8月21日，复宏汉霖(2696.HK)发布2026年度中期业绩。报告期内，公司展现出强劲的内生增长动能与高质量造血能力，实现营收人民币35.882亿元(下文中所有金额均以人民币计价)，同比增长27.3%;净利润4.304亿元，同比增长10.3%。2026年上半年，公司非国际财务报告准则(Non-IFRS)盈利达5.723亿元，同比增长46.7%;Non-IFRS经调整息税折旧摊销前利润(EBITDA)达9.041亿元，同比增长35.2%，核心财务指标与营运指标持续向好。凭借核心产品全球稳健放量与全产业链精益运营，公司持续实现营收与盈利质量的双重跃升。

复宏汉霖执行董事、首席执行官

朱俊博士表示

“2026年是复宏汉霖向C-MNC迈进的关键加速之年。上半年，我们的核心产品在全球商业化进程中持续兑现价值，与此同时，差异化创新管线也密集迈入价值验证的关键阶段，双轮驱动的成效正逐步显现。未来我们将始终锚定患者未被满足的临床需求，依托‘全球商业化反哺创新，差异化创新驱动出海’的良性飞轮，全面深化公司全球化 2.0 战略布局，在高质量、可持续发展的道路上行稳致远。

全球商业化多点开花

核心矩阵筑牢增长基本盘

截至目前，复宏汉霖已有10款产品于全球60多个国家及地区获批上市，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，惠及逾110万患者。2026年上半年，公司聚焦乳腺癌、肺癌、消化道肿瘤等优势治疗领域，全球产品销售收入达到29.386亿元，同比增长14.9%，海外产品销售收入同比大幅提升159.4%至1.053亿元，海外产品利润0.595亿元，为去年同期的4倍以上，全球商业化变现能力进一步增强。

在乳腺癌领域，公司持续深化“全程、全域、全球”战略布局，业绩期内实现乳腺癌领域产品全球销售收入16.983亿元。四款上市产品协同放量，汉曲优®(曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®)、汉倍优®(帕妥珠单抗，美国及欧洲商品名：POHERDY®)、汉奈佳®(奈拉替尼)、复妥宁®(伏维西利)分别实现销售收入14.844亿元、770万元、1.955亿元及0.107亿元。2026年上半年，汉倍优®接连获欧盟委员会和中国药监局批准上市，成为首个且唯一**在中、美、欧三大主流市场获批的国产帕妥珠单抗生物类似药，与汉曲优®组成首个中美欧获批的国产“曲帕双靶”方案，贯穿从新辅助、辅助到晚期一线全程治疗管理。同时，公司正加速布局包括新型内分泌疗法拉索昔芬HLX78、新表位抗HER2单抗HLX22、HER2 ADC HLX87、KAT6A/B口服抑制剂HLX97、HER2双表位ADC HLX49及首款国产帕妥珠单抗曲妥珠单抗皮下复方制剂HLX319等，致力打造全周期、多维度的完善乳腺癌治疗创新矩阵。

在肺癌、消化道肿瘤等实体瘤领域，多产品协同构筑增长新动能。 H药 汉斯状®(斯鲁利单抗，欧洲商品名：Hetronifly®)上半年全球销售收入达5.975亿元，其新增胃癌围术期适应症于6月经优先审评程序在中国获批，成为全球首个且唯一*获批用于该领域的抗PD-1单抗，填补了全球临床空白。国际拓展方面，2026年上半年，H药在欧盟新增获批一线治疗非鳞状非小细胞肺癌(nsqNSCLC)、食管鳞癌(ESCC)及鳞状非小细胞肺癌(sqNSCLC)三项适应症。截至目前，H药已在全球50多个国家和地区获批上市，并被纳入英国、德国、意大利、西班牙和瑞典等12个国家医保或公共支付体系。公司另一款核心抗肿瘤产品汉贝泰®(贝伐珠单抗)上半年实现收入2.182亿元，同比增长87.6%，其在美国的上市申请也有望于今年下半年获得批准。此外，通过合作引进的三代口服EGFR-TKI HLX903有望于2027年上半年获批上市，精准覆盖非小细胞肺癌EGFR突变人群的靶向治疗需求。

与此同时，成熟产品汉利康®(利妥昔单抗)与汉达远®(阿达木单抗)等持续在血液肿瘤和自身免疫领域贡献稳健现金流，分别基于与合作伙伴的约定实现销售及授权许可收入3.357亿元与0.304亿元;HLX14(地舒单抗)双规格BILDYOS®(60mg/mL)和 BILPREVDA®(120mg/1.7mL)于2025年下半年相继在美国、欧盟和英国获批，报告期内实现销售收入及授权许可收入0.731亿元。

2026年上半年，公司以中国为全球总部，通过构建商业合作、商业化运营、市场准入与定价、商业战略与运营、医学事务的五大核心职能，加速组建海外自有商业化团队，形成“自建团队+授权合作伙伴”双轮驱动模式。自2026年以来，公司接连达成三项重磅国际战略合作，全面深化全球2.0布局：深耕高价值成熟市场，与卫材(Eisai)就核心产品H药达成协议，授予其在日本市场的独家商业化权益;加速拓展新兴市场，与雅培(Abbott)建立战略合作，拓展H药在亚太、非洲、中亚及东欧等地的商业化版图;释放生物类似药全球价值，与山德士(Sandoz)达成深度合作，就至多10款生物类似药产品达成重磅战略合作，全面拓宽管线资产在全球主流市场的商业化布局。

创新管线加速落地

生物类似药出海势头高涨驱动全球价值释放

同时，公司持续加码创新，加速在全球范围内推进临床开发，业绩期内研发投入达14.507亿元，同比增长45.7%。公司差异化创新管线储备持续扩容，已形成下一代IO、Hanjugator ADC、多特异性TCE及AI 等技术平台，储备50余个在研早期分子，覆盖肿瘤、免疫炎症、神经和代谢等领域。

核心资产HLX43作为潜在同类最优(BIC)的广谱抗肿瘤PD-L1 ADC，在非小细胞肺癌(NSCLC)等多个实体瘤中已展现出"高效、低毒"的初步临床疗效，其在NSCLC领域的II期及II/III期国际多中心研究已于中国、欧洲、美国、日本及澳大利亚等国家和地区推进，其中晚期sqNSCLC II/III期研究已获日本PMDA默示许可并完成中国首例患者给药;联合H药汉斯状®或pimurutamab(HLX07)治疗晚期/转移性结直肠癌(mCRC)的Ib/II期研究亦已完成中国首例患者给药。目前，公司已开展十余项HLX43单药或联合临床研究，累计全球入组患者超1500例，持续验证其在多种实体瘤中的广谱治疗潜力。

其他重点在研资产同步高效推进，其中，dulpatatug***(HLX22)头对头对比一线标准疗法治疗HER2阳性胃癌的国际多中心III期临床研究稳步推进，已在中国、美国、欧洲、日本、澳大利亚、韩国及拉美等多个国家和地区完成首例患者入组;其用于治疗HER2低表达乳腺癌的II期研究、联合HER2 ADC HLX87一线治疗HER2阳性乳腺癌的II/III期研究亦持续推进中。Pimurutamab 联合汉斯状®及化疗一线治疗晚期sqNSCLC的II/III期临床试验已通过澳大利亚药品管理局的临床试验备案并完成中国首例患者给药。

与此同时，公司高效推进以HLX3901(DLL3 x DLL3 x CD3 x CD28四抗TCE)、HLX3902(STEAP1 x CD3 x CD28三抗TCE)、HLX48(c-MET x EGFR双抗ADC)、HLX97(KAT6A/B小分子抑制剂)及HLX316(B7-H3唾液酸酶融合蛋白)等为代表的具有BIC/FIC潜力的新一代创新分子，持续夯实长期增长储备。依托成熟的CMC工艺优势，公司进一步提高复杂分子成功开发的确定性，助力提高成药性，并积极推动AI技术赋能HLX203等创新分子的研发，持续提升新药发现与开发效率。

聚焦全球化2.0战略，公司依托中美双报路径，持续探索生物类似药全球价值。HLX05-N(西妥昔单抗生物类似药)及HLX18(纳武利尤单抗生物类似药)均已获中美临床许可并完成全球首例患者给药;HLX13(伊匹木单抗生物类似药)、HLX15(达雷妥尤单抗生物类似药)及HLX17(帕博利珠单抗生物类似药)均已完成中美首例受试者给药，持续积累全球临床数据，为后续注册开发及商业化奠定基础。

全球化 2.0 体系成型

全产业链一体化能力夯实C-MNC战略目标

复宏汉霖现已搭建覆盖全球研发、临床、注册、生产、商业化的体系化出海能力，稳步推进全球化2.0战略目标，标志着“C-MNC”(中国为总部的跨国生物制药企业)模式初具雏形。

在临床与注册端，公司在欧美日澳均设有自有团队，在近30个国家和地区同步开展临床研究，合作临床研究中心超1000家。报告期内，公司在全球新增获得32项临床试验申请批准及25项上市注册批件，覆盖近50个国家和地区。在生产与供应端，交付能力持续升级。截至目前，公司累计完成GMP商业化生产批次超1400批，公司顺利通过全球各国药监机构及国际合作方超百项实地核查与审计，核查通过率100%，期内成功完成9次药品首发及18次海外批量发货。

2026年上半年，复宏汉霖核心创新管线临床价值持续显现，国际化注册与商业化成果接连落地，全球研发、生产及商业化协同进一步深化，多重成果共同印证公司全球化2.0战略进入关键加速验证周期。面向2030年，复宏汉霖将坚持创新驱动与全球化发展，向C-MNC加速迈进，力争新增10款产品全球上市，其中超过5款登陆欧美市场，成长为具有全球影响力的国际化创新生物制药企业。

*2026年6月，斯鲁利单抗获得NMPA批准成为全球首个获批胃癌围术期治疗的抗PD-1单抗，截至2026年8月是唯一

** 2025年11月获美国FDA批准，2026年4月获欧盟EC批准，2026年5月获中国NMPA批准，截至2026年8月是首个且唯一

*** 药品通用名处于pINN状态

关于复宏汉霖

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。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8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、5款产品获得欧盟EC批准，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和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球超50个市场获批上市;同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22(通用名：dulpatatug)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 Reports 2026 Interim Results: Sustained Profitability Leap, Advancing Global Value Validation

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 https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.