HLB Applies for Pre-Approval Process of Liver Cancer Drug 'Rivoceranib' to US FDA

[Asia Economy Reporter Myunghwan Lee] HLB announced on the 16th that its subsidiary Elevar and China’s Hansoh Pharmaceutical have completed a Pre-New Drug Application (Pre-NDA) submission to the U.S. Food and Drug Administration (FDA) to proceed with the approval process for a first-line treatment for liver cancer.

Pre-NDA is a preliminary consultation with the FDA before the New Drug Application (NDA), where guidance on the application direction and submission materials is provided. According to the usual schedule, HLB explained that the Pre-NDA meeting between Elevar, Hansoh Pharmaceutical, and the FDA is expected to be held by mid-October at the latest.

HLB previously announced in May that the combination of Lenvatinib and Camrelizumab met the statistical significance of the primary efficacy endpoint in a Phase 3 clinical trial targeting first-line liver cancer patients. The full data will be disclosed at the European Society for Medical Oncology (ESMO) conference in September.

Separately, Elevar is also preparing for the accelerated approval process for Lenvatinib monotherapy in Phase 2 for cholangiocarcinoma. Cholangiocarcinoma is a difficult-to-treat cancer type, and global pharmaceutical companies have only attempted investigator-initiated trials, with no approval-directed clinical trials completed to date. HLB explained that if accelerated approval is granted, it would become the first treatment in this category.

Jang In-geun, Vice President of the Bio Strategy Planning Division, said, "In the field of first-line liver cancer treatments where many global pharmaceutical companies have failed, the Lenvatinib combination has demonstrated superior efficacy compared to Nexavar, raising high expectations among employees who have devoted long efforts to new drug development. We will devote ourselves to preparing the Pre-NDA materials during the remaining period to proceed with the NDA process as soon as possible."

Meanwhile, on the 12th, HLB announced a decision to conduct a paid-in capital increase to prepare for the approval and commercialization of Lenvatinib. The capital increase amount is approximately 325.6 billion KRW, and shareholders will have the right to preferentially subscribe at a ratio of 0.9 shares per 10 shares held, with a planned issue price of 34,050 KRW. From the 16th of this month until October 21, short selling is prohibited during the subscription period. If short selling occurs during this period, participation in the capital increase will be prohibited.

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