HLB Subsidiary Eleva Obtains First Sales License for Liver Cancer Treatment in New Jersey, USA

First U.S. Pharmaceutical Handling and Sales Approval
Simultaneous Commercialization Alongside NDA Preparation

HLB's U.S. subsidiary Eleva has obtained a pharmaceutical sales license from the New Jersey Department of Health, rapidly advancing preparations for the sale of Rivoceranib in the United States.

Just one week after submitting the NDA for the targeted anticancer drug Rivoceranib as a first-line treatment for liver cancer on the 16th, Eleva secured its first pharmaceutical sales license. The company shortened the timeline by simultaneously preparing for commercialization alongside the new drug approval process.

Considering that commercialization preparation in the U.S. typically takes over a year, Eleva has been conducting various licensing, registration procedures, and marketing preparations for several months. The license was obtained without issues in New Jersey. It is expected that pharmaceutical sales licenses will be acquired sequentially across the U.S. in the future.

HLB is preparing for Rivoceranib to be prescribed and distributed throughout the U.S. after FDA approval. The company has established a direct sales strategy for the U.S. and a technology export strategy for Europe and other regions. Marketing activities will focus on major cancer centers in the U.S., while in Europe, HLB plans to attend events such as ASCO and BIO USA to discuss collaboration plans with multinational pharmaceutical companies. In Korea, HLB Life Science is preparing to apply for product approval with the Ministry of Food and Drug Safety.

An HLB representative stated, "Rivoceranib and the combination therapy with Camrelizumab have demonstrated excellent efficacy and safety as a first-line treatment for liver cancer," adding, "We are confident that FDA approval will be obtained."

They continued, "Through the global Phase 3 trial (CARES 310), we showed the longest patient survival rate to date and demonstrated high therapeutic efficacy regardless of region or cause of onset," further stating, "After new drug approval, we expect the Rivoceranib combination therapy to be recognized as the standard treatment in its class and as 'Best-in-Class.'"

HLB holds the global patent rights for Rivoceranib. HLB Life Science holds the Korean rights and some revenue rights for Europe and Japan, while Hansoh Pharmaceutical holds the Chinese rights. Eleva holds the global rights for other regions.

This content was produced with the assistance of AI translation services.