Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 167

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 167
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 | Priority Review which regulators                                                                            
 may consider in cases of significant unmet medical need in solid tumors such as pancreatic or liver cancer. |

| ● | China’s                                                                                                                           
 Urgently Needed Overseas Drugs Pathway, which may be considered if supported by compelling clinical data and recognition in major 
 regulatory jurisdictions (e.g., FDA or EMA)..                                                                                     |

<div align='center'>104</div>

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 support ethnic sensitivity and dose justification. |

| ● | New Drug Application (NDA) submission upon completion of pivotal data and CMC review. The NDA will include full data on safety, efficacy, manufacturing, and quality, and must comply with both ICH and Chinese Pharmacopoeia standards. |

Given the increasing regulatory alignment between
NMPA and global standards, including China’s implementation of ICH E6 (R2) and E17 for multi-regional clinical trials (MRCTs), we are
designing our development program to enable seamless inclusion of Chinese sites in global pivotal trials.

Japan: we plan to engage with the Pharmaceuticals
and Medical Devices Agency (PMDA) to pursue regulatory approval under Japan’s standard NDA pathway. Given the innovation and potential
life-extending benefit of Liposomal-ARB in pancreatic cancer, we may seek qualification for the Sakigake designation, which supports expedited
development and review of promising therapies addressing high unmet needs in Japan.

Employees

We currently have
three (3) full-time employees, three (3) part time employee, and 10 experienced consultants, including two (2) on administrative level,
five (5) in the scientific and product development and three (3) in the medical (clinical trials) field. Our employees work at will and
are not represented by a collective bargaining unit. We believe our relationship with our employees is excellent in most cases. We require
all our employees and consultants to sign a confidentiality and non-disc