HLX-43

2026年2月27日，上海――复宏汉霖(2696.HK)宣布，其新表位HER2单克隆抗体HLX22，联合创新抗HER2抗体偶联药物(ADC)HLX87，用于一线治疗HER2阳性乳腺癌的II/III期临床研究(HLX87-BC001)已在中国完成首例患者给药。这一进展意味着HLX22在乳腺癌治疗领域的临床探索进一步扩大，未来有望惠及更多类型的乳腺癌患者。 过去二十年来，HER2靶向治疗虽显著改善了乳腺癌患者的临床结局1，但HER2阳性转移性乳腺癌(mBC)患者最终仍会因耐药而出现疾病进展。目前，一线标准方案为HER2靶向治疗联合化疗，但整体安全性仍有进一步提升的空间2,3。因此，临床对更高效、更安全、“免化疗”的新型HER2治疗策略的需求日益迫切。HLX22为靶向HER2的新表位单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，能通过与曲妥珠单抗“非重叠表位协同结合”，放大HER2内吞和降解作用。HLX22联合德曲妥珠单抗的动物实验结果以及同类临床研究的数据显示，HER2单抗联合HER2ADC的治疗策略具有协同抗肿瘤作用，且整体安全性良好。 基于以上背景，复宏汉霖进一步探索HLX22与HER2ADC联合治疗乳腺癌的方案，旨在为患者提供协同作用更强、毒性更可控的新治疗选择。复宏汉霖于2025年启动一项HLX22联合标准治疗或德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的II期临床研究(HLX22-BC201)，目前已于中国境内完成全部患者入组。 复宏汉霖深耕乳腺癌治疗领域，通过自主研发与合作引进，已建立覆盖乳腺癌全程全域治疗管线。公司乳腺癌核心产品曲妥珠单抗汉曲优(美国商品名：HERCESSI，欧洲商品名：Zercepac)已在全球50多个国家和地区获批上市；HER2阳性早期强化辅助治疗药物汉奈佳(奈拉替尼)与汉曲优续贯协同，降低复发风险；帕妥珠单抗POHERDY为美国首款且唯一的PERJETA生物类似药，并同步推进中国、欧洲与加拿大的上市申请，有望与汉曲优联用实现双靶协同增效；创新CDK4/6抑制剂复妥宁已在中国获批用于晚期HR+/HER2-乳腺癌的一线和二线治疗。同时，复宏汉霖加速布局新表位抗HER2单抗HLX22、新型内分泌疗法拉索昔芬片HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49、HER2ADC HLX87等多元类型高潜创新分子。未来，公司将持续强化管线协同，构建贯穿全病程的诊疗生态，为更多乳腺癌患者提供全面的解决方案。 关于HLX22 HLX22为靶向HER2的新表位单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得该产品能够与曲妥珠单抗同时结合至HER2，有效促进HER2二聚体(HER2同源二聚体及HER2/EGFR异源二聚体)的内吞和降解，将HER2的内吞效率提高了40%-80%，进而产生更强的HER2受体阻断效果。HLX22联合汉曲优(曲妥珠单抗，美国商品名：HERCESSI，欧洲商品名：Zercepac)治疗HER2阳性胃癌II期临床研究(HLX22-GC-201)更新结果于2025年美国临床肿瘤学会(ASCO)发布，数据显示经过长期随访(中位随访周期超2年)，HLX22在HER2阳性胃癌治疗中依然展现出稳定的疗效获益，远超历史数据4。在此基础上开展的HLX22-GC-301研究是一项头对头对比一线标准疗法(曲妥珠单抗+化疗±帕博利珠单抗)的国际多中心III期研究，旨在评估HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性转移性胃癌/胃食管结合部癌患者的疗效与安全性，研究不限PD-L1表达人群，致力于突破当前HER2阳性胃癌一线治疗的临床局限。HLX22于2025年先后获得美国食品药品监督管理局(FDA)与欧盟委员会(EC)授予的孤儿药资格认定(Orphan Drug Designation,ODD)，用于胃癌的治疗，标志着其成为全球首款同时获得欧盟和美国孤儿药资格认定的胃癌抗HER2靶向疗法，揭示了其在胃癌领域的巨大治疗潜力。目前，HLX22-GC-301研究已在中国、美国、日本、澳大利亚、阿根廷等多个国家和地区完成首例患者入组。除胃癌外，复宏汉霖2025年亦启动一项HLX22联合标准治疗或德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的II期临床研究(HLX22-BC201)，目前已于中国境内完成全部患者入组。 关于HLX87-BC001研究 该研究是一项评估HLX22联合HLX87一线治疗HER2阳性复发或转移性乳腺癌患者的开放、随机、多中心的II/III期临床研究。研究包括两个阶段，第一阶段是一项开放、多中心、随机、平行对照的II期临床研究，合格受试者将按照2:2:1:1的比例随机分配接受HLX22联合HLX87、帕妥珠单抗联合HLX87、帕妥珠单抗联合德曲妥珠单抗或帕妥珠单抗联合曲妥珠单抗及多西他赛治疗。第一阶段的主要目的是通过独立影像评估委员会(BICR)评估的客观缓解率(ORR)及无进展生存期(PFS)结果评价HLX22联合HLX87的临床疗效。第二阶段是一项开放、多中心、随机、平行对照的III期临床研究，合格受试者将按照1:1的比例随机分配接受HLX22联合HLX87或帕妥珠单抗联合曲妥珠单抗及多西他赛治疗。第二阶段的主要目的是通过BICR评估的PFS结果评价临床疗效，次要目的包括评估HLX22联合HLX87的安全性、耐受性、药代动力学(PK)特征及免疫原性，探索性目的为探索潜在的预测性或耐药性生物标志物。 复宏汉霖(2696.HK)是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EMA上市授权，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。 在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器(包括多特异性TCE)、抗体偶联药物(ADC)以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳(Best-in-Class)潜力，并在全球同步推进30余项临床研究。核心产品H药汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。 Henlius Doses First Patient in Phase2/3Trial of HLX22for First-Line Treatment of HER2-Positive Breast Cancer SHANGHAI,China�FEBUARY27,2026�Shanghai Henlius Biotech,Inc.(2696.HK)announced that the first patient has been dosed in China in a Phase2/3clinical trial(HLX87-BC001)evaluating its novel-epitope anti-HER2mAb HLX22in combination with the innovative anti-HER2antibody�drug conjugate(ADC)HLX87for the first-line treatment of HER2-positive breast cancer.This milestone marks a further expansion of HLX22’s clinical development in breast cancer and underscores its potential to benefit a broader range of patients in the future. Over the past two decades,HER2-targeted therapies have significantly improved patient outcomes.1However,patients with HER2-positive metastatic breast cancer(mBC)eventually develop resistance,leading to disease progression.While HER2-targeted therapy in combination with chemotherapy remains the current first-line standard of care,there is a clear unmet need to further improve the overall safety profile.2,3The clinical demand for more effective,safer,and chemotherapy-free HER2treatment strategies is therefore increasingly urgent.HLX22is a novel-epitope monoclonal antibody targeting HER2that binds to subdomain IV of the HER2extracellular region at a distinct epitope from trastuzumab.This allows HLX22to synergistically bind with trastuzumab at non-overlapping epitopes,enhancing HER2internalization and degradation.Animal studies of HLX22plus trastuzumab deruxtecan(T-DXd)and data from similar clinical combinations further suggest that combining a HER2monoclonal antibody with a HER2ADC may yield synergistic antitumour effects with manageable toxicity. Building on this background,Henlius is further exploring combination regimens of HLX22with HER2ADCs in breast cancer,with the aim of providing patients with new treatment options that offer enhanced synergistic activity and improved toxicity manageability.Henlius initiated a Phase2clinical trial in2025evaluating HLX22in combination with standard of care or T-DXd for patients with HER2-low,HR-positive locally advanced or metastatic breast cancer(HLX22-BC201),and the patient enrolment in China has been completed. Henlius has built a comprehensive pipeline covering the full continuum of breast cancer care through internal innovation and strategic collaborations.Its core product,HANQUYOU(trastuzumab,trade name:HERCESSI in the U.S.,Zercepac in Europe),has been approved in more than50countries and regions worldwide.HANNAIJIA(Neratinib Maleate)strengthens post-surgical risk reduction when used sequentially after HANQUYOU.POHERDY(pertuzumab),the first―and only―FDA-approved PERJETA biosimilar in the U.S.,is currently under review in China,the EU and Canada,and may be used in combination with HANQUYOU for dual HER2blockade.Henlius’innovative CDK4/6inhibitor FUTUONING(fovinaciclib citrate)has been approved in China for first-and second-line treatment of HR+/HER2-advanced breast cancer.Meanwhile,Henlius is accelerating development of multiple high-potential innovative assets,including novel-epitope HER2antibody HLX22,endocrine therapy candidate lasofoxifene HLX78,KAT6A/B inhibitor HLX97,LIV-1-targeting ADC HLX41,HER2×HER2biparatopic ADC HLX49,and HER2ADC HLX87.The company aims to strengthen its synergistic pipeline and build an end-to-end therapeutic ecosystem covering the entire disease course,bringing comprehensive solutions to breast cancer patients worldwide. About HLX22 HLX22is a novel-epitope monoclonal antibody targeting HER2.It binds to subdomain IV of the HER2extracellular region at an epitope distinct from that of trastuzumab,enabling simultaneous binding of HLX22and trastuzumab to the HER2receptor.This dual,non-overlapping epitope engagement effectively promotes the internalization and degradation of HER2dimers(including HER2homodimers and HER2/EGFR heterodimers),increasing HER2internalization efficiency by40%�80%and thereby achieving a more potent HER2receptor blockade.Updated results from the Phase2clinical trial of HLX22in combination with HANQUYOU(trastuzumab,trade name:HERCESSI in the U.S.,Zercepac in Europe)for HER2-positive gastric cancer(HLX22-GC-201)were presented at the American Society of Clinical Oncology(ASCO)2025Annual Meeting.The data showed that,after long-term follow-up(median follow-up exceeding two years),HLX22continued to deliver durable clinical benefits in HER2-positive gastric cancer,significantly outperforming historical benchmarks.4Based on the positive results of the Phase2trial,HLX22-GC-301is a randomized,head-to-head,international multicentre Phase3trial evaluating the efficacy and safety of HLX22plus trastuzumab and chemotherapy as first-line treatment with the current standard first-line regimen(trastuzumab plus chemotherapy±pembrolizumab)for patients with HER2-positive metastatic gastric cancer or gastroesophageal junction cancer.The trial includes patients regardless of PD-L1expression status and aims to address the limitations of current first-line treatment options for HER2-positive metastatic gastric and gastroesophageal junction cancer.In2025,HLX22was granted Orphan Drug Designation(ODD)by both the U.S.Food and Drug Administration(FDA)and the European Commission(EC)for the treatment of gastric cancer.This milestone marks HLX22as the world’s first anti-HER2targeted therapy for gastric cancer to receive Orphan Drug Designation in both the United States and the European Union,highlighting its significant therapeutic potential in this disease area.HLX22-GC-301has completed the dosing of the first patient across multiple countries and regions,including China,the United States,Japan,Australia,and Argentina.Beyond gastric cancer,Henlius also initiated a Phase2clinical trial in2025evaluating HLX22in combination with standard of care or T-DXd for patients with HER2-low,HR-positive locally advanced or metastatic breast cancer(HLX22-BC201),and the patient enrolment in China has been completed. About HLX87-BC001 The trial is an open-label,randomized,multicentre Phase2/3clinical trial designed to evaluate HLX22in combination with HLX87as first-line treatment for patients with HER2-positive recurrent or metastatic breast cancer.The trial consists of two stages. The first stage is an open-label,multicentre,randomized,parallel-controlled Phase2trial.Eligible patients will be randomized in a2:2:1:1ratio to receive one of the following treatment regimens:HLX22in combination with HLX87;pertuzumab in combination with HLX87;pertuzumab in combination with T-Dxd;or pertuzumab in combination with trastuzumab plus docetaxel.The primary objective of the first stage is to evaluate the clinical efficacy of HLX22in combination with HLX87,as assessed by objective response rate(ORR)and progression-free survival(PFS)determined by a blinded independent central review(BICR).The second stage is an open-label,multicentre,randomized,parallel-controlled Phase3study.Eligible patients will be randomized in a1:1ratio to receive either HLX22in combination with HLX87or pertuzumab in combination with trastuzumab plus docetaxel.The primary objective of the second stage is to evaluate clinical efficacy based on PFS assessed by BICR.Secondary objectives include the assessment of the safety,tolerability,pharmacokinetic(PK)profile,and immunogenicity of HLX22in combination with HLX87.Exploratory objectives include the identification of potential predictive or resistance biomarkers. 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 across60countries 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 authorized by the European Medicines Agency(EMA),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 than50early-stage innovative 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 anti�PD-1mAb approved for first-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 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. References Swain SM,Baselga J,Kim SB,Ro J,Semiglazov V,Campone M,et al.Pertuzumab,trastuzumab,and docetaxel in HER2-positive metastatic breast cancer.N Engl J Med2015;372(8):724-34. Loibl S,Gianni L.HER2-positive breast cancer.Lancet2017;389(10087):2415-29. Li H,Fu W,Gao X,Xu Q,Wu H,Tan W.Risk of severe diarrhea with dual anti-HER2therapies:a meta-analysis.Tumour Biol2014;35(5):4077-85. Jin Li et al.HLX22plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer(G/GEJC):Updated results with additional patients..JCO43,440-440(2025).DOI:10.1200/JCO.2025.43.4_suppl.440