Pimurutamab(Shanghai Henlius Biotech, Inc.)

2025 Jefferies全球医疗健康大会于11月17-20日在英国伦敦成功举办。作为全球最具影响力的医疗健康投资盛会之一，本次大会吸引了来自全球约4500位企业管理者、机构投资者及产业领袖齐聚伦敦。复星医药子公司复宏汉霖（2696.HK）执行董事兼首席执行官朱俊博士受邀发表主题演讲，系统介绍公司的全球布局进展、创新管线的潜在商业化价值和最新突破，向全球资本市场呈现一家中国创新型生物制药企业的国际化实力与发展潜力。 复宏汉霖执行董事兼首席执行官 朱俊博士 在演讲中，朱俊博士回顾了复宏汉霖在全球布局方面取得的阶段性成果。随着多款产品相继在欧洲及美国获批上市，公司海外业务保持高速增长，“体系出海”的能力日益完善，呈现出强劲的发展势头。凭借覆盖研发、生产、注册等环节的高效一体化平台，公司在海外市场形成了可持续增长的基础，也进一步加速了创新产品在全球范围的落地。 围绕创新研发，朱俊博士重点介绍了四款核心创新产品的最新进展和市场前景，包括全球首个获批用于小细胞肺癌一线治疗的抗PD-1单抗 H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®），具备差异化机制的新表位HER2单抗HLX22，具备广谱抗肿瘤潜力的潜在同类最优PD-L1 ADC HLX43，以及抗EGFR单抗HLX07。这些产品相关的临床研究在多个重大国际学术会议上持续释放积极数据，体现了复宏汉霖在全球肿瘤治疗领域日益增强的影响力。 其中，H药已在英国、德国、新加坡、印度等国家和地区获批上市，美国桥接研究（ASTRIDE）亦已完成全部入组，为未来向美国食品药品监督管理局（FDA）递交生物制品许可申请（BLA）奠定基础。HLX43已获中、美、澳等多国临床许可，目前已在中、美两国完成首例受试者给药，并获得FDA孤儿药资格认定用于胸腺上皮肿瘤的治疗。HLX22头对头对比一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）治疗胃癌的国际多中心III期临床目前于中澳美韩及拉美等国家和地区稳步推进，并获得FDA与欧盟委员会（EC）的孤儿药资格认定，全球开发前景广阔。HLX07联合H药的治疗方案在EGFR高表达鳞状非小细胞肺癌人群中展现出独特的临床潜能，为推动肺癌精准治疗带来了新的希望。 同时，公司展示了产品管线以及早期研发布局的“全景图”。目前，复宏汉霖正在推进涵盖融合蛋白、ADC、小分子等多技术路线的50余项具备全球竞争潜力的早研项目。通过不断丰富早期管线，公司正在构建一个面向国际市场、可持续迭代的创新研发引擎。 当前，复宏汉霖正以持续创新与国际化战略加速成长。凭借扎实的商业化基础和前瞻性的管线布局，公司正稳步迈向一家“全球布局、以创新驱动的国际化生物制药企业”。朱俊博士表示：“复宏汉霖正积极拥抱全球化机遇，持续以国际标准推动创新研发与商业化落地。通过与全球资本市场以及同行的深入沟通，我们希望进一步展示复宏汉霖在创新驱动下的全球竞争力，并以更加开放的姿态，为全球患者带来更多可负担的治疗选择。” 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10款产品，3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）、地舒单抗生物类似药Bildyos®和Bilprevda®，以及帕妥珠单抗POHERDY®。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 Participates in the 2025 Jefferies Global Healthcare Conference in London The 2025 Jefferies Global Healthcare Conference was successfully held in London from November 17–20. As one of the world’s most influential healthcare investment events, this year’s conference brought together approximately 4,500 corporate executives, institutional investors, and industry leaders. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius (2696.HK), was invited to deliver a keynote presentation, offering a comprehensive overview of the company’s global expansion, the commercial potential of its innovative pipeline, and its latest R&D breakthroughs—showcasing the international capabilities and growth momentum of a leading Chinese biopharmaceutical innovator. During his presentation, Dr. Zhu reviewed the significant progress Henlius has made in advancing its global strategy. With multiple products approved in Europe and the United States, the company’s global business continues to grow rapidly. Henlius has steadily strengthened its “systematic global expansion” capabilities, supported by an integrated platform spanning R&D, manufacturing, and regulatory affairs. This foundation has enabled sustainable global development and accelerated the global rollout of the company’s innovative products. Focusing on innovation-driven R&D, Dr. Zhu highlighted the latest progress and market potential of four core innovative assets: serplulimab (trade name in Europe: Hetronifly®), the world’s first PD-1 inhibitor approved for the first-line treatment of ES-SCLC; HLX22, a novel-epitope HER2 antibody with a differentiated mechanism of action; HLX43, a potentially best-in-class PD-L1 ADC with broad anti-tumour potential; and HLX07, an anti-EGFR mAb. Clinical results from these programs have been continuously presented at major international scientific congresses, underscoring Henlius’ growing global influence in oncology therapeutics. Serplulimab has been approved in the UK, Germany, Singapore, India, and other markets. Its U.S. bridging study (ASTRIDE) has completed full enrolment, laying a solid foundation for a future Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). HLX43 has received clinical trial approvals in countries including China, the U.S., and Australia, initiated first-patient dosing in both China and the U.S., and obtained FDA Orphan Drug Designation (ODD) for thymic epithelial tumours. HLX22 is being evaluated in a global Phase III head-to-head trial versus the standard first-line regimen (trastuzumab + chemotherapy ± pembrolizumab) for gastric cancer, with enrolment advancing steadily across countries and regions including China, Australia, the U.S., Korea, and Latin America. The program has also received ODD from both the FDA and the European Commission (EC), reinforcing its strong global development potential. Meanwhile, the combination of HLX07 and serplulimab has demonstrated promising clinical activity in EGFR-high squamous non-small cell lung cancer, opening new possibilities for precision lung cancer treatment. During the conference, Henlius also shared a “pipeline panorama” outlining its diversified early-stage R&D strategy. The company is currently advancing more than 50 early-stage programs with global competitiveness across multiple technology platforms, including fusion proteins, ADCs, and small molecules. By continuously expanding its early-stage portfolio, Henlius is building a sustainable and internationally oriented innovation engine. Henlius is accelerating its growth under a dual strategy of continuous innovation and global expansion. With strong commercial execution and a forward-looking pipeline, the company is steadily progressing toward its vision of becoming a “globally deployed, innovation-driven international biopharmaceutical enterprise.” Dr. Zhu concluded, “Henlius is actively embracing global opportunities and advancing innovation and commercialization in line with international standards. By engaging closely with the global capital market and industry peers, we aim to further demonstrate Henlius’ innovation-powered global competitiveness and, through greater openness and collaboration, bring more affordable treatment options to patients around the world.” 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. To date, 10 products have been approved for marketing across multiple countries and regions, and 3 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, denosumab Bildyos® and Bilprevda®, and pertuzumab Poherdy®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

2025 Jefferies全球医疗健康大会于11月17-20日在英国伦敦成功举办。作为全球最具影响力的医疗健康投资盛会之一，本次大会吸引了来自全球约4500位企业管理者、机构投资者及产业领袖齐聚伦敦。复宏汉霖（2696.HK）执行董事兼首席执行官朱俊博士受邀发表主题演讲，系统介绍公司的全球布局进展、创新管线的潜在商业化价值和最新突破，向全球资本市场呈现一家中国创新型生物制药企业的国际化实力与发展潜力。 复宏汉霖执行董事兼首席执行官 朱俊博士 在演讲中，朱俊博士回顾了复宏汉霖在全球布局方面取得的阶段性成果。随着多款产品相继在欧洲及美国获批上市，公司海外业务保持高速增长，“体系出海”的能力日益完善，呈现出强劲的发展势头。凭借覆盖研发、生产、注册等环节的高效一体化平台，公司在海外市场形成了可持续增长的基础，也进一步加速了创新产品在全球范围的落地。 围绕创新研发，朱俊博士重点介绍了四款核心创新产品的最新进展和市场前景，包括全球首个获批用于小细胞肺癌一线治疗的抗PD-1单抗 H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®），具备差异化机制的新表位HER2单抗HLX22，具备广谱抗肿瘤潜力的潜在同类最优PD-L1 ADC HLX43，以及抗EGFR单抗HLX07。这些产品相关的临床研究在多个重大国际学术会议上持续释放积极数据，体现了复宏汉霖在全球肿瘤治疗领域日益增强的影响力。 其中，H药已在英国、德国、新加坡、印度等国家和地区获批上市，美国桥接研究（ASTRIDE）亦已完成全部入组，为未来向美国食品药品监督管理局（FDA）递交生物制品许可申请（BLA）奠定基础。HLX43已获中、美、澳等多国临床许可，目前已在中、美两国完成首例受试者给药，并获得FDA孤儿药资格认定用于胸腺上皮肿瘤的治疗。HLX22头对头对比一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）治疗胃癌的国际多中心III期临床目前于中澳美韩及拉美等国家和地区稳步推进，并获得FDA与欧盟委员会（EC）的孤儿药资格认定，全球开发前景广阔。HLX07联合H药的治疗方案在EGFR高表达鳞状非小细胞肺癌人群中展现出独特的临床潜能，为推动肺癌精准治疗带来了新的希望。 同时，公司展示了产品管线以及早期研发布局的“全景图”。目前，复宏汉霖正在推进涵盖融合蛋白、ADC、小分子等多技术路线的50余项具备全球竞争潜力的早研项目。通过不断丰富早期管线，公司正在构建一个面向国际市场、可持续迭代的创新研发引擎。 当前，复宏汉霖正以持续创新与国际化战略加速成长。凭借扎实的商业化基础和前瞻性的管线布局，公司正稳步迈向一家“全球布局、以创新驱动的国际化生物制药企业”。朱俊博士表示：“复宏汉霖正积极拥抱全球化机遇，持续以国际标准推动创新研发与商业化落地。通过与全球资本市场以及同行的深入沟通，我们希望进一步展示复宏汉霖在创新驱动下的全球竞争力，并以更加开放的姿态，为全球患者带来更多可负担的治疗选择。” 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10款产品，3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）、地舒单抗生物类似药Bildyos®和Bilprevda®，以及帕妥珠单抗POHERDY®。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 Participates in the 2025 Jefferies Global Healthcare Conference in London The 2025 Jefferies Global Healthcare Conference was successfully held in London from November 17–20. As one of the world’s most influential healthcare investment events, this year’s conference brought together approximately 4,500 corporate executives, institutional investors, and industry leaders. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius (2696.HK), was invited to deliver a keynote presentation, offering a comprehensive overview of the company’s global expansion, the commercial potential of its innovative pipeline, and its latest R&D breakthroughs—showcasing the international capabilities and growth momentum of a leading Chinese biopharmaceutical innovator. During his presentation, Dr. Zhu reviewed the significant progress Henlius has made in advancing its global strategy. With multiple products approved in Europe and the United States, the company’s global business continues to grow rapidly. Henlius has steadily strengthened its “systematic global expansion” capabilities, supported by an integrated platform spanning R&D, manufacturing, and regulatory affairs. This foundation has enabled sustainable global development and accelerated the global rollout of the company’s innovative products. Focusing on innovation-driven R&D, Dr. Zhu highlighted the latest progress and market potential of four core innovative assets: serplulimab (trade name in Europe: Hetronifly®), the world’s first PD-1 inhibitor approved for the first-line treatment of ES-SCLC; HLX22, a novel-epitope HER2 antibody with a differentiated mechanism of action; HLX43, a potentially best-in-class PD-L1 ADC with broad anti-tumour potential; and HLX07, an anti-EGFR mAb. Clinical results from these programs have been continuously presented at major international scientific congresses, underscoring Henlius’ growing global influence in oncology therapeutics. Serplulimab has been approved in the UK, Germany, Singapore, India, and other markets. Its U.S. bridging study (ASTRIDE) has completed full enrolment, laying a solid foundation for a future Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). HLX43 has received clinical trial approvals in countries including China, the U.S., and Australia, initiated first-patient dosing in both China and the U.S., and obtained FDA Orphan Drug Designation (ODD) for thymic epithelial tumours. HLX22 is being evaluated in a global Phase III head-to-head trial versus the standard first-line regimen (trastuzumab + chemotherapy ± pembrolizumab) for gastric cancer, with enrolment advancing steadily across countries and regions including China, Australia, the U.S., Korea, and Latin America. The program has also received ODD from both the FDA and the European Commission (EC), reinforcing its strong global development potential. Meanwhile, the combination of HLX07 and serplulimab has demonstrated promising clinical activity in EGFR-high squamous non-small cell lung cancer, opening new possibilities for precision lung cancer treatment. During the conference, Henlius also shared a “pipeline panorama” outlining its diversified early-stage R&D strategy. The company is currently advancing more than 50 early-stage programs with global competitiveness across multiple technology platforms, including fusion proteins, ADCs, and small molecules. By continuously expanding its early-stage portfolio, Henlius is building a sustainable and internationally oriented innovation engine. Henlius is accelerating its growth under a dual strategy of continuous innovation and global expansion. With strong commercial execution and a forward-looking pipeline, the company is steadily progressing toward its vision of becoming a “globally deployed, innovation-driven international biopharmaceutical enterprise.” Dr. Zhu concluded, “Henlius is actively embracing global opportunities and advancing innovation and commercialization in line with international standards. By engaging closely with the global capital market and industry peers, we aim to further demonstrate Henlius’ innovation-powered global competitiveness and, through greater openness and collaboration, bring more affordable treatment options to patients around the world.” 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. To date, 10 products have been approved for marketing across multiple countries and regions, and 3 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, denosumab Bildyos® and Bilprevda®, and pertuzumab Poherdy®. 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