2023年9月9日至12日，由国际肺癌研究协会（IASLC）主理的2023年天下肺癌大会（World Conference on Lung Cancer, WCLC）将于新加坡举行。H药汉斯状^®（斯鲁利单抗）团结化疗用于一线治疗不行手术切除的局部晚期或转移性鳞状非小细胞肺癌（sqNSCLC）的注册性临床试验ASTRUM-004研究的无希望生涯期（PFS）、总生涯期（OS）等疗效和清静性的最终剖析效果将由牵头主要研究者、上海市肺科医院周彩存教授以口头陈诉的形式在此次聚会会议上首次宣布。

关于IASLC WCLC

国际肺癌研究协会 (IASLC) 建设于 1972 年，是一个由来自100多个国家的8,000多名肺癌专家组成的国际组织。IASLC成员致力于生长和促进肺癌的病因学、盛行病学、预防、诊断、治疗和所有其他方面的研究。IASLC的使命是增强科学家、医学界成员和民众对肺癌的相识和教育。

由IASLC主理的天下肺癌聚会会议 (WCLC) 是全球规模最大的肺癌和胸部肿瘤学领域聚会会议。WCLC云集一流的科学研究和着名专家，重点关注胸部肿瘤学和肺癌领域最先进的治疗、临床试验和研究。

关于H药

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，现在已有3项顺应症获批上市，2项顺应症上市申请划分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药正式获批上市，现在可用于治疗微卫星高度不稳固（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）及普遍期小细胞肺癌（ES-SCLC）。H药团结化疗一线治疗食管鳞状细胞癌（ESCC）和一线治疗普遍期小细胞肺癌（ES-SCLC）的上市申请也划分获得中国NMPA和欧盟EMA受理。聚焦肺癌和消化道肿瘤，复宏汉霖起劲推进H药与公司其他产物的协同以及与创新疗法的团结，相继获得中国、美国、欧盟等国家及地域的临床试验允许，在全球同步开展10余项肿瘤免疫团结疗法临床试验。阻止现在，H药已于中国、美国、土耳其、波兰、格鲁吉亚等国家和地域累计入组超3600人，其中2项国际多中央临床试验入组白人的比例凌驾30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药的3项要害性临床研究效果划分揭晓于着名期刊《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主要参考。外洋方面，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药对比一线尺度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肩负的高品质生物药，产物笼罩肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产物，在国际上市1款产物，18项顺应症获批，3个上市申请划分获中国药监局、美国FDA和欧盟EMA受理。自2010年建设以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主焦点能力贯串研发、生产及商业运营全工业链。公司已建设完善高效的全球创新中央，凭证国际药品生产质量治理规范（GMP）尺度举行生产和质量管控，一直夯实一体化综合生产平台，其中，上海徐汇基地已获得中国和欧盟GMP认证，松江基地（一）也已获得中国GMP认证。

复宏汉霖前瞻性结构了一个多元化、高质量的产物管线，涵盖20多种创新单克隆抗体，并周全推进基于自有抗PD-1单抗H药汉斯状^®的肿瘤免疫团结疗法。继海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，创新产物汉斯状^®（斯鲁利单抗）已获批用于治疗微卫星高度不稳固（MSI-H）实体瘤、鳞状非小细胞肺癌和普遍期小细胞肺癌，成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，其食管鳞状细胞癌顺应症的上市注册申请也正在审评中。公司亦同步就16个产物在全球规模内开展30多项临床试验，对外授权周全笼罩西欧主流生物药市场和众多新兴市场。

About IASLC WCLC

Founded in 1972, the International Association for the Study of Lung Cancer (IASLC) is an international organization of more than 8,000 lung cancer specialists from 100+ countries. IASLC members work towards developing and promoting the study of etiology, epidemiology, prevention, diagnosis, treatment, and all other aspects of lung cancer. IASLC’s mission is to enhance the understanding and education of lung cancer to scientists, members of the medical community and the public. In addition to the annual meeting, the IASLC publishes the Journal of Thoracic Oncology, a prized resource for medical specialists and scientists who focus on the detection, prevention, diagnosis, and treatment of lung cancer.

The IASLC World Conference on Lung Cancer (WCLC) is the largest international gathering in the field of lung cancer and thoracic oncology. With a stellar scientific program and well-known faculty, WCLC highlights the most advanced treatments, clinical trials and studies in thoracic oncology and lung cancer.

About HANSIZHUANG

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, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and 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) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the 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. 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 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.

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, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, 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 tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.