SHANGHAI, Dec. 12, 2023  /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the NDA for new indication of HANSIZHUANG, serplulimab, an innovative anti-PD-1 mAb independently developed by the company, in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA), which is the fifth indication for HANSIZHUANG accepted by the NMPA.

上海，2023年12月12日/PRNewswire/--上海恒流生物技术有限公司（2696.HK）宣布，该公司独立开发的创新抗PD-1单克隆抗体汉斯庄（serplulimab）新适应症的NDA，联合化疗作为局部晚期或转移性非鳞状非小细胞肺癌（nsNSCLC）患者的一线治疗已被国家医疗产品管理局（NMPA）接受，这是NMPA接受的韩思庄的第五个适应症。

To date, HANSIZHUANG has been approved for the treatment of microsatellite instability-high (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)..

迄今为止，韩思壮已被批准用于治疗微卫星不稳定性高（MSI-H）实体瘤，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）。。

Lung cancer is the cancer with the highest global mortality rate. According to the latest data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, the number of cancer deaths worldwide in 2020 reached 9.96 million, of which approximately 1.8 million died from lung cancer, accounting for 18%.

肺癌是全球死亡率最高的癌症。根据世界卫生组织国际癌症研究机构（IARC）发布的最新数据，2020年全球癌症死亡人数达到996万，其中约180万死于肺癌，占18%。

In China, the incidence rate and mortality of lung cancer rank first, and the incidence rate is increasing year by year. The non-small cell lung cancer (NSCLC) is the most common histological type of lung cancer, accounting for about 85% of lung cancer patients, among which nsNSCLC has the highest incidence rate.

在中国，肺癌的发病率和死亡率居首位，并且发病率逐年上升。非小细胞肺癌（NSCLC）是最常见的肺癌组织学类型，约占肺癌患者的85%，其中nsNSCLC的发病率最高。

In the treatment of NSCLC, immune checkpoint inhibitors (ICI), such as PD-1/PD-L1, have developed rapidly, notably, the anti-PD-1 mAb plus chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for nsNSCLC, and serplulimab therefore is expected to bring a new option for patients..

在NSCLC的治疗中，免疫检查点抑制剂（ICI），如PD-1/PD-L1，发展迅速，值得注意的是，最新的NCCN指南和CSCO指南推荐使用抗PD-1单克隆抗体加化疗作为nsNSCLC的一线治疗，因此，serplulimab有望为患者带来新的选择。。

The NDA for new indication of HANSIZHUANG is mainly based on a randomized, double-blind, multi-center phase 3 clinical study of HANSIZHUANG in combination with chemotherapy, or chemotherapy as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer. The study results demonstrated that HANSIZHUANG in combination with chemotherapy significantly prolonged progression-free survival (PFS) compared with chemotherapy, which has met the pre-specified superiority criteria, with good safety and no detection of new safety signal..

韩四庄新适应症的NDA主要基于韩四庄联合化疗或化疗作为晚期非鳞状非小细胞肺癌患者的一线治疗的随机，双盲，多中心3期临床研究。研究结果表明，与化疗相比，韩四庄联合化疗显着延长了无进展生存期（PFS），符合预先规定的优势标准，安全性良好，未检测到新的安全信号。。

HANSIZHUANG, Henlius' first self-developed innovative monoclonal antibody, focuses on lung and gastrointestinal cancer and has initiated more than 10 clinical studies on immuno-oncology combination therapies worldwide. It covers the full range of first-line treatment of lung cancer, in which a head-to-head bridging trial of HANSIZHUANG versus first-line standard-of-care atezolizumab for ES-SCLC was launched in the U.S.

Henlius的第一个自主开发的创新单克隆抗体HANSIZHUANG专注于肺癌和胃肠道癌，并在全球范围内启动了10多项免疫肿瘤学联合疗法的临床研究。它涵盖了肺癌一线治疗的全方位，其中韩思壮与ES-SCLC一线标准治疗atezolizumab的头对头桥接试验在美国启动。

in 2022, which is beneficial for its registration and commercialization in the U.S. In addition, the Marketing Authorization Application (MAA) for HANSIZHUANG on ES-SCLC has been validated by the European Medicines Agency (EMA), with approval expected in the first half of 2024. Previously, HANSIZHUANG was also granted orphan drug designations by the U.S.

2022年，这有利于其在美国的注册和商业化。此外，欧洲药品管理局（EMA）已经验证了ES-SCLC上韩思壮的上市授权申请（MAA），预计将在2024年上半年获得批准。此前，韩四庄还被美国授予孤儿药称号。

Food and Drug Administration (FDA) and European Commission (EC) for the treatment of SCLC. Furthermore, Henlius is steadily advancing a global phase 3 multi-center clinical research of HANSIZHUANG for the limited stage small cell lung cancer (LS-SCLC) and its first patients in China, the U.S., Europe, and Australia have been dosed, respectively..

食品和药物管理局（FDA）和欧盟委员会（EC）治疗小细胞肺癌。此外，Henlius正在稳步推进HANSIZHUANG针对有限期小细胞肺癌（LS-SCLC）的全球3期多中心临床研究，其在中国，美国，欧洲和澳大利亚的首批患者已分别服用。。

In the future, Henlius will continue to improve its innovation capabilities to meet patients' needs and create greater clinical value, aiming to provide more accessible, affordable, and high-quality products and solutions to patients around the world.

未来，亨利士将继续提高其创新能力，以满足患者的需求并创造更大的临床价值，旨在为世界各地的患者提供更易获得、价格合理和高质量的产品和解决方案。

About HANSIZHUANG

关于韩思庄

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, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world..

韩思壮（重组人源化抗PD-1单克隆抗体注射液，通用名：serplulimab注射液）是第一种用于SCLC一线治疗的抗PD-1单克隆抗体。迄今为止，有4种适应症已被批准在中国上市，中国和欧盟正在审查2种上市申请，全球正在进行10多项临床试验。。

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 application of the first-line treatment for ES-SCLC is under review by the EMA.

HANSIZHUANG于2022年3月推出，已被NMPA批准用于治疗MSI-H实体瘤，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）。EMA正在审查其ES-SCLC一线治疗的市场应用。

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.

围绕肺癌和胃肠道癌，韩思庄与公司内部产品和创新疗法的协同作用正在积极推广。先后在中国、美国、欧盟等国家和地区获得临床试验批准，在多种适应症下开展了10多项免疫肿瘤联合治疗临床试验。

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.

截至目前，该公司已在中国、美国、土耳其、波兰、格鲁吉亚等国家和地区招收3600多名受试者，两次MRCT中白人比例超过30%，使韩思壮成为全球最大的抗PD-1单克隆抗体临床数据库之一。韩思壮的3项关键试验结果分别发表在《美国医学会杂志》（JAMA）、《自然医学》和《英国癌症杂志》上。

Furthermore, HANSIZHUANG 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.

此外，韩思壮是由CSCO小细胞肺癌指南、CSCO非小细胞肺癌指南、CSCO食管癌指南、CSCO结直肠癌指南、CSCO免疫检查点抑制剂临床实践指南、中国食管癌放疗指南和其他权威指南推荐的，为肿瘤的临床诊断和治疗提供有价值的参考。

On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCL.

另一方面，serplulimab被美国FDA和EC授予孤儿药名称，用于治疗SCL。

About Henlius

关于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, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively.

Henlius（2696.HK）是一家全球生物制药公司，其愿景是为全球患者提供高质量，价格合理且创新的生物药物，重点关注肿瘤学，自身免疫性疾病和眼科疾病。迄今为止，已在中国推出5种产品，1种已被批准在海外市场销售，19种适应症已在全球获得批准，3种营销申请已分别在中国，美国和欧盟接受审查。

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..

自2010年成立以来，Henlius已经建立了一个集成的生物制药平台，其核心能力是高效和创新，贯穿于整个产品生命周期，包括研发、制造和商业化。它已根据全球良好生产规范（GMP）建立了全球创新中心和上海制造设施，包括中国认证的徐汇工厂和欧盟GMP以及中国GMP认证的松江第一工厂。。

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.

Henlius积极构建了涵盖20多种创新单克隆抗体（mAb）的多样化和高质量的产品线，并继续探索以专有韩思壮（抗PD-1 mAb）为骨干的免疫肿瘤联合疗法。除了推出的产品HANLIKANG（利妥昔单抗）外，中国第一个开发的生物仿制药HANQUYOU（注射用曲妥珠单抗，欧洲商品名：Zercepac®；澳大利亚商品名：Tuzucip®和Trastucip®），中国和欧洲第一个批准的中国开发的单克隆抗体生物仿制药HANDAYUAN（阿达木单抗）和HANBEITAI（贝伐单抗），创新产品HANSIZHUANG已被NMPA批准用于治疗MSI-H实体瘤，鳞状非小细胞肺癌（sqNSCLC）和广泛期小细胞肺癌（ES-SCLC）以及食管鳞状细胞癌（ESCC），使其成为世界上第一个用于SCLC一线治疗的抗PD-1单克隆抗体。

What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets..

此外，Henlius已对16种产品进行了30多项临床研究，扩大了其在主要市场和新兴市场的影响力。。

SOURCE Henlius

来源Henlius