2025年10月22日，復(fù)宏漢霖（2696.HK）宣布，公司自主研發(fā)的創(chuàng)新型抗PD-1單抗H藥 漢斯?fàn)?reg;（斯魯利單抗，歐洲商品名：Hetronifly®）在既往未經(jīng)治療的廣泛期小細(xì)胞肺癌（ES-SCLC）美國(guó)患者中開展的對(duì)比一線標(biāo)準(zhǔn)治療阿替利珠單抗（PD-L1免疫抑制劑）的橋接臨床試驗(yàn)（ASTRIDE研究）已順利完成招募計(jì)劃要求的全部200例患者入組，將為后續(xù)向美國(guó)食品藥品監(jiān)督管理局（FDA）遞交生物制品許可申請(qǐng)（BLA）奠定堅(jiān)實(shí)基礎(chǔ)。

ASTRIDE研究是一項(xiàng)隨機(jī)、對(duì)照、開放標(biāo)簽的臨床研究，旨在比較斯魯利單抗聯(lián)合化療與阿替利珠單抗聯(lián)合化療在美國(guó)ES-SCLC患者中的療效與安全性。研究結(jié)果將作為關(guān)鍵臨床數(shù)據(jù)支持H藥在美國(guó)市場(chǎng)的注冊(cè)申報(bào)。本研究由復(fù)宏漢霖美國(guó)臨床、注冊(cè)團(tuán)隊(duì)自主管理、獨(dú)立執(zhí)行，并在超過100家美國(guó)腫瘤中心開展，是美國(guó)入組規(guī)模最大的ES-SCLC臨床試驗(yàn)之一。此外，H藥也是目前唯一一款在美國(guó)開展橋接臨床試驗(yàn)的抗PD-1單抗。這一研究的順利推進(jìn)，充分彰顯了復(fù)宏漢霖在國(guó)際臨床研究設(shè)計(jì)、執(zhí)行及監(jiān)管溝通等全鏈條能力上的領(lǐng)先水平，也標(biāo)志著中國(guó)創(chuàng)新藥全球化步入更高階段。

ASTRIDE研究的牽頭主要研究者，加州大學(xué)戴維斯分校綜合癌癥中心（UCDCCC）名譽(yù)教授兼實(shí)驗(yàn)治療中心聯(lián)合主任David R. Gandara醫(yī)學(xué)博士表示

非常高興看到斯魯利單抗橋接研究順利完成全部入組。這項(xiàng)研究的完成，也讓我們離為美國(guó)廣泛期小細(xì)胞肺癌患者提供全新的治療選擇更近一步。

復(fù)宏漢霖全球產(chǎn)品開發(fā)部副總裁李靖表示

ASTRIDE研究全部患者入組的完成，不僅代表H藥在美國(guó)臨床運(yùn)營(yíng)上取得重要里程碑，也標(biāo)志著復(fù)宏漢霖在美國(guó)本土產(chǎn)品開發(fā)體系的全面落地，為未來更多創(chuàng)新管線的國(guó)際多中心研究奠定了堅(jiān)實(shí)基礎(chǔ)。

復(fù)宏漢霖美國(guó)首席醫(yī)學(xué)官Ely Benaim博士表示

ASTRIDE研究由復(fù)宏漢霖美國(guó)團(tuán)隊(duì)獨(dú)立執(zhí)行，充分體現(xiàn)了我們對(duì)美國(guó)臨床體系的深度融入。我們將繼續(xù)與研究者保持緊密合作，推進(jìn)H藥在美注冊(cè)申報(bào)進(jìn)程，盡早為更多患者帶來這一具有突破性的創(chuàng)新療法。

此前，復(fù)宏漢霖已針對(duì)H藥用于一線治療ES-SCLC開展一項(xiàng)隨機(jī)、雙盲、安慰劑對(duì)照的國(guó)際多中心III期臨床研究（ASTRUM-005）。該研究結(jié)果于2022年美國(guó)臨床腫瘤學(xué)會(huì)（ASCO）年會(huì)以口頭報(bào)告方式首次發(fā)布，并于全球四大頂級(jí)醫(yī)學(xué)期刊之一的《美國(guó)醫(yī)學(xué)會(huì)雜志》（JAMA）在線發(fā)表，成為全球首個(gè)登上JAMA主刊的小細(xì)胞肺癌免疫治療臨床研究。2025年美國(guó)臨床腫瘤學(xué)會(huì)（ASCO）年會(huì)上，ASTRUM-005研究公布研究結(jié)束分析結(jié)果，截至2024年12月31日（中位隨訪時(shí)間42.4個(gè)月），斯魯利單抗組的4年總生存期（OS）率達(dá)21.9%，對(duì)照組為7.2%，且安全性可控，進(jìn)一步夯實(shí)了H藥能為ES-SCLC患者帶來顯著的長(zhǎng)期生存獲益。

基于ASTRUM-005研究的優(yōu)異結(jié)果，H藥獲得了美國(guó)FDA與歐洲歐盟委員會(huì)（EC）的孤兒藥資格認(rèn)定（ODD），并已陸續(xù)在中國(guó)、英國(guó)、德國(guó)、新加坡、印度等近40個(gè)國(guó)家和地區(qū)獲批上市用于一線治療ES-SCLC。此外，H藥在小細(xì)胞肺癌領(lǐng)域的臨床數(shù)據(jù)被納入歐洲腫瘤內(nèi)科學(xué)會(huì)（ESMO）臨床獲益評(píng)估體系（MCBS），評(píng)分優(yōu)于同類產(chǎn)品，并多次在ESMO和世界肺癌大會(huì)（WCLC）等國(guó)際學(xué)術(shù)會(huì)議上作口頭報(bào)告和專題討論。復(fù)宏漢霖在全球范圍內(nèi)積極推進(jìn)H藥的獲批上市進(jìn)程。在小細(xì)胞肺癌領(lǐng)域，公司也在開展一項(xiàng)H藥聯(lián)合化療同步放療用于治療局限期小細(xì)胞肺癌（LS-SCLC）患者的國(guó)際多中心III期臨床研究（ASTRUM-020），該研究已于2025年1月完成所有受試者入組。

作為首批在美國(guó)境內(nèi)獨(dú)立開展創(chuàng)新型腫瘤免疫治療研究的中國(guó)藥企之一，復(fù)宏漢霖始終以科學(xué)證據(jù)為核心，通過符合國(guó)際標(biāo)準(zhǔn)的臨床實(shí)踐與本土化開發(fā)，推動(dòng)精準(zhǔn)治療策略的落地，為全球患者提供更加可負(fù)擔(dān)、可及且貼合臨床需求的創(chuàng)新治療選擇。

關(guān)于H藥 漢斯?fàn)?reg;

H藥 漢斯?fàn)?reg;為重組人源化抗PD-1單抗注射液（通用名：斯魯利單抗注射液，歐洲商品名：Hetronifly®），是全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗，目前已在中國(guó)、英國(guó)、德國(guó)、新加坡、印度等近40個(gè)國(guó)家和地區(qū)獲批上市。

2022年3月，H藥正式在中國(guó)獲批上市，目前可用于治療鱗狀非小細(xì)胞肺癌（sqNSCLC）、廣泛期小細(xì)胞肺癌（ES-SCLC）、食管鱗狀細(xì)胞癌（ESCC）及非鱗狀非小細(xì)胞肺癌（nsqNSCLC）。聚焦肺癌和消化道腫瘤，復(fù)宏漢霖積極推進(jìn)H藥與公司其他產(chǎn)品的協(xié)同以及與創(chuàng)新療法的聯(lián)合，相繼獲得中國(guó)、美國(guó)、歐盟等國(guó)家及地區(qū)的臨床試驗(yàn)許可，在全球同步開展10余項(xiàng)腫瘤免疫聯(lián)合療法臨床試驗(yàn)。截至目前，H藥已于中國(guó)、美國(guó)、土耳其、波蘭、格魯吉亞等國(guó)家和地區(qū)累計(jì)入組超5, 000人，其中2項(xiàng)國(guó)際多中心臨床試驗(yàn)入組白人的比例超過30%，是擁有國(guó)際臨床數(shù)據(jù)較多的抗PD-1單抗之一。H藥的3項(xiàng)關(guān)鍵性臨床研究結(jié)果分別發(fā)表于知名期刊《美國(guó)醫(yī)學(xué)會(huì)雜志》（JAMA）、《自然-醫(yī)學(xué)》（Nature Medicine）和British Journal of Cancer。此外，H藥還榮獲《CSCO 小細(xì)胞肺癌診療指南》、《CSCO 非小細(xì)胞肺癌診療指南》、《CSCO 食管癌診療指南》、《CSCO 結(jié)直腸癌診療指南》、《CSCO 免疫檢查點(diǎn)抑制劑臨床應(yīng)用指南》和《中國(guó)食管癌放射治療指南》等多部權(quán)威指南推薦，為腫瘤臨床診療提供重要參考。海外方面，H藥治療SCLC也已獲得美國(guó)FDA和歐盟EC的孤兒藥資格認(rèn)定，并于2025年6月在日本啟動(dòng)了一項(xiàng)橋接研究，旨在評(píng)估該產(chǎn)品聯(lián)合化療一線治療ES-SCLC在日本患者中的療效及安全性。

關(guān)于復(fù)宏漢霖

復(fù)宏漢霖（2696.HK）是一家國(guó)際化的創(chuàng)新生物制藥公司，致力于為全球患者提供可負(fù)擔(dān)的高品質(zhì)生物藥，產(chǎn)品覆蓋腫瘤、自身免疫疾病、眼科疾病等領(lǐng)域，已在全球獲批上市9款產(chǎn)品，4個(gè)上市申請(qǐng)分別獲中國(guó)藥監(jiān)局、美國(guó)FDA和歐盟EMA受理。自2010年成立以來，復(fù)宏漢霖已建成一體化生物制藥平臺(tái)，高效及創(chuàng)新的自主核心能力貫穿研發(fā)、生產(chǎn)及商業(yè)運(yùn)營(yíng)全產(chǎn)業(yè)鏈。公司已建立完善高效的全球創(chuàng)新中心，按照國(guó)際藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）標(biāo)準(zhǔn)進(jìn)行生產(chǎn)和質(zhì)量管控，不斷夯實(shí)一體化綜合生產(chǎn)平臺(tái)，其中，公司商業(yè)化生產(chǎn)基地已相繼獲得中國(guó)、歐盟和美國(guó)GMP認(rèn)證。

復(fù)宏漢霖前瞻性布局了一個(gè)多元化、高質(zhì)量的產(chǎn)品管線，涵蓋約50個(gè)分子，并全面推進(jìn)基于自有抗PD-1單抗H藥漢斯?fàn)?reg;的腫瘤免疫聯(lián)合療法。截至目前，公司已獲批上市產(chǎn)品包括全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗?jié)h斯?fàn)?reg;（斯魯利單抗，歐洲商品名：Hetronifly®）、自主研發(fā)的中美歐三地獲批單抗生物類似藥漢曲優(yōu)®（曲妥珠單抗，美國(guó)商品名：HERCESSI™，歐洲商品名：Zercepac®）、國(guó)內(nèi)首個(gè)生物類似藥漢利康®（利妥昔單抗）、以及地舒單抗生物類似藥Bildyos®和Bilprevda®。公司亦同步就19個(gè)產(chǎn)品在全球范圍內(nèi)開展30多項(xiàng)臨床試驗(yàn)，對(duì)外授權(quán)全面覆蓋歐美主流生物藥市場(chǎng)和眾多新興市場(chǎng)。

Henlius Completes Patient Enrolment in the U.S. Bridging Study of Serplulimab in Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Shanghai, China, October 22, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its independently developed innovative anti-PD-1 mAb serplulimab (trade name in Europe: Hetronifly®) has successfully completed enrolment of all 200 patients in the U.S. bridging clinical study (ASTRIDE) comparing serplulimab plus chemotherapy with atezolizumab plus chemotherapy in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC). This milestone paves the way for Henlius to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).

The ASTRIDE study is a randomized, controlled, open-label clinical trial designed to evaluate the efficacy and safety of serplulimab plus chemotherapy versus atezolizumab plus chemotherapy in U.S. patients with ES-SCLC. The results will serve as key clinical evidence supporting the registration of serplulimab in the U.S. market. The study is fully managed and executed by Henlius’ U.S. clinical and regulatory affairs teams across more than 100 oncology centres, representing one of the largest ES-SCLC clinical trials ever conducted in the U.S. with locally enrolled patients. Serplulimab is the only anti-PD-1 mAb currently conducting a bridging trial in the U.S. Its steady progress underscores Henlius’s global leadership in clinical design, execution, and regulatory engagement.

David R. Gandara, M.D., the principal leading investigator of the ASTRIDE study, Professor Emeritus and Co-Director of the Experimental Therapeutics Program at UC Davis Comprehensive Cancer Centre (UCDCCC), said: “I’m so pleased to see this bridging study of serplulimab complete accrual. I anticipate that this trial will add a new therapeutic option for our patients with extensive stage small cell lung cancer.”

Jing Li, Vice President of Global Product Development at Henlius, said: ”The completion of patient recruitment in the ASTRIDE study not only marks a major milestone in the U.S. clinical operation of serplulimab, but also signifies the full establishment of Henlius’ local product development in the U.S., laying a solid foundation for future global multicentre studies of the company’s innovative pipeline.”

Dr. Ely Benaim, U.S. Chief Medical Officer at Henlius, said: ”Our U.S. team’s independent execution of the ASTRIDE study reflects our deep integration into the U.S. clinical ecosystem. We are committed to maintaining close collaboration with our investigator network to advance serplulimab’s registration process and bring this promising therapy to patients in need.”

Henlius previously conducted a randomized, double-blind, placebo-controlled, international Phase 3 study (ASTRUM-005) to evaluate serplulimab for first-line treatment of ES-SCLC. The results were first presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in The Journal of the American Medical Association (JAMA)—marking the first small-cell lung cancer immunotherapy study ever featured in JAMA’s main edition. At the 2025 ASCO Annual Meeting, the final analysis of ASTRUM-005 was released: as of December 31, 2024 (median follow-up 42.4 months), the four-year overall survival (OS) rate was 21.9% in the serplulimab group versus 7.2% in the control group, with a manageable safety profile—further validating its durable survival benefit for patients with ES-SCLC.

Building on these positive results, serplulimab has been granted Orphan Drug Designation (ODD) by both the U.S. FDA and the European Commission (EC) for the treatment of SCLC and has been approved for first-line treatment of ES-SCLC in nearly 40 countries and regions including China, the U.K., Germany, Singapore and India. Serplulimab’s clinical data in SCLC have been included in the ESMO Magnitude of Clinical Benefit Scale (MCBS), ranking higher than peer products, and have been featured in oral and panel sessions at leading international congresses such as ESMO and the World Conference on Lung Cancer (WCLC). Henlius continues to advance its global regulatory and clinical program for serplulimab. In addition to the ES-SCLC program, the company is conducting an international multicentre Phase 3 trial (ASTRUM-020) evaluating serplulimab with concurrent chemoradiotherapy (cCRT), in patients with limited-stage small cell lung cancer (LS-SCLC), which completed full patient enrolment in January 2025.

As one of the first Chinese biopharmaceutical companies to independently conduct innovative immuno-oncology studies in the U.S., Henlius remains committed to a science-driven approach, advancing precision treatment strategies through internationally compliant clinical practices and localized development to deliver affordable, accessible, and patient-centred therapeutic innovations to patients worldwide.

About Serplulimab

Serplulimab is a recombinant humanized anti-PD-1 mAb injection (trade name in Europe: Hetronifly®). It is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and has been approved for marketing in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India.

In March 2022, serplulimab was officially approved for marketing in China and is currently indicated for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC).

Focusing on lung and gastrointestinal cancers, Henlius has been actively advancing the synergistic development of serplulimab with other in-house products and its combination with novel therapies. The product has received clinical trial authorizations in multiple countries and regions including China, the U.S., and the EU, and is being evaluated in over ten global, multicentre clinical trials on immuno-oncology combination therapies. To date, more than 5,000 patients have been enrolled in clinical studies of serplulimab across China, the U.S., Turkey, Poland, Georgia, and other countries, with over 30% of patients enrolled in two pivotal international studies being Caucasian, making it one of the anti-PD-1 mAbs with the most extensive international clinical data. Three pivotal clinical studies of serplulimab have been published in leading journals including The Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer. In addition, serplulimab has been included in several authoritative clinical guidelines, such as the CSCO Guidelines for SCLC, NSCLC, ESCC, Colorectal Cancer, Clinical Application of Immune Checkpoint Inhibitors, and Chinese Guidelines for Radiotherapy in Esophageal Cancer, providing important references for oncology clinical practice. Internationally, serplulimab for the treatment of SCLC has been granted Orphan Drug Designation (ODD) by both the U.S. FDA and the European Commission (EC). Furthermore, in June 2025, Henlius initiated a bridging study in Japan to evaluate the efficacy and safety of serplulimab plus chemotherapy as first-line treatment for ES-SCLC in Japanese 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. 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.