Nivolumab

-01- 引言 抗体偶联药物（ADC）是一类新兴的生物制药，旨在利用抗体靶点特异性将细胞毒性载荷选择性递送至恶性细胞，从而最小化系统毒性。截至2025年12月，已有19种ADC获得全球监管机构批准，超过370种新型ADC已进入临床阶段。 皮下注射（SC）是一种快速、单次（推注）给药方式，通过短小规格的针头和注射器将药物注入真皮与肌肉之间的皮下组织层。对于抗体类治疗药物，SC给药已日益普及，约76%的高浓度（≥100 mg/ml）抗体产品通过SC途径递送，所有已获批抗体治疗药物中约34%（138种中的47种）采用SC给药。在肿瘤学领域，抗体历来通过IV途径给药；然而，近期制剂和递送技术的进步，特别是与透明质酸酶的共配方，已推动了向SC给药模式的转变。 与传统的IV输注相比，SC给药提供了更大的便利性和显著缩短的给药时间（例如，SC OPDIVO QVANTIG为3-5分钟，而IV OPDIVO为30分钟），在某些情况下可实现自我给药或在家中的护理人员辅助给药，并减轻医疗系统的负担。SC递送还扩展了不同护理环境中的治疗可及性，包括医生办公室和社区诊所。此外，SC注射允许治疗静脉通路不佳的患者，并在有血管耗竭风险的患者中保留静脉资源。从产品生命周期管理的角度来看，IV到SC的转变还可能提供延长市场独占权的机会。 -02- 一、经SC给药的ADC药代动力学与药效学 单克隆抗体SC给药的基本药代动力学特征 单克隆抗体已通过皮下途径给药数十载，然而SC递送mAb的PK/PD和生物利用度的许多方面仍未完全阐明。由于其大分子尺寸，直接吸收进入毛细血管的可能性不大，系统摄取主要通过淋巴系统发生，FcRn介导的转胞吞作用可能有助于进入循环。因此，SC生物利用度通常低于100%，已有报道的人体生物利用度数据中mAb的值约为43%至88%不等。生物利用度降低归因于注射部位的局部代谢、降解或沉淀，以及到达系统循环之前在淋巴转运过程中的吞噬等消除过程。SC注射后的吸收速率和程度受分子特性、制剂特征和注射部位生理学之间复杂的相互作用控制。重要的是，从临床前模型到人类的SC生物利用度转化仍然具有挑战性，因为种属间差异是主要促成因素。 ADC在SC给药中的复杂PK/PD特征 IV给药的ADC是否可以直接外推至SC给药的ADC，其PK/PD行为仍不确定，主要原因是专门研究SC ADC的PK/PD的研究匮乏。尽管ADC可能与SC给药的mAb具有大致相似的吸收、分布、代谢和消除机制，但其结构复杂性引入了额外的考量。与未偶联抗体相比，ADC是异质性分子，其特征是药物-抗体比（DAR）物种的分布和连接子-载荷组分的存在。给药后，它们以多种循环分析物形式存在，包括总抗体（偶联加未偶联）、总ADC、总药物、游离药物和未偶联抗体，每种分析物对整体PK/PD行为的贡献各不相同。 -03- 二、Sc给药ADC的新兴临床证据 迄今为止，已有12种ADC进入SC途径的临床前或I/II期临床评估。其中，八个项目仍处于活跃状态，四个已在临床开发期间终止或撤回。12种ADC中，10种为肿瘤学适应症，两种为非肿瘤学适应症开发。实现ADC SC给药的策略大致可分为四类：（i）ADC的理性分子设计，包括定点偶联、增强的连接子稳定性和降低的疏水性，以改善局部耐受性、系统生物利用度和高浓度液体制剂的可开发性；（ii）与透明质酸酶共配方，以增强SC分散和吸收并增加注射体积；（iii）基于聚合物的递送策略；（iv）将研究性或已获批的传统ADC从IV转为SC给药。 理性分子设计策略 JSKN033是首个全球报道的ADC与抗体SC高浓度液体共配方，包含JSKN003和恩沃利单抗（envafolimab），采用理性分子设计策略开发。每1 ml JSKN033小瓶含有80 mg JSKN003和100 mg恩沃利单抗。JSKN033在液体制剂中的稳定性主要归因于其组分（JSKN003和恩沃利单抗）固有的优异溶解度和稳定性，以及ADC组分使用定点偶联技术。 JSKN033适合SC给药由几个互补因素驱动。首先，JSKN033是一种共配方，包含恩沃利单抗，一种单域抗体，是全球首个获批的SC PD-L1抑制剂。已知单域抗体与传统全长mAb相比具有高度可溶性和稳定性，这使得SC注射所需的高浓度液体制剂成为可能。其次，ADC实体JSKN003是通过定点偶联至亲本抗体anbenitamab（KN026）的Fc聚糖而产生的，产生具有良好控制DAR的均质稳定ADC。这种定点偶联策略减轻了异质偶联方法通常相关的疏水性增加和聚集倾向，从而增强了液体制剂中的稳定性。此外，JSKN-033的开发者Alphamab Oncology建立了专门设计用于通过优化选择的赋形剂和制剂技术来解决浓缩溶液中蛋白质稳定性和高粘度相关挑战的高浓度制剂平台。总之，这些特征使JSKN033能够配制成稳定的高浓度液体共配方，支持快速SC给药，与IV输注或需要长时间给药或复杂复溶的SC方法相比提供更大的便利性。 临床前研究证明了JSKN033的良好生物利用度和安全性，支持进一步的临床评估。在首次人体（FIH）I期研究（JSKN033-101，NCT06226766）中，该研究于2024年1月开始，入组11名重度预处理的晚期患者，SC给药的JSKN033表现出良好的安全性和令人鼓舞的抗肿瘤活性。这些早期发现支持其继续临床开发。FIH的JSKN033案例研究也突出了SC ADC给药的关键局限性，最显著的是注射部位反应（ISRs）的高发生率。在早期剂量递增数据中，约90%的患者经历了ISRs，尽管主要是轻微和可控的。当前临床数据表明，ISRs是与SC给药的JSKN033相关的最常报告的不良事件，主要表现为局部红斑、肿胀、疼痛和瘙痒。大多数ISR严重程度轻微，通常无需干预即可消退，或可在医生指导下通过抗组胺治疗有效管理。 JSKN016是Alphamab Oncology开发的首创双特异性ADC，同时靶向TROP2和HER3，这两种受体在乳腺癌和肺癌中频繁过表达，目前通过静脉给药。JSKN016HC是JSKN016的可皮下注射高浓度液体制剂，旨在相对于IV输注实现便捷、低体积的SC给药。“HC”制剂是单一药剂、高浓度液体ADC，经过优化用于SC递送，而非共配方的组合产品。通过实现SC给药，JSKN016HC具有改善患者便利性和扩展治疗灵活性的潜力，同时保留亲本ADC的双靶向机制和载荷递送。 GQ1007是下一代HER2靶向抗体-免疫激动剂偶联物，使用GeneQuantum专有的高度稳定和亲水性连接子以及位点特异性、均质酶促偶联技术开发。它旨在将toll样受体7/8（TLR7/8）激动剂递送至肿瘤，实现强效局部免疫激活同时最小化系统毒性。临床前研究证明了强效抗肿瘤活性、稳健的肿瘤特异性免疫刺激、优异的血浆稳定性（37°C下96小时无游离激动剂可检测释放），以及在GLP猴毒理学研究中的良好安全性特征，支持其推进至临床测试。GQ1007进入了包含四个子研究的FIH I期研究（ACTRN12622000513718），评估SC给药作为单药治疗或与PD-L1抗体恩沃利单抗联合使用。尽管其临床前特征和理性临床设计令人鼓舞，该研究于2022年9月被申办方撤回，原因是公司优先事项的战略转变。 与透明质酸酶共配方策略 自2013年以来，与透明质酸酶共配方已被用于实现抗体治疗药物的大体积SC递送，已有九种抗体-透明质酸酶组合产品获得FDA和EMA批准。这些产品最初为IV给药开发，后来适应于SC递送以增强患者便利性，并在某些情况下延长产品生命周期。在此先例基础上，首个ADC-透明质酸酶共配方项目于2024年通过Daiichi Sankyo与Alteogen之间的合作启动。Enhertu（fam-trastuzumab deruxtecan），一种HER2靶向ADC，最初于2019年获得美国FDA批准用于IV给药。为实现SC递送，Daiichi Sankyo与Alteogen合作，正在开发使用Hybrozyme平台的配方，该平台整合重组人透明质酸酶（ALT-B4），以暂时降解SC细胞外基质中的透明质酸，从而促进更大的注射体积并增强吸收。一项评估SC Enhertu在转移性实体瘤患者中的临床研究（NCT07015697）由Daiichi Sankyo和AstraZeneca于2025年7月启动。如果成功，该项目将代表首个由透明质酸酶技术实现的SC给药ADC，将先前针对未偶联mAb验证的策略扩展到结构更复杂的ADC。 基于聚合物的水凝胶策略 基于聚合物的SC ADC递送策略已在Detappe的一项非临床可行性研究中得到证明。在这项工作中，开发了基于两性离子壳聚糖的水凝胶，以实现ADC的受控和持续SC递送，使用Kadcyla（T-DM1，ado-trastuzumab emtansine），一种HER2靶向ADC，作为模型。水凝胶成功封装了IV配方的Kadcyla，并实现了与IV给药相当的SC给药系统暴露（AUC）。在小鼠和human皮肤外植体中的临床前评估显示，相对于无载体直接SC注射Kadcyla，具有良好的生物相容性和显著减少的局部炎症反应。重要的是，在HER2阳性异种移植模型中，水凝胶配方的Kadcyla的SC给药实现了与IV途径相当的抗肿瘤疗效。 传统ADC从IV向SC给药的转化 在探索的各种方法中，将研究性或已获批的传统ADC从IV转为SC给药是最早研究的策略之一。Immunomedics于2018年发布的两项专利披露了实现传统IV给药ADC的SC递送的方法，靶向Trop-2、HER2、CD20和CEACAM家族成员等抗原，使用SN-38作为细胞毒性载荷。SC sacituzumab govitecan（IMMU-132）在三阴性乳腺癌、转移性结直肠癌和胃癌患者中进行了评估。2-4 mg/kg的给药方案，每周一次持续一周或每周两到三次持续两周，总体耐受性良好。这些ADC的SC给药被发现至少与IV给药同样有效，没有引起无法管理的注射部位毒性，一些患者中观察到的局部红斑在几周内自发消退。 一项将IV Kadcyla转为SC给药的II期临床研究（PHERGAIN-2；NCT04733118）于2021年在欧洲启动，主要完成日期预计在2027年3月。PHERGAIN-2是一项多中心、开放标签、单臂、单阶段II期试验，旨在评估既往未经治疗的HER2阳性早期乳腺癌患者中化疗-free、病理完全缓解指导的治疗策略的疗效。该方案将SC给药的Phesgo（曲妥珠单抗、帕妥珠单抗和透明质酸酶的共配方）与单独给药的SC Kadcyla相结合，旨在确定病理完全缓解指导的方法是否可以在避免常规细胞毒性化疗的同时实现有利的临床结局。 Avida（Trastuzumab rezetecan，SHR-A1811）是一种ADC，由人源化抗HER2 IgG1 mAb曲妥珠单抗通过酶可裂解、含马来酰亚胺的四肽连接子与DNA拓扑异构酶I抑制剂（DXh，一种exatecan衍生物）连接组成。在连接子和载荷之间α-羰基位置引入手性环丙基增强了偶联物稳定性并限制了循环中的过早载荷释放。2025年5月，Avida获得中国国家药品监督管理局（NMPA）批准，用于既往接受过至少一种系统治疗的不可切除局部晚期或转移性HER2突变非小细胞肺癌成人患者，目前通过IV输注给药。为扩展给药选择，一项开放标签、多中心I期研究（SHR-A1811(sc)-101）已在中国启动，以评估SC制剂在实体瘤患者中的PK、安全性、耐受性和初步疗效（NCT07275242，CTR20254754）。 Pertuzumab zuvotolimod（SBT6050）是一种HER2靶向免疫激动剂偶联物，由抗HER2 mAb帕妥珠单抗与选择性TLR8激动剂连接组成。在I/1b期临床研究（NCT04460456）中，58名患者接受SBT6050作为单药治疗或与检查点抑制剂联合使用，SC剂量水平范围为0.15至1.2 mg/kg，治疗持续时间长达41周。观察到剂量依赖性的系统和瘤内暴露增加以及稳健的免疫激活PD证据。然而，作为单药治疗的抗肿瘤活性有限，细胞因子相关不良事件限制了剂量递增和与帕博利珠单抗的联合使用。在对临床前和临床数据进行全面审查后，SBT6050的开发被终止。值得注意的是，现有数据并未将项目终止明确归因于SC给药途径。 -04- 结语 ADC的SC给药代表了药物递送领域一个有前景但技术上要求严格的创新前沿。实现这一目标需要在理性分子设计、制剂科学、递送技术和转化临床开发之间的协调创新。目前的证据表明，SC递送虽然可实现，但成功高度依赖分子个体差异。将ADC从IV转向SC给药需要个案评估和跨理性分子设计、制剂以及非临床和临床开发的协调创新，以实现以患者为中心的完全获益。 参考文献： Subcutaneous administration of antibody-drug conjugates: current challenges, emerging opportunities, and future perspectives. Antib Ther. 2026 Jun 3;9(3):395-406.

SHANGHAI, Aug. 21, 2026 /PRNewswire/ -- On August 21, Henlius (2696.HK) announced its interim results for the 2026 fiscal year. During the reporting period, the company showcased strong organic growth momentum and sustainable earnings generation, with revenue reaching RMB 3.5882 billion, a 27.3% increase YoY, and net profit amounting to RMB 430.4 million, up 10.3% YoY. In the first half of 2026, Henlius reported non-IFRS profit of RMB 572.3 million, a 46.7% YoY increase, and adjusted EBITDA (a non-IFRS measure) of RMB 904.1 million, rising 35.2% YoY. Key financial and operational metrics maintained a steady upward trajectory. Driven by sustained global growth of its core products and end-to-end lean operations across the entire value chain, the company continues to strengthen both revenue scale and earnings quality. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "2026 marks a pivotal year of acceleration in Henlius' journey toward becoming a C-MNC. In the first half of the year, our core products continued to generate tangible value through global commercialization, while multiple differentiated pipeline assets entered critical stages of value validation. The benefits of this dual-engine growth model are increasingly taking shape. Looking ahead, we will remain anchored in addressing unmet patient needs, build on the virtuous cycle of 'global commercialization fueling innovation and differentiated innovation driving global expansion', further deepen our Globalization 2.0 strategy, and advance steadily toward high-quality, sustainable growth." Global Commercialization Advances Across Multiple Fronts, Core Portfolio Reinforces the Foundation for Growth As of the reporting period, Henlius has 10 products approved in over 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania, and has benefited over 1.1 million patients worldwide. In the first half of 2026, the company maintained its strategic focus on key therapeutic areas, including breast cancer, lung cancer, and gastrointestinal cancers. Global product sales revenue amounted to RMB 2.9386 billion, up 14.9% YoY. Notably, sales revenue from ex-China markets increased significantly by 159.4% year on year to RMB 105.3 million, while product profit from ex-China markets reached RMB 59.5 million, more than four times that of the same period last year, further strengthening the company's ability to generate value from global commercialization. In the breast cancer therapeutic area, the company continued to advance its "Full-Course, All-Domain, Global" breast cancer treatment landscape, with global sales revenue from its breast cancer product portfolio reaching RMB 1.6983 billion during the reporting period. The four marketed products collectively delivered strong volume growth, with HANQUYOU (trastuzumab, HERCESSI™ in the U.S. and Zercepac® in Europe), HANBEIYOU (pertuzumab, POHERDY® in the U.S. and Europe), HANNAIJIA (neratinib), and fovinaciclib generating sales revenues of RMB 1.4844 billion, RMB 7.7 million, RMB 195.5 million, and RMB 10.7 million, respectively. In the first half of 2026, HANBEIYOU received sequential marketing authorizations from the European Commission and China's NMPA, marking it as the first and only** Chinese-developed pertuzumab biosimilar approved across all three major markets—China, the U.S., and the EU. In combination with HANQUYOU, it establishes the first Chinese-developed dual HER2-targeted regimen combining trastuzumab and pertuzumab approved in China, the U.S., and the EU, spanning the treatment continuum from neoadjuvant setting to first-line treatment of advanced disease. Furthermore, the company is accelerating the development of a diversified breast cancer pipeline including lasofoxifene (HLX78), a novel endocrine therapy; dulpatatug* (HLX22), a novel-epitope monoclonal antibody (mAb) targeting HER2; HLX87, a HER2-targeted ADC; HLX97, an oral KAT6A/B inhibitor; HLX49, a HER2 biparatopic ADC; and HLX319, the first Chinese-developed fixed-dose subcutaneous co-formulation of pertuzumab and trastuzumab—all aimed at establishing a comprehensive, multidimensional breast cancer treatment portfolio across the disease continuum. In solid tumor indications, including lung cancer and gastrointestinal malignancies, a multi-product synergistic strategy is cultivating new growth momentum. Serplulimab (Hetronifly® in Europe) recorded global sales revenue of RMB 0.5975 billion in the first half of 2026. In June, the product received approval in China for the perioperative treatment of gastric cancer through a priority review pathway, becoming the first and only*** anti-PD-1 mAb globally to be approved for this indication and thereby addressing a significant unmet need in this treatment setting. In terms of international expansion, serplulimab has secured marketing approvals in over 50 countries and regions. During the reporting period, it has obtained approvals for three additional first-line indications—non-squamous non-small cell lung cancer (nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small cell lung cancer (sqNSCLC) in the EU—and has been incorporated into the national healthcare or public reimbursement systems of 12 European countries, including the United Kingdom (UK), Germany, Italy, Spain, and Sweden. HANBEITAI (bevacizumab), another key oncology product in the company's portfolio, generated sales revenue of RMB 0.2182 billion in the first half of the year, up 87.6% YoY, with a decision on its Biologics License Application expected in the second half of 2026. Furthermore, HLX903, a third-generation oral EGFR-TKI introduced via a licensing-in arrangement, is expected to receive marketing approval in the first half of 2027 and address targeted treatment needs among patients with EGFR-mutant NSCLC upon approval. In parallel, mature products including HANLIKANG (rituximab) and HANDAYUAN (adalimumab) continued to deliver stable cash flow contributions in the hematology and autoimmune disease therapeutic areas, generating RMB 335.7 million and RMB 30.4 million in sales revenue and licensing income, respectively, in accordance with the relevant collaboration agreements. HLX14 (denosumab), available in two dosage strengths as BILDYOS® (60mg/mL) and BILPREVDA® (120mg/1.7mL), secured regulatory approvals in the U.S. and European Union, and UK during the second half of 2025, and contributed sales revenue and licensing income of RMB 73.1 million in the reporting period. In the first half of 2026, with China as its global headquarters, the company moved swiftly to build out its international proprietary commercialization organization, establishing five core functional pillars—commercial alliance, affiliate commercial, market access and pricing, commercial strategy and operations, and medical affairs—thereby creating a dual-engine model combining in-house commercialization with strategic partnerships. Since the start of 2026, the company has announced three major international strategic collaborations in succession, reinforcing its Globalization 2.0 strategy across multiple fronts: in high-value mature markets, the company entered into an agreement with Eisai Co., Ltd., granting Eisai exclusive commercialization rights for serplulimab in Japan; to accelerate its presence in emerging markets, the company formed a strategic collaboration with Abbott to expand serplulimab's commercial footprint across Asia-Pacific, Africa, Central Asia, and Eastern Europe; and to maximize the global potential of its biosimilar portfolio, the company established a broad-based strategic partnership with Sandoz, covering up to ten biosimilar products, thereby substantially broadening the commercial reach of its pipeline assets across key global markets. Innovation Pipeline Accelerates, Global Biosimilar Expansion Drives Further Value Creation Meanwhile, the company continues to ramp up its innovation efforts, with R&D expenditure reaching RMB 1.4507 billion during the reporting period, representing a 45.7% YoY increase. The company's differentiated innovation pipeline continues to expand, and it has now established multiple technology platforms—next-generation IO, Hanjugator ADC, multi-specific T-cell engager (TCE), and AI—with more than 50 early-stage pipeline molecules in reserve, covering therapeutic areas including oncology, immunology and inflammation, neuroscience, and metabolism diseases. As a potential best-in-class (BIC) broad-spectrum anti-tumor PD-L1 ADC, HLX43 has demonstrated encouraging preliminary efficacy and a favorable safety profile across multiple solid tumors, including NSCLC. Its phase 2 and phase 2/3 international multi-center studies in NSCLC are advancing across regions including China, Europe, the United States, Japan, and Australia. Specifically, the phase 2/3 study in advanced sqNSCLC has received implied approval from Japan's PMDA and has dosed its first patient in China. In addition, the phase 1b/2 study of HLX43 in combination with serplulimab or pimurutamab (HLX07) for the treatment of advanced/metastatic colorectal cancer (mCRC) has also completed first-patient-in dosing in China. To date, the company has initiated more than ten clinical studies of HLX43 as monotherapy or in combination regimens, with over 1,500 patients enrolled globally, continuing to evaluate its broad therapeutic potential across multiple solid tumors. Other key pipeline assets are also advancing efficiently. Among them, dulpatatug* is making steady progress in an international multi-center phase 3 clinical study that features a head-to-head comparison against the current first-line standard of care for HER2-positive gastric cancer. First patient enrollment has been completed across a broad geographic footprint, including China, the U.S., Europe, Japan, Australia, South Korea, and Latin America. Concurrently, a phase 2 study of dulpatatug* for HER2-low breast cancer and a phase 2/3 study of dulpatatug* in combination with the HER2-directed ADC HLX87 for first-line treatment of HER2-positive breast cancer are also advancing steadily. The phase 2/3 clinical trial of pimurutamab in combination with serplulimab and chemotherapy for first-line treatment of advanced sqNSCLC has completed clinical trial notification with Australia's Therapeutic Goods Administration (TGA) and has reached first patient dosing in China. Meanwhile, next-generation innovative molecules with BIC/FIC potential, including HLX3901 (DLL3 x DLL3 x CD3 x CD28 tetra-specific TCE), HLX3902 (STEAP1 x CD3 x CD28 tri-specific TCE), HLX48( c-MET x EGFR bispecific ADC) , HLX97 (small-molecule KAT6A/B inhibitor) and HLX316 (B7-H3 sialidase fusion protein), are advancing efficiently in parallel with high efficiency, continuously strengthening the company's long-term growth pipeline. Furthermore, the Company will accelerate the development of early-stage assets, including HLX105 (PD-1×IL-2v fusion protein), HLX109 (IL-1R3 mAb), HLX49 (HER2 biparatopic ADC), and HLX403 (CDH17 ADC), with plans to submit Investigational New Drug (IND) applications for these candidates in the second half of 2026. By leveraging its robust CMC capabilities, the company is further increasing the probability of success in developing complex molecules, thereby enhancing overall drug developability. In addition, the company is proactively applying AI-powered approaches to the R&D of innovative molecules such as HLX203, with the goal of continuously improving the efficiency of drug discovery and development. In line with its Globalization 2.0 strategy, the company remains committed to unlocking the global potential of its biosimilar portfolio through a parallel China-U.S. development and registration pathway. HLX05-N (proposed cetuximab biosimilar) and HLX18 (proposed nivolumab biosimilar) have each received clinical trial authorizations from regulators in both China and the U.S., and dosed their first patient. In addition, HLX13 (proposed ipilimumab biosimilar), HLX15 (proposed daratumumab biosimilar), and HLX17 (proposed pembrolizumab biosimilar) have all achieved first subject dosing in both China and the U.S. The company is continuously accumulating global clinical data for these assets, laying the foundation for subsequent regulatory development and commercialization. Globalization 2.0 in Place, Integrated End-to-End Capabilities Reinforce the C-MNC Ambition Henlius has established a comprehensive and systematic capability for global expansion spanning R&D, clinical development, regulatory affairs, manufacturing, and commercialization, steadily advancing its Globalization 2.0 strategy and marking the initial formation of its "C-MNC" model—a China-headquartered multinational biopharmaceutical company. On clinical development and regulatory affairs, the company has established dedicated in-house teams in Europe, the U.S., Japan, and Australia, with clinical trials concurrently ongoing in nearly 30 countries and regions, in partnership with over 1,000 clinical research centers. During the reporting period, the company received 32 new clinical trial approvals and 25 marketing authorizations worldwide, covering nearly 50 countries and regions. On manufacturing and supply, its delivery capabilities continued to strengthen. To date, the company has completed more than 1,400 GMP commercial production batches and successfully passed over 100 on-site inspections and audits conducted by regulatory authorities worldwide and international collaborators, with a 100% pass rate. During the period, it also completed 9 first commercial shipments and 18 batch shipments to ex-China markets. In the first half of 2026, the clinical value of Henlius' core innovative pipeline continued to emerge, while international regulatory and commercialization milestones were achieved in succession. Synergies across global R&D, manufacturing, and commercialization were further strengthened, collectively demonstrating that the company's Globalization 2.0 strategy has entered a critical phase of accelerated validation. Looking toward 2030, Henlius will continue to pursue innovation-driven and global growth, accelerating its journey toward becoming a C-MNC. The company aims to bring 10 new products to markets worldwide, with over 5 expected to reach European and U.S. markets, and to grow into a globally influential innovative biopharmaceutical company. * Status: pINN ** Received U.S. FDA approval in November 2025, EC approval in April 2026, and NMPA approval in May 2026. As of August 2026, it remains the only one. *** In June 2026, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for perioperative gastric cancer treatment. As of August 2026, it remains the only one. 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. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight 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, 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 for perioperative gastric cancer. Up to date, it has been approved in 50 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 dulpatatug (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 and connect with us on LinkedIn at . SOURCE Henlius 21% more press release views with Request a Demo