HLX-22

近日，在第63届日本癌症治疗学会学术集会（JSCO）期间，复宏汉霖于日本横滨成功召开“共创新境 · Henlius Japan Reception 2025”专家交流会。本次活动汇聚了来自中国与日本肺癌及消化道肿瘤领域的多位临床研究者及合作伙伴，包括中国中山大学肿瘤防治中心肿瘤内科刘俊玲、日本横滨市立大学附属市民综合医疗中心消化系统疾病中心诹访雄亮、日本国立癌症研究中心中央医院消化内科平野秀和。与会者围绕公司“惠及全球患者”的愿景及自主研发的创新管线布局等议题展开了深入交流，重点探讨了包括PD-1抑制剂H药 汉斯状 （斯鲁利单抗，欧洲商品名：Hetronifly ）、潜在同类最优的PD-L1 ADC HLX43和新表位抗HER2单抗HLX22在内的多款核心创新产品。 落子核心市场，加速全球布局 复宏汉霖是一家国际化创新生物制药企业，始终致力于为全球患者提供高品质的创新生物药。公司已建立覆盖从研发到商业运营全产业链的自主核心能力，在全球获批上市9款产品，触达约60个国家和地区，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲。继深入美国、欧洲等市场后，复宏汉霖持续深化对日本这一核心医药市场的战略布局，为公司创新产品的海外拓展注入新动能。 复宏汉霖日本市场负责人、药政事务部副总裁李锦表示：“我们选择布局日本市场，不仅因其作为全球第四大医药市场的战略地位与规范环境，也着眼于其与中国在疾病谱上的相似性，这为临床数据的应用与产品开发提供了独特优势。目前，我们已在日本组建临床运营、质量、药政注册等核心团队，并正在积极获取日本上市许可持有人（MAH）资质。公司将全力推动创新产品在日本的注册与临床进程，力争早日惠及当地患者。” 复宏汉霖全球产品开发部副总裁李靖表示：“我们希望通过前瞻性布局差异化适应症，系统性地推动治疗范式的革新。HLX22旨在实现HER2阳性胃癌的精准突破；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，并有望联合多种治疗方案进一步探索在多种实体瘤中的治疗潜力；而H药更是在小细胞肺癌、胃癌围术期等领域创造了多个‘全球首个’临床里程碑。我们希望通过深刻改变现有治疗格局，让更多患者有机会获得长期生存。” 引领免疫治疗新范式， H药临床价值获国际认可 在本次交流活动中，多位中日临床专家围绕公司在肺癌及结直肠癌、胃癌等亚洲高发癌种领域的创新进展进行了深入探讨。其中，H药在肺癌和胃癌领域皆斩获全球突破性进展，是全球首个一线治疗广泛期小细胞肺癌的抗PD-1单抗，其胃癌围术期III期临床研究也于近日达到主要终点，成为全球首个胃癌围术期以免疫单药取代术后辅助化疗的治疗方案，广受业界瞩目。其卓越的临床数据与独特的治疗地位也赢得了与会专家的高度评价。 中国中山大学肿瘤防治中心肿瘤内科刘俊玲表示，“H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的III期临床研究ASTRUM-005四年总生存率（OS）达到21.9%，亚洲人群达22.4%，印证了其持久的生存获益。此外，中国ES-SCLC领域样本量最大的真实世界研究ASTRUM-005R显示，纳入的635例患者中位真实世界无进展生存期（rwPFS）为8.2个月，中位OS达17.2个月，再次验证了H药在临床实践中的卓越疗效。我们期待这样优秀的中国创新药能够造福更多全球患者。” 日本横滨市立大学附属市民综合医疗中心消化系统疾病中心诹访雄亮表示，“目前全球尚无覆盖pMMR/MSS型mCRC患者的一线免疫疗法获批，该患者群体存在巨大的未满足临床需求，我们对有望填补这一空白的斯鲁利单抗寄予厚望。现有试验证据表明，入组患者预后良好，毒副作用可控。” 日本国立癌症研究中心中央医院消化内科平野秀和表示，“斯鲁利单抗在胃癌围术期的探索，其核心在于尝试以免疫单药取代传统的术后辅助化疗，有望成为一种兼具卓越疗效及良好耐受性的治疗方案。这堪称一次‘范式转变’，将重塑胃癌围术期辅助治疗理念。我们对其后续进展充满期待。” 本次活动的圆满落幕，不仅展示了复宏汉霖在前沿领域的创新布局，更昭示了其作为中国药企的全球视野与担当。未来，公司将继续深化与国际伙伴的协作，将源自中国的智慧成果带向世界，为全球肿瘤治疗格局开创新境，不负“惠及全球患者”的坚定承诺。

近日，在第63届日本癌症治疗学会学术集会（JSCO）期间，复宏汉霖于日本横滨成功召开“共创新境 · Henlius Japan Reception 2025”专家交流会。本次活动汇聚了来自中国与日本肺癌及消化道肿瘤领域的多位临床研究者及合作伙伴，包括中国中山大学肿瘤防治中心肿瘤内科刘俊玲、日本横滨市立大学附属市民综合医疗中心消化系统疾病中心诹访雄亮、日本国立癌症研究中心中央医院消化内科平野秀和。与会者围绕公司“惠及全球患者”的愿景及自主研发的创新管线布局等议题展开了深入交流，重点探讨了包括PD-1抑制剂H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、潜在同类最优的PD-L1 ADC HLX43和新表位抗HER2单抗HLX22在内的多款核心创新产品。 落子核心市场，加速全球布局 复宏汉霖是一家国际化创新生物制药企业，始终致力于为全球患者提供高品质的创新生物药。公司已建立覆盖从研发到商业运营全产业链的自主核心能力，在全球获批上市9款产品，触达约60个国家和地区，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲。继深入美国、欧洲等市场后，复宏汉霖持续深化对日本这一核心医药市场的战略布局，为公司创新产品的海外拓展注入新动能。 复宏汉霖日本市场负责人、药政事务部副总裁李锦表示：“我们选择布局日本市场，不仅因其作为全球第四大医药市场的战略地位与规范环境，也着眼于其与中国在疾病谱上的相似性，这为临床数据的应用与产品开发提供了独特优势。目前，我们已在日本组建临床运营、质量、药政注册等核心团队，并正在积极获取日本上市许可持有人（MAH）资质。公司将全力推动创新产品在日本的注册与临床进程，力争早日惠及当地患者。” 复宏汉霖全球产品开发部副总裁李靖表示：“我们希望通过前瞻性布局差异化适应症，系统性地推动治疗范式的革新。HLX22旨在实现HER2阳性胃癌的精准突破；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，并有望联合多种治疗方案进一步探索在多种实体瘤中的治疗潜力；而H药更是在小细胞肺癌、胃癌围术期等领域创造了多个‘全球首个’临床里程碑。我们希望通过深刻改变现有治疗格局，让更多患者有机会获得长期生存。” 引领免疫治疗新范式， H药临床价值获国际认可 在本次交流活动中，多位中日临床专家围绕公司在肺癌及结直肠癌、胃癌等亚洲高发癌种领域的创新进展进行了深入探讨。其中，H药在肺癌和胃癌领域皆斩获全球突破性进展，是全球首个一线治疗广泛期小细胞肺癌的抗PD-1单抗，其胃癌围术期III期临床研究也于近日达到主要终点，成为全球首个胃癌围术期以免疫单药取代术后辅助化疗的治疗方案，广受业界瞩目。其卓越的临床数据与独特的治疗地位也赢得了与会专家的高度评价。 中国中山大学肿瘤防治中心肿瘤内科刘俊玲表示，“H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的III期临床研究ASTRUM-005四年总生存率（OS）达到21.9%，亚洲人群达22.4%，印证了其持久的生存获益。此外，中国ES-SCLC领域样本量最大的真实世界研究ASTRUM-005R显示，纳入的635例患者中位真实世界无进展生存期（rwPFS）为8.2个月，中位OS达17.2个月，再次验证了H药在临床实践中的卓越疗效。我们期待这样优秀的中国创新药能够造福更多全球患者。” 日本横滨市立大学附属市民综合医疗中心消化系统疾病中心诹访雄亮表示，“目前全球尚无覆盖pMMR/MSS型mCRC患者的一线免疫疗法获批，该患者群体存在巨大的未满足临床需求，我们对有望填补这一空白的斯鲁利单抗寄予厚望。现有试验证据表明，入组患者预后良好，毒副作用可控。” 日本国立癌症研究中心中央医院消化内科平野秀和表示，“斯鲁利单抗在胃癌围术期的探索，其核心在于尝试以免疫单药取代传统的术后辅助化疗，有望成为一种兼具卓越疗效及良好耐受性的治疗方案。这堪称一次‘范式转变’，将重塑胃癌围术期辅助治疗理念。我们对其后续进展充满期待。” 本次活动的圆满落幕，不仅展示了复宏汉霖在前沿领域的创新布局，更昭示了其作为中国药企的全球视野与担当。未来，公司将继续深化与国际伙伴的协作，将源自中国的智慧成果带向世界，为全球肿瘤治疗格局开创新境，不负“惠及全球患者”的坚定承诺。 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。 On Site at JSCO | Henlius Advances Treatment Innovations in High-Incidence Cancers Across Asia Recently, during the 63rd Annual Meeting of the Japan Society of Clinical Oncology (JSCO), Henlius successfully hosted the “Bridging Horizons · Henlius Japan Reception 2025” expert exchange symposium in Yokohama, Japan. The event brought together leading clinical researchers and partners from both China and Japan in the fields of lung cancer and gastrointestinal tumors, including Prof. Liu Junling from the Sun Yat-sen University Cancer Center, Dr. Yusuke Suwa from the Yokohama City University Medical Center, and Dr. Hidekazu Hirano from the National Cancer Center Hospital (Tokyo). The participants held in-depth discussions around Henlius’ vision of “benefiting patients worldwide,” focusing on its self-developed innovative biologics pipeline, including the PD-1 inhibitor HANSIZHUANG (serplulimab, Europe trade name: Hetronifly®), the potential best-in-class PD-L1 ADC HLX43, and the novel epitope anti-HER2 monoclonal antibody HLX22. Strengthening Presence in Core Global Markets Henlius is a global biopharmaceutical company committed to delivering high-quality, innovative biologics to patients around the world. With fully integrated capabilities spanning from R&D to commercial operations, the Company has launched 9 products worldwide, reaching approximately 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania. Following its expansion into the U.S. and Europe, Henlius is now accelerating its strategic deployment in Japan — one of the world’s most mature healthcare markets — injecting new momentum into the global rollout of its innovative therapies. Ms. Jin Li, Head of Japan Market & Vice President of Regulatory Affairs at Henlius remarked, “We chose Japan not only for its strategic position as the world’s fourth-largest pharmaceutical market with well-established regulatory systems, but also because of its shared disease profiles with China — a unique advantage for clinical data utilization and product development. We have already established core teams in clinical operations, quality, and regulatory affairs in Japan and are actively pursuing Marketing Authorization Holder (MAH). Henlius will spare no effort to advance regulatory filings and clinical development in Japan, striving to bring our innovative therapies to local patients as early as possible.” Mr. Jing Li, Vice President of Global Product Development at Henlius added, “Our strategy is to proactively target differentiated indications that can fundamentally reshape treatment paradigms. For example, HLX22 is designed to precisely address HER2-positive gastric cancer; our potential best-in-class PD-L1 ADC HLX43 shows broad anti-tumor potential with high efficacy, low toxicity, and inherent I/O functionality, and may unlock further benefits in combination regimens across various solid tumors. Meanwhile, serplulimab has already set multiple global clinical milestones in small cell lung cancer and perioperative gastric cancer. By deeply transforming the current treatment landscape, we want to enable more patients to achieve long-term survival.” Serplulimab Gains Strong Expert Backing During the event, Chinese and Japanese clinical experts shared their perspectives on Henlius’ progress in lung cancer, colorectal cancer, gastric cancer and other high-incidence cancers in Asia. Serplulimab has achieved several global breakthroughs: it is the world’s first anti-PD-1 monoclonal antibody approved as first-line therapy for extensive-stage small cell lung cancer, and the only anti-PD-1 monoclonal antibody to succeed in a phase 3 perioperative gastric cancer trial. Its recent achievement of the primary endpoint in the perioperative gastric cancer phase 3 study has drawn widespread attention. Serplulimab's robust clinical performance and unique positioning in these indications have earned high recognition from attending experts.  Prof. Liu Junling remarked, “In the phase 3 ASTRUM-005 study of serplulimab plus chemotherapy as first-line treatment for ES-SCLC, the 4-year overall survival (OS) rate reached 21.9%, and 22.4% in Asian patients, demonstrating durable survival benefits. Moreover, ASTRUM-005R — the largest real-world study in China for ES-SCLC to date — showed a median real-world PFS of 8.2 months and median OS of 17.2 months among 635 patients, once again validating its strong clinical efficacy. We look forward to seeing this outstanding Chinese innovation benefit more patients globally.” Dr. Yusuke Suwa commented, “There is currently no available PD-1 antibody for pMMR/MSS-type mCRC, leaving a significant unmet need in this population. We see serplulimab as a promising candidate to bridge this gap. So far, the enrolled patients have shown encouraging prognosis with manageable toxicities.” Dr. Hidekazu Hirano added, “Serplulimab’s exploration in perioperative gastric cancer is pioneering in its attempt to replace traditional postoperative chemotherapy with immunotherapy monotherapy. It has the potential to deliver both superior efficacy and better tolerability. This is nothing short of a paradigm shift, and we are eager to see how the data evolves.” The success of the event reflects not only Henlius’ robust innovation pipeline in cutting-edge therapeutic areas but also its global vision and commitment as a leading Chinese biopharmaceutical company. Moving forward, Henlius will continue to deepen international collaboration, bringing scientific innovations from China to the world, and steadfastly advancing its mission to “benefit 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