（来源：复星医药）

转自：复星医药

H药 汉斯状®是全球首个获批一线治疗ES-SCLC的抗PD-1单抗，迄今惠及逾110,000位患者

H药 汉斯状®目前已在近40个国家和地区获批上市，覆盖全球近半数人口

H药成为印度首个且唯一用于一线治疗小细胞肺癌（SCLC）并商业化落地的抗PD-1单抗

2025年7月31日，复宏汉霖（2696.HK）宣布，公司自主研发和生产的抗PD-1单抗H药（商品名：汉斯状®，斯鲁利单抗，欧洲商品名：Hetronifly®）完成首批面向印度市场的供货，标志着这款中国原创创新药正式启程迈入全球人口第一大国，助力满足小细胞肺癌（SCLC）领域的迫切临床需求。H药是全球首个获批用于一线治疗广泛期小细胞肺癌（ES-SCLC）的抗PD-1单抗，迄今已在中国、英国、德国、印度、印度尼西亚、新加坡等近40个国家和地区获批上市，覆盖全球近半数人口[1]。

复宏汉霖总裁

黄玮表示

造福全球病患，是复宏汉霖始终坚守的战略愿景。此次H药完成印度首批发货，不仅充分验证了我们全球供应体系的高效运营能力，更是中国原研创新药持续走向世界、造福全球的又一例证。自上市以来，H药已惠及全球逾11万名患者，持续拓展全球免疫治疗的可及边界。未来，我们将继续发挥全球一体化研产销优势，将更多优质的创新药物带给全球更广泛的患者群体

复宏汉霖首席商务发展官兼高级副总裁

曹平表示

我们始终以解决全球患者的临床需求为中心，并以务实行动兑现对合作伙伴的承诺。H药在印度获批后迅速供货，正是公司与合作伙伴Intas高效协同、共同推进的成果。凭借H药的差异化优势，以及Intas在本地商业化网络方面的深厚经验和资源，我们将持续致力于将更多高品质、可负担的创新药物带给更多患者，切实提升其用药可及性。

H药于2025年6月获印度中央药品标准控制组织（CDSCO）批准，用于一线治疗广泛期小细胞肺癌，成为印度首个在该适应症获批的抗PD-1单抗。印度作为全球人口第一大国[2]，肺癌在当地癌症发病率和死亡率中均位居前列。2022年新发病例超过81,000例，死亡人数逾75,000人[3]。H药在印度的上市与商业化落地，有望为当地肺癌患者提供一线创新免疫治疗选择，改善患者生存预后，回应该领域长期未满足的临床需求。

复宏汉霖合作伙伴Intas负责H药在印度的商业化推广。作为印度领先的制药企业，Intas具备深厚的本地市场洞察和广泛的销售网络，将有力推动H药在当地的准入与覆盖，帮助更多患者尽早受益。未来，复宏汉霖将继续深化与全球合作伙伴的协作，推进更多高品质药物的全球上市进程，惠及更多患者。

参考文献

[1] World Population Prospects 2024 Demographic indicators by region, subregion and country

[2] UNFPA (United Nations Population Fund), 2025. “The Real Fertility Crisis: The pursuit of reproductive agency in a changing world.” ¬State of World Population 2025. New York: UNFPA. ISBN: 9789211542837

[3] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.

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，4款产品在国际获批上市，5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）、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®）以及汉奈佳®（奈拉替尼）。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。

First India Shipment of Henlius' Serplulimab

- Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC, benefiting over 110,000 patients to date

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

- Serplulimab becomes the first and only commercialized anti-PD-1 therapy for first-line treatment of SCLC in India

Shanghai, China, July 31, 2025 — Henlius (2696.HK) today announced that the company’s independently developed and manufactured anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly®), has completed its first shipment to the Indian market. This milestone marks the official entry of this innovative therapy developed in China into the world’s most populous country, further addressing the urgent clinical needs in the treatment of small cell lung cancer (SCLC). Serplulimab is the world’s first anti-PD-1 therapy approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and has been approved in nearly 40 countries and regions including China, the United Kingdom, Germany, India, Indonesia, and Singapore, reaching close to half of the global population [1].

Ms. Wei Huang, President of Henlius, stated: "Improving global patient access remains at the heart of Henlius’ strategic vision. The first shipment of serplulimab to India not only demonstrates the strength and efficiency of our global supply system, but also represents another solid step forward in the journey of Chinese innovation benefiting patients worldwide. Since launch, serplulimab has benefited over 110,000 patients globally, and continues to expand the accessibility of immuno-oncology worldwide. Moving forward, we will continue to leverage our integrated global capabilities in R&D, manufacturing and commercialisation to deliver more high-quality innovative medicines to patients around the world."

Ms. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, stated: "We remain committed to addressing the clinical needs of patients worldwide and delivering on our promises to partners through practical action. The swift commercial supply of serplulimab following its approval in India is a result of the close collaboration and efficient execution between Henlius and our partner Intas. By leveraging the differentiated strengths of serplulimab and Intas' deep expertise and robust commercial network in the local market, we aim to bring more high-quality, affordable innovative medicines to patients in need and further enhance treatment accessibility globally."

In June 2025, serplulimab was approved by the Central Drugs Standard Control Organization (CDSCO) of India for the first-line treatment of ES-SCLC, making it the first anti-PD-1 therapy approved for this indication in the country. As the world’s most populous nation [2], India faces a significant burden from lung cancer, which ranks among the leading causes of cancer incidence and mortality. In 2022 alone, India reported over 81,000 new lung cancer cases and more than 75,000 related deaths [3]. The launch and commercialisation of serplulimab in India is expected to provide an innovative treatment option for patients and improve survival outcomes in this historically underserved area.

Henlius' partner, Intas, is responsible for the commercialization of serplulimab in India. As a leading pharmaceutical company in India, Intas brings deep local market expertise and an extensive commercial network, which is expected to accelerate patient access and product availability across the country. Looking ahead, Henlius will continue to deepen collaboration with global partners and advance the worldwide availability of high-quality therapies to benefit more patients.

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, 4 have been approved for marketing in overseas markets, and 5 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 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), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.