Dulpatatug

2026年7月16日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自主开发的纳武利尤单抗生物类似药HLX18（重组抗PD-1人源化单克隆抗体注射液）在多种已切除实体瘤患者中开展的国际多中心I期临床研究（HLX18-MRST001）于中国完成首例患者给药。此前，HLX18的IND申请也已获得美国食品药品监督管理局（FDA）许可。截至目前，在中国及欧美日等全球生物药主流市场尚无获批上市的纳武利尤单抗生物类似药。HLX18是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规开发的纳武利尤单抗生物类似药，经药学和非临床比对研究证明，HLX18与原研纳武利尤单抗相似。目前纳武利尤单抗已在多个国家和地区获批用于黑色素瘤、非小细胞肺癌、恶性胸膜间皮瘤、肾细胞癌、经典型霍奇金淋巴瘤、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、肝细胞癌等一系列适应症。根据IQVIA数据，纳武利尤单抗2025年度全球范围销售额为117.85亿美元。未来，复宏汉霖将继续聚焦未满足的临床需求，依托一体化的全球研发与临床体系，持续拓展更多疾病领域的前瞻性布局，致力于为全球患者带来更多治疗选择。关于HLX18-MRST001本研究为一项多中心、随机、双盲、平行对照的1期临床试验，旨在评估HLX18与OPDIVO在多种已切除实体瘤（食管癌或胃食管连接部癌[EC/GEJC]、黑色素瘤[MEL]或尿路上皮癌[UC]）患者中的药代动力学（PK）特征、有效性、安全性及免疫原性的相似性。筛选合格的患者将按照1:1的比例随机分配A组或B组，A组接受HLX18单药治疗，B组前4个治疗周期接受OPDIVO单药治疗，随后转为接受HLX18单药治疗；每4周为一个治疗周期，持续治疗至随机化后的12个月（约13个周期）或疾病进展等情况。本研究的主要研究终点为首次给药前至给药后28天的血清药物浓度－时间曲线下面积（AUC0-28d）和第4次给药后稳态给药间隔内的血清药物浓度－时间曲线下面积（AUCss）。次要研究终点为其他PK参数、有效性、安全性和免疫原性指标。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。First Patient Dosed in China for International Multi-centre Phase 1 Clinical Trial of Henlius’ Nivolumab Biosimilar HLX18Shanghai, China, July 16, 2026 – Henlius (2696.HK) announced that the first patient in China has been dosed in the international multicenter Phase 1 clinical trial (HLX18-MRST001) of its self-developed nivolumab biosimilar HLX18 (recombinant anti-PD-1 humanized monoclonal antibody injection) in patients with resected solid tumors. Previously, the Investigational New Drug (IND) application for HLX18 was also cleared by the U.S. Food and Drug Administration (FDA).  To date, no nivolumab biosimilar has been approved in China or other major global biologics markets, including the United States, Europe, and Japan.HLX18 is a nivolumab biosimilar developed by Henlius in strict accordance with biosimilar regulatory guidelines in China, the European Union, and the United States. Analytical and non-clinical comparability studies have demonstrated similarity between HLX18 and reference nivolumab. Nivolumab has been approved in multiple countries and regions for a broad range of indications, including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, esophageal cancer, colorectal cancer, and hepatocellular carcinoma. According to IQVIA data, global sales of nivolumab reached USD 11.785 billion in 2025.Looking ahead, Henlius will continue to focus on unmet medical needs, leveraging its integrated global R&D and clinical development capabilities to expand its presence across therapeutic areas and deliver more treatment options to patients worldwide.About HLX18-MRST001This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 clinical study designed to evaluate the similarity of pharmacokinetic (PK) profiles, efficacy, safety, and immunogenicity between HLX18 and OPDIVO in participants with multiple resected solid tumors, including esophageal cancer or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC). Eligible participants will be randomized in a 1:1 ratio to either Group A or Group B. Group A will receive HLX18 monotherapy, while Group B will receive OPDIVO monotherapy for the first 4 treatment cycles, followed by a switch to HLX18 monotherapy. Treatment will be administered once every 4 weeks per cycle and continue for up to 12 months after randomization (approximately 13 cycles) or until disease progression or other discontinuation criteria are met. The primary endpoints of the study are the area under the serum concentration-time curve from time 0 to 28 days (AUC0-28d) after the first dose, and the area under the serum concentration-time curve within a dosing interval at steady state (AUCss) after the fourth dose. Secondary endpoints include other PK parameters, efficacy, safety, and immunogenicity indicators.About HenliusShanghai 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 style="max-width: 100%;box-sizing: border-box;">(复星医药 动态宝)

2026年7月13日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自主开发的达雷妥尤单抗生物类似药HLX15（重组抗CD38全人单克隆抗体）皮下注射剂型（HLX15-SC）一线治疗新诊断多发性骨髓瘤(NDMM)的国际多中心I期临床研究（HLX15-SC-NDMM-001）完成美国首例患者给药。此前，该研究已于中国完成首例患者给药，后续还计划在澳大利亚、塞尔维亚、格鲁吉亚等多个国家进一步推进国际多中心临床研究。截至目前，欧美日等全球生物药主流市场尚无获批上市的达雷妥尤单抗生物类似药。 HLX15是复宏汉霖自主开发的一款全人源抗CD38 IgG1κ单克隆抗体，是达雷妥尤单抗静脉注射剂型Darzalex和皮下注射剂型Darzalex Faspro的生物类似药候选药物。2025年2月，复宏汉霖与Dr. Reddy’s达成授权合作，授予其HLX15皮下注射和静脉注射两种剂型在美国及42个欧洲国家和地区的独家商业化权益。 未来，复宏汉霖将继续聚焦未满足的临床需求，持续拓宽公司在更多疾病领域的前瞻性布局，为全球患者带去高品质、可负担的创新治疗方案。 *Darzalex和Darzalex Faspro为强生公司（Johnson & Johnson）的注册商标。 关于HLX15-SC-NDMM-001 本研究是一项在不适合移植的新诊断多发性骨髓瘤患者中，比较HLX15-SC 和对照药美国市售的DARZALEX FASPRO（US-DARZALEX FASPRO）联合来那度胺-地塞米松（Rd）的PK相似性、安全性、耐受性和免疫原性的多中心、随机、双盲、平行对照I期研究。本研究的主要目的是在目标患者中比较单次和多次SC注射后HLX15-SC 与对照药的PK相似性。次要目的是比较单次和多次SC注射后HLX15-SC与对照药的PK特征、安全性、耐受性、免疫原性和有效性。 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。 First Patient Dosed in the U.S. for International Multi-center Phase 1 Clinical Trial of Henlius’ Subcutaneous Daratumumab Biosimilar HLX15-SC Shanghai, China, July 13, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient in the U.S. has been dosed in the international multi-center Phase 1 clinical trial (HLX15-SC-NDMM-001) of its self-developed subcutaneous formulation of daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody), HLX15-SC, for the first-line treatment of newly diagnosed multiple myeloma (NDMM). Previously, the trial also completed first patient dosed in China, and further international multicenter clinical studies are planned to advance across multiple countries, including Australia, Serbia, and Georgia. To date, no daratumumab biosimilar has been approved in major global biologics markets including the United States, Europe and Japan. HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius and is being developed as a biosimilar candidate to both the intravenous formulation Darzalex and the subcutaneous formulation Darzalex Faspro of daratumumab. In February 2025, Henlius entered into a license agreement with Dr. Reddy’s Laboratories, granting Dr. Reddy’s the exclusive commercialization rights to both the SC and IV formulations of HLX15 in the United States and 42 European countries and regions. Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more disease areas, commit to bring quality and affordable treatments for patients worldwide. *Darzalex & Darzalex Faspro are registered trademarks of Johnson & Johnson. About HLX15-SC-NDMM-001 This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 trial in transplant-ineligible patients with newly diagnosed multiple myeloma, aiming to compare the pharmacokinetic (PK) characteristics, safety, tolerability, and immunogenicity of HLX15-SC versus the US-licensed DARZALEX FASPRO (US-DARZALEX FASPRO), each in combination with lenalidomide and dexamethasone (Rd). The primary objective of this study is to evaluate the PK similarity of HLX15-SC and US-DARZALEX FASPRO after single and multiple SC injections in the target patient population. The secondary objective is to compare the PK characteristics, safety, tolerability, immunogenicity, and efficacy of HLX15-SC and the reference product following single and multiple SC injections. About Henlius返回搜狐，查看更多