Camrelizumab

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 05, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has initiated the Phase III part of the Phase II/III trial to evaluate the efficacy of the combination of surufatinib, camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (“PDAC”) in China. The first patient received the first dose on December 30, 2025. PDAC is a highly aggressive form of cancer, representing over 90% of pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with an average five-year survival rate of less than 10%. In China, an estimated 119,000 people were diagnosed with pancreatic cancer, causing approximately 106,000 deaths in 2022. 1 Treatments such as chemotherapy, surgery and radiation are commonly employed, but have not shown significant improvement in patient outcomes. Under 20% of metastatic pancreatic cancer patients survive for more than a year. 2 The trial is a multicenter, randomized, open-label, active-controlled Phase II/III study to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel and gemcitabine (“S+C+AG”) versus nab-paclitaxel plus gemcitabine (“AG”) in adults with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy. A total of 62 patients were enrolled in the Phase II part, with plans to enroll approximately 400 additional patients in the Phase III part. The primary endpoint for the Phase III part is overall survival (OS). Secondary endpoints include progression-free survival (“PFS”), objective response rate (“ORR”), duration of response (DoR), disease control rate (“DCR”), quality of life and safety. Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital are the leading principal investigators of this study. Additional details may be found at clinicaltrials.gov , using identifier NCT06361888 . Results from the Phase II part were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress . 3 As of the data cut-off of July 24, 2025, the median PFS follow-up duration was 8.15 months. The S+C+AG regimen demonstrated a median PFS of 7.20 months compared to 5.52 months for the AG arm (stratified hazard ratio [HR] 0.499, log-rank p=0.0407), representing a 50.1% reduction in the risk of progression or death. Consistent benefits were observed across other key efficacy endpoints, including ORR (67.7% vs 41.9%, p=0.0430) and DCR (93.5% vs 71.0%, p=0.0149). Although overall survival data were immature at the time of analysis, a favorable trend was observed (not reached vs 8.48 months, unstratified HR 0.555), with 9 events in the S+C+AG arm (N=31) and 15 events in the AG arm (N=31). The safety pro manageable. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 80.6% of patients in the S+C+AG arm compared to 61.3% in the AG arm. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA ® . HUTCHMED currently retains all rights to surufatinib worldwide. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Camrelizumab has been approved in China for multiple indications in areas such as lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer and cervical cancer. Camrelizumab is marketed in China by Hengrui Pharma under the brand name AiRuiKa ® . About HUTCHMED HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of PDAC and the further development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support a new drug application submission of surufatinib for the treatment of PDAC or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety pro surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib and the timing of these events. In addition, as certain studies rely on the use of other drug products such as camrelizumab, nab-paclitaxel and gemcitabine as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000 ______________________________ REFERENCES 1 The Global Cancer Observatory, China fact sheet. . Accessed December 3, 2025 2 Sarantis P et al . Pancreatic ductal adenocarcinoma: Treatment hurdles, tumor microenvironment and immunotherapy. World J Gastrointest Oncol . 2020;12(2):173-181. DOI: 10.4251/wjgo.v12.i2.173 3 Qin S et al. 375P - Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: Results from phase II part of a randomized, open-label, active-controlled, phase II/III study. Annals of Oncology (2025) 36 (suppl_4): S1859-S1939. 10.1016/annonc/annonc1989

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.