Serplulimab

近日，复宏汉霖2025年科学顾问委员会（SAB）会议于上海成功举行。本届会议汇聚了全球顶尖科研机构的权威学者和临床专家，包括斯坦福大学医学院分子和细胞生理学以及结构生物学教授、美国国家科学院、医学院双院士Christopher Garcia教授，西湖大学生命科学学院讲席教授管坤良教授，清华大学医学院讲席教授傅阳心教授，米兰Humanitas大学病理学名誉教授Alberto Mantovani教授，纽约大学格罗斯曼医学院病理系助理教授王俊教授等。围绕肿瘤免疫治疗、自身免疫疾病及创新药物研发等前沿领域，与会专家展开深度对话，为公司的全球化创新布局提供战略指引。 会上，科学顾问与临床专家围绕生物医药领域的最新科研突破展开分享，内容涵盖肿瘤免疫治疗新策略、新型细胞因子药物开发、模拟抗体新技术、炎症/肿瘤治疗新靶点、自免疾病治疗新路径等前沿方向。这些全球领先的研究方向与突破性策略，将助力公司进一步挖掘真正未满足的临床需求，加速推进具有全球竞争力的差异化创新疗法，为实现“可负担的创新”注入科学动力。 复宏汉霖首席科学官袁纪军博士主持了后续的头脑风暴环节。与会专家围绕新型抗体的设计优化、ADC技术创新与突破、转化医学的推进策略等关键议题进行了深入且开放的交流。在袁博士的引导下，多位学者与产业专家观点充分碰撞，不仅激发了多项具有前瞻性的科学设想，也为复宏汉霖下一步的研发规划与管线布局提供了清晰且富有建设性的方向指引。 近一年来，复宏汉霖持续贯彻创新驱动的发展战略，深耕肿瘤和自身免疫等疾病领域，加速拓展以抗体药物为核心的前沿创新管线，多个创新项目取得关键进展： 全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗H药在胃癌新辅助/辅助治疗、结直肠癌领域显示差异化治疗潜力，已完成局限期小细胞肺癌、结直肠癌、胃癌新辅助临床患者入组，并计划于2026年向FDA递交广泛期小细胞肺癌的上市申请。 新表位HER2单抗HLX22相继获美、欧孤儿药资格认定（ODD），高效迈入关键临床（全球多中心III期）阶段，有望改变现有胃癌一线标准疗法。 潜在Best-in-Class的PD-L1 ADC HLX43展现出高效、低毒、兼具I/O功能的广谱抗肿瘤潜力，不依赖患者PD-L1表达。I期临床数据显示其在EGFR野生型非小细胞肺癌（NSCLC）中疗效卓越，且有望填补胸腺癌（TC）这一罕见瘤种的后线治疗空白；目前HLX43已步入全球多中心II期临床。 围绕这些极具开发潜力的爆款分子，专家顾问协同复宏汉霖研发团队展开了深入研讨，旨在进一步优化产品的临床开发策略和路径，最大化其临床价值与市场潜力。 多款核心产品外，公司在靶点覆盖广度与分子多样性维度取得持续突破，研发管线厚度显著提升。聚焦临床前阶段的多个潜力分子，科学顾问就靶点创新性、技术路线及转化策略展开了深入分析，高度认可其科学价值，并为加速推进临床转化提出了重要建议。自主创新的同时，复宏汉霖还与多家全球领先的生物制药公司建立战略合作，引进具有突破性潜力的新分子、新平台，持续拓展创新边界。 复宏汉霖执行董事、首席执行官朱俊博士表示，公司始终坚持以临床需求为导向的研发理念，通过差异化研发构建全球竞争力。当前，复宏汉霖已形成风险平衡的多元管线布局，在深耕成熟靶点、打造差异化“Best-in-Class”产品的同时，稳步迈入创新深水区，战略性探索“First-in-Class”产品的开发。"我们期待与科学顾问团队深化交流，共同优化研发决策体系，加速推动更多创新药物的全球开发进程。" 复星国际联席首席执行官陈启宇先生莅临会议现场并发表致辞，他充分肯定了复宏汉霖近16年来的发展与转型历程——从生物类似药起步到成功推进包括H药斯鲁利单抗及HLX43（抗PD-L1 ADC）在内的多个关键创新项目，体现了公司“临床需求、科学验证、国际标准”三位一体的研发理念。未来，期待复宏汉霖进一步夯实自主创新能力，不断完善具有全球竞争力的研发管线，向着国际一流生物制药企业的目标稳步迈进。 未来，公司将继续聚焦未被满足的临床需求，以国际视野统筹创新研发，紧密联动科学顾问委员会（SAB）及全球顶尖专家，专注于开发具有临床价值的突破性治疗方案，加速创新成果转化，让更多优质药物早日惠及全球患者。 关于复宏汉霖 复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市9款产品，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。 复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Henlius Holds 2025 Scientific Advisory Board Meeting in Shanghai, Gathering Global Experts to Advance Frontier Innovations Recently, Henlius (2696.HK) successfully convened its 2025 Scientific Advisory Board (SAB) Meeting in Shanghai. The event brought together world-renowned scholars and clinical experts from leading institutions, including Professor K. Christopher Garcia, a Professor of Molecular and Cellular Physiology, and of Structural Biology at the Stanford University School of Medicine. members of the US National Academy of Science and the National Academy of Medicine; Professor Kun-Liang Guan, a Chair Professor at Westlake University College of Life Sciences; Professor Yang-Xin Fu, an Endowed Professor at Tsinghua University; Professor Alberto Mantovani, Emeritus Professor of Pathology at the Humanitas University in Milan; Professor Jun Wang, an Assistant Professor of Pathology at NYU Grossman School of Medicine New York University; The meeting facilitated in-depth discussions on frontier areas such as cancer immunotherapy, autoimmune diseases, and innovative drug development, providing strategic guidance for the company’s global innovation initiatives. During the meeting, Henlius scientific advisors and clinical experts shared breakthroughs in biopharmaceutical research, covering novel strategies in immuno-oncology, next-generation cytokine therapies, antibody-mimetic technologies, emerging targets in inflammation and oncology, and innovative approaches for autoimmune diseases. These advancements are expected to help Henlius address indeed unmet clinical needs and accelerate the development of differentiated innovative therapies with global competitiveness, reinforcing its commitment to "affordable innovation." In brainstorming sessions moderated by Dr Jijun Yuan, Chief Scientific Officer of Henlius, participants engaged in a high-level international dialogue on critical topics such as the design and optimization of novel antibodies, breakthroughs in ADC technology, and strategies to advance translational medicine research. Under Dr Yuan’s guidance, the exchange sparked forward-looking scientific concepts and provided actionable insights for Henlius’ R&D pipeline optimization. Over the past year, Henlius has deepened its innovation-driven strategy focused on oncology and autoimmune diseases, accelerating the expansion of its antibody-based pipeline while achieving significant milestones for the core innovative products. Serplulimab，the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC), has demonstrated differentiated potential as neoadjuvant/adjuvant therapy for gastric cancer (GC), as well as first-line treatment of metastatic colorectal cancer (mCRC) . Patient enrollment has been completed in pivotal clinical trials targeting limited-stage SCLC, colorectal cancer, and neoadjuvant gastric cancer. Additionally, a Biologics License Application (BLA) is planned for submission to the U.S. FDA in 2026 for extensive-stage SCLC. The novel epitope anti-HER2 mAb HLX22 has advanced into pivotal global Phase 3 clinical studies. It has been granted Orphan Drug Designation (ODD) by both the U.S. FDA and the European Commission (EC), demonstrating significant potential to redefine first-line standard therapy for HER2-positive gastric cancer‌. HLX43, a potential best-in-class anti-PD-L1 ADC, demonstrates promising broad-spectrum antitumor activity with a favorable safety profile. It mediates a dual mechanism of action integrating immune checkpoint inhibition with targeted cytotoxic payload delivery, and exhibits efficacy independent of PD-L1 expression status. Phase I clinical data have shown that, HLX43 has superior efficacy in the EGFR wild-type NSCLC subgroup and breakthrough potential in later-line treatment of thymic carcinoma (TC), positioned to address the critical gap as ADC therapies for this rare, highly aggressive malignancy. To date, HLX43 has progressed into muti-regional phase 2 clinical trials. By leveraging these high-potential molecules, clinical experts and scientific advisors joined forces with Henlius’s R&D team to enhance the clinical development strategy, maximizing their therapeutic and commercial impact. Beyond the core product portfolio, Henlius has made continuous progress in expanding target coverage and molecular diversity. For the cutting-edge preclinical molecules, the scientific advisors conducted a thorough analysis of their pioneering science and development strategy. Their resounding endorsement of its scientific merit was coupled with key insights for navigating the transition from discovery to clinical proof-of-concept. While driving independent innovation, the company has also forged strategic partnerships with leading global biopharmaceuticals to access next-generation molecules and platforms, further pushing the boundaries of innovation. Dr Jason Zhu, Executive Director & CEO of Henlius stated‌: "Driven by unmet medical needs, Henlius has established global competitiveness through differentiated R&D. Our pipeline now balances risk diversification—excelling in validated targets to deliver ‘Best-in-Class’ (BIC) candidates while strategically advancing into ‘First-in-Class’ innovation. We look forward to deeper collaboration with our Scientific Advisory Board to refine decision-making and accelerate the global development of novel therapeutics." Mr Qiyu Chen, Co-CEO of Fosun International, addressed the meeting: "Henlius’ nearly 16-year journey—from biosimilars to differentiated innovative products like anti-PD-1 mAb, serplulimab and PD-L1 ADC HLX43, exemplifies its R&D philosophy integrating unmet clinical needs, scientific rigor, and international standards. Moving forward, we expect Helius to further strengthen internal R&D capabilities, continuously enhance its globally competitive pipeline, and progress steadily towards a world-class biopharmaceutical company." Moving forward, Henlius remains committed to addressing unmet medical needs through globalized R&D strategy. By leveraging close collaborations with Scientific Advisory Board (SAB) and world-renowned experts, the company will accelerate the development of groundbreaking therapies with clear clinical value, ensuring broader and faster access to high-quality therapeutics for patients worldwide.  About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 9 products have been approved for marketing worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab Bildyos® and Bilprevda®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式 媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容 点击下方按钮·分享 ·收藏 ·点赞 ·在看

REDMOND, Wash., Sept. 24, 2025 /PRNewswire/ -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced the presentation of data on iza-bren (izalontamab brengitecan) and BL-M07D1, two distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. Iza-bren, a potentially first-in-class EGFRxHER3 bispecific ADC, is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China. "The breadth of data we are presenting at ESMO this year reflects not only the strength of our ADC platform but also the speed and depth with which we are advancing our clinical pipeline across tumor types," said Dr. Jie D'Elia, Ph.D., Chief Executive Officer of SystImmune. "From our late-stage pivotal trials to our earlier proof-of-concept studies, these achievements demonstrate SystImmune's ability to translate our differentiated ADC platform into potential medicines that have the power to change treatment paradigms for cancer patients worldwide." Key data to be presented at ESMO include: Highlighting the continued clinical advancement of iza-bren: Late-breaking data from the first randomized, open-label, multicenter, Phase III study evaluating iza-bren versus physician's choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma in China Results from the first Phase 1 study of iza-bren in a global patient population (BL-B01D1-LUNG-101) with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors Safety and efficacy results of iza-bren as a monotherapy in patients with advanced stages of ovarian cancer in China Safety and efficacy results of iza-bren in combination with serplulimab, an anti-PD-1 monoclonal antibody, in patients with extensive-stage small cell lung cancer in China Demonstrating strength of ADC platform with a second novel ADC program BL-M07D1 Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) will be presented. "We are excited to present the first randomized data of iza-bren compared to systemic chemotherapy in advanced nasopharyngeal carcinoma demonstrating the clinical benefit of iza-bren for these patients. In addition, the breadth of data being presented at ESMO underscores the potential versatility of iza-bren across multiple tumor types," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are strongly encouraged by the single-agent activity seen in ovarian cancer and EGFR-mutated NSCLC, as well as the potential for rational combinations observed in small cell lung cancer. These results reinforce our commitment to advancing iza-bren as a therapy that could meaningfully expand treatment options for patients with difficult-to-treat cancers." Details of the presentations at ESMO are below: Iza-Bren (BL-B01D1), an EGFR×HER3 Bispecific Antibody-drug Conjugate, versus Physician's Choice of Chemotherapy in Heavily Pretreated Recurrent/Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter, Phase III, Pivotal study Trial Reference: BL-B01D1-303 (NCT06118333), China Session Title: Proffered paper session: Development therapeutics Presentation Number: LBA35 Speaker: Huaqiang Zhou (Guangzhou, China) Session Date & Time: Sunday, October 19th, 2025, 2:45 PM-4:15 PM CEST Phase 1 Global Study of Iza-Bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors Trial Reference: BL-B01D1-LUNG-101 (NCT05983432), Global Session Title: Mini oral session: Developmental therapeutics Presentation Number: 921MO Speaker: Helena A. Yu (New York, USA) Session Date & Time: Friday, October 17th, 2025, 4:00 PM-5:30 PM CEST Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC) Trial Reference: BL-B01D1-204-01 (NCT06437509), China Session Title: Developmental therapeutics Presentation Number: 934P Speaker: Fei Zhou (Shanghai, China) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST Phase Ib/II Study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Recurrent Metastatic Ovarian Cancer (OC) Trial Reference: BL-B01D1-202 (NCT05803018, NCT05990803), China Session Title: Developmental therapeutics Presentation Number: 933P Speaker: Wu Yong (Shanghai, China) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST A phase 1/2a, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors Trial Reference: CA244-0001 (NCT06618287), Global Session Title: NSCLC, metastatic Presentation Number: 2080eTIP Speaker: Marie Florescu (Montreal, Canada) BL-M07D1, a novel HER2 antibody-drug conjugate, in subjects with locally advanced or metastatic breast cancer and other solid tumors: Results from a phase 1 study Trial Reference: BL-M07D1-101 (NCT05461768), China Session Title: Developmental therapeutics Presentation Number: 935P Speaker: Hong Zong (Zhengzhou, China, Henan) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST Primary efficacy and safety of BL-M07D1 in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) Trial Reference: BL-M07D1-101, 102, 202 (NCT05461768, NCT05631964, NCT06031584), China Session Title: Developmental therapeutics Presentation Number: 937P Speaker: Shuqin Ni (Jinan, China) Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST About iza-bren SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren's therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death. About BL-M07D1 SystImmune is developing BL-M07D1, an ADC comprising a monoclonal antibody component binding HER2 and a linker-payload component composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. HER2 is highly expressed in multiple solid tumors. BL-M07D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to HER2 on cancer cells. In addition, the binding to HER2 causes its internalization followed by the release of the payload, which then kills the tumor cell. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider. This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements. While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. For additional information about the company, please visit . SOURCE SystImmune, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED