Press Releases

• FDA assigns a PDUFA target action date of April 9, 2027
• Combination 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

FORT LEE, N.J., Nov. 4 – 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 U.S. Food and Drug Administration (FDA) acknowledged receipt of the resubmission of a new drug application (NDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 9, 2027. HCC is the most common type of liver cancer.

On Oct. 9, 2026, Elevar resubmitted the NDA for rivoceranib, while Hengrui Pharma resubmitted a biologics license application (BLA) for camrelizumab. The FDA will review the applications under an integrated review process for the two-drug combination regimen. The resubmission includes Elevar’s and Hengrui Pharma’s response to previously raised concerns by the FDA in its Complete Response Letter issued in July 2026.

“The results from the CARES-310 study support our continued evaluation of the combination of camrelizumab and rivoceranib as a potential first-line therapy to improve outcomes for patients facing limited treatment options in unresectable hepatocellular carcinoma, which we continue to keep top of mind while navigating the regulatory landscape,” said Dong-Gun Kim, chief executive officer of Elevar Therapeutics. “We are pleased to receive classification of this NDA resubmission, jointly with Hengrui’s BLA resubmission for camrelizumab and will work closely with the FDA as it reviews the applications.”

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. However, rivoceranib and camrelizumab are investigational in the United States and have not been approved by the FDA, so their safety and effectiveness for the proposed indication have not yet been established.

“Hepatocellular carcinoma remains a major cause of cancer-related mortality worldwide,” said Arndt Vogel, M.D., Ph.D., scientist in the Division of Gastroenterology and Hepatology at Toronto General Hospital Research Institute, and a medical oncologist at the UHN-Princess Margaret Cancer Centre at the University of Toronto. “The potential approval of camrelizumab plus rivoceranib would be particularly encouraging because it would expand the therapeutic armamentarium for patients with advanced HCC and may improve outcomes across diverse healthcare settings, especially in regions with a high disease burden. Importantly, the clinical development program for this combination extends well beyond the pivotal Phase 3 studies. It has been investigated across early, intermediate, and advanced stages of HCC, both alone and in combination with locoregional therapies, and has consistently demonstrated clinically meaningful antitumor activity together with a manageable safety profile. These findings highlight the potential of this regimen to become an important component of multidisciplinary HCC management.”

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 across multiple tumor types. 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 focusing on elevating treatment outcomes for patients with cancer. A subsidiary of HLB Co., Ltd. based in Fort Lee, New Jersey, Elevar is focused on identifying, developing and commercializing medicines for complex health conditions, with the goal of making a meaningful difference in the lives of patients. With the 2026 FDA approval of LYRFIGTU™ in the cholangiocarcinoma setting, Elevar became the first subsidiary of a Korean company to directly bring a novel cancer drug to commercialization in the U.S. For more information, follow us on LinkedIn and X or visit ElevarTX.com.

Media Contact:

Mason Levinson

RoseComm

mlevinson@rosecomm.com

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