clinical                                                                                      
 Trial Application (CTA): A CTA will be submitted to initiate clinical studies in China, with  
 the potential for waiver or abbreviated trials if global data are robust and a local bridging 
 study is sufficient.                                                                          |

| ● | Local                                                                                      
 PK/bridging studies: May be required to