NDA and BLA were resubmitted to the FDA by partner Jiangsu Hengrui Pharmaceuticals in compliance with supplementary requirements
[by Kang, In Hyo] HLB announced on January 26 that its U.S. subsidiary, Elevar Therapeutics (hereinafter referred to as Elevar), together with its partner, Jiangsu Hengrui Pharmaceuticals, completed the resubmission of the application for their 바카라사이트 홈런 cancer drug candidates to the U.S. Food and Drug Administration (FDA) on January 23 (local time).
On the same day, Elevar submitted a New Drug Application (NDA) for rivoceranib, a small-molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), while Jiangsu Hengrui Pharmaceuticals filed a Biologics License Application (BLA) for camrelizumab, an anti-PD-1 monoclonal antibody. As the two candidates were evaluated clinically as 바카라사이트 홈런 therapy, the FDA will assess them as a single treatment approach and conduct an integrated regulatory review.
Both parties stated that the resubmission fully addressed all supplementary requirements raised during the previous review process. The 'rivoceranib + camrelizumab' combination therapy demonstrated the longest overall survival (OS) reported to date among patients with unresectable hepatocellular carcinoma (HCC) in a global Phase 3 clinical trial, achieving a median overall survival (MOS) of 23.8 months, the longest currently observed among first-line 바카라사이트 홈런 cancer treatments. Importantly, the regimen showed consistent efficacy and a manageable safety profile across diverse patient subgroups. The final clinical data were published in 2025 in the prestigious international oncology journal, The Lancet Oncology.
Moreover, even prior to novel drug approval, HLB's 바카라사이트 홈런 cancer combination therapy was formally incorporated as a first-line treatment option in the '2025 Barcelona Clinic 바카라사이트 홈런 Cancer (BCLC) Treatment Strategy' and the 'European Society for Medical Oncology (ESMO) 2025 Guidelines,' underscoring its significant clinical value.
“We have diligently addressed the issues raised during the previous review process, while also comprehensively re-evaluating, reorganizing, and resubmitting all application materials. We will continue to closely monitor and respond throughout the entire review process and will engage in good-faith communication with the U.S. FDA to achieve the outcomes anticipated by the company,” HLB commented.