复星医药子公司复宏汉霖H药汉斯状进入拉美市场，获秘鲁药监局批准上市

• H药 汉斯状是全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗

• H药 汉斯状目前已在40个国家和地区获批上市，覆盖全球近半数人口

• H药 汉斯状成为公司第四款在拉美市场获批上市的产品

复星医药子公司复宏汉霖（2696.HK）宣布，公司自主研发的抗PD-1单抗 H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）正式获得秘鲁药监局（Dirección General de Medicamentos, Insumos y Drogas, “DIGEMID”）批准上市，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗。此次获批标志着H药成为拉美地区首个且唯一获批该适应症的抗PD-1单抗。H药在秘鲁的本地商业化由合作伙伴Abbott负责，商品名为Olizu。

此次H药在秘鲁的获批主要基于欧盟委员会（EC）已批准斯鲁利单抗联合卡铂和依托泊苷用于成人广泛期小细胞肺癌（ES-SCLC）一线治疗的决定，以及ASTRUM-005研究的临床结果。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。在2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布了研究结束分析结果，数据显示中位随访达42.4个月时，斯鲁利单抗联合化疗对比安慰剂联合化疗的中位OS分别为15.8个月 vs. 11.1个月（分层风险比[HR] 0.60，95% CI 0.49–0.73）；两组4年OS率（95% CI）分别为21.9%（17.6–26.6）和7.2%（3.8–12.1），证实了该免疫治疗方案对ES-SCLC患者的长期生存获益。

肺癌是全球发病率和死亡率最高的恶性肿瘤，据GLOBOCAN最新数据显示，在拉美地区，肺癌在癌症发病率和死亡率中均位列第4位，2022年新发病例10.5万，死亡病例9.1万 [1]。小细胞肺癌（SCLC）约占肺癌总数的15%，是肺癌中侵袭性最强的亚型，治疗选择有限。H药 汉斯状为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，此次在秘鲁成功获批上市，有望为当地肺癌患者带来更多治疗选择，解决该领域长期以来存在的治疗空白。继汉曲优、汉利康、汉贝泰之后，汉斯状成为公司第四款在拉美市场获批上市的产品，也是公司在该地区获批的首款创新型药物，开启了公司扩展新兴市场的战略新篇章。作为公司全球化战略的重要支点，H药正持续加速其全球布局。截至目前，H药已在中国、英国、德国、印度、印度尼西亚、新加坡等40个国家和地区获批上市，覆盖全球近半数人口。未来，公司将持续践行“以患者为中心”的使命，携手国际合作伙伴，加速创新疗法的全球布局，让更多患者受益于前沿医疗成果。

【参考文献】

[1] Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. DOI: 10.3322/caac.21834

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，已在全球获批上市9款产品，4个上市申请分别获中国药监局、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，涵盖约50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全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）、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）、国内首个生物类似药汉利康（利妥昔单抗）、以及地舒单抗生物类似药Bildyos和Bilprevda。公司亦同步就19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。

Serplulimab Approved in Peru, Expanding into LATAM

• Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC

• The product has been approved in 40 countries and regions, covering close to half of the world’s population

• Serplulimab’s approval in Peru becomes Henlius’ fourth product to be approved in the Latin America market

Recently, Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly) has been approved in Peru by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval establishes serplulimab as the first and only anti-PD-1 mAb approved for the first-line treatment of ES-SCLC in the LATAM. Serplulimab will be commercialized by Henlius’ partner, Abbott, in Peru under the brand name Olizu.

The approval was primarily supported by the European Commission (EC) approval of serplulimab in combination with carboplatin and etoposide as a first-line treatment of adult patients with ES-SCLC, along with the clinical results from the ASTRUM-005 study.

The ASTRUM-005 study is a randomized, double-blind, placebo-controlled international multi-centre Phase 3 study, evaluating the efficacy and safety event profile of serplulimab in combination with chemotherapy versus placebo with chemotherapy as a first-line treatment for ES-SCLC. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, the results from the final analysis of ASTRUM-005 and 42.4 months of median follow-up data were presented. As of data cutoff on May 7, 2024, median OS was 15.8 in the serplulimab arm vs.11.1 months (stratified HR 0.60, 95% CI 0.49–0.73) in the placebo arm; estimated 4-year OS rate (95% CI) was 21.9% (17.6–26.6) and 7.2% (3.8–12.1). These results further confirm the long-term survival benefit of this immunotherapy-based regimen for patients with ES-SCLC.

Lung cancer continues to be malignancy with the highest global incidence and mortality rates. According to the latest GLOBOCAN data, lung cancer mortality ranked 4th among all cancer types in Latin America. Latin America witnessed approximately 105,000 new lung cancer cases and 91,000 deaths in 2022[1]. Small cell lung cancer (SCLC), one of the most aggressive subtypes, accounts for approximately 15% of all lung cancer cases and is associated with limited treatment options. The approval of serplulimab in Peru will bring a new first-line immunotherapy option to local lung cancer patients, and is expected to fill the long-standing treatment gap in this field.

Following the commercialization of HLX02 (trastuzumab), HLX01 (rituximab) and HLX04 (bevacizumab) in the Latin American market, serplulimab has become the Henlius’ fourth product to be approved there through diverse partnership agreements. It is also the company's first innovative product approved in this area, signifying a pivotal milestone in the company's strategic expansion into emerging markets. As a core product of Henlius’ globalisation strategy, serplulimab has now been approved in 40 countries and regions including China, the UK, Germany, India, Indonesia and Singapore, covering close to half of the world’s population. Looking ahead, Henlius will continue to collaborate with global partners to enhance accessibility and bring more innovative therapies to patients worldwide.

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. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 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 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 about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

(复星医药)