显著延长PFS！复宏汉霖创新抗PD-1单抗H药以国际品质进军鳞状肺癌，昨日正式获批！

张连山博士诚邀朋友们出席大会，共同探讨「从引进到出海，中国新药如何做好国际化布局？」这一重要课题！

2022年11月1日，上海——复宏汉霖（2696.HK）宣布，旗下首款自主研发的创新生物药抗PD-1单抗H药——汉斯状^®（通用名：斯鲁利单抗注射液）新适应症上市申请获得国家药品监督管理局（NMPA）批准，联合卡铂和白蛋白紫杉醇用于一线治疗不可手术切除的局部晚期或转移性鳞状非小细胞肺癌（sqNSCLC）新适应症，为肺鳞癌患者提供了用药新选择。此前，H药已获批治疗微卫星高度不稳定 (MSI-H) 实体瘤，广泛的适应症布局推动更多患者获益。

显著延长PFS！复宏汉霖创新抗PD-1单抗H药以国际品质进军鳞状肺癌，昨日正式获批！

复宏汉霖董事长、执行董事兼首席执行官张文杰表示：

“

H药获批sqNSCLC标志着这款高品质抗PD-1单抗正式应用于肺癌临床治疗，以国际品质造福广大患者，也进一步提升了H药在该领域的影响力。肺癌是我国乃至世界高发癌种，临床治疗需求巨大，复宏汉霖对此进行了多元化的布局且多个相关适应症的临床研究正稳步推进，期待未来更多积极临床结果的产出，协同H药自身独特优势，为肿瘤治疗作出新贡献。

”

H药sqNSCLC III期临床研究主要研究者，同济大学附属上海市肺科医院肿瘤科主任、同济大学医学院肿瘤研究所所长周彩存教授表示：

“

sqNSCLC约占非小细胞肺癌（NSCLC）的25%-30%，是NSCLC的第二大亚型，临床需求较大。斯鲁利单抗针对sqNSCLC所开展的国际多中心临床是中国研究者牵头开展的样本量最大的sqNSCLC国际性临床研究，全球范围共入组500余名受试者。试验结果表明斯鲁利单抗已达到预设的主要研究终点，显著延长患者无进展生存期（PFS）。该研究取得的积极结果是肿瘤免疫治疗的又一利好，期待其在临床实践中让更多患者获益。

”

国际品质满足更多临床需求

此次获批主要基于一项随机、双盲、国际多中心III期临床研究 (ASTRUM-004)，该研究于全球多地包括中国、欧盟波兰、土耳其等国家开设研究中心，其中纳入白人的比例超过30%，充分的国际临床试验数据有望支持海外市场的申报，也为全球性临床应用奠定基础。临床研究结果表明，H药联合卡铂和白蛋白紫杉醇治疗既往未接受治疗的局部晚期或转移性sqNSCLC患者获益显著，达到预设的主要终点，且具有良好的安全性和耐受性。

肺癌是全球最常见癌症之一，是中国发病率和死亡率最高的恶性肿瘤。根据国家癌症中心发布的最新全国癌症统计数据显示，肺癌新发病例82.8万，总死亡人数65.7万^[1]。NSCLC约占所有肺癌的80%-85%^[2]，约50%的NSCLC患者在诊断时已处于不适合手术切除的局部晚期或已发生转移。而晚期sqNSCLC约占晚期NSCLC的30%，治疗模式多以含铂双药化疗为主，疗效不甚理想，患者的中位生存期较短，很多不超过1年，因此，该领域存在着巨大的未满足的医疗需求。近年来，免疫检查点抑制剂在临床治疗中取得了诸多突破，在NSCLC方面也获得了长足的发展，尤其是抗PD-1单抗联合卡铂+白蛋白紫杉醇治疗晚期或转移性sqNSCLC已获得NCCN、CSCO等国内外权威指南推荐，并推动晚期NSCLC进入免疫治疗时代。H药的获批将为该病理亚型带来新的用药选择，促进免疫治疗在肺癌临床治疗中更广泛的应用，也进一步助力肺癌治疗创新发展。

持续创新深耕肺癌一线治疗

H药作为复宏汉霖首个创新型单抗，适应症布局广泛并在全球开展10余项免疫联合疗法临床研究，覆盖肺癌、肝细胞癌、食管癌、头颈鳞癌和胃癌等高发癌种，全球累计入组已超过3100名受试者，也是拥有国际临床数据较多的抗PD-1单抗，加码H药国际化进程。在肺癌领域，H药更是全面覆盖其一线治疗，除了sqNSCLC，还在非鳞状非小细胞肺癌（nsqNSCLC）和小细胞肺癌 (SCLC) 等领域开展临床试验。其中，H药治疗广泛期小细胞肺癌（ES-SCLC）的III期临床试验获得积极结果，是全球首个一线治疗ES-SCLC获得阳性结果的抗PD-1单抗。目前，该适应症的上市申请已获得NMPA受理，有望成为全球首个一线治疗SCLC的抗PD-1单抗。NSCLC方面，复宏汉霖也正积极开展多项临床研究，包括H药联合创新型抗EGFR单抗HLX07一线治疗EGFR高表达sqNSCLC、H药联合汉贝泰^®（贝伐珠单抗）一线治疗nsqNSCLC等。公司潜心深耕肺癌领域，不断扩大针对该领域的适应症布局，并以创新的联合治疗方案助力肺癌患者实现更高质量的长期生存。

“以患者需求为核心”是复宏汉霖研发的根本价值，我们将继续以此为创新动力，致力解决临床治疗难点和痛点，让患者获得高质量、更长久的生存。H药也将承载挽救更多病患的使命，继续在肺癌和更多肿瘤领域不断探索和突破，给予更多患者生命的力量。

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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），是复宏汉霖首个自主研发的创新型单抗，目前2项适应症获批上市，2项适应症上市申请获受理，11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)。围绕H药，复宏汉霖积极推进其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11项肿瘤免疫联合疗法临床试验，广泛覆盖肺癌、食管癌、头颈鳞癌和胃癌等适应症，全面覆盖肺癌一线治疗。截至目前，H药已于中国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3100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药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）和食管鳞状细胞癌（ESCC）的NDA已获得NMPA受理，H药有望成为全球首个一线治疗小细胞肺癌（SCLC）的抗PD-1单抗。此外，该药入选《2022 CSCO小细胞肺癌诊疗指南》作为ES-SCLC治疗推荐，针对ES-SCLC的国际多中心临床研究ASTRUM-005成为全球首个登上JAMA的小细胞肺癌免疫治疗临床研究，其治疗SCLC也已获得美国FDA孤儿药资格认定。

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，在国际上市1款产品，15项适应症获批，4个上市注册申请获得中国药监局受理。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，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，其广泛期小细胞肺癌和食管鳞状细胞癌2项适应症的上市注册申请也正在审评中。公司亦同步就13个产品、11个免疫联合治疗方案在全球范围内开展20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 sqNSCLC

Shanghai, China, Nov, 1st, 2022 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection), in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), has been approved by the National Medical Products Administration (NMPA), providing an alternative treatment option for patients. HANSIZHUANG had already been approved for the treatment of Microsatellite Instability-High (MSI-H) solid tumors, and it covers a wide variety of indications to benefit a broader population of patients.

Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, “the approval marks that HANSIZHUANG steps into the clinical practice of lung cancer, benefiting patients with its world-class quality, and actively expands its presence. Lung cancer is a kind of cancer with high incidence in China and world, which has a huge demand for clinical treatment. Henlius has a sound indication plan in a diverse variety of lung cancer, in which many clinical studies are forging ahead. We will fully tap the potential of HANSIZHUANG and look forward to more positive study results to make further contributions in cancer treatment.”

Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University School of Medicine, said, “sqNSCLC accounts for about 25%-30% of non-small cell lung cancer (NSCLC), with the 2nd highest incidence rate among NSCLC, and has a large demand for clinical treatment. In terms of the study, this is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrate that serplulimab injection has reached the predefined primary study endpoint and extended progression-free survival (PFS) significantly. It is another key achievement of immunotherapy and is ready to benefit more patients.”

Fulfill the clinical medication needs with world-class quality

The approval was primarily based on a randomized, double-blind, global multi-center Phase 3 clinical trial (ASTRUM-004) initiated in many countries around the world, including China, Poland, Turkey, etc., of which more than 30% are white. Its global clinical trial data will support NDAs in overseas markets and lay a foundation for clinical practice all over the world in the future. The results indicate that HANSIZHUANG in combination with carboplatin and albumin-bound paclitaxel could bring significant benefits in the treatment of previously untreated locally advanced or metastatic sqNSCLC patients, which meets the primary endpoint and has good safety and tolerability.

Lung cancer is one of the most common cancers in the world, and it is the malignant tumor with the highest morbidity and mortality in China. According to the latest national cancer statistics released by the National Cancer Center, there are 828,000 new cases of lung cancer, with a total death toll of 657,000^[1], in which NSCLC accounts for about 80% – 85% of all lung cancers ^[2], and about 50% of NSCLC patients are in local advanced stage that is not suitable for surgical resection or have metastasized at the time of diagnosis. The advanced sqNSCLC, making up about 30% of the advanced NSCLC, is given first place to a platinum-based doublet chemotherapy, which has limited efficacy, and the median survival time (MST) is quite short, many of which are less than 1 year. Therefore, there are huge unmet medical needs. In recent years, immune checkpoint inhibitors have made breakthroughs in NSCLC treatment, especially, the anti-PD-1 mAb combined with carboplatin and albumin-bound paclitaxel have been recommended by domestic and international authoritative guidelines for the treatment of advanced or metastatic sqNSCLC, which push forward the treatment of the advanced NSCLC into the era of immunotherapy. Furthermore, the approval of HANSIZHUANG brings a new option for sqNSCLC, promoting immunotherapy in clinical treatment of lung cancer, and boosting innovation-driven development.

Keep innovating in the first-line treatment of lung cancer

As the first innovative monoclonal antibody developed by Henlius, HANSIZHUANG covers a wide variety of indications and has initiated more than 10 clinical studies on immuno-oncology combination therapies around the world, including many high-incidence cancers such as lung cancer, hepatocellular carcinoma, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer. As of now, the company has enrolled more than 3,100 subjects worldwide and HANSIZHUANG is also an anti-PD-1 mAb with one of the largest global clinical data pools, which speed up the commercial expansion in overseas markets. Notably, HANSIZHUANG covers the full range of first-line treatment of lung cancer, including sqNSCLC, non-squamous non-small cell lung cancer (nsqNSCLC) and small cell lung cancer (SCLC), etc., in which HANSIZHUANG achieved positive results in the phase 3 clinical trial of extensive-stage small cell lung cancer (ES-SCLC) and it is also the first anti-PD-1 mAb in the world gaining positive results in the first-line treatment of ES-SCLC. Its NDA is under review and potentially to be the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. In terms of NSCLC, HANSIZHUANG has initiated many clinical studies, such as in combination with innovative anti-EGFR mAb HLX07 for the first-line treatment of sqNSCLC with EGFR overexpression, in combination with HANBEITAI (bevacizumab) for the first-line treatment of nsqNSCLC. The company has devoted itself to lung cancer with a sound indication plan and makes explorations in combination therapies, aiming for a higher quality of life and long-term survival in patients.

Henlius has consistently adhered to the principle of patient-centered care and keeps innovating to address the difficulties and pain points in clinical treatment, while HANSIZHUANG will explore more in lung cancer and other tumors to bring confidence and hope to patients.

【参考文献】

[1] Rongshou Zheng, Siwei Zhang, Hongmei Zeng, et al. Cancer incidence and mortality in China, 2016. Journal of the National Cancer Center, 2022, ISSN 2667-0054, dio: 10.1016/j.jncc.2022.02.002

[2] About Lung Cancer. American Cancer Society. https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00

About HANSIZHUANG

HANSIZHUANG (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA, and 11 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 and squamous non-small cell lung cancer (sqNSCLC). Its synergy with in-house products of the company and innovative therapies are forging ahead. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, 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 NDAs of the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC, and the related clinical trial has also become the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designation by the FDA for treatment of SCLC.

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 approved for marketing in overseas markets, 15 indications approved worldwide, and 4 New Drug Applications (NDAs) accepted for review in China. 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; 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 and squamous non-small cell lung cancer (sqNSCLC). Its NDAs for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) are under review. What’s more, Henlius has conducted over 20 clinical studies for 13 products and 11 combination therapies, expanding its presence in major markets as well as emerging markets.