Erfonrilimab

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary 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: www.hutch-med.com 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 but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. 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企业动态 No.1 / 复星医药2024财报：营收410.67亿元，制药业务利润增长 2025年3月25日，复星医药（600196.SH/2196.HK）发布2024年度业绩报告。公司全年营业收入410.67亿元，同比基本持平（-0.80%）；归母净利润27.70亿元，同比增长16.08%。期内研发投入共计55.54亿元，其中制药业务研发投入49.10亿元。 按业务划分，复星医药制药业务2024年营收达到289.24亿元（-4.29%），占总营收比重70.43%；通过整合优化研发体系、聚焦优势管线，实现利润增长65.73%至32.50亿元。其中抗肿瘤及免疫调节核心产品、心血管系统核心产品销售收入显著增长，分别达到80.85亿元（+5.84%）、19.12亿元（+14.00%）。汉曲优（注射用曲妥珠单抗生物类似药）、汉利康（利妥昔单抗注射液生物类似药）、PD-1单抗汉斯状（斯鲁利单抗注射液）、肝素系列制剂在2024年销售规模超10亿元。 报告期内，复星医药自主研发及许可引进的 7 个创新药/生物类似药共 16 项适应证获批上市，8 个创新药/生物类似药进入上市前审批/关键临床阶段，共有 18 项创新药/生物类似药项目（按适应证计算）获批开展临床试验。 医疗器械与医学诊断业务录得43.23亿元（-1.53%），占总营收比重10.53%；业绩下滑主要受新冠相关产品收入下降、诊断试剂带量采购、诊断业务价格承压等因素的影响。医疗健康服务收入同比增长14.61%至76.47亿元，占总营收比重从16.12%上升至18.62%；主要得益于重点专科建设、智慧医疗与一体化运营提效。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 云顶新耀2024财报：商业化高效落地，收入激增461%超7亿元 2025年3月26日，云顶新耀（1952.HK）发布2024年度业绩公告。公司全年总收入7.067亿元，同比激增461%；非国际财务准则计量的年内经调整亏损收窄25%至5.376亿元。截至2024年12月31日，公司拥有现金及现金等价物以及银行存款为人民币16.033亿元。 云顶新耀三款已上市的核心产品商业化布局高效落地。全球首个对因治疗IgA肾病药物耐赋康年内实现3.534亿元收入，同比增长1581%。全球首个氟环素类抗菌药物依嘉全年收入3.528亿元，同比增长256%。自身免疫性疾病领域的同类最佳药物伊曲莫德（VELSIPITY）已在中国澳门和新加坡获批上市，并通过“港澳药械通”政策进入粤港澳大湾区，惠及中国内地患者。其新药上市申请已于2024年12月在中国大陆（维适平）和中国香港（维长宁）获受理。 在研管线中，新一代共价可逆BTK抑制剂EVER001已取得积极临床数据，个性化mRNA肿瘤治疗性疫苗EVM16已进入临床阶段，通用型现货mRNA肿瘤治疗性疫苗EVM14已在美国获批临床。云顶新耀将积极推进EVER001和AI+mRNA技术平台的创新研发。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 康宁杰瑞2024财报：收入增长192.58%，恩维达录得近1.6亿元 2025年3月26日，康宁杰瑞生物制药（康宁杰瑞，9966.HK）发布2024年度业绩公告。公司全年营业收入640.08百万元，同比增长192.58%；首次实现年度财务盈利，年内利润166.34百万元。期内研发开支404.15百万元，同比基本持平。截至2024年12月31日，公司拥有现金储备1571.47百万元。 2024年，康宁杰瑞实现药品销售及特许权使用费收入159.46百万元，主要源于其与思路迪合作研发的全球首个皮下注射PD-(L)1抑制剂恩维达（恩沃利单抗注射液）。该产品已于2021年在中国获批上市，2024年1月在中国澳门获批。康宁杰瑞与思路迪还在去年与Glenmark达成协议，授予Glenmark在印度、亚太地区（除新加坡、泰国、马来西亚）、中东和非洲、俄罗斯、独联体和拉丁美洲开发和商业化恩维达用于肿瘤适应证的独家许可权益。 在研管线中，KN026（HER2异二聚体双抗）、JSKN003（HER2双抗ADC）、JSKN016（HER3×TROP2双抗ADC）、KN046（CTLA-4×PD-L1双特异性抗体）均已进入临床开发阶段。康宁杰瑞正在加码生产基地建设，以满足临床阶段与商业化阶段的规模化生产需求；2024年在原有产能基础上新建了ADC原液和制剂车间，并即将投产。 ->点击文末阅读原文，解锁完整双语新闻 No.4 / 华润医疗2024财报：收益98.55亿元，利润增长104.9% 2025年3月25日，华润医疗控股有限公司（华润医疗，1515.HK）发布2024年度业绩公告。公司全年收益为98.55亿元，同比下降2.5%；年度利润为6.72亿元，同比增长104.9%。 截至2024年12月31日，华润医疗在中国10个省、市共管理运营105家医疗机构。报告期内，自有医院常规诊疗门诊量和住院量分别约为1032万人次和56万人次，分别同比增长1.9%及1.0%。医院业务分部营业额为人民币91.85亿元，同比下降2.4%。受医保控费影响，门诊和住院次均收入分别下降2.4%和4.3%。 ->点击文末阅读原文，解锁完整双语新闻 No.5 / 19.7亿美元！默沙东获得恒瑞医药HRS-5346全球权益 2025年3月25日，恒瑞医药（600276.SH）宣布，与默沙东就其Lp(a)口服小分子项目（包括名为HRS-5346的先导化合物）达成独家许可协议。 根据协议条款，恒瑞医药将HRS-5346在大中华区以外的全球范围内开发、生产和商业化的独家权利有偿许可给默沙东。恒瑞医药将收取2亿美元的首付款，并有资格获得不超过17.7亿美元的与特定的开发、监管和商业化相关的里程碑付款，以及如果相关产品获批上市，基于HRS-5346的净销售额的销售提成。 Lp(a)是一类独特的脂蛋白，含有低密度脂蛋白（LDL）样颗粒，具有促动脉粥样硬化、促炎、促钙化等作用，靶向Lp(a)的降脂疗法成为心血管疾病防治的重要突破点之一。HRS-5346是一种在研的Lp(a)口服小分子抑制剂，目前正在中国进行Ⅱ期临床试验。 ->点击文末阅读原文，解锁完整双语新闻 No.6 / 燃石医学2024年财报：连续四个季度盈利 2025年3月25日，燃石医学（Nasdaq：BNR）发布了2024年第四季度和2024年全年业绩公告，2024年第四季度实现营收1.26亿元，2024年全年实现营收5.158亿元。当前公司运营效率和盈利能力持续提高，在扣除研发及非现金项目后，2024年全年，燃石医学实现连续四个季度盈利。 2024年第四季度，公司院内检测收入为4350万元，同比增长50.9%，连续四季度领先中心实验室；中心实验室检测收入为3930万元；药企合作收入为4330万元人民币，同比增长5.6%。2024年全年，公司药企合作收入为1.157亿元，较2023年的1.159亿元基本持平。 全年公司研发费用为2.323亿元，同比下降33.1%；销售和市场费用为1.909亿元，同比下降22.9%；一般及行政费用为2.616亿元，同比下降40.2%。公司成本为1.534亿元，同比降低11.9%；毛利为3.624亿元，与2023年基本持平；毛利率为70.3%，同比2023年的67.6%稳步提升。 截至2024年12月31日，燃石医学现金、现金等价物和受限现金为5.222亿元。 ->点击文末阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ xujingou@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻