Apatinib Mesylate

FORT LEE, N.J., July 10, 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 cancer patients, today 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. 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 HCC in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines, formally recognizing its clinical value. 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, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), 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 monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety pro other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (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 Life Science Co., Ltd. in South Korea. Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023) by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd. (Hengrui Pharma), under the brand name Aitan®. 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 and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for HCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. 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 for commercialization from Hengrui Pharma worldwide excluding Greater China and Korea. About Elevar Therapeutics Elevar Therapeutics, Inc. is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for patients who have limited or inadequate therapeutic options. A subsidiary of HLB Group 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 Twitter or visit ElevarTX.com. Media Contact: Rosemary Ostmann RoseComm rostmann@rosecomm.com (201) 615-7751

The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and rivoceranib at the FDA. U.S. regulators have declined to approve the anti-PD-1/VEGFR combo for a third time as a first-line treatment for liver cancer, Hengrui and Elevar’s parent company, HLB Group, said in separate announcements Friday. The problem, again, is manufacturing. Only this time, the complete response letter (CRL) stemmed from deficiencies the FDA had identified in April at the plant producing rivoceranib, also known as apatinib, unlike the previous two rejections , which centered on Hengrui’s camrelizumab facility, according to the Chinese pharma. The rivoceranib manufacturer had passed an inspection by EU authorities in 2025, it noted. Still, three CRLs do not necessarily mean three strikes and you're out for Hengrui and Elevar. “The company has thoroughly evaluated the regulator’s feedback and is taking steps to implement appropriate corrective measures,” Hengrui said in a securities filing (Chinese, PDF) in Shanghai. “The company will actively communicate with the FDA and our partner, Elevar Therapeutics, to establish the next resubmission plan.” Elevar “intends to promptly address the aforementioned deficiencies and resubmit the application for FDA approval,” HLB said in its own securities filing to the Korea Exchange. As Elevar noted, a re-inspection by the FDA may be required to determine that the facility meets CGMP compliance requirements. More than two years have passed since the FDA first snubbed the camrelizumab-rivoceranib regimen in May 2024. The second CRL arrived in March 2025. And Elevar refiled the newest application on Jan. 23, 2026. The latest CRL does not raise any issues with clinical data, Hengrui said. For this application, the two companies provided updated final analysis from the phase 3 Cares-310 trial, which showed a 36% death risk reduction for camrelizumab and rivoceranib versus Bayer’s Nexavar in first-line unresectable hepatocellular carcinoma. Chinese companies have long viewed follow-on PD-1 inhibitors as a viable entry point into the highly lucrative U.S. innovative drug market. However, these candidates have faced a string of regulatory and operational setbacks along the way. In a high-profile decision that triggered ripple effects across the industry, the FDA in 2022 refused to approve Innovent Biologics’ then Eli Lilly-partnered Tyvyt, citing predominantly China-only data as a problem. Thanks to that policy, Novartis abandoned its U.S. submission plan in first-line non-small cell lung cancer for Tevimbra before returning the asset to BeOne Medicines, then known as BeiGene. The same fate met CStone Pharmaceuticals’ PD-L1 inhibitor sugemalimab and its partnership with EQRx, which was absorbed into Revolution Medicines in 2023. Besides Hengrui, Fosun Pharma is also angling its China-approved PD-1 inhibitor, serplulimab, for an initial FDA approval in extensive-stage small cell lung cancer. Despite the positive phase 3 Astrum-005 trial, which showed the drug beat placebo, both added to chemotherapy, Fosun had to conduct a U.S. bridging study that compared serplulimab to Roche’s Tecentriq. With that study recently complete, Fosun is in discussions with the FDA about a potential filing this year.