202两年-9月22日，伤害-复宏汉霖（2696.HK）公布，集团公司数字化研发项目管理的创新技术抗PD-1单抗H药——汉斯状®（普通名：斯鲁利单抗注射器液）联合技术含氟尿嘧啶类和铂类用量使用于PD-L1阳性反应的不能够做手术不规则胆襄癌/的复发率或更换性食管鳞状组织癌(ESCC)的闽东南医疗新应用症的销售注册网站提交申请(NDA)兑换国度中药饮片监查菅理局提出申请，为食管鳞癌患病者带来了医疗新使用。在此之前，H药已应用医疗微北斗卫星高速不安稳(MSI-H)实物瘤、鳞状非小组织肝癌患病者（sqNSCLC）和具有广泛性期小组织肝癌患病者（ES-SCLC）每项应用症。复宏汉霖维持促进推动H药在肝癌患病者、消化酶道癌症等层面的差距化、多层面合理布局，得以促进推动患病者兑换更大受惠。
复宏汉霖监事长兼执行力监事张文杰
H药应用第4项适用症主要用于的治疗食管鳞癌，象征着这车高品级抗PD-1单抗欺负治的代谢道肉瘤行业领域行业带来了新小编希望。自明年12月应用销售起来，H药在临床药理社会实践中密切受惠代谢道肉瘤、肺肿瘤等行业领域行业患有，树立远大理想起充分的用户口碑，并导致茶叶品牌效用。将来，让我们将持续起着H药优缺点和价值，快速H药专业市场户外拓展培训动作，为全.球越多患有带去可承担的创新发展口服药物。
复宏汉霖继续完成董监事、顶尖继续完成官、顶尖总裁兼顶尖公司财务官朱俊
以药学的需求为向导，复宏汉霖深耕细作肝癌免疫性抗体精准脱贫治療行业，凝聚肝癌关键病种，深入组织开展H药多瘤种布局合理，积极向上进取加快推进其在全世界面积这一次组织开展的诸多免疫性抗体共同针灸应力测试。这一次H药新批食管鳞癌，进第这一步核验了H药的治療竞争力，宽裕展示复宏汉霖的革新革新影响力。我期待H药将来一些积极向上进取药学但是的产出率，进第这一步造福一方更广泛的的肝癌客户。
H药食管鳞癌Ⅲ期临床研究主要研究者、全国中医学科学技术院癌肿医院口腔科黄镜讲师
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。根据国内闻名学术交流杂志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研究分析成果展已陆续现身于2022 ESMO Asia大会、2023 ASCO大会等国际英文学术性研讨会，领取国际上学界界较高喜爱。
紧扣H药，新公司凝聚肺癌患者与化解道肉瘤两种癌种，积极进取深入推进H药与公司另一设备的协同作战或与全新自然疗法的综合，于世界上一起开展业务10多个恶性肿瘤免疫抗体联合技术物理疗法监床校正，累记在组逾3600名受试者，国际英文化的临床护理调查资料还有机会为世界十大澳大利亚红酒进口报关给予坚实保障。对化解道恶性肿瘤，H药已将建MSI-H实体线瘤适用于症，为MSI-H多发的结结肠癌和胃溃疡等人群带去手术治疗还望。同时，该药在食道癌新配套/配套个方面已进入到Ⅲ期临床试验探讨，有机会使食道癌患有在前线便从癌症免役针灸中收益。肺肿瘤邻域，H药已将建sqNSCLC和ES-SCLC两种适应性症，并将成为全球排名第一家将建不错制疗小组织肺肿瘤（SCLC）的抗PD-1单抗，企业亦规划于2025年下一年后就H药不错制疗非鳞状非小组织肺肿瘤（nsNSCLC）在全球出具销售申办。与此互相，H药进行手术治疗SCLC会相继兑换了美国的肉食品消毒产品开展经营局（FDA）和欧盟国家理事会会理事会会（EC）评为的流浪儿童药资本评估，该药优质进行手术治疗ES-SCLC的欧盟国家理事会会开卖经营许可资料报考（MAA）在202四年4月兑换欧式消毒产品经营局（EMA）业务办理，已成定局于2026年上几个月兑换获准。复宏汉霖亦在新加坡开始了项H药相比二线规范治疗方法阿替利珠单抗应用于ES-SCLC的头对头桥接疲劳试验，进度表于2026年在新加坡出具面市同意个人申请（BLA)。最后，复宏汉霖还平稳持续推进H药停留期小组织肺癌患者（LS-SCLC）的全世界多心中Ⅲ期临床学习学习。
工工餐饮业性区户外拓展培训项目管理方面，复宏汉霖共性H药展开了高瞻性的结构，并连续多向度、渠道方式提高自己该物品的可及性，截止期近几年，H药已造福逾3.2万名我们病号，并在我们境区成功完成29个省市的招标公示挂网，还，已到伤害市、上海市、宁波市市、福州市、浙江省省、青海回族自治权区等二十二个省/市里环保定制家具型工工餐饮业性区及时补充医疗机构保险金列表。共性园区的茶叶行业，复宏汉霖与KGbio于2020年达到目标的合作，获取其H药首届单药的治疗方法及2项联手的治疗方法在东南方亚地段10个部委独有建设和工工餐饮业性区化合法权；2026年10月，大装修公司进每一步就H药在中东地区北非板块13个部委的独有工工餐饮业性区化合法权获取KGbio。不但，大装修公司还获取银河集团官网
医药公司H药在新西兰的茶叶行业的独有工工餐饮业性区化合法权，协同管理户外拓展培训项目H药的园区的茶叶行业结构，致力于打造重叠全球各地更广泛的的病号群体心理。
未来生活，复宏汉霖将一直加强研产量全产链终合水准，精耕脱贫中药调理与应用探析的中药调理机制，多层次保持H药临床实验使用价值，一直开发肉瘤免疫系统中药调理新标杆企业，为全.球爱美者带去关爱留守儿童与渴望。
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）也是家國際化的科技转型升级怪物怪物医药集团集团企业，秉承于为全球最大性在工作中出示可负税的高好商品怪物药，好商品包裹癌肿、在工作中免疫细胞慢性病、眼科整形慢性病等这个领域，已在在我国大陆地区国家韩国面市5款好商品，在國際韩国面市1款好商品，19项应用症应用，4个韩国面市申請分辨获韩国FDA和欧洲联盟EMA审批。自20二十年筹建建国以来，复宏汉霖已完成混合式化怪物怪物医药集团app工作平台，更高效、性价比最高及科技转型升级的独立核心区技能推动研发培训、生育制造及商用运营的全产业化链。集团企业已形成健全完善更高效、性价比最高的全球最大性科技转型升级中心局，是以國際消毒产品生育制造效率控制规范性（GMP）规则实现生育制造和效率安全控制，迅速筑牢混合式化整体生育制造app工作平台，进来，沪徐汇营地已赚取在我国国家和欧洲联盟GMP认证服务证书，松江营地（一）也已赚取在我国国家GMP认证服务证书。
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.
【参阅论文资料】
[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.
