HLB's Liver Cancer Drug 'Lenvatinib'... "Entering FDA Full Review"

HLB announced on the 17th that its liver cancer treatment drug, 'Rivoceranib,' has entered the FDA's final review stage, leaving only the last approval step remaining.

On the 17th, Jin Yang-gon, Chairman of HLB Group, announced through the company's YouTube channel, "HLB's U.S. subsidiary, Elevate, has received notification from the FDA of the formal start of the New Drug Application (NDA) review." Since beginning the development of Rivoceranib in 2008, it has been 15 years, and they are finally approaching the milestone of success in anticancer drug development.

HLB's U.S. subsidiary, Elevate, successfully completed the global Phase 3 trial of the combination therapy of Rivoceranib and Camrelizumab, and submitted the NDA for Rivoceranib as a first-line treatment for liver cancer to the FDA on May 16. With the FDA initiating the NDA review under the standard review process, the approval decision is expected to be made by May 16, 2024, at the latest, within 10 months, according to the Prescription Drug User Fee Act (PDUFA).

PDUFA is a law that allows the FDA to collect fees from applicants to review the approval of prescription drugs. Based on this, the FDA will expand its review personnel and begin a full-scale review. Jeong Se-ho, CEO of Elevate, said, "With the formal acceptance of the NDA, we have reached an important milestone for the combination therapy of Rivoceranib and Camrelizumab to become a treatment for unresectable liver cancer," adding, "We earnestly hope that through close cooperation with the FDA in the remaining process, liver cancer patients will soon be able to improve treatment outcomes and quality of life through the Rivoceranib combination therapy."

With the commencement of the final review, HLB will accelerate preparations for commercialization, including expanding drug sales licenses and establishing joint marketing execution strategies, while also doing its best with Hansoh Pharmaceutical to prepare for the upcoming FDA CMC (Chemistry, Manufacturing, and Controls) inspection.

Chairman Jin Yang-gon expressed strong confidence, saying, "We have set very ambitious internal goals and are making progress step by step," and added, "With the challenges and boldness we have shown so far in developing a difficult global anticancer drug, we believe we can fully achieve our goals."

Rivoceranib is a targeted anticancer drug for which HLB holds global patent rights. HLB Life Science holds the Korean distribution rights and some revenue rights for Europe and Japan, while Hansoh Pharmaceutical holds the Chinese distribution rights. Elevate holds the global distribution rights for other regions.

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