Apatinib Mesylate

Phase 3 trial assessed the efficacy and safety of Elevar’s rivoceranib in combination with camrelizumab as a first-line therapy for uHCC The combination continued to show clinically meaningful survival improvement versus sorafenib, a standard first-line treatment for uHCC Elevar plans to resubmit its new drug application for camrelizumab/rivoceranib combination therapy in January 2026 Dec. 03, 2025 -- 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 who have limited or inadequate therapeutic options, today announced that the final analysis of its Phase 3 CARES-310 study was published in The Lancet Oncology. The study assessed the efficacy and safety of the combination of Elevar’s drug candidate rivoceranib, an oral TKI, and camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC). In the randomized, open-label, international trial (NCT03764293), which included 543 patients at 95 study sites across 13 countries/regions, camrelizumab plus rivoceranib continued to show clinically meaningful survival improvement versus sorafenib (median overall survival of 23.8 vs. 15.2 months), a standard first-line treatment for uHCC, and a manageable safety profile. Elevar plans resubmission of a New Drug Application to the U.S. Food and Drug Administration for the combination therapy of camrelizumab and rivoceranib in January 2026. "Having our Phase 3 study final analysis published in a prestigious journal such as The Lancet Oncology is momentous for Elevar Therapeutics and, even more so, for the global liver cancer patient community,” said Bryan Kim, chief executive officer of Elevar. “The data clearly showed the potential of our combination treatment of camrelizumab and rivoceranib, as it significantly improved survival compared to the standard treatment option. This is evidence that our hard work developing better therapies for patients with few options is paying off. We're proud of everyone on our team and our partners for hitting this milestone, and we’re focused on getting this promising treatment to patients everywhere as soon as possible." Between June 28, 2019, and March 24, 2021, 543 patients (457 [84%] males; 450 [83%] were Asian) were randomly assigned to receive camrelizumab-rivoceranib (n=272) or sorafenib (n=271). At final analysis on June 14, 2023, the median follow-up was 22.1 months (IQR 11.9-30.3) in the camrelizumab-rivoceranib group and 14.9 months (7.2-28.3) in the sorafenib group. Median overall survival was 23.8 months (95% CI 20.6-27.2) with camrelizumab-rivoceranib and 15.2 months (13.2-18.5) with sorafenib (hazard ratio [HR] 0.64 [95% CI 0.52-0.79]; one-sided p<0.0001). Median progression-free survival was 5.6 months (95% CI 5.5-7.4) with camrelizumab-rivoceranib and 3.7 months (95% CI 3.1-3.7) with sorafenib (HR 0.54 [95% CI 0.44-0.67]; one-sided p<0.0001). The most common grade 3 or 4 treatment-related adverse events were hypertension (104 [39%] of 272 patients in the camrelizumab-rivoceranib group vs. 40 [15%] of 269 patients in the sorafenib group), palmar-plantar erythrodysesthesia syndrome (33 [12%] vs. 42 [16%]), increased aspartate aminotransferase (47 [17%] vs. 14 [5%]), and increased alanine aminotransferase (38 [14%] vs. 8 [3%]). Treatment-related serious adverse events were reported in 69 (25%) patients in the camrelizumab-rivoceranib group and 18 (7%) patients in the sorafenib group. Treatment-related deaths occurred in one patient each in the camrelizumab-rivoceranib group (multiple organ dysfunction syndrome) and sorafenib group (respiratory failure and circulatory collapse). 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. 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 a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include 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 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). 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 in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in 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. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®. 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 uHCC (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. The content above comes from the network. if any infringement, please contact us to modify.

BERLIN, Oct. 20, 2025 /PRNewswire/ -- From October 17 to 21, the European Society for Medical Oncology (ESMO) Annual Congress convened in Berlin, bringing together global leaders in oncology and pharmaceutical innovation. Representing China's advancing biopharmaceutical landscape, Hengrui Pharma not only returned with a comprehensive portfolio of oncology research but also debuted as an exhibitor, marking a new milestone in its global academic engagement. Since 2016, Hengrui has presented pioneering research at the ESMO Annual Congress for ten consecutive years. This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology. In parallel, Hengrui scheduled a series of academic events, fostering in-depth dialogue with leading global experts and clinical researchers on cutting-edge topics in oncology. These initiatives established a dynamic platform for international academic exchange and infused Chinese innovation into the global landscape of cancer diagnosis and treatment – marking a new chapter in Hengrui's journey of international scientific engagement. As one of the world's premier oncology platforms, the ESMO Annual Congress attracts more than ten thousand experts and hundreds of leading international pharmaceutical companies each year. The meeting showcases the latest advances in cancer research and therapeutics, serving as a high-level hub for academic exchange and collaboration. It continues to catalyze innovation and clinical translation across the oncology community, aligning with the 2025 Congress vision: "Standing by those who care about cancer." Global Vision: China Innovation Going Global At the ESMO 2025 Annual Congress, Hengrui co-hosted the roundtable "China Innovation Going Global," bringing together leading Chinese and international experts to discuss strategic pathways and future prospects for the globalization of China-origin innovations. During the global launch of the CARES-009 study, featuring Hengrui's innovative therapeutic combination of camrelizumab and rivoceranib, Academician Jia Fan of the Chinese Academy of Sciences and Professor Jian Zhou of Zhongshan Hospital, Fudan University, jointly presented the latest global data from the study, garnering widespread attention from the international oncology community. Ms. Jo Feng, President and Chief Operating Officer of Hengrui Pharma, led the company's delegation at this year's Congress. She stated, "ESMO serves as a premier global platform for oncology exchange, and this year, Hengrui proudly presented 46 research achievements – highlighting our growing academic presence on the world stage. As an innovation-driven global pharmaceutical company, Hengrui places medical innovation at the heart of its strategic vision, with a steadfast commitment to addressing unmet clinical needs. Looking ahead, we remain firmly patient-centric, continuing to advance groundbreaking therapies to improve the lives of patients worldwide." Breakthroughs Across Multiple Cancer Types At this year's ESMO Annual Congress, Hengrui had 46 oncology research projects accepted, including four LBAs, spanning 14 innovative therapeutic programs. Among these, nine were selected for oral presentations, two for mini oral sessions, 32 as posters, and three as e-posters. Collectively, these studies encompass more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, pancreatic cancer, lung cancer, sarcoma, biliary tract cancer, head and neck squamous cell carcinoma, prostate cancer, and thyroid cancer. In breast cancer, Hengrui had 11 research studies accepted, comprising one oral presentation, one mini oral, eight posters, and one e-poster. Notably, an LBA featuring Hengrui's antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) compared with pyrotinib plus capecitabine for patients with HER2-positive advanced or metastatic breast cancer was selected for presentation. Multiple studies highlighting both established and emerging therapies, including pyrotinib, dalpiciclib, and adebrelimab, demonstrate Hengrui's deep and sustained commitment to advancing breast cancer research. In gastrointestinal cancers, 14 studies were accepted, including two oral presentations, 11 posters, and one e-poster. Alongside flagship therapies such as camrelizumab and rivoceranib, four studies on adebrelimab in the gastrointestinal field were featured. In addition, investigational agents including HRS-4642 (a KRAS G12D inhibitor) and SHR-1701 (a PD-L1/TGF-β bifunctional antibody) were also presented, reflecting the strong momentum of both Hengrui's established portfolio and emerging pipeline in advancing care for patients with gastrointestinal malignancies. In lung cancer, six poster presentations featuring camrelizumab and adebrelimab were accepted, underscoring Hengrui's expanding footprint in this therapeutic area. These studies covered both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), further validating the clinical potential and versatility of these regimens. Across additional disease areas, including gynecologic tumors, thymic epithelial tumors, head and neck squamous cell carcinoma, sarcoma, prostate cancer, and thyroid cancer, Hengrui had 13 studies accepted, featuring a diverse range of innovative therapies such as camrelizumab, fuzuloparib, rivoceranib, rezvilutamide, adebrelimab, famitinib, HRS-7058, and HRS-4642. These included six oral presentations, one mini oral, five posters, and one e-poster, highlighting Hengrui's robust and broad-based R&D capabilities. In addition, two posters were accepted on hetrombopag and ondansetron oral soluble films, focusing on the prevention and management of chemotherapy-induced thrombocytopenia, nausea, and vomiting. Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, stated: "At this year's ESMO Annual Congress, we unveiled a broader and more impactful portfolio of research findings. The concentrated release of these breakthrough data not only reflects Hengrui's robust R&D capabilities, but also highlights the results of our science-driven, globally oriented innovation R&D strategy. Our pipeline is both deep and forward-looking – while reinforcing our existing product portfolio, we are also actively expanding into cutting-edge therapeutic areas. We firmly believe that through this in-depth engagement with the global oncology community, we can better enable our breakthroughs to benefit more patients worldwide." A Decade of ESMO Participation: China Innovation Going Global Since 2016, Hengrui Oncology has participated in the ESMO Annual Congress for 10 consecutive years, consistently setting new benchmarks for Chinese pharmaceutical companies. Between 2023 and 2025, Hengrui presented a total of 119 research achievements: 2023: 36 studies accepted, including two preferred oral presentations, six mini oral presentations, and 28 posters, covering multiple therapeutic areas such as gastrointestinal cancers, breast cancer, cervical cancer, pancreatic cancer, and melanoma. 2024: 37 studies accepted, spanning 13 innovative therapies and more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, and lung cancer. 2025: Marking its first-ever exhibition booth at ESMO, Hengrui presented 46 studies across 14 innovative medicines. This milestone represents a significant step forward in Hengrui's internationalization strategy and its commitment to advancing global cancer care. Commitment to Global Impact with the Promise of Patient Focus Hengrui remains steadfast in its commitment to science and innovation driven by the goal of addressing unmet patient needs. Leveraging a global R&D network, the company is advancing innovative medicines onto the international stage. Through a strategically structured pipeline, continuous breakthroughs across multiple cancer types, and active participation in global academic exchange, Hengrui Oncology is accelerating the internationalization and bringing new hope and broader treatment options to patients worldwide. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Hengrui Oncology Hengrui Oncology specializes in the development, production, and global commercialization of innovative cancer therapies. It is the first business unit within Hengrui to achieve technological breakthroughs and successfully enter international markets. Hengrui Oncology has established a robust and diversified oncology pipeline encompassing multiple tumor types, with a comprehensive portfolio that includes immunotherapies, targeted therapies, and ADCs. In key areas such as breast cancer, Hengrui Oncology provides full-course treatment solutions that span multiple lines of therapy. To date, 14 novel oncology agents developed by Hengrui have been approved for marketing in China. SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED