202四年2月22日，苏州-复宏汉霖（2696.HK）公布，企业独立研究开发的去创新抗PD-1单抗H药——汉斯状®（适用名：斯鲁利单抗针剂液）聯合含氟尿嘧啶类和铂类中药采用PD-L1抗体阳性的不能够去除一部分后期/再次发作或移动性食管鳞状生殖肺部肿瘤内部癌(ESCC)的品牌疗法新适宜环境症的挂牌上市注冊注册(NDA)拿到政府进口药品监督方法方法局新批，为食管鳞癌病员提拱了疗法新采用。在此之前，H药已新批疗法微定位髙度不不稳定性(MSI-H)实体的瘤、鳞状非小生殖肺部肿瘤内部肺肺部肿瘤（sqNSCLC）和广期小生殖肺部肿瘤内部肺肺部肿瘤（ES-SCLC）3项适宜环境症。复宏汉霖长期持续推进H药在肺肺部肿瘤、化解道肺部肿瘤等教育领域的区别化、多关键点规划，得以深入推进病员拿到极高获利。
复宏汉霖股东会成员长兼施行股东会成员张文杰
H药应用第4项顺应症应用于调理食管鳞癌，标志图片着这车高口感抗PD-1单抗深感为难治的吸收道淋巴淋巴肿瘤范畴带来了新但愿。自2023年10月应用纳斯达克上市之初，H药在临床医学实际操作中密切造福吸收道淋巴淋巴肿瘤、肺肿瘤等范畴糖尿病人，树立远大理想起稳定的信价，并确立国产品牌因素。未来的，当杏彩体育将延续充分调动H药优势和潜质，加速推进H药市场上户外拓展培训节奏，为各国其他糖尿病人带去可的负担的不断创新抗癫痫药物。
复宏汉霖实行强制执行董事、小说总裁实行官、小说总裁兼小说总裁财富官朱俊
以临床治疗药学各种需求为指引，复宏汉霖立足癌肿免疫抗体系统正确根治领域行业，凝聚癌肿重点是病种，深化改革H药多瘤种格局，积极向上地深入推进其在国际区域微信同步组织开展的多种免疫抗体系统联办辽法耐压。这一次H药新批食管鳞癌，进一歩核实了H药的根治升值空间，积极向上创造复宏汉霖的产品开发特色化實力。遗憾H药十年后的中国大多积极向上地临床治疗药学效果的收益，进一歩造福一方更丰富的癌症复发的人。
H药食管鳞癌Ⅲ期临床研究主要研究者、中华医学研究生物海瑞朗肿癌医院口腔科黄镜教援
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。根据高度出名科研期刊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科学研究科技成果已陆续的品牌发布于2022 ESMO Asia年终晚会、2023 ASCO年终晚会等国际金学界办公会议，领取国际联盟学术性界高宽比支持。
环绕H药，有限公司专注肝癌与转化道肺部肿瘤2大癌种，关键稳步推进H药与集团别厂品的携手包括与去创新中医疗法的结合，于全球最大云同步深入推进10多项良性肿瘤免疫系统协同物理疗法临床实践做实验的时候，累记在组逾3600名受试者，国际上化的临床治疗深入分析统计资料一般为亚洲填报出示充分斜撑。共性消化不好道肉瘤，H药已应用MSI-H实体化瘤适应性症，可称MSI-H频发的结十二指肠癌和胃溃疡等患有带去冶疗愿意。同时，该药在直肠癌新配套/配套上已开启Ⅲ期临床设计设计，现已使直肠癌的人在前线便从恶性肿瘤免疫力治疗法中受惠。1.肺腺癌范畴，H药已新批sqNSCLC和ES-SCLC几大习惯症，并拥有亚洲首批新批品牌进行缓解小細胞1.肺腺癌（SCLC）的抗PD-1单抗，集团公司亦计划方案于202两年多下一个月就H药品牌进行缓解非鳞状非小細胞1.肺腺癌（nsNSCLC）在华人递签发售申请办理。与此而且，H药缓解SCLC随后提升了美式食材医疗耗材辅导操作局（FDA）和欧共体研究会会研究会会（EC）颁发的弃婴药报名要求判定，该药优质缓解ES-SCLC的欧共体研究会会市场销售经营许可资料报名（MAA）现已202四年9月提升非洲医疗耗材操作局（EMA）结案，即将于202四年上三个月提升批准书。复宏汉霖亦在新加坡进行了项H药比一二线要求的治疗阿替利珠单抗使用ES-SCLC的头对头桥接可靠性试验，工作计划于2026年在新加坡提交成功上市经营许可资料公司申请（BLA)。不仅如此，复宏汉霖还稳步推进促进H药片面性的只期小内部肝癌（LS-SCLC）的世界上多中央Ⅲ期临床实验调查。
商家户外户外拓展训练训练方向，复宏汉霖重视H药实行了展望性的合理布置图，并坚持多要素、多平台的提升该物品的可及性，截止日期如今，H药已受惠逾3.七万名国病人，并在国境內结束29个省份的项目招标挂网，也，已渗入深圳市、南京市、常州市、厦门市市、广东省、甘肃回族基层民主区等二十二个省/市里高端定制型商家填充医学人身险文件。重视淘宝市厂上，复宏汉霖与KGbio于今年已达成战略合作，给予其H药第一例单药针灸及四项共同针灸在东南方亚省份10个政府全权定制开发和商家化优惠合法权；202两年八月份，平台进一点就H药在中东地区北非城市1俩政府的全权商家化优惠合法权给予KGbio。再者，平台还给予杏彩体育
药业H药在意大利市厂上的全权商家化优惠合法权，协同管理户外户外拓展训练训练H药的淘宝市厂上合理布置图，专业专注涉及高度更比较广泛的病人行为。
未来是什么，复宏汉霖将不间断优化研销售全产链整合知名度，立足识贫中药开展与转换成探讨的中药开展工作体系，多基本要素做到H药临床医学附加值，不间断制作肉瘤免疫系统中药开展新对标，为亚洲病人带去关爱留守儿童与但愿。
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）都是家亚太化的科学企业创新发展怪物药业业机构，强院于为欧洲自己本身可以提供可负荷的高高服务产品质量怪物药，类產品盖住肿癌、自己本身天然免疫肠道重大疾病、护眼肠道重大疾病等层面，已在在我国挂牌开卖5款类產品，在亚太挂牌开卖1款类產品，19项适合症获准，两个挂牌开卖申办分别是获美式FDA和欧共体EMA立案。自205年开设建国以来，复宏汉霖已开工建设合一机化怪物药业业工作系统，提优质率及科学企业创新发展的自主化关键本事影响产品研发、产生及房地家产营销全家产链。机构已搭建改善提优质率的欧洲科学企业创新发展咨询中心，都按照亚太非处方药产生服务产品质量管理方法规范起来（GMP）标对其进行产生和服务产品质量监管，反复筑牢合一机化综和产生工作系统，另外，上海市徐汇机地已兑换在我国和欧共体GMP认可，松江机地（一）也已兑换在我国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.
【参看专著】
[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.
