全球開發(fā)提速：HLX43針對(duì)NSCLC的國(guó)際多中心II期臨床在中歐美日澳等地啟動(dòng)，加速產(chǎn)品全球開發(fā)進(jìn)程
NSCLC全人群覆蓋：HLX43在鱗狀/非鱗狀、有無(wú)EGFR突變、有無(wú)腦/肝轉(zhuǎn)移、PD-L1陽(yáng)性/陰性的NSCLC患者中都展現(xiàn)療效，且安全性良好
“高效低毒”持續(xù)驗(yàn)證：HLX43針對(duì)NSCLC更新數(shù)據(jù)即將以口頭報(bào)告形式亮相2026ASCO，持續(xù)驗(yàn)證“高效低毒”特質(zhì)，提示其多線治療潛力
2026年5月21日，復(fù)星醫(yī)藥（HK2196）子公司復(fù)宏漢霖（HK2696）宣布，公司創(chuàng)新型程序性死亡-配體1(PD-L1)抗體偶聯(lián)藥物(ADC)注射用HLX43在晚期非小細(xì)胞肺癌(NSCLC)患者中開展的國(guó)際多中心II期臨床研究(HLX43-NSCLC201)已于西班牙完成歐盟首例受試者給藥。HLX43-NSCLC201研究目前已在中國(guó)、歐盟、美國(guó)、日本、澳大利亞等地全面啟動(dòng)并，標(biāo)志著這一全球首創(chuàng)PD-L1ADC的臨床開發(fā)實(shí)現(xiàn)全球主要市場(chǎng)的全面覆蓋。憑借在全人群中展現(xiàn)出的廣泛療效與良好的安全性特征，HLX43針對(duì)NSCLC的最新研究結(jié)果亦將于近期以口頭報(bào)告的形式重磅亮相2026年美國(guó)臨床腫瘤學(xué)會(huì)(ASCO)年會(huì)。
據(jù)GLOBOCAN最新數(shù)據(jù)顯示，肺癌是全球發(fā)病率和死亡率最高的癌癥，2022年全球約有超過248萬(wàn)新發(fā)肺癌病例，占所有癌癥新發(fā)病例的12.4%1。大部分肺癌患者確診時(shí)已處于疾病晚期階段2，存在巨大的尚未滿足的臨床需求。非小細(xì)胞肺癌(NSCLC)是最常見的肺癌類型(約85%)，主要包括鱗狀細(xì)胞癌(約30%)和肺腺癌(約50%)等。在全部NSCLC患者中，EGFR野生型占比高達(dá)70%-85%，涵蓋幾乎所有的鱗癌患者和半數(shù)以上的肺腺癌患者(50-55%)3。當(dāng)前療效優(yōu)異的產(chǎn)品仍較少，特別在接受過標(biāo)準(zhǔn)治療的后線人群治療上，現(xiàn)行臨床實(shí)踐仍高度依賴以多西他賽為基礎(chǔ)的化療方案，且臨床獲益有限4,5。
HLX43是一款靶向程序性死亡-配體1(PD-L1)的廣譜抗腫瘤ADC，由全人源IGG（HK0799）1抗PD-L1抗體與創(chuàng)新連接子-拓?fù)洚悩?gòu)酶抑制劑荷載偶聯(lián)而成，藥物抗體比(drug-to-antibody ratio,DAR)約為8。HLX43兼具毒素精準(zhǔn)殺傷(ADC)和腫瘤免疫治療(IO)的復(fù)合功能：其毒素不僅能夠藉靶點(diǎn)內(nèi)吞進(jìn)入腫瘤細(xì)胞后進(jìn)行釋放，并在腫瘤微環(huán)境中釋放后借助旁觀者效應(yīng)進(jìn)入腫瘤細(xì)胞，阻斷DNA復(fù)制，從而導(dǎo)致腫瘤細(xì)胞凋亡；此外，HLX43的PD-L1靶向抗體可激活免疫調(diào)節(jié)機(jī)制，發(fā)揮協(xié)同抗腫瘤效應(yīng)。在2025美國(guó)臨床腫瘤學(xué)會(huì)(ASCO)年會(huì)上，HLX43的I期臨床數(shù)據(jù)首次發(fā)布，展現(xiàn)出令人鼓舞的初步療效和安全性，對(duì)鱗狀/非鱗狀非小細(xì)胞肺癌(NSCLC)，有無(wú)EGFR突變、有無(wú)腦/肝轉(zhuǎn)移、PD-L1陽(yáng)性/陰性的NSCLC患者都展現(xiàn)了優(yōu)異的治療潛力，且安全性良好。2025年11月，HLX43肺癌領(lǐng)域的關(guān)鍵數(shù)據(jù)更新發(fā)布，并整合了HLX43-NSCLC201臨床研究的初步結(jié)果。此次分析明確了2.0mg/kg或2.5mg/kg作為HLX43用于治療NSCLC的II/III期推薦劑量(RP2/3D)，并持續(xù)印證了HLX43在對(duì)應(yīng)劑量下的療效和安全性。
復(fù)宏漢霖（HK2696）正全力推進(jìn)HLX43臨床開發(fā)進(jìn)程，其用于晚期鱗狀非小細(xì)胞肺癌的II/III期國(guó)際多中心臨床研究(HLX43-NSCLC302)將于中國(guó)、美國(guó)、日本等多國(guó)開展，其III期研究階段有望成為HLX43首個(gè)、同時(shí)也是其在非小細(xì)胞肺癌領(lǐng)域的關(guān)鍵注冊(cè)臨床研究，為既往標(biāo)準(zhǔn)治療失敗后的sqNSCLC患者這一難治群體帶來新的治療選擇。除NSCLC外，公司積極探索其在多種實(shí)體瘤中的治療潛力，包括食管鱗癌、宮頸癌、乳腺癌、胃癌/胃食管交界部(G/GEJ)癌、頭頸鱗癌等。單藥之外，HLX43聯(lián)用其他產(chǎn)品的臨床試驗(yàn)也正在進(jìn)行中，進(jìn)一步探索ADC與其他療法的協(xié)同抗腫瘤療效。HLX43不僅展現(xiàn)出克服PD-1/L1免疫療法不響應(yīng)或耐藥問題的臨床潛力，并對(duì)化療、TKI治療失敗的患者都具有潛在療效，有望為更多晚期/轉(zhuǎn)移性實(shí)體瘤患者帶來新的治療選擇。
關(guān)于HLX43-NSCLC201
本研究為一項(xiàng)評(píng)估HLX43在晚期非小細(xì)胞肺癌(NSCLC)患者的開放、國(guó)際多中心II期臨床試驗(yàn)，旨在評(píng)估HLX43在晚期非小細(xì)胞肺癌(NSCLC)患者中的有效性和安全性。研究分為兩個(gè)階段：第一階段將進(jìn)行劑量探索，以選擇合適的HLX43劑量進(jìn)行第二階段研究；第二階段為單臂、多中心II期臨床研究。本研究的主要研究目的為評(píng)估HLX43在晚期非小細(xì)胞肺癌(NSCLC)中的臨床療效；主要研究終點(diǎn)為由盲態(tài)獨(dú)立中心審查委員會(huì)(BICR)根據(jù)RECIST v1.1標(biāo)準(zhǔn)評(píng)估的客觀緩解率。
關(guān)于復(fù)宏漢霖
復(fù)宏漢霖（HK2696）(2696.HK)是一家國(guó)際化創(chuàng)新生物制藥企業(yè)，致力于為全球患者提供高品質(zhì)、可負(fù)擔(dān)的生物藥，產(chǎn)品覆蓋腫瘤、自身免疫疾病、眼科疾病等領(lǐng)域。自2010年成立以來，公司已構(gòu)建涵蓋全球研發(fā)、臨床、注冊(cè)、生產(chǎn)及商業(yè)化的全產(chǎn)業(yè)鏈平臺(tái)，擁有全球員工近4,000人，并在中國(guó)、美國(guó)和日本等多地設(shè)有運(yùn)營(yíng)及分支機(jī)構(gòu)。依托生物類似藥形成的穩(wěn)健現(xiàn)金流反哺創(chuàng)新研發(fā)，復(fù)宏漢霖（HK2696）正穩(wěn)步邁入“全球化2.0”階段，持續(xù)打造可復(fù)制、可持續(xù)的全球增長(zhǎng)模式。截至2026年初，公司共有10款產(chǎn)品在全球60余個(gè)國(guó)家和地區(qū)獲批上市，其中7款已在中國(guó)獲批。在歐美主流生物藥市場(chǎng)，復(fù)宏漢霖（HK2696）亦取得多項(xiàng)里程碑式突破，已有4款產(chǎn)品獲得美國(guó)FDA批準(zhǔn)、5款產(chǎn)品獲得歐盟EC批準(zhǔn)，充分體現(xiàn)了公司在研發(fā)體系、質(zhì)量管理及生產(chǎn)能力方面已全面對(duì)標(biāo)國(guó)際最高標(biāo)準(zhǔn)。
在創(chuàng)新驅(qū)動(dòng)方面，復(fù)宏漢霖（HK2696）依托上海、美國(guó)等多地協(xié)同布局的研發(fā)體系，構(gòu)建了多元化、平臺(tái)化的創(chuàng)新技術(shù)矩陣，覆蓋免疫檢查點(diǎn)抑制劑、免疫細(xì)胞銜接器(包括多特異性TCE)、抗體偶聯(lián)藥物(ADC)以及AI驅(qū)動(dòng)的早期研發(fā)平臺(tái)等前沿方向。目前，公司擁有50余項(xiàng)處于早期階段的創(chuàng)新資產(chǎn)，其中約70%具備同類最佳(Best-in-Class)潛力，并在全球同步推進(jìn)30余項(xiàng)臨床研究。核心產(chǎn)品H藥漢斯?fàn)?斯魯利單抗，歐洲商品名：Hetronifly)作為全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗，正加速全球布局，已在全球40余個(gè)市場(chǎng)獲批上市；同時(shí)，多款潛力創(chuàng)新資產(chǎn)，包括PD-L1ADC HLX43及新表位HER2單抗HLX22正全面推進(jìn)全球關(guān)鍵性臨床研究。依托通過中、歐、美三地GMP認(rèn)證的生產(chǎn)體系，復(fù)宏漢霖（HK2696）已建成總產(chǎn)能達(dá)84,000升的生物藥生產(chǎn)平臺(tái)，形成覆蓋全球六大洲的穩(wěn)定供應(yīng)網(wǎng)絡(luò)。未來，復(fù)宏漢霖（HK2696）將始終堅(jiān)持以患者為中心，聚焦未滿足的臨床需求，持續(xù)推動(dòng)創(chuàng)新成果向臨床價(jià)值與患者可及轉(zhuǎn)化，在全球生物醫(yī)藥創(chuàng)新生態(tài)中創(chuàng)造長(zhǎng)期而穩(wěn)健的價(jià)值。
Global Development Accelerates Further:Henlius’PD-L1ADC HLX43Completes First（FFBC） Patient Dosing in EU for Phase2MRCT
Global Development Accelerated:Phase2MRCT for HLX43in NSCLC fully initiated across China,the U.S.,Australia and Japan
Broad Efficacy in NSCLC:HLX43demonstrates broad efficacy in NSCLC patients,regardless of histology(squamous or non-squamous),EGFR mutation status,presence of brain/liver metastases,or PD-L1expression,with a favorable safety profile
Continued Validation of High Efficacy and Low Toxicity:Updated clinical data for HLX43in NSCLC will be featured in an upcoming oral presentation at the2026ASCO Annual Meeting,further validating its exceptional efficacy,favorable tolerability,and immense potential across multiple lines of therapy.
Shanghai,China,May21,2026—Shanghai Henlius Biotech,Inc.(2696.HK)today announced that the First（FFBC） patient in the European Union(EU)has been successfully dosed in Spain in the International（IGIC） multi-center Phase2clinical trial(HLX43-NSCLC201)evaluating HLX43,an Innovative（IIPR） programmed death-Ligand（LGND）1(PD-L1)targeting antibody-drug conjugate(ADC),for the treatment of advanced non-small cell lung cancer(NSCLC).The HLX43-NSCLC201study has now been fully initiated across China,the EU,the United States,Japan,and Australia,marking comprehensive coverage of major global markets for the clinical development of this First（FFBC）-in-class PD-L1ADC.Building on its broad efficacy and favorable safety profile across diverse patient populations,the latest research results of HLX43in NSCLC are also scheduled for a highly anticipated oral presentation at the2026ASCO Annual Meeting.
Lung cancer is the most common cancer worldwide in terms of incidence and mortality.According to GLOBOCAN2022,there were over2.48million new cases of lung cancer globally in2022,accounting for12.4%of all new cancer cases.1The majority of lung cancer patients are diagnosed at advanced stages,2indicating a significant unmet clinical need.Non-small cell lung cancer(NSCLC)is the most common type of lung cancer(approximately85%).By histology,NSCLC can be classified into squamous cell carcinoma(approximately30%),adenocarcinoma(approximately50%)and other subtypes including large cell carcinoma.EGFR wild-type cases account for70%-85%of all NSCLC patients,including nearly all squamous cell carcinoma cases and50-55%of adenocarcinoma cases.3Currently,the treatment landscape of EGFR wild-type NSCLC remains limited by a scarcity of highly effective options,particularly in second-line and later(2L+)therapy,where docetaxel-based chemotherapy continues to serve as the standard of care despite its suboptimal efficacy.4,5
HLX43is a broad-spectrum anti-tumor ADC candidate targeting PD-L1,composed of a fully humanized anti-PD-L1IGG（HK0799）1antibody,a novel tripeptide linker and topoisomerase inhibitor payload.The drug-to-antibody ratio(DAR)is around8.Its mechanisms of action integrate targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1blockade.Upon bonding to tumor cells with PD-L1expression,the cytotoxic payload of HLX43will be delivered into tumor cells via dual mechanisms.HLX43will undergo receptor-mediated endocytosis,releasing the cytotoxic payload intracellularly via linker cleavage,and the payload further diffuses into neighboring tumor cells via bystander effect,thereby blocking DNA replication and trIGG（HK0799）ering tumor cell apoptosis.Meanwhile,the anti-PD-L1antibody of HLX43activates immune modulation and blocks immune checkpoints,driving synergistic anti-tumor efficacy.The results from the phase1clinical trial of HLX43has been First（FFBC） released at the2025ASCO Annual Meeting,demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC,including squamous and non-squamous NSCLC patients(sqNSCLC and nsqNSCLC),patients with or without EGFR mutation,patients with or without brain/liver metastasis,and PD-L1positive or negative patients.In November2025,updated data in lung cancer—integrating preliminary results from the HLX43-NSCLC201study—were released.This analysis established2.0mg/kg or2.5mg/kg as the recommended Phase2/3dose(RP2/3D)for HLX43in NSCLC,consistently validating the drug's efficacy and safety at these dose levels.
Henlius is vigorously advancing the clinical development of HLX43.An International（IGIC） multi-center Phase2/3study(HLX43-NSCLC302)for advanced squamous NSCLC(sqNSCLC)is slated to launch across multiple countries,including China,the US,and Japan.The Phase3portion of this study is poised to become the First（FFBC） pivotal registrational trial for HLX43in NSCLC,potentially offering a novel therapeutic option for the hard-to-treat population of sqNSCLC patients who have failed prior standard therapies.Beyond NSCLC,the company is actively exploring the potential of HLX43across various solid tumors,including esophageal squamous cell carcinoma(ESCC),cervical cancer,breast cancer,gastric/gastroesophageal junction(G/GEJ)cancer,and head and neck squamous cell carcinoma(HNSCC).In addition to monotherapy,clinical trials investigating HLX43in combination with other agents are ongoing to further explore the synergistic anti-tumor efficacy of ADCs with complementary therapies.HLX43demonstrates the clinical potential to overcome primary or acquired resistance to PD-1/L1immunotherapies and offers potential efficacy for patients who have failed chemotherapy or TKI treatments,bringing hope for a new generation of treatments to patients with advanced or metastatic solid tumors.
About HLX43-NSCLC201
This is an open-label,multi-centre,International（IGIC） phase2clinical study to evaluate HLX43in patients with advanced non-small cell lung cancer(NSCLC).This study aims to evaluate the efficacy and safety of HLX43in advanced non-small cell lung cancer(NSCLC)patients.It consists of two parts:Part1,which focuses on dose exploration to identify the optimal HLX43dosage for Part2;and Part2,which is a single-arm,multi-centre phase2clinical trial.The primary objective of this study is to evaluate the clinical efficacy of HLX43in advanced non-small cell lung cancer(NSCLC)patients.The primary endpoint of the study is objective response rate evaluated by the Blinded Independent Central Review(BICR)according to RECIST v1.1.
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 in2010,Henlius has established an integrated,end-to-end biopharmaceutical platform encompassing global R&D,clinical operations,regulatory affairs,manufacturing,and commercialisation.The Company employs nearly4,000people 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“Globalisation2.0”phase,building a scalable and sustainable global growth model.As of early2026,Henlius has achieved regulatory approvals for10products across over60countries 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 five 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（DHC）,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 than50early-stage Innovative（IIPR） assets,approximately70%of which are expected to be best-in-class,with over30clinical trials ongoing globally.Henlius’core product,serplulimab(trade name:Hetronifly in Europe),is the world’s First（FFBC） anti–PD-1mAb approved for First（FFBC）-line treatment of small cell lung cancer and has been approved in more than40markets worldwide with an accelerated globalisation process.In parallel,multiple high-potential Innovative（IIPR） assets—including the PD-L1ADC HLX43and the novel epitope anti-HER2mAb HLX22—are advancing through global pivotal clinical development.Supported by a biologics manufacturing network with a total capacity of84,000L 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/.
