摘要：2024年12月3日，上海——复宏汉霖（2696.HK）宣布，公司自主研发的创新型抗PD-1单抗H药 汉斯状（通用名：斯鲁利单抗注射液）正式获得国家药品监督管理局（NMPA）批准，联合培美曲塞和卡铂适用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激

2024年12月3日，上海——复宏汉霖（2696.HK）宣布，公司自主研发的创新型抗PD-1单抗H药 汉斯状（通用名：斯鲁利单抗注射液）正式获得国家药品监督管理局（NMPA）批准，联合培美曲塞和卡铂适用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌（nsNSCLC）的一线治疗。这是H药在中国获批的第五项适应症，也是继鳞状非小细胞肺癌（sqNSCLC)、广泛期小细胞肺癌（ES-SCLC)后，该产品在肺癌领域获批的第三项适应症，有望为众多肺癌患者带来更多治疗选择。

复宏汉霖执行董事、首席执行官朱俊博士

H药在肺癌治疗领域再获新适应症的批准，意味着该产品将进一步拓展其受益群体，惠及广大晚期非小细胞肺癌患者。公司始终坚持以患者为中心，以创新为驱动，围绕H药进行了差异化和多维度的适应症布局，未来我们将持续深化该产品在肺癌、消化道肿瘤等领域的多元研究和应用，让创新治疗方案造福更多患者。

H药非鳞NSCLC Ⅲ期临床试验主要研究者、中国医学科学院肿瘤医院石远凯教授

肺癌是我国发病率和死亡率最高的恶性肿瘤。免疫治疗联合化疗是驱动基因阴性晚期非小细胞肺癌（NSCLC）的标准治疗方法。临床研究结果表明，对于驱动基因阴性的晚期非鳞NSCLC患者，H药联合化疗显著延长了其无进展生存期。此次H药联合化疗一线治疗晚期非鳞NSCLC患者适应症的获批，为这类患者提供了新的有效的治疗选择。

复宏汉霖董事长、执行董事张文杰

复宏汉霖持续在肺癌治疗领域深耕细作，致力为全球肺癌患者带去更多、更优的治疗选择。此次H药成功获批非鳞状非小细胞肺癌，不仅是该产品发展历程中的重要里程碑，也标志着公司在肺癌治疗领域取得了又一关键性进展。我们将充分发挥H药的优势，全力加速其市场布局和拓展，推动这一创新药物惠及更多患者，助力医疗领域向更高水平发展。

聚焦临床需求，带来全新治疗选择

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-002）。研究结果表明，汉斯状联合化疗（卡铂-培美曲塞）对比化疗（卡铂-培美曲塞）一线治疗晚期非鳞状非小细胞肺癌（NSCLC），无进展生存期（PFS）显著延长，达到预设的优效标准，且具有良好的安全性，未观察到新的安全性信号。

拓展覆盖人群，肺癌一线全面布局

H药为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，已在中国和多个东南亚国家获批，惠及患者逾8万人。此前，H药已在中国获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC）等适应症。此外，H药已获得欧洲药品管理局人用药品委员会积极意见，支持其用于一线治疗ES-SCLC。

聚焦肺癌和消化道肿瘤等高发癌种，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4400人。在肺癌领域，公司临床布局已全面覆盖肺癌一线治疗。除已获批的sqNSCLC、ES-SCLC和nsNSCLC外，公司正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验；并在美国开展一项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，以进一步支持H药在美国的上市申报。

未来，复宏汉霖将继续秉持以患者为中心的理念，持续巩固创新研发实力，着眼于临床实际需求，让高质量、可负担的创新治疗方案惠及更广泛的人群。

【参考文献】

[1] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024.

[2] 中华医学会肿瘤学分会，中华医学会杂志社. 中华医学会肺癌临床诊疗指南（2023版）. 中国综合临床，2023，39(06):401-423.

[3] 中国抗癌协会肺癌专业委员会，中华医学会肿瘤学分会肺癌学组. Ⅲ期非小细胞肺癌多学科诊疗专家共识(2019版). 中华肿瘤杂志，2019，41(12):881-890.

[4] 中国临床肿瘤学会（CSCO）非小细胞肺癌诊疗指南2023

[5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non-Small Cell Lung Cancer V.3.2023

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，已在中国和多个东南亚国家获批上市。截至目前，H药已有5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药于中国正式获批上市，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）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC）。H药一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请已获得欧盟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，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4400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，已有6款产品在中国获批上市，3款产品在国际获批上市，25项适应症获批，3个上市申请分别获美国FDA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。截至目前，公司已获批上市产品包括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）、汉贝泰（贝伐珠单抗）以及汉奈佳（奈拉替尼），此外，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、食管鳞状细胞癌和非鳞状非小细胞肺癌，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) Receives NMPA Approval for the Treatment of nsNSCLC

Shanghai, China, December 3rd, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the new drug application (NDA) for new indication of its self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), in combination with pemetrexed and carboplatin for the first-line treatment of patients with unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutation and anaplastic lymphoma kinase (ALK), has been approved by the National Medical Products Administration (NMPA). This marks the fifth approved indication for HANSIZHUANG in China and the third indication in the field of lung cancer, following squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), bringing more treatment options to lung cancer patients in China.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated:“The approval of a new indication for HANSIZHUANG in the treatment of lung cancer signifies a broadened therapeutic application, directly benefiting a large number of patients with advanced non-small cell lung cancer. Being patient-centric and driven by innovation, the company has developed a differentiated and multi-faceted strategy centered around HANSIZHUANG. Looking ahead, we are committed to advancing diverse research endeavors and expanding its use in lung cancer, gastrointestinal tumors, and beyond, ensuring that innovative treatment solutions reach and benefit an even greater number of patients.”

Prof. Yuankai Shi, the leading principal investigator from Cancer Hospital Chinese Academy of Medical Sciences, said, "lung cancer stands as one of the most prevalent malignancies in China. Immunotherapy in combination with chemotherapy is the standard of care for advanced nsNSCLC that is negative for driver mutations. Recent clinical research has demonstrated that serplulimab in combination with chemotherapy significantly extends progression-free survival among patients with driver-gene-negative locally advanced or metastatic nsNSCLC. The approval of serplulimab introduces a novel and effective treatment alternative for patients with advanced nsNSCLC. "

Wenjie Zhang, Chairman and Executive Director of Henlius, said: "Henlius continues to delve deeply into the field of lung cancer treatment, committed to bringing more and better treatment options to lung cancer patients worldwide. The successful approval of HANSIZHUANG for nsNSCLC not only marks a significant milestone in the product's development but also signifies another key advancement for the company in the field of lung cancer treatment. We will maximize the strengths of HANSIZHUANG to expedite its market penetration, ensuring wider patient access and propelling the medical sector forward."

Addressing clinical needs by offering novel treatment options

The approval was primarily based on a randomized, double-blind, multicentre phase 3 clinical study. The results indicated that HANSIZHUANG in combination with chemotherapy (carboplatin-pemetrexed) versus chemotherapy (carboplatin-pemetrexed) as first-line treatment of advanced nsNSCLC significantly prolonged PFS, met the prespecified superiority criteria, with good safety profile and no new safety signals were observed.

Expanding reach for the first-line treatment of lung cancer

HANSIZHUANG, Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of ES-SCLC. Up to date, It has been approved in China and several Southeast Asian countries, benefiting over 80,000 patients. Previously in China, it has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours, sqNSCLC, ES-SCLC, and esophageal squamous cell carcinoma (ESCC). Besides, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of HANSIZHUANG as a first-line treatment of ES-SCLC.

Focus 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 over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,400 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to sqNSCLC, ES-SCLC and nsNSCLC, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). Henlius is also running a bridging head-to-head trial in the U.S. to compare HANSIZHUANG with standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC, which is expected to propel the product towards U.S. market approval further.

Going forward, Henlius stays dedicated to its patient-centred approach, bolstering its R&D innovation to tackle real clinical needs and making high-quality, affordable, and innovative treatments accessible to a broader audience.

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 and has been approved in China and several SEA countries. Up to date, 5 indications are approved for marketing, 1 marketing applications is under review in EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was approved in China in March 2022 and 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), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). The marketing applications of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (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. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,400 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. The results of 4 pivotal 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-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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 3 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 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 over 50 molecules 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, 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), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC), 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.

来源：动态宝