Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 165

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 165
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 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-disclosure agreement. Our success relies on our ability to hire additional
employees, particularly on the local sales side. We believe there are numerous quality people to choose from throughout our area of targeted
expansion.

Subsidiaries

The Company has two wholly-owned subsidiary,
Revium Rx, Ltd. and LipoVation Ltd., each organized under the laws of the State of Israel.

Corporate Office

Our principal executive office is at Azrieli
Business Center, 89 Medinat HaYehudim Herzliya, Israel. Our main telephone number is 1 800 519