2026年11月22日，重庆-复宏汉霖（2696.HK）官宣了，单位自由研制开发的研发抗PD-1单抗H药——汉斯状®（普通名：斯鲁利单抗皮下注射液）联办含氟尿嘧啶类和铂类类药中用PD-L1抗体阳性的不能切除术整体肺麟癌/复发率或变动性食管鳞状人体神经元核癌(ESCC)的品牌缓解新适合症的开卖申请表注册申请表(NDA)得到 国度处方药远程监控菅理局许可，为食管鳞癌朋友打造了缓解新选取。前次，H药已新批缓解微小行星较高不安全(MSI-H)片体瘤、鳞状非小人体神经元核1.1.肺淋巴肿瘤（sqNSCLC）和宽泛期小人体神经元核1.1.肺淋巴肿瘤（ES-SCLC）三项评分适合症。复宏汉霖保持推进改革H药在1.1.肺淋巴肿瘤、消化系统道淋巴肿瘤等方面的区别化、多维度战略布局，以达到推向朋友得到 极高收效。
复宏汉霖董监事长兼来执行董监事张文杰
H药应用第4项适应能力症代替医疗食管鳞癌，图标着是一款高品味抗PD-1单抗欺负治的消化吸收酶道癌症范围引来新期盼。自22年2月应用成功上市来，H药在临床医学实践经验中宽泛劳有所得消化吸收酶道癌症、肺肿瘤等范围患病者，牢固树立起正常的信誉，并生成国产品牌效果。前景，我门将重新起到H药竞争优势和竟争力，较快H药市扬开拓改革创新发展，为全世界大多患病者带去可额外的负担的创新发展口服药。
复宏汉霖实行董监事、顶尖实行官、ceo兼顶尖财务人员官朱俊
以医学手术冶疗需求分析为导识，复宏汉霖深入良性肿癌免疫性抗体有目的手术冶疗方向，专注良性肿癌重心病种，扎实实施H药多瘤种规划，正面实施其在世界各国位置同步操作深入推进的单选免疫性抗体携手保健法测试。旨在H药应用食管鳞癌，进一歩核验了H药的手术冶疗发展潜力，能够充分展示复宏汉霖的研制研发有实力。希望H药发展其他正面医学手术冶疗最终结果的涌现出，进一歩谋福利更诸多的癌症复发朋友。
H药食管鳞癌Ⅲ期临床研究主要研究者、国内 中医学科学课院良性肿瘤大医院黄镜教受
食管鳞癌为食管癌中最为常见的病理类型，临床需求较大且总体预后相对较差。斯鲁利单抗围绕不能手术切除的局部晚期或转移性食管鳞癌开展了一项Ⅲ期临床研究（ASTRUM-007）并取得优异结果，该研究基于大样本量的本土人群数据，充分确证了斯鲁利单抗联合化疗一线治疗局部晚期/转移性、PD-L1阳性（PD-L1 CPS≥1）食管鳞癌患者，能够带来PFS、OS的显著获益，期待其在临床实践中惠及更多患者。
食管癌是全球第六大癌症死亡原因，也是我国的高发恶性肿瘤。统计显示，中国食管癌发病率和死亡率分别位列恶性肿瘤的第六和第四位，其中食管鳞癌为最常见的病理类型，约占中国所有食管癌病例的85.79%[1]。由于早期症状不明显，在我国约70%的患者确诊时已为局部晚期或转移性食管鳞癌，失去了手术治疗机会[2]。近年来，多项研究表明抗PD-1单抗联合化疗可为食管癌患者带来生存获益，免疫检查点抑制剂联合化疗已成为我国食管癌的一线治疗标准[3]。
此次获批主要基于一项随机、双盲、多中心的Ⅲ期临床研究（ASTRUM-007），旨在研究斯鲁利单抗对比安慰剂联合化疗（顺铂+5-FU）在既往未接受治疗、PD-L1阳性（PD-L1 CPS≥1）的晚期食管鳞癌患者中的疗效和安全性。根据国际着名学术研究杂志期刊Nature Medicine发表的ASTRUM-007临床研究结果显示，斯鲁利单抗联合化疗带来了总生存期（OS）和无进展生存期（PFS）的全面生存获益，并具备良好的安全性。值得注意的是，PD-L1高表达人群接受斯鲁利单抗联合化疗较意向性治疗（ITT）人群具有更大生存获益，在针对PD-L1 CPS≥10人群的分析中，斯鲁利单抗联合化疗组的中位OS长达18.6个月，较对照组绝对延长4.7个月，死亡风险降低41%。目前，ASTRUM-007实验结果已随后惊艳亮相于2022 ESMO Asia大会、2023 ASCO大会等世界科研商务会议，提升国际英文学术研究界超高批准。
着眼于H药，大公司专注肺癌患者与助肠道肉瘤两种癌种，主动性全面推进H药与单位许多物料的信息化与与技术创新物理疗法的综合，于亚洲微信同步实施10多项淋巴肿瘤免疫抗体携手物理疗法临床研究实验设计，累会计入组逾3600名受试者，国家化的监床科学研究数剧可能为世界十大上报提供了扎实支撑体系。重视化解道肉瘤，H药已将建MSI-H实体型瘤顺应症，即为MSI-H比较严重的结肠道癌和食道癌等糖尿病患者带去诊治我希望。的同时，该药在直肠癌新助手/助手方便已进人Ⅲ期临床检验探析，有希望使直肠癌客户在前线便从肿癌免疫检测辽法中受益。癌症方面，H药已应用sqNSCLC和ES-SCLC两种适应环境症，并被选为全国首位应用一专多能方法小神经细胞膜癌症（SCLC）的抗PD-1单抗，装修公司亦准备于202四年下一年就H药一专多能方法非鳞状非小神经细胞膜癌症（nsNSCLC）在国家提交出现报名。与此一起，H药根治SCLC会相继刷快了美式肉制品放射性保健药品督察治理制度局（FDA）和西方经济共同体国家理事会会（EC）评为的弃婴药从业资格认定书，该药中俄原油管道根治ES-SCLC的西方经济共同体国家主板上市同意公司申请（MAA）已经和202三年7月刷快西方放射性保健药品治理制度局（EMA）授理，即将于202历经四年上一个月刷快申批。复宏汉霖亦在美发动没事项H药价格对比标杆标准的制疗阿替利珠单抗用以ES-SCLC的头对头桥接试验报告，计划书于202四年在美提出申办销售许可证申办（BLA)。于此，复宏汉霖还平稳积极推动H药停留期小内部1.肺癌（LS-SCLC）的环球多咨询中心Ⅲ期临床治疗研究方案。
商家服务拓张问题，复宏汉霖对于H药展开了全局观性的构造图，并将持续多层级、多桥梁升降该货品的可及性，到现下，H药已劳有所得逾3.七万之名中国现代有糖尿病患病者，并中国的市面现代有国内完全29个省区的招标项目挂网，同時，已进人杭州市、重庆市、浙江宁波市、宁波市、湖南省、甘肃回族自治权区等二十六个省/地市级设计型商家服务填写医疗保健保障列表。对于在美利坚的市面，复宏汉霖与KGbio于2021实现合作的，获得其H药首批单药方式及两种聯合方式在东南方亚地段10个部委獨家开放和商家服务化基本权利；202几年10月，大有限公司进一大步就H药在中东地区北非空间区域1俩个部委的獨家商家服务化基本权利获得KGbio。除此以外，大有限公司还获得银河集团官网
健康安全H药在美利坚的市面的獨家商家服务化基本权利，联合拓张H药的在美利坚的市面构造图，锐意创新涵盖亚洲更诸多的糖尿病患病者目标群体。
未来是什么，复宏汉霖将延续升高研产供销全产链整合實力，深入招商精准改善与转成学习的改善组织体制，多角度构建H药诊疗币值，延续构造恶性肿瘤免役改善新创一流，为环球自身带去献爱心与也希望。
H药 汉斯状®为重组人源化抗PD-1单抗注射液（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，目前已有4项适应症获批上市，1项适应症上市申请在欧盟获受理，10余项临床试验同步在全球开展。
2022年3月，H药正式获批上市，目前可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（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请也获得欧盟EMA受理。聚焦肺癌和消化道肿瘤，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，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展10余项肿瘤免疫联合疗法临床试验。截至目前，H药已于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3600人，其中2项国际多中心临床试验入组白人的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药的3项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）和British Journal of Cancer。此外，H药还荣获《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，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验。
复宏汉霖（2696.HK）一家新国际性联盟化的特色化海洋生态学学药业机构，专业专注于为高度最大的人带来可负税的高品控海洋生态学学药，的企业货品盖住淋巴肿瘤、在工作中免疫细胞症状、眼科医生症状等这个领域，已在我国国内内地推出5款的企业货品，在新国际性联盟推出1款的企业货品，19项融入症应用，3个推出申请办理对应获荷兰FDA和欧洲经济共同体委员会EMA业务办理。自20五年我司设立来党，复宏汉霖已投入使用立体式化海洋生态学学药业机构，高及特色化的自主学习基本点程度包括开发、产出及商业性的经营全工业链。机构已确立改善高的高度最大特色化监管中心，以新国际性联盟otc药品产出质理监管规程（GMP）条件展开产出和质理监管，一个劲增强立体式化综合管理产出机构，这其中，北京徐汇集散地已有全球内地和欧洲经济共同体委员会GMP申请审核，松江集散地（一）也已有全球内地GMP申请审核。
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20多种创新单克隆抗体，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。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，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、广泛期小细胞肺癌和食管鳞状细胞癌，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' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC
Shanghai, China, Sep 22nd, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the new drug application (NDA) for new indication of HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by the company, in combination with drugs containing fluorouracil and platinum for the first-line treatment of patients with PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC), has been approved by the National Medical Products Administration (the "NMPA"), providing a new treatment option for patients with ESCC. Up to date, HANSIZHUANG has been approved for the treatment of microsatellite instability-high (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), and extensive stage small cell lung cancer (ES-SCLC). To further benefit patients, Henlius continues to differentiate and optimize product portfolios and the roadmap of HANSIZHUANG in lung cancer, gastrointestinal cancer, and other cancers.
Wenjie Zhang, Chairman, and Executive Director of Henlius, remarked, "ESCC is the fourth approved indication of HANSIZHUANG and its approval signifies that this high-quality anti-PD-1 mAb offers a new ray of hope for the treatment of difficult-to-treat gastrointestinal cancer. Since it launched in March 2022, HANSIZHUANG has benefited a wide range of patients with lung cancer, gastrointestinal cancer, and other tumors, further solidifying its positive reputation with a strong brand effect. Moving forward, we will continue leveraging the strengths of HANSIZHUANG and fully tapping its potential to accelerate market expansion to provide affordable, innovative treatments to more patients worldwide."
Jason Zhu, Executive Director, Chief Executive Officer, President and Chief Financial Officer of Henlius, said, "Henlius is driven by unmet clinical needs and has devoted itself to precision immunotherapy for tumors. We are focusing on major cancer types, steadily expanding the clinical layout of HANSIZHUANG in multiple cancer types, and actively initiating immune combination therapy trials worldwide. The approval of ESCC further validates the potential of HANSIZHUANG and demonstrates the innovation capabilities of Henlius. We look forward to more positive study results of HANSIZHUANG to make further contributions to cancer treatment for more cancer patients."
Prof. Jing Huang, the leading principal investigator of ASTRUM-007, from Cancer Hospital Chinese Academy of Medical Sciences, said, "ESCC is the most common pathological type of esophageal cancer with high clinical demand and relatively poor overall prognosis. The phase 3 clinical study (ASTRUM-007) on serplulimab plus chemotherapy for unresectable locally advanced/metastatic esophageal cancer achieved promising results, which was conducted on a large sample of the local population and fully demonstrated that serplulimab in combination with chemotherapy as a first-line treatment for locally advanced/metastatic and PD-L1 positive (PD-L1 CPS≥1) esophageal cancer patients can significantly improve progression-free survival (PFS) and overall survival (OS). We are hoping that serplulimab will benefit more patients in clinical practice."
Providing a new solution for urgent clinical needs
Esophageal cancer is the sixth leading cause of cancer-related deaths worldwide as well as a prevalent malignant tumor in China. According to the data, the incidence and mortality of esophageal cancer rank sixth and fourth, respectively, among all malignant tumors in China, of which ESCC is the most common pathological type that accounts for about 85.79% of all esophageal cancer cases[1]. As the symptoms of early esophageal cancer are often subtle, about 70% of patients are diagnosed at mid-to-late stage, missing out on surgical treatment[2]. In recent years, many studies have shown that anti-PD-1 mAb combined with chemotherapy can bring survival benefits to patients with esophageal cancer. Up to date, immune checkpoint inhibitor combined with chemotherapy has become the standard first-line treatment for advanced esophageal cancer in China[3].
The approval was primarily based on ASTRUM-007, a randomized, double-blind, multicenter, phase 3 study aiming to compare the efficacy and safety of serplulimab versus placebo in combination with chemotherapy (5-FU + cisplatin) in patients with previously untreated, PD-L1–positive (PD-L1 CPS≥1), advanced ESCC. According to the study results published in the international leading journal Nature Medicine, serplulimab in combination with chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS), its safety was also manageable. Notably, the PD-L1 high-expression group receiving serplulimab combined with chemotherapy gained a greater survival benefit comparing to the intention-to-treat (ITT) group, in the analysis of the group with PD-L1 CPS≥10, the combination of serplulimab and chemotherapy group had a median OS of 18.6 months, with an absolute extension of 4.7 months compared to the control group and a 41% reduction in the risk of death. The results of ASTRUM-007 have been released at many world-class conferences, such as the 2022 ESMO Asia Congress and the 2023 ASCO Annual Meeting, receiving high recognition from the international academic community.
Widening indication coverage for patients worldwide
Henlius focuses on lung and gastrointestinal cancer and promotes the synergy of HANSIZHUANG with innovative therapies, in which more than 10 clinical trials on immuno-oncology combination therapies have been initiated worldwide. As of now, the company has enrolled more than 3,600 subjects, and the global clinical research data will provide strong support for its NDAs in overseas markets. In terms of gastrointestinal cancer, HANSIZHUANG has been approved for the treatment of MSI-H solid tumours, which brings hope to patients with MSI-H colorectal cancer and MSI-H gastric cancer. Furthermore, HANSIZHUANG has led the way with a phase 3 clinical study on neoadjuvant/adjuvant therapies for gastric cancer, striving to benefit gastric cancer patients from the early line of immunotherapy. In the field of lung cancer, HANSIZHUANG has been approved for sqNSCLC and ES-SCLC, making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. The company also plans to submit a marketing application for HANSIZHUANG as a first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) in China in the second half of 2023. In addition, HANSIZHUANG was also granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and European Commission (EC) for the treatment of SCLC, and its Marketing Authorization Application (MAA) for the first-line treatment of ES-SCLC was validated by the European Medicines Agency (EMA) in March 2023, with the expectation of approval in the first half of 2024. Henlius also lanuched a head-to-head bridging trial of HANSIZHUANG versus first-line standard-of-care atezolizumab for ES-SCLC in the U.S. and the company plans to submit a Biologics License Application (BLA) for HANSIZHUANG in the U.S. in 2024. Furthermore, Henlius is steadily advancing a global multi-center clinical research of HANSIZHUANG for the limited stage small cell lung cancer (LS-SCLC).
Henlius proactively promotes the commercialization of HANSIZHUANG to enhance its accessibility through multiple dimensions and channels. Up to date, HANSIZHUANG has benefited over 37,000 Chinese patients and has completed the tendering process on the procurement platform in 29 provinces in Chinese mainland and was included into the customized commercial medical insurance directory in 26 Provinces and cities such as Shanghai, Chengdu, Ningbo, Xiamen, Fujian, Ningxia Hui Autonomous Region, etc. For the overseas market, Henlius forged a partnership with Kalbe Genexine Biologics (KGbio) to grant it an exclusive license to develop and commercialize HANSIZHUANG in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries. In August 2023, the company further granted KGbio exclusive development and commercialization authorizations of HANSIZHUANG in 12 Middle East and North Africa (MENA) countries. In addition, Henlius entered into an exclusive license agreement with Fosun Pharma for the commercialization of HANSIZHUANG in the U.S., aiming to expand the overseas market layout of HANSIZHUANG and reach out to a wider range of global patients.
In the future, Henlius will continue to enhance its capabilities in innovation, manufacturing, and commercialization, dedicating its efforts to the development of a system for precision treatment and translational medicine research and maximizing the clinical value of HANSIZHUANG to set the pace in tumor immunotherapy to deliver warmth and hope to patients all over the globe.
【考虑期刊论文】
[1] Chen R, Zheng R, Zhang S, et al. Patterns and trends in esophageal cancer incidence and mortality in China: an analysis based on cancer registry data[J]. Journal of the National Cancer Center, 2023.
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HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 4 indications are approved for marketing in China, 1 marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world.
HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Its marketing applications of the first-line treatment for ES-SCLC are under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.
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, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, 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) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), 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.
