Rituximab biosimilar(Intas Biopharmaceuticals Ltd.)

10月28 - 30日，2025世界制药原料展（CPHI Worldwide）在德国法兰克福国际会展中心（Messe Frankfurt）举行。复宏汉霖在3.1A92展台成功呈现了其多元化的产品管线与领先技术平台，吸引了众多国际专业人士驻足交流，并参与了70多场会面。 左右滑动查看更多 复宏汉霖高级副总裁、首席商务发展官曹平女士表示：“CPHI Worldwide作为全球制药行业最具影响力的专业展会之一，汇聚了业界顶尖企业及专家，为我们提供了深度参与技术前沿探讨、拓展行业资源的重要平台。借助此次机会，复宏汉霖进一步深化了全球合作网络，发掘了更多潜在伙伴，我们也将持续借助国际合作推动生物制药创新，致力于让高品质、可负担的药物惠及全球患者。” 在展会现场，复宏汉霖系统展示了其丰富的研发管线，包括已实现中美欧三地获批的汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、全球首个获批用于小细胞肺癌一线治疗的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、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®与Bilprevda®等9款上市产品。在研核心产品如HLX43（PD-L1 ADC）、HLX22（新表位HER2单抗）和HLX07（抗EGFR单抗）也吸引了广泛关注。此外，复宏汉霖Henozye®为代表的新一代重组人透明质酸酶技术平台在展会中也备受瞩目，成为探讨合作的焦点。该平台凭借卓越的酶稳定性和广泛的相容性，有望为多类分子的高浓度皮下制剂及共制剂开发提供高效的解决方案，显著延长产品的生命周期价值和用药便捷性。展会期间，复宏汉霖参展团队与多家企业代表开展了多轮富有成效的洽谈，为后续合作奠定了坚实基础。 通过携手具备丰富商业化经验的合作伙伴，复宏汉霖正持续加快其产品在全球主流市场与新兴国家的布局。今年以来，公司携手Dr. Reddy’s，共同推进抗CD38抗体HLX15的临床阶段研发；与Lotus就抗PD-1单抗 H药在韩国多项适应症达成独家商业化和半独家开发合作；并与Sandoz达成协议，推动抗CTLA-4抗体HLX13在美、欧、日等主流市场的商业化进程。公司亦与Accord、Eurofarma、Organon等国际合作伙伴通力协作，加速推进多款产品在全球范围内的上市注册进程，共同推动中国生物医药创新成果的全球化发展。 展望未来，复宏汉霖将持续深化创新，并协同全球合作伙伴，将更多高品质、可负担的治疗方案加速惠及全球患者。 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 Shines at CPHI 2025: Accelerating Global Access to China’s Biopharma Innovations From October 28 to 30, the CPHI Worldwide 2025 was held at Messe Frankfurt in Germany. Henlius showcased its robust biologic pipeline and advanced R&D platform at booth #3.1A92. Henlius drew a large crowd at the booth and concluded the conference with over 70 meetings. Ping Cao, Senior Vice President and Chief Business Development Officer at Henlius, stated, “As one of the most influential events in the global pharmaceutical industry, CPHI Worldwide convenes leading enterprises and experts from across the sector, serving as a key platform for in-depth engagement in cutting-edge technological discourse and strategic expansion of resources. Leveraging this opportunity, Henlius has further strengthened its global collaboration network and identified several potential partners. The company remains committed to advancing biopharmaceutical innovation through international cooperation and to delivering high-quality, affordable therapeutics to patients worldwide.” At the conference, Henlius provided a comprehensive overview of its robust R&D pipeline, including HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab Bildyos® and Bilprevda®. In addition, core underdevelopment innovative products such as HLX43 (PD-L1 ADC), HLX22 (novel enpitope anti-HER2 mAb), and HLX07 (anti-EGFR mAb), have also attracted widespread attention. In addition, Henlius’ advanced platform, exemplified by Henozye®, proprietary next-generation recombinant human hyaluronidase platform, attracted significant attention at the exhibition and emerged collaboration discussions. Leveraging its exceptional enzyme stability and broad compatibility, the platform is poised to deliver efficient solutions for the development of high-concentration subcutaneous formulations and co-formulations across diverse therapeutic molecules, thereby enhancing product lifecycle value and improving patient convenience in drug administration. Throughout the event, Henlius team engaged in multiple rounds of productive discussions with representatives from numerous global biopharmaceutical companies, establishing a strong foundation for future partnerships. Henlius is accelerating the global expansion of its products by partnering with experienced commercialization companies. Recently, the company has collaborated with Dr. Reddy’s to advance the clinical development of the anti-CD38 antibody HLX15, granted Lotus exclusive license for the commercialization and co-exclusive for the development of HANSIZHUANG, and reached an agreement with Sandoz to promote the commercialization of the ipilimumab biosimilar HLX13 in key markets including the US, Europe, and Japan. Henlius is also working closely with Accord, Eurofarma, Organon, and other international partners to speed up the registration and launch of multiple products worldwide, driving the global reach of China’s biopharmaceutical innovations. Looking ahead, Henlius will continue to advance innovation and strengthen collaboration with global partners to accelerate the global delivery of high-quality, affordable treatment options 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

欧洲与印度首张处方先后开出：从“监管许可”走向“临床可及”的关键一步，彰显中国创新药企的全球落地实力 快速惠及患者：H药在印度上市仅12天，就已有150余位患者接受用药，显示出市场对其临床价值与差异化优势的高度认可 全球可及版图持续拓展：H药已在近40个国家和地区获批，惠及逾12万名患者，“让高质量生物药惠及全球患者”的愿景正在加速实现 近期，复星医药子公司复宏汉霖自主研发和生产的抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲与印度商品名：Hetronifly®）先后在欧洲德国和印度开出首张处方，标志着这款中国原研创新药在欧洲及全球人口第一大国[1]均实现临床使用。这一进展不仅为当地患者带来了新的治疗选择，也彰显了中国创新药企在全球落地的执行力与生命力。 复宏汉霖首席商务发展官兼高级副总裁 曹平表示 欧洲与印度首张处方的开出，意味着H药已在更多海外市场实现了快速落地。我们将始终以解决全球患者的临床需求为中心，持续深化与全球合作伙伴的高效协同，把更多高品质、可负担的创新药物带给更多患者，切实提升其用药可及性，让中国创新真正造福世界。 Intas全球商务发展与战略高级副总裁Alex Falgas表示：“H药在欧洲和印度开出首张处方，是Accord与Intas的重要里程碑，充分体现了我们将创新疗法快速带给患者的能力。凭借在肿瘤学、市场准入和患者触达方面的深厚经验，我们成功将复宏汉霖的科学创新转化为这两大关键市场的可及治疗方案。这一成果进一步巩固了Accord与Intas作为全球可信赖合作伙伴的地位，并彰显了我们致力于提升高质量、改变生命的药物可及性的承诺，为患者生活带来切实改变。” 欧洲与印度首张处方开出 迈出临床可及关键一步 2025年上半年，H药先后获得欧盟委员会（EC）和印度中央药品标准控制组织（CDSCO）批准，用于一线治疗广泛期小细胞肺癌（ES-SCLC）成人患者，成为首个在上述地区获批上市、用于该适应症的抗PD-1单抗。近期，德国与印度也先后开出了H药的首张处方。H药在欧洲和印度的顺利落地，得益于复宏汉霖与合作伙伴Intas及其子公司Accord Healthcare的高效协作。作为区域市场商业化主导方，Intas与Accord Healthcare分别负责印度和欧洲市场的准入、定价与渠道部署，复宏汉霖提供全链条生产与跨境供应支持。 根据欧洲肿瘤内科学会（ESMO）临床获益量表（MCBS），H药在ES-SCLC的治疗中获得了 4 分——这是目前该适应症已评估药物中的最高分，充分证明了其在改善生存和生活质量方面的显著临床获益。该评分是基于国际多中心Ⅲ期临床研究 ASTRUM-005 的结果。该研究的最终分析结果已在2025年美国肿瘤学会（ASCO）年会上公布。长期随访数据显示（中位随访时间42.4个月），H药组4年OS率达21.9%，对照组为7.2%，且安全性可控。 全球战略 持续拓展创新药可及版图 作为复宏汉霖全球化战略的代表产品，H药是全球首个获批一线治疗ES-SCLC的抗PD-1单抗，目前已在中国、英国、德国、印度、印度尼西亚、新加坡等近40个国家和地区获批上市，惠及逾12万名患者，并先后获得美国食品和药品监督管理局（FDA）、欧盟委员会（EC）、瑞士药品监督管理局（Swissmedic）授予的孤儿药资格，并获韩国食品药品安全部（MFDS）授予用于ES-SCLC的孤儿药资格。与此同时，公司正积极推进H药在全球更多市场的注册与临床布局。在美国和日本，H药分别在开展对比一线标准治疗的桥接试验，以进一步支持其上市申报。 此次H药欧洲和印度首例处方的落地不仅标志着公司首款自研自产创新药在主流生物药市场完成“从研发到获批、从上市到使用”的全链条闭环，也为公司后续多款创新产品的国际化提供了可复制经验。目前，公司正积极协同合作伙伴，推动H药在更多国家及地区的准入和处方覆盖，加速实现“让高质量生物药惠及全球患者”的愿景。 参考文献 [1] UNFPA (United Nations Population Fund), 2025. “The Real Fertility Crisis: The pursuit of reproductive agency in a changing world.” ¬State of World Population 2025. New York: UNFPA. ISBN: 9789211542837 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，已有6款产品在中国获批上市，4款产品在国际获批上市，6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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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’ Serplulimab Prescribed for the First Time in Both Europe and India, Marking a Milestone Toward Global Accessibility First prescriptions in Europe and India: From regulatory approval to clinical accessibility, demonstrating the global execution and vitality of Chinese biopharma innovation Benefiting patients rapidly: Within just 12 days of launch in India, more than 150 patients have already received treatment with serplulimab, reflecting strong market recognition of its clinical value and differentiated advantages Expanding global footprint: Serplulimab has been approved in over 40 countries and regions, benefiting more than 120,000 patients. Henlius’ mission to deliver high-quality biologics to patients around the world is being realized at an accelerated pace Shanghai Henlius Biotech, Inc. (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab was recently prescribed for the first time in both Europe and India. This milestone marks that this Chinese innovative biologic is now in clinical use in Europe as well as the world’s most populous country[1], further accelerating the global accessibility of innovative biologics. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said:“The first prescriptions in Europe and India demonstrate that serplulimab has rapidly achieved clinical rollout across diverse overseas markets. We remain committed to addressing global patient needs, strengthening efficient collaborations with our partners, and delivering more high-quality, affordable innovative medicines to patients worldwide—ensuring Chinese innovation benefits the world.” Alex Falgas, Global SVP - BD Portfolio & Strategy of Intas said: “The first prescriptions of Hetronifly® in Europe and India mark a proud and significant milestone for Accord and Intas, showcasing our ability to swiftly bring innovative therapies to patients. By combining our strong expertise in oncology, market access, and patient reach, we have transformed Henlius’ scientific innovation into real-world treatment options across two critical regions. This accomplishment reinforces Accord and Intas’ position as trusted global partners in expanding access to high-quality, life-changing medicines which will have a real impact on patients’ lives.” First Prescriptions in Europe and India: A Key Step Toward Clinical Accessibility In the first half of 2025, serplulimab received approvals from both the European Commission (EC) and the Central Drugs Standard Control Organization (CDSCO) of India for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), becoming the first anti-PD-1 monoclonal antibody approved for this indication in these regions. Recently, the first prescriptions of serplulimab were issued in Germany and India, marking its official entry into clinical use. The successful rollout in both regions was made possible through Henlius’ efficient collaboration with partner Intas and its subsidiary Accord Healthcare. Intas and Accord Healthcare are responsible for market access, pricing, and distribution in India and Europe respectively, while Henlius provides end-to-end production and cross-border supply support. According to the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS), serplulimab received a score of 4 for the treatment of ES-SCLC—the highest among evaluated therapies for this indication—demonstrating its significant clinical benefit in prolonging survival and improving quality of life. The score is based on results from the ASTRUM-005 study, an international multi-centre Phase 3 study. The final analysis of the study was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Long-term follow-up data (median follow-up: 42.4 months) showed a 4-year overall survival (OS) rate of 21.9% in the serplulimab arm versus 7.2% in the control arm, with a manageable safety profile. Global Strategy: Expanding the Accessibility of Innovative Biologics As a key asset in Henlius’ globalization strategy, serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of ES-SCLC. It has been approved in over 40 countries and regions, including China, the U.K., Germany, India, Indonesia, and Singapore, benefiting more than 120,000 patients worldwide. It has received orphan drug designations for small cell lung cancer from the U.S. Food and Drug Administration (FDA), the EC, the Swiss Agency for Therapeutic Products (Swissmedic), and the Korean Ministry of Food and Drug Safety (MFDS) for ES-SCLC. Henlius is actively advancing the registration and clinical development of serplulimab in additional markets. In the U.S. and Japan, independent bridging studies comparing serplulimab to the current first-line standard of care, are underway to support respective regulatory filings. The first prescriptions in Europe and India mark the completion of a full-cycle success—research, approval, launch, and clinical use—of Henlius’ first self-developed and -manufactured innovative biologic in major pharmaceutical markets. These achievements set a replicable precedent for the company’s other innovative assets as they advance toward international markets. Henlius is working closely with its partners to expand market access and prescription coverage in more countries and regions, accelerating its mission to deliver high-quality biologics 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. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 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 HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.