2024年世界肺癌大会(World Conference on Lung Cancer,WCLC)将于当地时间9月7日至10日在美国圣地亚哥举行。复宏汉霖首个自主研发的创新型单抗H药汉斯状(斯鲁利单抗)的三项最新研究结果将以壁报形式在本次大会上发布。

　　 H药是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。以临床需求为导向，公司围绕H药进行了差异化、多维度布局，广泛覆盖肺癌、消化道肿瘤等高发大癌种。截至目前，H药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(sqNSCLC)、广泛期小细胞肺癌(ES-SCLC)及食管鳞状细胞癌(ESCC)，惠及患者超过7.5万人。

　　肺癌是全球最常见的恶性肿瘤之一。据GLOBOCAN数据显示，2022年全球肺癌新发病例达250万[1]。公司陆续开展了H药一线治疗sqNSCLC、ES-SCLC和局限期小细胞肺癌(LS-SCLC)的国际多中心III期临床试验等多项免疫联合疗法临床试验，全面覆盖肺癌一线治疗。公司亦在美国启动了一项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。

　　入选本次2024WCLC大会的三项H药相关研究如下：

　　 ASTRUM-005R:斯鲁利单抗联合化疗一线治疗ES-SCLC的真实世界多中心研究

　　编号：P1.13A.07.

　　牵头主要研究者：邬麟(湖南省肿瘤医院)胡成平(中南大学湘雅医院)

　　展示时间：太平洋夏令时2024年9月8日(星期日)中午12:00

　　一项回顾性研究：含斯鲁利单抗在内的免疫联合化疗对比化疗新辅助治疗LS-SCLC的真实世界研究

　　编号：EP.13C.04.

　　牵头主要研究者：周清华(四川大学华西医院)

　　展示时间：太平洋夏令时2024年9月7日(星期六)上午11:58

　　前瞻性研究：斯鲁利单抗联合化疗新辅助治疗后手术的角色

　　编号：EP.13C.03.

　　牵头主要研究者：钟文昭(广东省人民医院)

　　展示时间：太平洋夏令时2024年9月7日(星期六)上午11:58

　　参考文献

　　[1]International Agency for Research on Cancer.Global Cancer Observatory:Cancer Today[DB/OL].http://gco.iarc.who.int/today[2024-02-01]

　　关于H药汉斯状

　　 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，已在中国和印度尼西亚获批上市。截至目前，H药已有4项适应症获批上市，2项适应症上市申请分别在中国和欧盟获受理，10余项临床试验同步在全球开展。

　　2022年3月，H药正式于中国获批上市，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非鳞状非小细胞肺癌(nsNSCLC)和一线治疗广泛期小细胞肺癌(ES-SCLC)的上市申请也分别获得中国NMPA和欧盟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，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4000人。H药的4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)、Cancer Cell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的头对头桥接试验。

　　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，已在中国上市5款产品，在国际获批上市3款产品，23项适应症获批，3个上市申请分别获中国药监局和欧盟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。继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)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 to Showcase Latest Results of Serplulimab in the Field of Lung Cancer at2024WCLC

　　2024World Conference on Lung Cancer(“WCLC2024”)will be held from September7-10in San Diego,United States.Multiple updated results of Henlius’self-developed innovative anti-PD-1mAb,HANSIZHUANG(serplulimab),will be released as poster presentations at the meeting.

　　 HANSIZHUANG(serplulimab)is a recombinant humanised anti-PD-1monoclonal antibody(mAb)injection independently developed by Henlius,and the world's first anti-PD-1mAb approved for the first-line treatment of small cell lung cance(SCLC).Underpinned by clinical needs,Henlius has carried out a differentiated and multi-dimensional layout of HANSIZHUANG in the field of lung cancer and gastrointestinal cancer.Up to date,it has been approved by the National Medical Products Administration(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),benefitting over75,000patients.

　　 Lung cancer is one of the most common malignancies around the world.According to GLOBOCAN,there were2.5million new lung cancer cases in2022worldwide[1].Henlius has successively conducted a number of immuno-combination therapy clinical trials with serplulimab,including several global multi-centre phase3clinical trials regarding sqNSCLC,ES-SCLC and limited-stage small cell lung cancer(LS-SCLC),covering the full range of first-line treatments of lung cancer.Moreover,Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab(anti-PD-L1mAb)for the first-line treatment of ES-SCLC.

　　 Updated results to be presented at the2024WCLC conference are as follows:

　　 ASTRUM-005Study Presentation Number:P1.13A.07.

　　 Title:Real-World First-Line Serplulimab-Based Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer:The Multicenter ASTRUM-005R Study Leading PI:Lin Wu(Hunan Cancer Hospital),Chengping Hu(Xiangya Hospital,Central South University)

　　 Time:Sunday,September8,2024at12:00PM PDT/UTC-7

　　 A retrospective study Presentation Number:EP.13C.04.

　　 Title:Is Neoadjuvant Chemoimmunotherapy Better Than Chemotherapy in Patients with Limited-Stage Small Cell Lung Cancer Leading PI:Qinghua Zhou(West China Hospital,Sichuan University)

　　 Time:Saturday,September7,2024at11:58AM PDT/UTC-7

　　 A prospective study Presentation Number:EP.13C.03.

　　 Title:Investigating Surgery's Role in Stage IIB-IIIB Small Cell Lung Cancer Following Chemo-immunotherapy Leading PI:Wenzhao Zhong(Guangdong Provincial People’s Hospital)

　　 Time:Saturday,September7,2024at11:58AM PDT/UTC-7

　　 About HANSIZHUANG HANSIZHUANG(recombinant humanized anti-PD-1monoclonal antibody injection,generic name:serplulimab injection)is the first anti-PD-1mAb for the first-line treatment of SCLC and has been approved in China and Indonesia.Up to date,4indications are approved for marketing,2marketing applications are under review in China and the EU,and more than10clinical trials are ongoing across the world.

　　 HANSIZHUANG was approved in China in March2022and has been approved by the National Medicinal Products Administration(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).The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer(nsNSCLC)and ES-SCLC are under review by the NMPA and the European Medicines Agency(EMA),respectively.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 than10clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than4,000subjects enrolled in China,the U.S.,Turkey,Poland,Georgia and other countries and regions.The results of4pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association(JAMA),Nature Medicine,Cancer Cell and British Journal of Cancer,respectively.Furthermore,HANSIZHUANG was respectively 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-L1mAb)for the first-line treatment of ES-SCLC is well under way.

　　 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,5products have been launched in China,3have been approved for marketing in overseas markets,23indications are approved worldwide,and3marketing applications have been accepted for review in China and the EU,respectively.Since its inception in2010,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 over50molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG(anti-PD-1mAb)as 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),and esophageal squamous cell carcinoma(ESCC),making it the world’s first anti-PD-1mAb for the first-line treatment of SCLC.What’s more,Henlius has conducted over30clinical studies for16products,expanding its presence in major markets as well as emerging markets.

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