Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. (028300.KQ), said on Friday that the U.S. FDA has issued a complete response letter (CRL) for its new drug application (NDA) seeking approval of Rivoceranib, an oral tyrosine kinase inhibitor, in combination with Camrelizumab, an anti-PD-1 antibody, as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma.
Hepatocellular carcinoma is the most common form of liver cancer, often linked to chronic liver inflammation, and remains a leading cause of cancer-related deaths worldwide. Elevar emphasized its commitment to advancing treatment options for patients with limited therapies and will continue engaging with the FDA to address the regulatory concerns.
The FDA's decision was based on deficiencies identified during a cGMP inspection of a manufacturing site listed in the Rivoceranib NDA. Elevar stated it is reviewing the letter and will work closely with the agency to determine the appropriate path forward. "While we are disappointed by this outcome, we remain committed to patients with hepatocellular carcinoma and to advancing the development of rivoceranib and camrelizumab," said Dong-Gun Kim, CEO of Elevar Therapeutics.
The NDA submission was supported by results from the global Phase 3 CARES-310 study, which showed the Rivoceranib-Camrelizumab combination achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC— the longest overall survival reported to date among first-line treatments for the disease. The regimen demonstrated consistent efficacy across patient subgroups with a manageable safety profile, and the final analysis was published in The Lancet Oncology in December 2025.
The combination has already been recognized internationally, having been included as a first-line treatment options in the 2025 Barcelona Clinic Liver Cancer strategy and European Society for Medical Oncology guidelines. Rivoceranib is approved in China in combination with Camrelizumab for first-line treatment for HCC under the brand name Aitan, marketed by Hengrui Pharma.
028300.KQ has traded between KRW 25,650.00 and KRW 69,200.00 for the past year. The stock is currently trading at KRW 25,650, down 29.92%, touching a new 52-week low.
For comments and feedback contact: editorial@rttnews.com
Business News
September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.