H药汉斯状®（斯鲁利单抗）获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广泛期小细胞肺癌

PD1 汉斯状小细胞肺癌

复星医药

09/23

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H药汉斯状^®是全球首个获批一线治疗ES-SCLC的抗PD-1单抗

H药汉斯状^®有望成为首个且唯一在欧洲上市用于一线治疗 ES-SCLC的抗PD-1单抗

H药汉斯状^®目前已在中国、印度尼西亚、柬埔寨、泰国等国家获批上市，惠及约80,000位患者

2024年9月20日，复宏汉霖（2696.HK）宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已发布推荐公司自主开发的抗PD-1单抗 H药汉斯状^®（斯鲁利单抗）获得上市许可的积极意见，建议批准其用于一线治疗广泛期小细胞肺癌（ES-SCLC）适应症。2023年，复宏汉霖与Intas达成合作，授权其H药在欧洲和印度共50多个国家的独家开发和商业化权益。此次获CHMP积极意见，标志着H药距离在欧洲实现更广泛的可及性更近一步。

复宏汉霖执行董事、首席执行官

朱俊博士

此次CHMP的积极意见标志着复宏汉霖在推动产品加速走向全球的努力取得了重大进展，进一步验证了公司‘以患者为中心’的研发理念和践行国际化战略的坚定决心。期待这一治疗方案在欧洲的正式获批，并为当地乃至全球更多患者带去更多治疗选择和希望。

Accord欧洲中东和北非地区执行副总裁

Paul Tredwell先生

我们对于CHMP给出的积极意见感到非常振奋。这不仅进一步巩固了我们与复宏汉霖的合作伙伴关系，更意味着斯鲁利单抗有望成为更多广泛期小细胞肺癌患者的重要治疗选择。对于这些治疗选择有限且预后不佳的患者而言，这无疑是一个重大的突破。

守正创新，聚焦小肺临床需求

肺癌是全球发病率和死亡率最高的癌症，据GLOBOCAN最新数据显示，2022年全球约有超过248万新发肺癌病例，占癌症新发病例的12.4%^[1]。小细胞肺癌（SCLC）占肺癌总数的15%-20%，具有恶性程度高、转移早、疾病进展迅速等特点，预后极差。SCLC分为局限期和广泛期，其中约30%-40%的患者确诊时处于局限期，其余处于广泛期。在欧盟，SCLC的患者比例约为人口总数万分之一至五^[2]，符合欧盟对于孤儿药资格认定的范畴。2022年12月，H药治疗SCLC获得欧盟委员会（EC）授予的孤儿药资格认定，并于2023年3月获EMA受理H药用于治疗SCLC的欧盟上市许可申请（MAA）。

此次H药获欧盟上市积极意见主要基于ASTRUM-005研究，ASTRUM-005研究是一项随机、双盲、安慰剂对照的国际多中心III期研究，旨在评估斯鲁利单抗联合化疗对比安慰剂联合化疗用于ES-SCLC一线治疗的疗效和安全性。该试验在中国、欧盟波兰、土耳其、格鲁吉亚等多个国家共开设128个试验中心，入组585例受试者，其中约31.5%为白人。ASTRUM-005临床试验结果于2022年美国临床肿瘤学会（ASCO）年会以口头报告方式首次发布，并于全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA）发表，成为全球首个登上JAMA主刊的SCLC免疫治疗临床研究。基于ASTRUM-005研究，H药已在中国和东南亚多国获批用于一线治疗ES-SCLC，成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。

全球布局，创新驱动高质出海

作为复宏汉霖首个自主研发的创新型单抗，H药聚焦肺癌和消化道肿瘤等高发癌种，已在中国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）、ES-SCLC及食管鳞状细胞癌（ESCC），复宏汉霖同步在全球开展10余项以H药为核心的免疫联合疗法临床研究。在肺癌领域，公司现已全面覆盖肺癌一线治疗，除已获批的sqNSCLC和ES-SCLC外，H药联合化疗一线治疗非鳞状非小细胞肺癌（nsNSCLC）的上市申请已获得中国国家药品监督管理局（NMPA）受理，并在全球范围开展一项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。此外，公司正在美国开展一项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。

H药的全球化步伐正不断加速，截至目前，该产品已在中国、印度尼西亚、柬埔寨、泰国等国家获批上市，对外授权覆盖美国、欧洲、东南亚、中东和北非等70多个国家和地区。2023年12月22日，复宏汉霖获得就H药生产线签发的欧盟GMP证书，标志着公司徐汇基地及松江基地（一）就H药相关生产区域顺利通过欧盟GMP检查，符合欧盟GMP标准。2024年第一季度，公司高效完成H药的首批海外发货，标志着H药成为首个登陆东南亚国家的国产抗PD-1单抗，为全球更多病患带来新的治疗选择。

未来，复宏汉霖将继续以患者为核心，聚焦未满足的临床需求，创新升级，加速推进中国优质药物惠及全球患者。

【参考文献】

[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

[2] Dingemans AC, Früh M, Ardizzoni A, et al. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021;32(7):839-853. doi:10.1016/j.annonc.2021.03.207

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，24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。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 Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

HANSIZHUANG (serplulimab) is the world’s first anti-PD-1 mAb for first-line treatment of ES-SCLC -
HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC -
HANSIZHUANG (serplulimab) has already been approved in China, Indonesia, Cambodia, and Thailand, benefiting around 80,000 patients

Shanghai, China, September 20, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of HANSIZHUANG (serplulimab), Henlius’ independently developed anti-PD-1 monoclonal antibody (mAb), as a first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). In 2023, Henlius entered into an exclusive license agreement with Intas Pharmaceuticals Limited (“Intas”) for the development and commercialisation a total of more than 50 countries in Europe and India. This positive opinion from CHMP marks another step closer for both companies to providing serplulimab for patients in Europe. If approved, serplulimab will be marketed by Intas’ subsidiary, Accord Healthcare Ltd, in Europe.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: “The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius’ patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide.”

Paul Tredwell, Executive Vice President of EMENA at Accord, said, "I am thrilled with the CHMP's positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis.”

Innovative Approach to Address Clinical Needs of SCLC

According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. ^[1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer, which is featured by high malignancy, early metastasis, and rapid disease progression, with extremely poor prognosis. SCLC is divided into limited-stage and extensive-stage, with approximately 30%-40% of patients diagnosed at the limited stage and the rest at the extensive stage. With a prevalence of 1-5 per 10,000 people in the European community, SCLC has an orphan disease designation. ^[2] In December 2022, HANSIZHUANG was granted orphan drug designation by the European Commission (EC) for the treatment of SCLC, and in March 2023, EMA validated the marketing authorisation application (MAA) of HANSIZHUANG for ES-SCLC.

The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. The study has set up a total of 128 sites in various countries including China, Poland, Turkey, and Georgia, and enrolled 585 subjects, among whom 31.5% were Caucasians. The ASTRUM-005 clinical trial results were firstly presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), making it the first study published on JAMA in SCLC immunotherapy. Based on the ASTRUM-005 study, HANSIZHUANG has been approved in China and Southeast Asian countries for first-line treatment of ES-SCLC, making it the world’s first anti-PD-1 mAb approved for first-line treatment of SCLC.

Global Strategy to Fuel Innovation-driven Expansion

HANSIZHUANG, Henlius’ first innovative mAb developed in-house, focuses on high-incidence cancers such as lung cancer and gastrointestinal tumours. In China, it has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC). The company is also conducting more than 10 clinical studies on immuno-oncology combination therapies worldwide.

Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to sqNSCLC and ES-SCLC, HANSIZHUANG’s marketing application for first-line treatment of non-squamous NSCLC (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). Additionally, 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.

The global expansion of HANSIZHUANG is accelerating. It has already been approved in several countries, including China, Indonesia, Cambodia, and Thailand, and has been licensed to over 70 countries and regions, including the US, Europe, Southeast Asia, the Middle East, and North Africa. On December 2023, Henlius received the European Union (EU) GMP Certificates for the production lines of HANSIZHUANG, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The first overseas shipment of HANSIZHUANG was completed in Q1 2024, making it the first Chinese anti-PD-1 mAb to enter Southeast Asian, offering new treatment options for more global patients.

Looking ahead, Henlius will continue to prioritize patient needs, address unmet clinical demands, and accelerate efforts to deliver high-quality biologics from China to patients worldwide.