PART A：主要目的：评估HLX53+HLX10 +HLX04 一线治疗晚期HCC中的安全性和耐受性次要目的：初步评估HLX53+HLX10+HLX04一线治疗晚期HCC中的临床疗效 PART B：主要目的：评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04一线治疗晚期HCC中的临床疗效次要目的：初步评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04一线治疗晚期HCC中的安全性和耐受性评估HLX53+HLX10+HLX04对比安慰剂+HLX10+HLX04治疗晚期HCC的潜在预测性生物标志物及耐药生物标志物

开始日期2024-08-05

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT06491355 / Not yet recruiting临床2期IIT

Efficacy and Safety of First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer: A Prospective, Multicenter, Randomized, Controlled Trial (ASTRUM-IUmCRC)

This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer.
This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).

开始日期2024-07-01

申办/合作机构

Sir Run Run Shaw Hospital

NCT06349980 / Not yet recruiting临床2期

A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined With Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

开始日期2024-05-10

申办/合作机构

上海复宏汉霖生物技术股份有限公司

100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的临床结果

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100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的转化医学

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100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的专利（医药）

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项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的文献（医药）

2024-09-01·Med

First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial

Article

作者: Wang, Feng ; Ke, Ying ; Cao, Bangwei ; Sun, Meili ; Luo, Suxia ; Liang, Xinjun ; Yang, Liu ; Zhang, Mingjun ; Li, Jing ; Jin, Yongdong ; Xu, Rui-Hua ; Wang, Qingyu ; Chen, Kehe ; Wang, Wei ; Deng, Yanhong ; Lin, Yuan ; Zhu, Jun ; Cheng, Ying ; Wang, Zi-Xian ; Li, Zhen ; Peng, Junjie ; Zhang, Jingdong ; Yu, Haoyu

BACKGROUND:

Whether or not the addition of immunotherapy to current standard-of-care treatments can improve efficacy in proficient mismatch repair (pMMR)/microsatellite-stable (MSS) metastatic colorectal cancer (mCRC), the predominant type of mCRC, is unclear.

METHODS:

This randomized, double-blind, phase 2 part of a phase 2/3 trial was conducted at 23 hospitals across China (ClinicalTrials.gov: NCT04547166). Patients with unresectable metastatic/recurrent colorectal adenocarcinoma and no prior systemic therapy were randomly assigned 1:1 to receive every-3-weeks intravenous serplulimab (300 mg) plus HLX04 (7.5 mg/kg) and XELOX (serplulimab group) or placebo (300 mg) plus bevacizumab (7.5 mg/kg) and XELOX (placebo group). The primary endpoint was independent radiology review committee (IRRC)-assessed progression-free survival (PFS). Secondary endpoints included other efficacy endpoints and safety.

FINDINGS:

Between July 16, 2021, and January 20, 2022, 114 patients were enrolled and randomly assigned to the serplulimab (n = 57) or placebo (n = 57) group. All patients had stage IV CRC, and 95.7% of the patients with available microsatellite instability (MSI) status were MSS. With a median follow-up duration of 17.7 months, median PFS was prolonged in the serplulimab group (17.2 vs. 10.7 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.31-1.14). Although the median overall survival (OS) was not reached for either group, a trend of an OS benefit was observed for the serplulimab group (HR, 0.77; 95% CI, 0.41-1.45). 36 (65.5%) and 32 (56.1%) patients in the serplulimab and placebo groups had grade ≥3 treatment-related adverse events, respectively.

CONCLUSIONS:

Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC.

FUNDING:

This work was funded by Shanghai Henlius Biotech, Inc.

2024-09-01·Med

Adding first-line PD-1 inhibition to anti-VEGF and XELOX in pMMR metastatic colorectal cancer: Steppingstones, stumbling blocks, and next phase

Article

作者: Søreide, Kjetil ; Veen, Torhild

In the randomized, double-blind, multicenter study by Wang et al.,¹ the addition of serplulimab (a PD-1 antibody) to anti-VEGF (HLX04; a bevacizumab biosimilar) together with chemotherapy (XELOX) was deemed to be tolerable and safe and may improve progression-free survival. However, even if adverse events were comparable, oncological endpoints including survival need to be confirmed in the next phase 3 study.

2023-07-01·Analytical and Bioanalytical Chemistry

Demonstrating analytical similarity of a biosimilar HLX04 to bevacizumab with a panel of state-of-the-art methods and tiering of quality attributes.

Article

作者: Fei, Mengdan ; Cao, Yanjing ; Wang, Hongya ; Yu, Lu ; Shen, Pengcheng ; Qin, Peilan ; Lu, Lihong ; Xu, Yanpeng ; Gao, Wenyuan ; Zhang, Lei ; Liu, Kemeng ; Zhang, Zhongli

Therapeutical monoclonal antibodies are structurally and functionally complex, whereas the innovator's manufacturing processes are proprietary. With respect to the similarity assessment, a proposed biosimilar product needs to demonstrate a side-by-side comparison between the reference product (RP) and candidate product in terms of physicochemical properties and biological activities, as well as nonclinical and clinical outcomes. Here, a comprehensive analytical similarity assessment was performed for in-depth comparison of HLX04, China-sourced Avastin^® (CN-Avastin^®), and Europe-sourced Avastin^® (EU-Avastin^®) following a tier-based quality attribute (QA) evaluation. A series of orthogonal and state-of-the-art analytical techniques were developed for the assessment. Ten lots of HLX04 were compared with 29 lots bevacizumab RP. Referred to the characterization results, HLX04 is highly similar to the RPs with respect to physicochemical properties and biological functions. In addition, HLX04 was found with similar stability and degradation behaviors upon multiple stressed conditions to bevacizumab. Minor differences were observed in glycosylation, aggregates, FcγRIIIa(F), and FcγRIIIa(V) binding activities; nevertheless, they were evaluated and demonstrated not to impact clinical outcomes. According to the reported clinical results, the totality of evidence, including the pharmacokinetic, efficacy, safety, and immunogenicity, further shows that HLX04 is similar to CN-/EU-Avastin^®.

233

项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的新闻（医药）

2024-12-17

·复宏汉霖

汉霖快讯 | 复宏汉霖加入Biosimilars Forum

近期，Biosimilars Forum（生物类似药论坛组织）宣布复宏汉霖成为其最新成员企业。Biosimilars Forum作为一个非营利组织，致力于推动生物类似药在美国的发展，扩大生物药物的可及性并改善医疗保健。复宏汉霖的首席商务官曹平女士表示：“复宏汉霖致力于与行业合作伙伴携手推进共同的使命，为全球患者提供高质量、可负担且高效的生物类似药。我们非常高兴能够在这一关键节点加入论坛。在当前阶段，提高这些药物的可及性和接受度对于降低医疗成本并改善患者健康状况至关重要。” Biosimilars Forum执行主任Juliana M. Reed女士表示：“我很高兴欢迎复宏汉霖成为生物类似药论坛的最新成员，我们的理事会和我都期待与复宏汉霖团队密切合作，共同致力于为患者提供低成本、安全且高效的生物类似药治疗选择。” 复宏汉霖是一家快速发展的生物制药企业，专注于开发、生产和销售优质的生物药，其产品已覆盖全球50多个国家，惠及患者超过70万人。迄今为止，复宏汉霖已自主开发并上市四款生物类似药，并全速推进10余款在研生物类似药的开发。其中，汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）是在中国、欧盟、美国获批的“中国籍”单抗生物类似药，现已成功于美国、英国、加拿大、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、泰国等国家和地区获批上市，并进入中国、英国、法国和德国等多个国家的医保目录。近期，公司亦完成汉曲优®首批美国商业化发货。复宏汉霖携手商业合作伙伴Accord、Abbott、Eurofarma、Organon和KGbio等国际一流的生物制药企业，前瞻性地开展了全球商业化布局。未来，复宏汉霖将继续深化与全球合作伙伴的协作，推进更多高品质药物的全球上市进程，惠及更多患者。关于Biosimilars Forum Biosimilars Forum致力于在美国推进生物类似药，旨在扩大生物药的可及性和可用性，从而改善医疗保健。该论坛通过提供基于证据的信息，支持和制定有助于提高生物类似药认知度、可及性和采纳率的公共政策。 Biosimilars Forum的成员包括大多数拥有重要美国生物类似药开发项目的企业，具体包括Amneal Pharmaceuticals、Biocon Biologics、复宏汉霖（Henlius）、Meitheal Pharmaceuticals、欧加隆（Organon）、辉瑞（Pfizer Inc.）、三星生物（Samsung Bioepis）、山德士（Sandoz）以及梯瓦制药（Teva Pharmaceuticals）。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，3款产品在国际获批上市，25项适应症获批，4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50多个分子，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）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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 Becomes Newest Member of Biosimilars Forum Recently, Henlius has been announced as the newest member company of the Biosimilars Forum, a coalition that advances biosimilars in United States with the intent of expanding access and availability of biological medicines and improving health care. "Henlius is committed to working with our industry partners to advance our mission of providing patients around the world with high-quality, affordable, and effective biosimilar medicines," said Ping Cao, CBO of Henlius. "We are so excited to join the Forum at this critical impasse — where access and adoption of these medicines is necessary to lower costs and improve healthcare outcomes for patients.” "I am excited to welcome Henlius as the latest member of the Biosimilars Forum," said Juliana M. Reed, Executive Director of the Biosimilars Forum. "Our Board of Directors and I look forward to collaborating with the Henlius team as we work to make biosimilars accessible to patients as lower-cost, safe, and effective options." Henlius is a rapidly growing biopharmaceutical provider that develops, manufactures, and distributes leading biologics in over 50 countries worldwide, serving more than 700,000 patients. To date, Henlius has independently developed and launched four biosimilars, in addition to more than 10 biosimilar candidates under development. Among them, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) is a China-developed mAb biosimilar that has been approved in China, the European Union (EU) and U.S. It is approved in the United States, United Kingdom, Canada, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. Recently, HANQUYOU completed its first shipment to the United States. In collaboration with leading global biopharmaceutical companies such as Accord, Abbott, Eurofarma, Organon, and KGbio, Henlius has proactively established a global commercial layout for its biosimilar product portfolio. Looking ahead, Henlius will continue to strengthen its collaborations with global partners to accelerate the global launch of more high-quality medicines, benefiting more patients worldwide. About Biosimilars Forum The Biosimilars Forum works to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The Biosimilars Forum provides evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars. The members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios, specifically Amneal Pharmaceuticals, Biocon Biologics, Henlius, Meitheal Pharmaceuticals, Organon, Pfizer Inc., Samsung Bioepis, Sandoz, and Teva Pharmaceuticals. 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, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 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 over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Apart from the launched products 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) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 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 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

生物类似药上市批准

2024-12-16

·医药笔记

复宏汉霖PD-1抗体H药：诚邀临床合作伙伴，共塑免疫治疗新星！

全球首个获批一线治疗小细胞肺癌的抗PD-1单抗 H药汉斯状®斯鲁利单抗临床合作正在招募中！新分子？新靶点？新技术？新平台？ 1+?=∞ 期待碰撞出不一样的火花项目组邮箱：Serplulimab_combo@henlius.com 携手打造免疫治疗领域的明日之星，照亮肿瘤治疗的未来更多详情，参见👇原文链接合作沟通，详询项目组邮箱：Serplulimab_combo@henlius.com H药汉斯状®（通用名：斯鲁利单抗注射液）是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，自上市以来展现出优异的临床疗效。目前，该产品在中国获批治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC）等5项适应症，同时在印尼、柬埔寨、泰国等东南亚国家获批上市，治疗小细胞肺癌的欧盟上市许可也已经获得欧盟委员会积极意见，获批上市在即。斯鲁利单抗从分子结构到作用机制上呈现出一系列的差异化优势，奠定了其优异的临床疗效和安全性。此外，斯鲁利单抗与其他产品的创新联合疗法还在全球同步开展10余项MRCT，在中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4400人，其中包括ASTRUM-005在内的2项国际多中心临床试验入组白人人群的比例均超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。复宏汉霖还在美国启动了一项斯鲁利单抗对比一线标准治疗阿替利珠单抗的头对头桥接试验。2024年10月，斯鲁利单抗联合贝伐珠单抗与化疗一线治疗转移性结直肠癌（mCRC）患者的国际多中心III期临床研究完成了日本首例患者给药，此项研究正在中国和印度尼西亚等地区同步开展。斯鲁利单抗关键性学术发表与指南推荐一览：获国际知名期刊JAMA,Nature Medicine, Cancer Cell和Med等发表，纳入《CSCO 小细胞肺癌诊疗指南》、《CSCO非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO结直肠癌诊疗指南》、《CSCO免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐。关于超新星计划 ✦ 【合作对象】面向所有制药企业及科研/临床机构开放申请【合作要求】 1、创新分子（小分子或大分子）、创新靶点或创新技术 2、作用机制明确，联合斯鲁利单抗治疗特定癌种的科学依据合理 3、产权/专利清晰【合作方式】 1、有意愿的制药企业及科研/临床机构提出合作需求，签署保密协议后提供研究计划及必要的支持数据 2、复宏汉霖团队和临床专家评估可行后进行甄选 3、双方共同确定临床研究方案，以共同投入、共享产出为原则，签订合作协议【联系方式】项目组邮箱：Serplulimab_combo@henlius.com 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，3款产品在国际获批上市，25项适应症获批，4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50多个分子，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）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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。

CSCO会议临床3期上市批准引进/卖出

2024-12-16

·复宏汉霖

2024 ESMO IO | 复宏汉霖H药汉斯状®新辅助治疗食管鳞癌研究数据发布

2024年欧洲肿瘤内科学会免疫肿瘤大会（ESMO IO）于当地时间12月11日至13日在瑞士日内瓦及线上同步举行。会上，由复宏汉霖自主研发的创新型单抗H药汉斯状®（斯鲁利单抗）联合化疗新辅助治疗可切除局晚期食管鳞癌的单臂II期试验数据以壁报形式发布。该研究由浙江大学医学院附属第二医院吴明、沈虹教授团队开展。 H药汉斯状®（通用名：斯鲁利单抗注射液）为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国和多个东南亚国家获批，惠及患者约9万人。截至目前，H药已在中国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）等5项适应症，此外，H药一线治疗ES-SCLC的上市申请也已获得欧盟EMA受理，有望于2025年获批上市。聚焦肺癌和消化道肿瘤等瘤种，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展10余项肿瘤免疫联合疗法临床试验，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超4600人。其中，H药联合化疗治疗不可切除局部晚期/复发或转移性食管鳞癌(ESCC)的一线治疗方案已于2023年9月获得中国国家药监局（NMPA）批准上市，为我国食管鳞癌患者带来了免疫治疗新选择。以下为此次发布的详细信息：左右滑动查看更多图片论文题目：斯鲁利单抗联合化疗新辅助治疗可切除局晚期食管鳞癌的一项单臂II期试验报告时间：2024年12月12日（日内瓦时间）研究设计：关键入组标准： -病理学和影像学确诊的可手术切除的食管鳞癌初治受试者； -分期为II-IVA 期（AJCC 第八版食管鳞癌临床分期）； -治疗前评估可R0手术切除的患者； -ECOG评分0~1。治疗方案：新辅助治疗：斯鲁利单抗4.5mg/kg，i.v，d1+白蛋白紫杉醇260 mg/m2，d1+卡铂AUC=5，i.v，d1，每21天重复一次，治疗三周期。末次给药后4~6周行食管癌根治切除手术。主要研究终点：病理完全缓解率(Pathological complete response，pCR率)。结果： 45例患者最终接受手术，并全部（100%）达到了R0切除，其中3例完全缓解，30例部分缓解，ORR（Objective Response Rate，客观缓解率）达到68.8%，DCR（Disease control rates，疾病控制率）为100%。在病理学上，有14例患者达到原发肿瘤和淋巴结的完全缓解，pCR为31.1%。只有2例患者出现了≥3级AE。结论：这项单臂的II期研究证实了斯鲁利单抗联合化疗新辅助治疗局部进展期食管鳞癌显示出值得期待的疗效和可耐受的安全性。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，3款产品在国际获批上市，25项适应症获批，4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50多个分子，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）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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。 Latest Results of Serplulimab in The Neoadjuvant Treatment of ESCC Released In 2024 ESMO IO From 11 to 13 December 2024, the 2024 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress took place in Geneva, Switzerland, and online. At this congress, the results of a phase 2 clinical trial of serplulimab in combination with chemotherapy in the neoadjuvant treatment of oesophagexal squamous cell carcinoma have been published in poster presentation. This study was led by Professor Ming Wu and and Professor Hong Shen from the Second Affiliated Hospital Zhejiang University School of Medicine. HANSIZHUANG (serplulimab), Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Up to date, it has been approved in China and several Southeast Asian countries, benefiting about 90,000 patients. In China, it has been approved by the NMPA for the treatment of 5 indications including squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Furthermore，the marketing applications of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA), which is expected to be approved in 2025. Focusing 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 more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,600 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. From which, HANSIZHUANG in combination with chemotherapy for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC has been approved by the China National Medical Products Administration (NMPA) in September 2023, providing a new treatment option for patients with ESCC. The detailed results of the study released at 2024 ESMO-IO are as follows: Title: Serplulimab Combined with Chemotherapy in The Neoadjuvant Treatment of Resectable Oesophagexal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial Time: December 12, 2024(CET) Study Design: Key Inclusion Criteria: -Histologically or cytologically diagnosed with ESCC; -Clinical stage II-IVA, based on the American Joint Committee on Cancer (AJCC) 8th edition; -Pre-treatment evaluation indicates potential for R0 resection; -Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Treatment: Three cycles of neoadjuvant therapy (21 days per cycle):Serplulimab (4.5mg/kg intravenously on day 1), Carboplatin (AUC=5 intravenously on day 1),Albumin paclitaxel (260 mg/m2 intravenously on day 1).Surgery (4-6 weeks after the last neoadjuvant treatment cycle). Primary Outcome: Pathological complete response (PCR). Results: Three patients opted out of surgical treatment and withdrew from the study. A total of 45 patients underwent minimally invasive oesophagectomy following serplulimab-based neoadjuvant therapy, and all achieved R0 resection. Complete pCR in both primary tumor and lymph nodes was achieved in 14 patients (31.1%). Only two patients experienced grade 3 AEs. Conclusion: In this single-arm phase 2 study, serplulimab in combination with chemotherapy in the neoadjuvant setting for locally advanced ESCC has shown promising antitumor activity and an acceptable safety profile. 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, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 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 over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Apart from the launched products 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) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 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 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

上市批准临床2期临床3期临床结果申请上市

100 项与贝伐珠单抗生物类似药 (上海复宏汉霖) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC07	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
输卵管癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
卵巢上皮癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
原发性腹膜癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
宫颈癌	中国	上海复宏汉霖生物制药有限公司	2023-01-03
结直肠癌	中国	上海复宏汉霖生物制药有限公司	2021-11-30
非小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2021-11-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非鳞状非小细胞肺癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
肝细胞癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-11-15
湿性年龄相关性黄斑变性	临床3期	俄罗斯	上海复宏汉霖生物技术股份有限公司	2021-04-06
转移性结直肠癌	临床3期	日本	上海复宏汉霖生物技术股份有限公司	2021-03-10
晚期肺非鳞状非小细胞癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2019-12-12
鳞状非小细胞肺癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2019-12-02
门静脉血栓形成	临床2期	-	上海复宏汉霖生物技术股份有限公司	2021-08-01
晚期肝细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2019-09-24
晚期恶性实体瘤	临床1期	中国	上海复宏汉霖生物技术股份有限公司	2018-11-27
卵巢癌	临床申请	中国	上海复宏汉霖生物技术股份有限公司	2022-10-11

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04547166 (ASCO_GI2024) 人工标引	临床2/3期	转移性结直肠癌一线 Deficient DNA Mismatch Repair (dMMR) \| MSI-High \| Microsatellite Stable (MSS) \| ... 更多	114	Serplulimab+HLX04+XELOX	願遞鹹觸醖顧襯齋淵範(簾夢鹽範襯獵積積構襯) = 鏇築艱積鏇憲糧構鹹構鬱遞齋觸網齋網膚襯壓 (餘獵構齋鬱淵構繭顧襯 ) 更多	积极	2024-01-18
				Placebo+ bevacizumab+ XELOX	願遞鹹觸醖顧襯齋淵範(簾夢鹽範襯獵積積構襯) = 衊蓋憲壓築鏇鏇蓋膚願鬱遞齋觸網齋網膚襯壓 (餘獵構齋鬱淵構繭顧襯 ) 更多
NCT03973112 (Corporate Publications) 人工标引	临床2期	晚期肝细胞癌	41	Serplulimab 3 mg/kg+HLX04 5 mg/kg	窪鬱衊襯構積襯膚鏇醖(遞鏇鏇窪範糧餘選齋襯) = 齋積製網壓淵淵餘鑰餘齋膚膚網淵製選鏇廠膚 (餘蓋選觸顧壓鹽製窪網 ) 更多	积极	2022-08-30
				Serplulimab 3 mg/kg+HLX04 10 mg/kg	窪鬱衊襯構積襯膚鏇醖(遞鏇鏇窪範糧餘選齋襯) = 獵窪窪鹽顧構淵壓餘鬱齋膚膚網淵製選鏇廠膚 (餘蓋選觸顧壓鹽製窪網 ) 更多
NCT03511963 (HLX04-mCRC03, Corporate Publications) 人工标引	临床3期	结直肠癌一线	675	Chemotherapy+HLX04	膚願衊獵憲顧簾膚淵壓(願製壓鬱構繭鬱蓋鹹築) = 鏇艱憲構觸範網窪範遞膚鏇獵獵窪構膚簾衊範 (積構衊構觸醖憲衊製鬱 ) 更多	相似	2021-09-26
				Chemotherapy+bevacizumab	膚願衊獵憲顧簾膚淵壓(願製壓鬱構繭鬱蓋鹹築) = 鹹膚窪製壓鹹膚範積憲膚鏇獵獵窪構膚簾衊範 (積構衊構觸醖憲衊製鬱 ) 更多
HLX04-mCRC03 (CSCO2021)	临床3期	转移性结直肠癌一线	677	HLX04	觸鹽遞齋鹹醖鹹糧衊鬱(膚鏇獵製積製醖齋餘醖) = 糧膚觸選積簾鬱鏇鏇觸憲構網遞窪蓋繭範齋積 (壓網鹽願壓築製窪齋鑰 ) 更多	积极	2021-09-25
				Reference bevacizumab	觸鹽遞齋鹹醖鹹糧衊鬱(膚鏇獵製積製醖齋餘醖) = 壓艱艱膚製範鬱網廠壓憲構網遞窪蓋繭範齋積 (壓網鹽願壓築製窪齋鑰 ) 更多
NCT03511963 (HLX04-mCRC03, Pubmed) 人工标引	临床3期	转移性结直肠癌一线	677	XELOX or mFOLFOX6+HLX04	築鑰鹹淵衊鬱憲積積築(艱鑰遞構網餘廠觸衊膚) = 遞糧繭繭觸鹹糧廠齋遞淵窪築獵醖遞積構糧齋 (蓋夢鹽繭繭遞獵廠蓋築, 41.1 ~ 51.8)	相似	2021-07-01
				XELOX or mFOLFOX6+Bevacizumab	築鑰鹹淵衊鬱憲積積築(艱鑰遞構網餘廠觸衊膚) = 醖積鹽築範網窪築製簾淵窪築獵醖遞積構糧齋 (蓋夢鹽繭繭遞獵廠蓋築, 45.4 ~ 56.1)
NCT03511963 (HLX04-mCRC03, ESMO_ASIA_VIRTUAL2020)	临床3期	转移性结直肠癌一线	675	HLX04	襯鹽廠壓顧築願繭糧夢(膚築獵積選構範構遞淵) = 鬱鹽鹽遞鬱積廠築選鏇繭範鑰遞願鬱鏇衊製選 (鏇願願衊選艱壓淵衊積 )	积极	2020-11-22
				Bevacizumab	襯鹽廠壓顧築願繭糧夢(膚築獵積選構範構遞淵) = 觸遞廠窪鹽遞簾網選鏇繭範鑰遞願鬱鏇衊製選 (鏇願願衊選艱壓淵衊積 )
HLX04-mCRC03 (ESMO_ASIA2018)	临床3期	转移性结直肠癌一线	640	HLX04	膚憲艱膚齋窪淵顧壓憲(淵範顧壓壓醖夢憲簾築) = 鹽願夢淵顧鑰鹽構選餘鹹襯簾築繭鏇積網夢築 (膚遞鹽鹹糧壓遞顧選網 )	积极	2018-11-24
				Avastin® sourced from US, EU or CN	膚憲艱膚齋窪淵顧壓憲(淵範顧壓壓醖夢憲簾築) = 襯鑰願淵糧範顧築製憲鹹襯簾築繭鏇積網夢築 (膚遞鹽鹹糧壓遞顧選網 )