復宏漢霖H藥 漢斯狀獲EMA積極意見, 推薦批準兩項新適應癥 | 正心Ecosphere

來源：市場資訊

（來源：正心谷資本）

2026年3月30日，復宏漢霖（2696.HK）宣布，公司自主研發的抗PD-1單抗 H藥 漢斯狀?（斯魯利單抗，歐洲商品名：Hetronifly?）獲得歐洲藥品管理局（EMA）人用藥品委員會（CHMP）兩項積極意見，推薦批準其聯合化療用于一線治療局部晚期或轉移性非鱗狀非小細胞肺癌（nsqNSCLC）和用于PD-L1陽性的不可切除的局部晚期、復發或轉移性食管鱗狀細胞癌（ESCC）。此前，H藥已在歐盟獲批一線治療廣泛期小細胞肺癌（ES-SCLC）。根據歐盟法規，CHMP的積極意見將提交至歐盟委員會進行最終審議，若順利獲批，H藥在歐盟成員國及歐洲經濟區國家的適應癥范圍將得到進一步拓展。

復宏漢霖執行董事、首席執行官

朱俊博士表示

CHMP發布的積極意見，是對H藥卓越臨床價值和堅實科學證據的有力印證，也標志著我們在拓展全球抗腫瘤版圖上的又一重要里程碑。肺癌和消化道腫瘤是嚴重威脅人類健康的重大疾病，在歐洲乃至全球仍存在巨大且迫切的未滿足臨床需求。這兩項新適應癥若能順利獲批，將為當地患者帶來新的治療選擇和生存獲益。未來，我們將持續推進創新療法的全球開發與注冊進程，攜手合作伙伴加速推動創新成果惠及更多患者。

堅實臨床數據支撐，療效與安全性獲權威認可

此次CHMP積極意見主要基于ASTRUM-002和ASTRUM-007兩項研究結果。相關研究均為隨機、雙盲、多中心III期臨床試驗，旨在評估斯魯利單抗在相應適應癥患者中的療效和安全性。相關研究結果已在國際學術會議及學術期刊上公布。這兩項臨床證據此前已分別支持H藥用于一線治療nsqNSCLC和ESCC的適應癥在中國獲批上市。

ASTRUM-002由國家癌癥中心/國家腫瘤臨床醫學研究中心/中國醫學科學院北京協和醫學院腫瘤醫院石遠凱教授擔任牽頭主要研究者，旨在研究斯魯利單抗聯合化療（卡鉑-培美曲塞）對比化療（卡鉑-培美曲塞）一線治療晚期nsqNSCLC的療效與安全性。研究結果表明，斯魯利單抗組的無進展生存期（PFS）顯著延長，達到預設的優效標準，且具有良好的安全性。ASTRUM-002研究的最終分析結果入選ESMO大會的LBA（Late-breaking Abstract），以口頭匯報形式首次正式公布總生存期（OS）數據。最終分析結果顯示，斯魯利單抗聯合化療組的中位總生存期（mOS）達到26.8個月，成功突破兩年的長期生存獲益。

ASTRUM-007由國家癌癥中心/國家腫瘤臨床醫學研究中心/中國醫學科學院北京協和醫學院腫瘤醫院黃鏡教授擔任牽頭主要研究者，旨在研究斯魯利單抗對比安慰劑聯合化療（順鉑+5-FU）在既往未接受治療、PD-L1陽性的晚期ESCC患者中的療效和安全性。研究結果顯示，斯魯利單抗聯合化療帶來了總生存期（OS）和無進展生存期（PFS）的全面生存獲益，并具備良好的安全性。ASTRUM-007研究此前刊登于國際權威期刊Nature Medicine。

歐洲商業化穩步推進，可及性持續提升

作為全球首個獲批用于廣泛期小細胞肺癌（ES-SCLC）一線治療的抗PD-1單抗，H藥自2025年2月獲得歐盟委員會批準上市以來，復宏漢霖攜手歐盟區域合作伙伴Intas子公司Accord，持續推進其在歐洲的準入與落地進程。截至目前，H藥已在12個歐盟國家實現上市銷售，并已在奧地利、丹麥、德國、愛爾蘭、意大利、西班牙和瑞典等7個歐盟成員國納入醫保或公共支付體系，進入當地主流醫療保障體系，進一步提升符合適應癥患者的治療可及性。

在歐盟市場，創新藥物通常需要經過嚴格的衛生技術評估（HTA），綜合考量臨床療效、安全性、患者獲益及成本效益等多方面因素。根據2025年4月IQVIA發布的歐洲創新藥可及性研究報告（數據周期2020-2023），創新藥在歐洲納入醫保平均周期為578天1。H藥則在歐盟獲批一年內即實現多國醫保覆蓋，體現了其臨床價值及在成熟醫療體系中的可及性潛力。

機制優勢賦能，全球研發與注冊持續推進

憑借其差異化的機制，H藥在多種實體瘤的治療中展現出獨特優勢，該藥物不僅具備更強的PD-1內吞作用，可減少T細胞表面PD-1受體2，實現快速、強效的免疫激活；還能減少PD-1對共刺激分子CD28的募集，從而更大程度保留CD28信號傳導3-5，增強下游AKT蛋白活性6，促進T細胞持續活化。聚焦肺癌與消化道腫瘤，H藥已在中國獲批用于治療鱗狀非小細胞肺癌（sqNSCLC）、廣泛期小細胞肺癌（ES-SCLC）、食管鱗癌（ESCC）及非鱗狀非小細胞肺癌（nsqNSCLC）等多個適應癥，并已在中國、英國、歐盟、新加坡、印度、瑞士、秘魯等40多個國家和地區獲批上市，覆蓋全球近半數人口。

與此同時，復宏漢霖正全面推進H藥的全球臨床開發計劃，目前已在全球開展超過10項腫瘤免疫聯合治療研究，累計入組患者超過5,100例，并在美國和日本同步開展ES-SCLC的橋接試驗。在消化道腫瘤領域，III期臨床研究（ASTRUM-006）評估了H藥聯合化療作為新輔助治療，以及H藥單藥作為輔助治療用于胃癌圍手術期的治療方案。該研究是全球首個以術后免疫單藥替代術后輔助化療的胃癌圍手術期治療方案，是該領域的重要臨床突破7。作為全球首個胃癌圍手術期以免疫單藥取代術后輔助化療的治療方案，該適應癥上市許可申請已獲CDE受理并被納入優先審評，有望于2026年于中國獲批。在結直腸癌領域，III期國際多中心臨床研究（ASTRUM-015）已完成患者入組。該研究評估了H藥聯合貝伐珠單抗及化療用于轉移性結直腸癌（mCRC）一線治療的療效與安全性。同時，其II期臨床的最新數據進一步凸顯了H藥在帶來高疾病負擔的惡性消化道腫瘤領域持續拓展臨床價值的潛力8。

未來，復宏漢霖將持續推進H藥在全球范圍內的注冊和臨床開發，進一步拓展其在不同腫瘤類型中的治療潛力。

關于復宏漢霖

復宏漢霖（2696.HK）是一家國際化創新生物制藥企業，致力于為全球患者提供高品質、可負擔的生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域。自2010年成立以來，公司已構建涵蓋全球研發、臨床、注冊、生產及商業化的全產業鏈平臺，擁有全球員工近4,000人，并在中國、美國和日本等多地設有運營及分支機構。依托生物類似藥形成的穩健現金流反哺創新研發，復宏漢霖正穩步邁入“全球化2.0”階段，持續打造可復制、可持續的全球增長模式。截至2026年初，公司共有10款產品在全球60個國家和地區獲批上市，其中7款已在中國獲批。在歐美主流生物藥市場，復宏漢霖亦取得多項里程碑式突破，已有4款產品獲得美國FDA批準、4款產品獲得歐盟EC批準，充分體現了公司在研發體系、質量管理及生產能力方面已全面對標國際最高標準。

在創新驅動方面，復宏漢霖依托上海、美國等多地協同布局的研發體系，構建了多元化、平臺化的創新技術矩陣，覆蓋免疫檢查點抑制劑、免疫細胞銜接器（包括多特異性TCE）、抗體偶聯藥物（ADC）以及AI驅動的早期研發平臺等前沿方向。目前，公司擁有50余項處于早期階段的創新資產，其中約70%具備同類最佳（Best-in-Class）潛力，并在全球同步推進30余項臨床研究。核心產品H藥 漢斯狀?（斯魯利單抗，歐洲商品名：Hetronifly?）作為全球首個獲批一線治療小細胞肺癌的抗PD-1單抗，正加速全球布局，已在全球40余個市場獲批上市；同時，多款潛力創新資產，包括PD-L1 ADC HLX43及新表位HER2單抗HLX22正全面推進全球關鍵性臨床研究。依托通過中、歐、美三地GMP認證的生產體系，復宏漢霖已建成總產能達84,000升的生物藥生產平臺，形成覆蓋全球六大洲的穩定供應網絡。未來，復宏漢霖將始終堅持以患者為中心，聚焦未滿足的臨床需求，持續推動創新成果向臨床價值與患者可及轉化，在全球生物醫藥創新生態中創造長期而穩健的價值。

Henlius Receives Two Positive CHMP Opinions for Serplulimab, Advancing Global Regulatory Progress

• The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued two positive opinions recommending new indications for serplulimab in 30 EEA countries

• As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), serplulimab has been launched in 12 EU countries and included in reimbursement schemes in 7

• Serplulimab has been approved in over 40 countries and regions worldwide, covering nearly half of the global population

Shanghai, China – March 30, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly?), has received two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP recommends approval of serplulimab in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma (nsqNSCLC) and with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (whose tumours express PD-L1 with a CPS ≥ 5.).

Serplulimab has previously been approved in the European Union (EU) for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Under EU regulatory procedures, the CHMP’s positive opinion will be submitted to the European Commission (EC) for final decision. If approved by the EC, the indications of serplulimab in the EU Member States and the European Economic Area (EEA) will be further expanded.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinions strongly validate the clinical value and robust scientific evidence of serplulimab, marking another significant milestone in expanding our global oncology footprint. Lung cancer and gastrointestinal tumours pose severe threats to human health, representing substantial and urgent unmet medical needs in Europe and globally. If approved, these two new indications will provide local patients with new treatment options and survival benefits. Moving forward, we will continuously advance the global development and regulatory submissions of our innovative therapies, working alongside our partners to accelerate the delivery of clinical benefits to more patients.”

Robust Clinical Evidence with Recognized Efficacy and Safety

The CHMP opinions are primarily based on results from the ASTRUM-002 and ASTRUM-007 studies. These two Phase 3 clinical trials previously supported the approval of serplulimab in China for first-line treatment of nsqNSCLC and ESCC, respectively.

Both studies are randomized, double-blind, multicentre Phase 3 trials designed to evaluate the efficacy and safety of serplulimab in the respective patient populations. Results have been presented at international academic conferences and published in peer-reviewed journals.

ASTRUM-002, led by Professor Yuankai Shi from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, evaluated serplulimab in combination with chemotherapy (carboplatin and pemetrexed) versus chemotherapy alone in patients with advanced nsqNSCLC. The study demonstrated a statistically significant improvement in progression-free survival (PFS), meeting its primary endpoint with a favourable safety profile. Final results of ASTRUM-002 were presented as a late-breaking abstract at the European Society for Medical Oncology Annual Meeting (ESMO), showing a median overall survival (mOS) for the serplulimab plus chemotherapy group reached 26.8 months, successfully surpassing the two-year mark.

ASTRUM-007, led by Professor Jing Huang from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, evaluated serplulimab in combination with chemotherapy (cisplatin and 5-FU) versus placebo plus chemotherapy in previously untreated patients with PD-L1-positive advanced ESCC. The study demonstrated significant improvements in both overall survival (OS) and progression-free survival (PFS), with a favourable safety profile. The results were published in Nature Medicine.

Steady Commercialization and Enhanced Accessibility in Europe

As the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC, serplulimab has made steady progress in the European market since receiving EC approval in February 2025.

Henlius, together with its EU regional partner Accord Healthcare Ltd (“Accord”), a subsidiary of Intas, has continued to drive market access and commercialization efforts in Europe. To date, Hetronifly? has been launched in 12 EU countries and has been reimbursed in Austria, Denmark, Germany, Ireland, Italy, Spain and Sweden so far, entering mainstream healthcare systems and supporting improved outcomes for eligible patients.

Reimbursement decisions in the EU are typically subject to stringent health technology assessment (HTA) processes, evaluating clinical efficacy, safety, patient benefit and cost-effectiveness. According to IQVIA, the average reimbursement approval lead time cross EU Member States is 578 days. 1

Achieving reimbursement coverage across multiple Member States within one year of EU approval reflects recognition of the clinical value and real-world applicability of serplulimab within mature European healthcare systems. It also marks a key step in transitioning from regulatory approval to broader patient accessibility across the region.

Differentiated Mechanism and Global R&D Advancement

Serplulimab demonstrates unique advantages in treating various solid tumours via its differentiated mechanism of action. The drug not only induces stronger PD-1 internalization, reducing PD-1 receptor presence on T cells for rapid and potent immune activation 2—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signalling, 3-5 enhancing downstream AKT activity, 6 and promoting sustained T-cell activation.

Serplulimab has been approved in China for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, ESCC, and nsqNSCLC. Up to date, it has been approved in over 40 countries and regions including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the global population.

Henlius continues to advance an extensive global clinical programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,100 patients enrolled. Bridging studies for ES-SCLC are being conducted in the United States and Japan.

In gastrointestinal cancers, ASTRUM-006, the phase 3 study is evaluating serplulimab in perioperative gastric cancer, including neoadjuvant combination therapy and adjuvant monotherapy, representing a novel treatment approach. 7 As the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy, its New Drug Application (NDA) has been accepted by the National Medical Products Administration (NMPA) and granted Priority Review. The indication is expected to be approved in China in 2026. In colorectal cancer, ASTRUM-015, the global phase 3 study evaluating serplulimab in combination with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.8

Looking ahead, Henlius will continue to advance global registration and clinical development of serplulimab, further expanding its potential across tumour types and bringing innovative treatment options to patients worldwide.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly? in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

References

1.EFPIA Patients W.A.I.T. Indicator 2024 Survey, IQVIA, published in Apr.2025

2.Issafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972.

3.Hui E, et al. T cell costimulatory receptor CD28 is a primary target for PD-1-mediated inhibition. Science. 2017;355(6332):1428-1433.

4.Patsoukis N, et al. Interaction of SHP-2 SH2 domains with PD-1 ITSM induces PD-1 dimerization and SHP-2 activation. Commun Biol. 2020;3(1):128.

5.Fenwick C, et al. Tumor suppression of novel anti-PD-1 antibodies mediated through CD28 costimulatory pathway. J Exp Med. 2019;216(7):1525-1541.

6.Primavera E, et al. Computer-Aided Identification of Kinase-Targeted Small Molecules for Cancer: A Review on AKT Protein. Pharmaceuticals (Basel). 2023;16(7):993.

7.China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer. Henlius. December 12, 2025. Accessed December,232025. https://www.henlius.com/en/NewsDetails-5670-26.html

8.Wang ZX, Peng J, Liang X, et al. First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. Med. 2024;5(9):1150-1163.e3. doi:10.1016/j.medj.2024.05.009

聯系方式

媒體：PR@Henlius.com

投資者：IR@Henlius.com