转自：复星医药

近日，复星医药子公司复宏汉霖自主研发的抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®），分别获得新加坡卫生科学局（HSA）和马来西亚国家药品监管局（NPRA）批准，用于治疗广泛期小细胞肺癌（ES-SCLC），商品名为Zerpidio®。此次获批是继印度尼西亚、柬埔寨、泰国获批后，该产品在东南亚市场的又一重要拓展。H药在东南亚的商业化由印度尼西亚制药公司PT Kalbe Farma Tbk.子公司KGbio负责，该公司被授予H药在东盟十国的部分适应症及疗法的独家开发和商业化权利。

突破桎梏，重塑SCLC长生存希望

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，2022年，东南亚地区肺癌新发病例18.6万，死亡病例16.6万，其中，新加坡和马来西亚的肺癌死亡率高居该国所有癌种首位[1]。小细胞肺癌（SCLC）是肺癌中侵袭性最强的亚型，约占肺癌总数的15%，分为局限期小细胞肺癌（LS-SCLC）和ES-SCLC。据统计，约80%的患者首次确诊已处于广泛期阶段，且临床病情恶化快，总体预后不良[2]。近年来，以PD-1/PD-L1免疫检查点抑制剂为代表的免疫治疗兴起，为SCLC患者带来了更多的治疗选择及生存获益。

H药是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在全球30多个国家和地区获批上市，惠及逾11万名患者。此次H药在新加坡和马来西亚获批主要基于ASTRUM-005研究，该研究在全球开设了128个试验中心，入组585例受试者，研究结果于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。在今年ASCO大会上，ASTRUM-005首次公布了4年OS率。长期随访数据（中位随访时间42.4个月）显示斯鲁利单抗组的4年OS率达21.9%，对照组为7.2%， 进一步夯实了该方案能为ES-SCLC患者带来显著的长期生存获益。

拓展全球，推动更多患者获益

2019年，复宏汉霖与KGbio就H药签订独家许可协议，授予其H药在东盟十国的部分适应症及疗法的独家开发和商业化权利。2023年8月，双方深化合作，KGbio获得在沙特阿拉伯、阿联酋、埃及、卡塔尔、约旦、摩洛哥等12个中东和北非地区（MENA）国家针对H药包括ES-SCLC在内的两项适应症进行独家开发和商业化的权益。得益于双方紧密协作，H药的国际化进程持续提速。2023年12月，H药迎来首个海外获批，获得印度尼西亚食品药品监督管理局（BPOM）批准用于治疗ES-SCLC，成为首个于东南亚获批上市的国产抗PD-1单抗。2024年4月和7月，H药相继在柬埔寨和泰国获批治疗ES-SCLC；2025年1月，H药于印度尼西亚和泰国新增获批鳞状非小细胞肺癌（sqNSCLC），东南亚市场影响力进一步扩大。

除东南亚市场外，H药的全球化布局也正加速向多区域纵深推进。截至目前，H药已在中国获批用于治疗sqNSCLC、ES-SCLC、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC)。2025年2月，H药获欧盟批准用于一线治疗ES-SCLC，成为欧盟首个且唯一获批该适应症的抗PD-1单抗，实现了国产创新药在欧美主流生物药市场的关键突破。目前，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，以支持其美国上市申报。此外，H药治疗SCLC已获美国食品和药品监督管理局（FDA）、欧盟委员会（EC）、瑞士药品监督管理局（Swissmedic）授予孤儿药资格，并获韩国食品药品安全部（MFDS）授予用于ES-SCLC孤儿药资格。

复宏汉霖始终坚持以患者为中心，未来将继续携手全球合作伙伴，通过创新与合作，为全球患者带来更多优质、可负担的治疗选择。

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。

Expanding Southeast Asian Presence: Serplulimab Approved in Singapore and Malaysia

Recently, Henlius' self-developed anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) has secured approvals in Singapore and Malaysia through its local license holder, KGbio (a subsidiary of PT Kalbe Farma Tbk.), under the trade name Zerpidio® for the treatment of extensive-stage small cell lung cancer (ES-SCLC). This marks another significant expansion in Southeast Asia following earlier approvals in Indonesia, Cambodia, and Thailand. Under the agreement, serplulimab’s commercialization in Southeast Asia is managed by KGbio, which holds exclusive rights to develop and commercialize the drug for certain indications and therapies across 10 ASEAN countries. 

SCLC Survival Breakthrough: Renewing Hope for Patients

Lung cancer continues to be the malignancy with the highest global incidence and mortality rates. According to the latest GLOBOCAN data, Southeast Asia witnessed approximately 186,000 new lung cancer cases and 166,000 deaths in 2022. Notably, lung cancer mortality ranked highest among all cancer types in both Singapore and Malaysia[1]]. Small cell lung cancer (SCLC), accounting for roughly 15% of all lung cancer cases, stands as one of its most aggressive subtypes. It is classified into limited-stage (LS-SCLC) and ES-SCLC. Statistics indicate that nearly 80% of patients are diagnosed at the extensive stage, with rapid clinical deterioration and poor overall prognosis[2]. In recent years, advances in immunotherapy, particularly PD-1/PD-L1 immune checkpoint inhibitors, have expanded treatment options and improved survival outcomes for SCLC patients.

Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of SCLC, having been approved for marketing in over 30 countries and regions worldwide, benefiting over 110,000 patients. This approval of serplulimab in Singapore and  Malaysia is primarily based on the ASTRUM-005 study, which established 128 trial centers globally and enrolled 585 subjects. The study results were first released via oral presentation at the 2022 American Society of Clinical Oncology (ASCO) annual meeting and published in the Journal of the American Medical Association (JAMA), one of the world's four top-tier medical journals, making it the world's first SCLC immunotherapy clinical research published in JAMA's main journal. At this year's ASCO conference, the ASTRUM-005 trial, for the first time, reported the 4-year overall survival (OS) rate. Long-term follow-up data (median follow-up: 42.4 months) showed a 4-year OS rate of 21.9% in the serplulimab-treated group versus 7.2% in the control group, further confirming that this regimen can bring significant long-term survival benefits to ES-SCLC patients.

Global Expansion: Helping More Patients Worldwide

In 2019, Henlius entered into an exclusive licensing agreement with KGbio for serplulimab, granting KGbio exclusive rights to develop, register and commercialize serplulimab for certain indications and therapies across 10 ASEAN countries. Building on this partnership, the collaboration expanded in August 2023 with KGbio securing exclusive commercialization rights for two indications – including ES-SCLC – in 12 Middle East and North Africa (MENA) countries, notably Saudi Arabia, UAE, Egypt, Qatar, Jordan, and Morocco. Accelerated by this strategic collaboration, serplulimab's global rollout has achieved significant milestones. In December 2023, serplulimab achieved its first overseas approval, receiving authorization from the Indonesian Food and Drug Administration (BPOM) for the treatment of ES-SCLC. This made it the first China-developed anti-PD-1 monoclonal antibody approved for marketing in Southeast Asia. In April and July 2024, serplulimab was successively approved for the treatment of ES-SCLC in Cambodia and Thailand. In January 2025, serplulimab received additional approvals for squamous non-small cell lung cancer (sqNSCLC) in Indonesia and Thailand, further expanding its influence in the Southeast Asian market.

Beyond the Southeast Asia, serplulimab's global deployment is accelerating across multiple key markets. To date, the drug has gained four Chinese approvals for the treatment of sqNSCLC, ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC). A pivotal milestone was achieved in February 2025 when the European Commission approved serplulimab as first-line therapy for ES-SCLC – making it the first and only anti-PD-1 mAb authorized for this indication in the EU. This authorization represents a landmark breakthrough for China-developed biologics in Western regulated markets. To support US registration, the company is steadily advancing the bridging head-to-head trial in the US to compare serplulimab to standard-of-care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. Furthermore, serplulimab has earned Orphan Drug Designations for SCLC from the US FDA, European Commission, and Swissmedic, along with specific designation for ES-SCLC from Korea's Ministry of Food and Drug Safety (MFDS).

Henlius remains committed to a patient-centric approach. Moving forward, we will continue to collaborate closely with global partners, leveraging innovation and cooperation, to deliver more high-quality, affordable treatment options 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. 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.

References

[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

[2] 中国临床肿瘤学会小细胞肺癌专家委员会, 中国医师协会肿瘤多学科诊疗专业委员会. 小细胞肺癌免疫治疗专家共识（2025版）[J]. 中华肿瘤杂志, 2025, 47(1): 65-75. 

（转自：复星医药）