HLB子公司Elevar就卡瑞利珠单抗+rivoceranib一线肝癌组合向FDA重新提交NDA（第四次申报，回应7月CRL）

Combination achieved mOS of 23.8 months in patients with unresectable or metastatic HCC
FORT LEE, N.J., Oct. 14, 2026 (GLOBE NEWSWIRE) -- 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 patients with cancer, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment option for unresectable or metastatic hepatocellular carcinoma (uHCC).
In July 2026, the FDA issued a Complete Response Letter (CRL) for a previous NDA submitted in January 2026. Following work with the FDA and its partner, Hengrui Pharma, Elevar resubmitted the NDA on October 9, 2026, in response to the CRL.
“Our Elevar team has remained steadfast in our commitment to bring a novel combination therapy for uHCC to patients and healthcare providers, as uHCC remains an area of significant unmet medical need,” said Dong-Gun Kim, chief executive officer of Elevar Therapeutics. “Following submission of our response to the Complete Response Letter (CRL), we look forward to continued engagement with the FDA as it reviews the NDA for this combination therapy, which demonstrated positive overall survival and progression-free survival results and a manageable safety profile in the CARES-310 study.”
The NDA is based on the global Phase 3 CARES-310 study, in which first-line camrelizumab plus rivoceranib combination therapy achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months (HR = 0.64, 95% CI 0.52 - 0.79, P< 0.0001). Results observed across multiple patient subgroups were generally consistent. In December 2025, the final analysis was published in
The Lancet Oncology
, a leading international medical journal. In addition, prior to regulatory approval, the combination regimen was included as a first-line treatment option for advanced HCC in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines in recognition of the treatment’s clinical relevance.
For more information about the combination of camrelizumab and rivoceranib, visit
ElevarTX.com
.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.
About Rivoceranib
Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf
®
). Rivoceranib, under the name apatinib (Aitan
®
), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma, is the license-holder of rivoceranib in the Chinese territory.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid cancers. Camrelizumab is developed by Hengrui Pharma. Under the brand name AiRuiKa
®
, Camrelizumab is currently approved for 10 indications in China, covering lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and cervical cancer. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab in combination with rivoceranib for HCC for commercialization from Hengrui Pharma worldwide excluding Greater China and South Korea.
About Elevar Therapeutics
Elevar Therapeutics, Inc., is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for cancer patients. A subsidiary of HLB Co., Ltd. based in Fort Lee, New Jersey, Elevar’s expertise is rooted in oncology and grounded in compassion. Our team of experienced scientists and industry leaders is highly focused on identifying and developing medicines for complex yet under-treated health conditions, with a shared goal of making a meaningful difference in the lives of patients. For more information, follow us on
LinkedIn
and
X
or visit
ElevarTX.com
.
Media Contact:
Mason Levinson
mlevinson@rosecomm.com
Cell: (908) 358-4826