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IGCC 2025 | 复宏汉霖H药 汉斯状®胃癌领域最新研究结果入选

由国际胃癌协会(International Gastric Cancer Association, IGCA)主办的第16届国际胃癌大会(International Gastric Cancer Congress, IGCC 2025)将于2025年5月7日-10日在荷兰阿姆斯特丹召开。此届大会上,复宏汉霖自主研发的创新型单抗H药 汉斯状®(斯鲁利单抗,欧洲商品名:Hetronifly®)两项胃癌领域的最新研究结果入选。其中,斯鲁利单抗同步放化疗新辅助治疗胃食道结合部腺癌的II期研究入选大会口头报告。



H药 汉斯状®是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗,已在中国、欧洲和东南亚等30多个国家和地区获批上市。截至目前,H药已获批用于治疗鳞状非小细胞肺癌(sqNSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)和非鳞状非小细胞肺癌(nsNSCLC)。聚焦肺癌和消化道肿瘤等全球高发癌种,复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究,于中国、美国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4900人。消化道肿瘤方面,公司持续探索结直肠癌、胃癌等领域治疗研究。其中,H药联合化疗用于新辅助/辅助治疗胃癌III期临床研究正在积极推进,H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌(mCRC)患者的国际多中心临床研究(ASTRUM-015)进入III期临床阶段并于中国、印度尼西亚和日本完成首例受试者给药,H药 汉斯状®有望成为全球首个治疗non-MSI-H mCRC的抗PD-1单抗。


入选此次IGCC 2025大会的两项H药胃癌领域研究如下:





论文题目:Neoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated Results 斯鲁利单抗同步放化疗新辅助治疗胃食道结合部腺癌的II期研究数据

编号:oral abstract 01.1.13

口头报告时间: 5月8日 荷兰阿姆斯特丹时间(UTC+2)

场次:Session 2b:radiation oncology

汇报人:赵林,北京协和医院




论文题目:Efficacy and Safety of Neoadjuvant Anti-PD-1, Thymosin, and SOX in cStage III Gastric Cancer PD-1抑制剂联合胸腺法新和SOX新辅助治疗cStage Ⅲ期胃/胃食管结合部腺癌的疗效及安全性

场次:Poster Session 

编号:P684

主要研究者:徐皓、徐泽宽,江苏省人民医院 

关于复宏汉霖

复宏汉霖(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已有6款产品在中国获批上市,4款产品在国际获批上市,5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心,按照国际药品生产质量管理规范(GMP)标准进行生产和质量管控,不断夯实一体化综合生产平台,其中,公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。


复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖约50个分子,并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前,公司已获批上市产品包括国内首个生物类似药汉利康®(利妥昔单抗)、自主研发的中美欧三地获批单抗生物类似药汉曲优®(曲妥珠单抗,美国商品名:HERCESSI™,欧洲商品名:Zercepac®)、汉达远®(阿达木单抗)、汉贝泰®(贝伐珠单抗)、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®(斯鲁利单抗,欧洲商品名:Hetronifly®)以及汉奈佳®(奈拉替尼)。公司亦同步就19个产品在全球范围内开展30多项临床试验,对外授权全面覆盖欧美主流生物药市场和众多新兴市场。



Henlius to Present Latest Results of Serplulimab in Gastric Cancer at IGCC 2025


The 16th International Gastric Cancer Congress (IGCC 2025), organized by the International Gastric Cancer Association (IGCA), will take place in Amsterdam, the Netherlands, from May 7 to 10, 2025. The latest results on Henlius’ self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) will be presented at the congress. Among them, a phase 2 study evaluating serplulimab combined with concurrent chemoradiotherapy as neoadjuvant treatment for resectable esophagogastric junction adenocarcinoma will be orally presented.

 

HANSIZHUANG is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and has been approved for marketing in over 30 countries and regions, including China, Europe and Southeast Asia. Up to date, it has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,900 subjects enrolled in China, the U.S., Japan, Turkey, Poland, Georgia and other countries and regions. In the field of gastrointestinal cancers, the company continues to explore therapeutic research in colorectal cancer and gastric cancer. The company is actively advancing a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer. The phase 3 stage of the international multi-centre clinical trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) has dosed the first patients in China, Indonesia and Japan, potentially making it the first anti-PD-1 mAb in non-MSI-H mCRC worldwide.

 

Details of the results of serplulimab to be presented at IGCC 2025 are as follows:


Title: Neoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated Results

Number: oral abstract 01.1.13

Oral presentation time: 2025/5/8(UTC+2)

Session: Session 2b:radiation oncology

Presenter: Lin Zhao, Peking Union Medical College Hospital

Title: Efficacy and Safety of Neoadjuvant Anti-PD-1, Thymosin, and SOX in cStage III Gastric Cancer

Session: Poster Session 

Number: P684

PI: Hao Xu, Zekuan Xu, Jiangsu Province Hospital

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.


Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.


联系方式

媒体:PR@Henlius.com

投资者:IR@Henlius.com



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