Serplulimab

SHANGHAI, March 20, 2026 /PRNewswire/ -- Henlius (2696.HK) today announced its annual results for the year ended December 31, 2025. During the reporting period, the Company recorded revenue of RMB 6.6666 billion, representing a year-on-year increase of 16.5%, and net profit of RMB 0.8270 billion. Total R&D investment reached RMB 2.4919 billion, an increase of 35.4%. Amid continued investment in innovation, pre-R&D profit grew to RMB 2.3425 billion, up 26.2% year-on-year. This marks the third consecutive year of profitability and sustained growth of revenue since the Company first achieved full-year profitability in 2023, demonstrating resilient and sustainable profitability, alongside high-quality growth. In 2025, Henlius continued to strengthen its global growth momentum, with global product revenue reaching RMB 5.7746 billion, up 17.0% year-on-year. Driven by sustained ex-China revenue growth from its core products—serplulimab (trade name: Hetronifly® in Europe) and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe)—as well as the accelerating realisation of licensing payments from strategic partnerships, the Company's ex-China business expanded significantly. Ex-China product revenue exceeded RMB 200 million in 2025, doubling year-on-year, while ex-China product profit increased to RMB 93.9 million. To date, Henlius has achieved approval for 10 products across 60 countries and regions worldwide, including 7 products approved in China, 4 products approved by the U.S. FDA, and 4 products authorized by the European Commission (EC), benefiting more than one million patients globally. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, commented: "2025 marked not only a pivotal year for Henlius as we advanced into the era of Globalisation 2.0, but also a year in which our innovation pipeline began to deliver meaningful progress. With continued growth in our ex-China business and ongoing pipeline breakthroughs, we remain firmly committed to a first-principles approach to biopharmaceutical innovation—focusing on deeply understanding and addressing fundamental clinical needs. Looking ahead, Henlius will continue to leverage its integrated platform and global operating capabilities to bring more biologics with quality to patients worldwide, delivering on our long-term commitment to patients through robust innovation." Product Revenue Reaches New High, Driven by a Synergistic Commercial Portfolio In 2025, the synergistic contribution from Henlius' innovative biologics and biosimilars drove total product revenue to a new high. The Company's flagship product, serplulimab (trade name: Hetronifly® in Europe), continued to deliver global commercial momentum. During the reporting period, it recorded global sales revenue of RMB 1.4926 billion, representing a year-on-year increase of 13.7%. It received approvals in 2025 in Europe and multiple emerging markets for first-line treatment of extensive-stage SCLC (ES-SCLC), as well as in Indonesia and Thailand for squamous non-small cell lung cancer (sqNSCLC). It has also been included in public reimbursement systems in seven EU countries, including Germany, Italy, and Spain. To date, serplulimab has been approved in over 40 countries and regions worldwide, with continued progress in lung and gastrointestinal cancers, including the potential to set multiple new cancer treatment standards. As the first anti–PD-1 mAb approved globally for first-line treatment of small cell lung cancer, serplulimab is also the first perioperative gastric cancer treatment globally to replace adjuvant chemotherapy with immunotherapy monotherapy. In addition, its international multi-centre phase 3 trial for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, with the potential to become the first immunotherapy for first-line treatment of microsatellite stable (MSS) mCRC. With its global commercial potential and differentiated clinical value continuing to expand, Henlius aims to position serplulimab as the next China-developed innovative biologic to surpass RMB 10 billion in annual global sales. Focusing on broader clinical needs, clinical development and regulatory progress for serplulimab advance with full acceleration across China, the European Union, the United States, Japan, and other emerging markets. In China, the product has been granted Breakthrough Therapy Designation by the National Medical Products Administration for perioperative treatment of gastric cancer. The corresponding marketing application has been accepted and granted priority review, with approval anticipated in the first half of 2026. In parallel, a New Drug Application (NDA) for limited-stage SCLC (LS-SCLC) is planned for submission in China in 2026. In the EU, additional indications—including squamous and non-squamous NSCLC and esophageal squamous cell carcinoma (ESCC)—are expected to receive approval in 2026. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026. In 2025, Henlius' breast cancer franchise maintained strong growth momentum. During the reporting period, global sales revenue from breast cancer products reached RMB 3.2675 billion. Through a combination of in-house R&D and strategic collaborations, the Company has established a comprehensive, end-to-end global treatment portfolio for breast cancer. Its core product HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) achieved global sales revenue of RMB 2.9645 billion, up 5.5% year-on-year. To date, HANQUYOU has been approved in more than 50 countries and regions and has been included in reimbursement systems across multiple markets, including China, the United Kingdom, France, and Germany. HANNAIJIA (neratinib) generated sales revenue of RMB 0.3012 billion, representing a year-on-year increase of 564.2%, further strengthening its position as a leading brand in extended adjuvant therapy for HER2-positive early-stage breast cancer. The innovative CDK4/6 inhibitor FUTUONING (fovinaciclib) achieved its first prescriptions in the second half of 2025 and was included in the updated National Reimbursement Drug List. HLX11 (pertuzumab) received approval from the U.S. FDA in the second half of 2025 under the brand name POHERDY®, becoming the first and only1 biosimilar of pertuzumab approved in the U.S. market. In the EU, HLX11 has also received a positive opinion from the European Medicines Agency (EMA), with marketing appliacations submitted in both China and Canada. In this therapeutic area, the Company continues to expand a comprehensive innovation portfolio, including novel endocrine therapy, novel epitope anti-HER2 mAb, HER2-targeted ADC, KAT6A/B oral small-molecule inhibitor, subcutaneous formulation of pertuzumab and trastuzumab, dual-epitope HER2 ADC, and LIV-1 ADC. Meanwhile, mature commercialized products continued to generate stable cash flow. HANBEITAI (bevacizumab) generated sales revenue of RMB 0.3564 billion, up 80.8%. Pursuant to agreements with its partners, the Company generated RMB 0.6117 billion in sales and licensing revenue from HANLIKANG (rituximab), up 11.1% year-on-year; HANDAYUAN (adalimumab) achieved sales and licensing revenue of RMB 59.2 million, up 47.6%. In the second half of 2025, two dosage strengths of HLX14 (denosumab) were approved in the United States, the European Union, and the UK under the trade names BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), respectively, and were recently approved in Canada under the trade names BILDYOS® and TUZEMTY®, becoming the first "China-developed" denosumab to approved in ex-China markets. Currently, the two dosage strengths of HLX14 have been commercially launched in the United States as well as in Germany, Spain and the UK, generating sales revenue of RMB 9.8 million during the reporting period. Accelerating Global Expansion and Advancing Innovation Pipeline In 2025, Henlius accelerated its Globalisation 2.0 strategy. During the reporting period, the Company continued to expand its footprint in international regulatory filings and commercial collaborations. It secured 27 Investigational New Drug (IND) approvals and 28 new marketing approvals worldwide, covering more than 60 countries and regions across China, the United States, Europe, Japan, and Canada. At the same time, clinical studies are being actively advanced in nearly 30 countries and regions, further accelerating the global development of its pipeline. Meanwhile, Henlius continued to expand its global partnership network. During the reporting period, the Company entered into collaborations with leading international partners including Abbott, Eisai and Lotus regarding rights to serplulimab. In addition, Henlius established licensing partnerships with Dr. Reddy's and Sandoz for HLX15 (daratumumab) and HLX13 (ipilimumab), respectively. As a key innovative asset of the Company, dulpatatug (HLX22)2, a novel epitope anti-HER2 mAb, continues to make steady progress in its international multi-centre phase 3 clinical trial for the treatment of HER2-positive gastric cancer in a head-to-head comparison with standard first-line therapy. The study has initiated first patient dosing across multiple countries and regions, including China, the United States, Europe, Japan, Australia, South Korea, and Latin America. Two years of follow-up results from its phase 2 study in gastric cancer were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating durable efficacy and favourable outcomes compared to historical benchmarks, with an approximately 80% reduction in the risk of disease progression or death in the overall population. Beyond gastric cancer, dulpatatug is being further developed across additional indications, including breast cancer. Its phase 2 study in HER2-low breast cancer has completed patient enrolment, while a phase 2/3 study evaluating dulpatatug in combination with the HER2-targeted ADC HLX87 for first-line treatment of HER2-positive breast cancer has completed first patient dosing. HLX43, a PD-L1-targeted ADC with potential best-in-class (BIC) characteristics and broad anti-tumour activity across multiple tumour types, continues to demonstrate its "pipeline-in-a-pill" potential. Early clinical data from its first-in-human study, along with multiple proof-of-concept results across solid tumours, have been presented at several international scientific conferences, showing a favourable efficacy and safety profile. Notably, in non-small cell lung cancer (NSCLC), HLX43 has demonstrated activity without the need for biomarker-based patient selection, suggesting potential applicability across a broad patient population. In addition to NSCLC, encouraging signals have also been observed in gynecological tumours, esophageal squamous cell carcinoma (ESCC), and other solid tumours. Beyond monotherapy, the Company is actively exploring combination strategies of HLX43 with anti-EGFR mAb pimurutamab (HLX07) and serplulimab, aiming to further expand its clinical potential. In 2026, Henlius plans to accelerate proof-of-concept studies across a broader range of solid tumours while advancing multiple global pivotal trials efficiently. In 2025, Henlius continued to strengthen its platform-based innovation capabilities, establishing a multi-dimensional technology ecosystem. This includes a next-generation immuno-oncology (IO) platform, the proprietary Hanjugator™ ADC platform, a tri-specific T-cell engager (TCE) platform, and HAI Club—an AI-driven, integrated platform for early-stage antibody discovery and development. During the reporting period, multiple candidates—including HLX37 (PD-L1 × VEGF bispecific antibody), HLX97 (KAT6A/B small-molecule inhibitor), HLX3901 (DLL3 × DLL3 × CD3 × CD28 tetra-specific TCE), and HLX316 (B7-H3 sialidase fusion protein)—received Investigational New Drug (IND) approvals. Meanwhile, the Company continues to advance a number of promising pipeline assets, including HLX3902 (STEAP1 × CD3 × CD28 tri-specific TCE), HLX48 (EGFR × c-MET bispecific ADC), HLX49 (HER2 dual-epitope ADC), and HLX109 (IL-1R3 mAb), further enriching its globally competitive innovation portfolio. As a critical foundation for its Globalisation 2.0 strategy, Henlius continued to enhance its manufacturing and quality systems. The Company's Xuhui Site, Songjiang Site I, and Songjiang Site II have a total installed capacity of 84,000 litres. To date, Henlius has completed more than 1,300 GMP commercial production batches, enabling stable and continuous global supply of its products. The Company's commercial manufacturing facilities and associated quality management systems have successfully undergone nearly 100 on-site inspections and audits conducted by regulatory authorities and international partners worldwide, with no critical findings and a 100% pass rate. Henlius has obtained GMP certifications from China, the European Union, the United States, and multiple member countries of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), as well as three ISO certifications, including ISO 9001, ISO 14001, and ISO 45001. During the reporting period, the Company further strengthened its global commercial supply capabilities. Four products—serplulimab, HANQUYOU, and two dosage strengths of denosumab (HLX14)—achieved their first ex-China shipments, covering eight countries, including the United States, the UK, Germany, Spain, and India. In total, more than 30 ex-China shipments were completed during the year. Meanwhile, Henlius continued to advance its international manufacturing and quality infrastructure. In 2025, HLX14 marked its first commercial shipment to Europe, with the Company completing the full regulatory approval process in its role as Marketing Authorization Holder (MAH) for the first time. In Japan, the supporting quality system for MAH operations has also been successfully established. Patient-Centric Approach, Advancing a China-Rooted Global Biopharma Model Looking ahead, Henlius remains committed to its patient-centric mission. Leveraging its solid commercial foundation, continuously evolving innovation engine, and increasingly integrated global operations, the Company aims to bring more biologics with quality to patients worldwide. Guided by its 2030 vision, Henlius will continue to advance its global strategy and further evolve into a globally operating biopharmaceutical company headquartered in China. Looking forward, Henlius targets achieving more than 20 product approvals globally, including over 15 in the United States and Europe, further strengthening its position as an internationally competitive and globally influential biopharmaceutical company. 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 era of "Globalisation 2.0" , building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries 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 approved by the European Commission, 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 has been approved in more than 40 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 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

序号 受理号 药品名称 申请人名称 适应症 注册分类 1 CXHL2600055 注射用硼[10B]法仑 华硼中子科技（杭州）有限公司 不可切除的局部晚期或局部复发的头颈部恶性肿瘤。 2.2 2 CXHL2600052 HS-20152注射液 上海翰森生物医药科技有限公司;江苏豪森药业集团有限公司 阵发性睡眠性血红蛋白尿症 1 3 JXHL2600008 宗艾替尼片 Boehringer Ingelheim International GmbH 非小细胞肺癌 2.4 4 CXSL2600042 重组人血小板源生长因子凝胶 华芢生物科技（青岛）股份有限公司 新鲜创面 1 5 CXSL2600041 重组人血小板源生长因子凝胶 华芢生物科技（青岛）股份有限公司 新鲜创面 1 6 CXSL2600040 重组人血小板源生长因子凝胶 华芢生物科技（青岛）股份有限公司 慢性放射性溃疡 1 7 CXSL2600039 重组人血小板源生长因子凝胶 华芢生物科技（青岛）股份有限公司 慢性放射性溃疡 1 8 CXSL2600038 重组人血小板源生长因子凝胶 华芢生物科技（青岛）股份有限公司 压疮 1 9 CXSL2600037 重组人血小板源生长因子凝胶 华芢生物科技（青岛）股份有限公司 压疮 1 10 CXSL2600035 SCTB41注射液 神州细胞工程有限公司 本品联合化疗用于驱动基因阴性局部晚期或转移性非小细胞肺癌 治疗用生物制品:1类 11 CXHB2600009 HRS-6209胶囊 江苏恒瑞医药股份有限公司 1.本品联合HRS-1358或HRS-8080或芳香化酶抑制剂或氟维司群用于乳腺癌的治疗。 2.本品联合HRS-2189+HRS-8080、或联合HRS-2189+HRS-1358、或联合HRS-2189+氟维司群用于恶性肿瘤的治疗。 3.本品联合HRS-2189和芳香化酶抑制剂用于乳腺癌的治疗。 4.本品联合HRS-6208+HRS-8080，或联合HRS-6208+HRS-1358，或联合HRS-6208+氟维司群，或联合HRS-6208+芳香化酶抑制剂用于实体瘤的治疗。 1 12 CXSL2600046 注射用维贝柯妥塔单抗 乐普生物科技股份有限公司 本品联合普特利单抗注射液，用于围手术期治疗局部晚期可切除头颈鳞癌患者。 2.2 13 CXHL2600044 注射用TRD209 北京泰德制药股份有限公司 成人急性髓系白血病。 1 14 CXHL2600043 IN10028肠溶片 应世生物科技（南京）有限公司 拟用于晚期实体瘤的治疗 1 15 CXHL2600042 IN10028肠溶片 应世生物科技（南京）有限公司 拟用于晚期实体瘤的治疗 1 16 CXSL2600044 CM336注射液 康诺亚生物医药科技有限公司;成都康诺行生物医药科技有限公司 干燥综合征 1 17 CXSL2600043 CM336注射液 康诺亚生物医药科技有限公司;成都康诺行生物医药科技有限公司 干燥综合征 1 18 CXHL2600041 HRS9531注射液 福建盛迪医药有限公司 用于降低动脉粥样硬化性心血管疾病患者的主要心血管不良事件风险。 1 19 CXHL2600040 HRS9531注射液 福建盛迪医药有限公司 用于降低动脉粥样硬化性心血管疾病患者的主要心血管不良事件风险。 1 20 CXHL2600039 HRS9531注射液 福建盛迪医药有限公司 用于降低动脉粥样硬化性心血管疾病患者的主要心血管不良事件风险。 1 21 CXSL2600023 SAL0150片 深圳信立泰药业股份有限公司 本品适用于成人2型糖尿病合并外周动脉疾病伴间歇性跛行的患者 1 22 CXSL2600022 SAL0150片 深圳信立泰药业股份有限公司 本品适用于成人2型糖尿病合并外周动脉疾病伴间歇性跛行的患者 1 23 CXSL2600021 SAL0150片 深圳信立泰药业股份有限公司 本品适用于成人2型糖尿病合并外周动脉疾病伴间歇性跛行的患者 1 24 CXSL2600020 SAL0150片 深圳信立泰药业股份有限公司 本品适用于成人2型糖尿病合并外周动脉疾病伴间歇性跛行的患者 1 25 CXHL2600038 HS-10587片 江苏豪森药业集团有限公司;上海翰森生物医药科技有限公司;常州恒邦药业有限公司 MTAP缺失的晚期实体瘤 1 26 CXHL2600037 HS-10587片 江苏豪森药业集团有限公司;上海翰森生物医药科技有限公司;常州恒邦药业有限公司 MTAP缺失的晚期实体瘤 1 27 CXSL2600019 BL-ARC002注射液 成都百利多特生物药业有限责任公司;四川百利药业有限责任公司 拟用于包括但不限于标准治疗失败或无法获得标准治疗的局部晚期或转移性实体瘤。 1 28 CXHL2600032 SL-0044 上海则正医药科技股份有限公司 用于治疗成年男性原发性早泄。 2.4 29 CXHL2600031 SL-0044 上海则正医药科技股份有限公司 用于治疗成年男性原发性早泄。 2.4 30 CXHL2600030 SL-0044 上海则正医药科技股份有限公司 用于治疗成年男性原发性早泄。 2.4 31 CXHL2600029 SL-0044 上海则正医药科技股份有限公司 用于治疗成年男性原发性早泄。 2.4 32 CXHL2600028 SL-0044 上海则正医药科技股份有限公司 用于治疗成年男性原发性早泄。 2.4 33 CXSL2600018 SH009注射液 南京圣和药业股份有限公司 本品联合其他药物（化疗、靶向治疗等）用于晚期实体瘤（食管癌、胃癌、肝细胞癌等）的治疗。 1 34 CXHL2600020 HS-10529胶囊 江苏豪森药业集团有限公司;上海翰森生物医药科技有限公司 KRAS G12D突变的晚期实体瘤（胰腺癌、结直肠癌、非小细胞肺癌等）。 1 35 CXSL2600017 BM230冻干制剂 苏州博奥明赛生物制药有限公司 HER2相关实体瘤 1 36 JXHB2600002 BI 1291583 片 Boehringer Ingelheim International GmbH 治疗支气管扩张症 1 37 CXSL2600001 重组抗PD-1人源化单克隆抗体注射液 复星汉霖（成都）生物技术有限公司;上海复宏汉霖生物医药有限公司 非小细胞肺癌；恶性胸膜间皮瘤；头颈部鳞状细胞癌；尿路上皮癌；胃癌、胃食管连接部癌或食管腺癌；食管癌；结直肠癌；肝细胞癌 3.3 38 CXHL2600171 HCXT-2001片 上海瀚辰星泰医药科技有限公司 银屑病 1 39 CXHL2600170 HCXT-2001片 上海瀚辰星泰医药科技有限公司 银屑病 1 40 CXSL2501123 GO321重组溶瘤痘苗病毒注射液 上海锦斯生物技术有限公司 晚期难治性实体瘤 1