Denosumab biosimilar(Shanghai Henlius)

10月28日，复星医药交出的三季报简直是医药界的“狂飙猛涨”。创新药品收入突破67亿元，同比增长18.09%，这不单是几个数据的堆砌，而是复星医药手握全球化研发与商业化能力的硬核证明。一家国产药企不仅在国内市场拿下乳腺癌适应症，还直接让地舒单抗注射液登上美国和欧盟的舞台。看着这些数据，不得不感慨一句：国产药企，真的站起来了！ 复星医药在财报中亮出的“金字招牌”，不仅让投资者眉开眼笑，也给业内注入了不小的震动。前三季度，公司营业收入达到近294亿元，归母净利润稳稳窜上25亿大关，分别同比增长25.5%。更是靠着33.82亿元的现金流背书，再一次向市场传递了它不仅是靠数据亮眼，更是经营质量名副其实。换句话说，复星那手“创新驱动战略”，是真的玩出了自己的风格。 翻看这一季的成绩单，无论是国产创新药“走向世界”，还是国内新适应症接连获批，复星都一步步构筑起自己的医药帝国版图。尤其是它的首款海外获批的国产生物类似药地舒单抗，正是一个教科书版的案例——国产品牌不再满足做“跟随者”，而是大胆做“超越者”。试想，国产药企曾被外企压制多年，如今硬生地挤入国际市场，不就是给全球医药巨头“摆了个场子”？这才是中国药企硬核出海的意义所在。 与此同时，复星在中国市场持续深耕，“呵护”乳腺癌患者的CDK4/6抑制剂复妥宁®，拿下新适应症直接丰富了治疗选择。更别提那款CAR-T产品布瑞基奥仑赛，一出现就让国内细胞治疗界眼前一亮。而汉斯状®在胃癌围术期治疗研究中更是拿出全球级别的突破——以免疫单药取代术后的化疗。这一波波扎实的研发进展简直就是生物医药界告诉全世界的最强音：国产研发，解决痛点，搞出硬科技！ 数据背后，另一面是研发的持续投入。据财报显示，复星医药前三季度的总投入高达39.98亿元，同比增长2.12%。这絮絮叨叨的数字放在其它领域可能没什么感觉，但在药研发，特别是核药、细胞治疗、靶向抗体的全球多中心临床研究上，这是实实在在的“烧钱”。然而，投入不仅仅只是钱上的事，更是人才和模式的事。8月份，复星发了个10亿元中长期科技创新债，也给自己核心团队上了股权激励计划，为的就是绑紧那些能够创造未来的“药创新智囊”。 严格意义上，复星医药的这份财报不仅是对自己的交代，更是对国内药企市场的一次综合提振。它告诉整个市场，不靠炒概念、不玩空壳，靠硬研发、走全球化、谋长远战略，就是一条能玩的出路。那些一味追求速效和市值泡沫的企业，看完这些，是不是应该坐下来，好好琢磨琢磨怎么把核心产品做实，让模式扎根？ 最后，再回头看看国内医药市场，难道我们不能问一句：都有复星这样的企业拼命开路了，其他跟随者还甘心只跟着看风向么？创新药的每一次突破，不只是盐酸与单抗的分子式堆叠，而是真正在“救命”这个朴素但深刻的需求上做文章。所以问题来了，中国医药究竟能不能飞得更高？答案或许就在复星式的创新里！

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