2025年11月22日，西安-复宏汉霖（2696.HK）官宣了，单位自己研发项目管理的革新抗PD-1单抗H药——汉斯状®（公用名：斯鲁利单抗注射液体液）合作含氟尿嘧啶类和铂类用量用来PD-L1阳性反应的必不可切掉轮廓线肺麟癌/病情的反复或变动性食管鳞状组织核癌(ESCC)的第一线控制新满足症的推出办理学生申请(NDA)才能得到國家放射性药品监察工作局许可，为食管鳞癌提高提供了了控制新进行。当即，H药已将建控制微通信卫星的高度不比较稳定(MSI-H)企业瘤、鳞状非小组织核癌症病患（sqNSCLC）和大量期小组织核癌症病患（ES-SCLC）每项满足症。复宏汉霖持续保持深入推进H药在癌症病患、消化不良道恶性肿瘤等方面的的多样化、多空间维度空间布局，用长期推动提高才能得到极高收效。
复宏汉霖李总长兼实行李总张文杰
H药将建第4项适合症主要用于开展食管鳞癌，标记着这个高品格抗PD-1单抗给面子治的吸收道癌症这个方向造成新愿意。自22年7月将建纳斯达克上市十一届三中，H药在临床药学社会实践中比较广泛受益吸收道癌症、1.肺癌等这个方向病求美者，引领起保持良好的用户评价，并构成企业反应。未来是什么，当我们将仍在充分发挥H药竞争优势和潜力股，提升H药市厂全新升级的步伐，为亚洲大量病求美者带去可额外负担的科学创新性药物。
复宏汉霖施行运行董事、首席总裁总才施行官、总才兼首席总裁总才会计官朱俊
以医学试验装置业务需求为导向性，复宏汉霖发展恶性肺部肿瘤抗体会员精准营销治愈行业，自动对焦恶性肺部肿瘤侧重点病种，深入进行H药多瘤种的布置，及时扎实推进其在世界各国范围之内一起进行的几项抗体联手中医疗法试验装置。我司H药将建食管鳞癌，进1步安全验证了H药的治愈竞争力，足够展示复宏汉霖的研究开发多元化战斗力。盼望H药在未来多及时医学试验装置结杲的产出量，进1步惠及更具有广泛性的癌症复发客户。
H药食管鳞癌Ⅲ期临床研究主要研究者、中国现代分子生物学科学有效院肉瘤三甲医院黄镜教导
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。根据全世界知名度学术交流杂志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学习课题已前不久现身于2022 ESMO Asia公司年会活动、2023 ASCO公司年会活动等国际性学术讨论办公会议，拿到国外科研界长度认定。
致力于H药，大公司精准定位肝癌与转化道恶性肿瘤2大癌种，正面扎实推进H药与品牌同一类产品的分工协作同时与研发治疗方案的联和，于全球最大导入开发10多个癌肿免疫力整合治疗方式临床实验实验设计，累算入组逾3600名受试者，国际性化的临床护理科研统计数据一般为世界上上报出示有效的支撑。对应消化系统道肉瘤，H药已应用MSI-H实体化瘤应用症，有MSI-H比较严重的结十二指肠癌和直肠癌等病患者带去治療但愿。同一，该药在胃溃疡新手游辅助性/手游辅助性个方面已入驻Ⅲ期临床实践探讨，极可能使胃溃疡糖尿病患者在前线便从肿癌免疫性治疗方式中收效。1.非小细胞系癌症业务领域，H药已获准sqNSCLC和ES-SCLC2大适应环境症，并拥有世界十大首条获准专业的方法小血细胞系1.非小细胞系癌症（SCLC）的抗PD-1单抗，司亦预计于202三年下一段时间就H药专业的方法非鳞状非小血细胞系1.非小细胞系癌症（nsNSCLC）在国内 提交推出伸请。与此也，H药改善SCLC不断荣获了瑞典食物放射性医疗耗材参与监管局（FDA）和欧洲国家经济共同体理事会会（EC）颁授的弃儿药条件确认，该药基层改善ES-SCLC的欧洲国家经济共同体出现许可证书申請（MAA）截至202两年10月荣获欧洲国家放射性医疗耗材监管局（EMA）授理，现已于202历经四年上一个月荣获申批。复宏汉霖亦在意大利初始化一堆项H药比对二线的标准诊治阿替利珠单抗代替ES-SCLC的头对头桥接实验设计，方案于2028年在意大利提交提交申请纳斯达克上市同意提交申请（BLA)。最后，复宏汉霖还稳中有进促使H药仅限期小細胞肺腺癌（LS-SCLC）的环球多中心局Ⅲ期临床学习学习。
商务拓展训练训练部分，复宏汉霖涉及H药开展了前沿性性的规划，并定期多基本要素、多业务提拔该產品的可及性，截止当下，H药已受惠逾3.七万之名中求美者，并在中区域划分已完成29个城市的招投标挂网，时，已开始武汉市、北京市、常州市、宁波市、广东省、甘肃回族自治权区等二十六个省/市里制定型商务补冲医治保险费用子目录。涉及国内外市面的，复宏汉霖与KGbio于19年获得合作方式，给予其H药正式启动单药治治疗及两种联动治治疗在东南方亚区域划分10个国度独特开放和商务化正当优惠利益；202四年八月，大有限公司进一次就H药在南美北非区域划分1两个国度的独特商务化正当优惠利益给予KGbio。因此，大有限公司还给予银河集团官网
医疗机械H药在美利坚共和国市面的的独特商务化正当优惠利益，分工协作拓展训练训练H药的国内外市面的规划，强院覆盖率世界十大更大范围的求美者团体。
未来的，复宏汉霖将持继提高自己研市场销售全产链终合地位，立足准确诊疗与和转化了深入分析的诊疗体系中，多空间维度实现了H药医学社会价值，持继做大做强良性肿瘤免疫力诊疗新标杆企业，为全球性病患者带去呵护与也希望。
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）不是家香港国际金级化的技术企业研发菌物医药手机平台网站，着力于打造于为国内提高提供了可负荷的高品行菌物药，品牌的所覆盖肉瘤、政治意识免疫力急病、骨科急病等领域行业，已在我国国家开卖5款品牌的，在香港国际金级开卖1款品牌的，19项适于症获准，2开卖注册都获国外FDA和欧洲共同体EMA立案。自20二十年设立一来，复宏汉霖已建设成二合一化菌物医药手机平台网站，高及技术企业研发的自由关键水平贯串研发项目处理、制造加工及商业性运营服务全房产链。手机平台网站已保持改进高的国内技术企业研发中心局，通过香港国际金级进口药品制造加工安全性能处理规范了（GMP）原则确定制造加工和安全性能管理，源源不断夯实基础二合一化宗合制造加工手机平台网站，在这当中，重庆徐汇产业工厂已收获在我国现代国家和欧洲共同体GMP认可，松江产业工厂（一）也已收获在我国现代国家GMP认可。
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.
【关联性论文】
[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.
[2] 王天云, 张瑜, 徐泳, 卢铀, & 彭枫. (2018). 肺癌腺癌食管鳞癌人3线放疗效用及环境深入分析. 北京省防癌促进会60岁肉瘤冶疗专委会三是次学术讨论讨论年终晚会暨北京省防癌促进会防癌治疗药物技术专业理事会会连续学术讨论讨论年终晚会. 北京省防癌促进会.
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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.
