HLB said on the 26th that U.S. subsidiary Elevar Therapeutics (hereafter Elevar) and partner Jiangsu Hengrui Pharmaceuticals on the 23rd (local time) completed resubmitting a new drug application to the U.S. Food and Drug Administration (FDA) for a combination therapy of the targeted anticancer drug Rivoceranib and the immunotherapy Camrelizumab for liver cancer.
Elevar submitted a new drug application (NDA) for Rivoceranib, a small-molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), and Jiangsu Hengrui Pharmaceuticals submitted a biologics license application (BLA) for Camrelizumab, an anti–PD-1 antibody. Because the two drugs were tested as a combination therapy, the FDA regards them as a single treatment and is conducting an integrated review.
Last year, HLB sought FDA approval but was turned down. The reason for the rejection was not the efficacy or safety of Rivoceranib but issues with the manufacturing process and facilities for Camrelizumab. At the time, the FDA requested additional information related to chemistry, manufacturing and controls (CMC).
HLB said, "We thoroughly addressed the points raised during the previous review, rechecked and refined the overall submission materials, and proceeded with the resubmission." The company emphasized, "We will closely review and respond to the overall review procedures going forward, faithfully communicate with the FDA, and do our best to achieve the results the company expects."
According to the company, the Rivoceranib–Camrelizumab combination therapy recorded a median overall survival (mOS) of 23.8 months for patients with unresectable hepatocellular carcinoma in a prior global phase 3 trial, confirming the longest survival among current first-line treatments for liver cancer. Subgroup analyses across diverse patient populations also showed consistent efficacy and manageable safety. The final clinical data were published last year in the prestigious international journal The Lancet Oncology.
The company added that HLB's liver cancer combination therapy has been listed as a first-line treatment option in the 2025 BCLC (Barcelona Clinic Liver Cancer) treatment strategy and the European Society for Medical Oncology (ESMO) 2025 guidelines, earning official recognition for its high clinical value.