Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding its new drug application (NDA) for the combination of rivoceranib, an oral TKI, and camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment option for unresectable or metastatic hepatocellular carcinoma (HCC).

The FDA's decision was related to deficiencies identified during a cGMP inspection of a manufacturing site listed on the Rivoceranib NDA.

“The Company is reviewing the contents of the letter and intends to work closely with the FDA 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, Chief Executive Officer of Elevar Therapeutics. "We will engage with the FDA promptly to fully understand the agency's feedback and determine the most effective path forward. Importantly, we continue to believe in the strength of the clinical data supporting this combination and remain committed to pursuing opportunities that may bring this treatment option to patients in need."

The Company noted that the FDA has previously acknowledged substantial clinical data supporting the application. The NDA was based on the global Phase 3 CARES-310 study, in which the camrelizumab plus rivoceranib combination therapy achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, representing the longest overall survival reported to date among first-line treatments for HCC. Consistent efficacy was observed across multiple patient subgroups, with a manageable safety profile.