Pertuzumab Biosimilar (Henlius)

上证报中国证券网讯（记者 何昕怡）8月25日，复星医药披露2026年中期业绩。报告期内，公司实现营收204.42亿元，同比增长4.75%；归母净利润17.21亿元，同比增长1.15%；归母扣非净利润11.44亿元、同比增长19.09%；经营活动产生的现金流量净额为24.24亿元，同比增长13.59%；研发总投入32.47亿元，同比增长25.66%。 今年上半年，创新与国际化成为驱动复星医药业绩增长的核心引擎。创新药品收入49.11亿元、同比增长13.84%，占制药业务收入比重达33.21%，同比提升2.17个百分点。 具体来看，报告期内，复星医药创新药品进入密集获批兑现期，共有7个创新药品共20项适应症于境内外获批上市，在肺癌、乳腺癌、消化道肿瘤等实体瘤领域，多产品协同、全球商业化已形成差异化竞争优势。 其中，H药汉斯状（斯鲁利单抗）于中国新增胃癌围术期适应症，于欧盟新增获批一线治疗鳞状非小细胞肺癌、食管鳞癌、非鳞状非小细胞肺癌三项适应症；截至目前，H药已在全球约50个国家和地区上市，并被纳入英国、德国、意大利、西班牙和瑞典等12个国家医保或公共支付体系；汉倍优（帕妥珠单抗）接连在欧盟、中国获批上市；复迈宁（芦沃美替尼片）新增获批2岁及2岁以上经系统治疗后复发/难治的朗格汉斯细胞组织细胞增生症儿童及青少年适应症，填补国内临床空白。 复星医药神经退行性疾病领域诊疗一体化布局不断夯实。甘露特钠胶囊于中国境内的上市后确证性临床稳步推进，截至2026年7月31日累计入组超1000例，超过计划入组例数的50%。帕金森病在研药物HT001已在澳大利亚启动I期临床。与此同时，“磁波刀”临床应用与相关诊断试剂的研发有序推进。 作为国内较早实现全球化布局的制药企业，复星医药正从“产品出海”向“体系出海”持续升级，在研发、注册、生产、商业化等维度持续深化国际化能力。 对外授权方面，控股子公司复宏汉霖就斯鲁利单抗注射液先后与卫材、雅培达成战略合作：授予卫材在日本及约定领域的开发、生产及独家商业化权利；授予雅培在亚洲、中东、非洲及东欧共42个国家和地区的独家商业化许可，加速自主创新成果的全球化落地。 许可引进方面，复星医药与AriBio就阿尔茨海默病在研药物AR1001达成全球独家选择权合作，在原有中国及东南亚区域权益基础上，有权进一步拓展至美国、欧洲、日本等全球核心市场，并将作为该产品对应区域的上市许可持有人。目前AR1001用于治疗早期阿尔茨海默病的国际多中心III期临床试验已完成最后一位患者的最后一次访视，顶线数据将于2026年内公布。

（2026年8月25日，中国上海）8月25日，复星医药（600196.SH；02196.HK）公布2026年中期业绩。2026年上半年，复星医药营收人民币204.42亿元，同比增长4.75%，按恒定汇率口径计算，营业收入同比增长7.17%；归母扣非净利润11.44亿元、同比增长19.09%，利润增速持续优于营收表现，盈利质量持续优化。经营活动产生的现金流量净额为24.24亿元，同比增长13.59%。 创新与国际化成为驱动业绩增长的核心引擎：创新药品收入49.11亿元、同比增长13.84%，占制药业务收入比重达33.21%、同比提升2.17个百分点；中国大陆以外地区和其他国家业务收入63.79亿元，同比增长16.45%，占营业收入比重达31.21%、同比提升3.14个百分点，收入结构持续优化。 聚焦核心治疗领域 加速创新药临床转化 复星医药坚持以临床价值为导向，聚焦肿瘤、免疫炎症、神经退行性疾病三大核心治疗领域，并同步拓展CVRM(心血管、肾及代谢)、抗感染、罕见病等领域，通过自主研发、合作开发、许可引进、基金孵化、产业投资等开放式创新体系，加速临床转化，持续推进创新转型。 2026年上半年，复星医药研发总投入32.47亿元，同比增长25.66%；其中，创新药品相关研发投入占研发总投入的81.61%，主要投入HLX43、HLX22、GR1803、FXR0906等管线，以及新一代小分子药物、核药等前沿技术平台。 报告期内，复星医药创新药品进入密集获批兑现期，共有7个创新药品共20项适应症于境内外获批上市，在肺癌、乳腺癌、消化道肿瘤等实体瘤领域，多产品协同、全球商业化已形成差异化竞争优势。汉利康®（利妥昔单抗）、汉曲优®（曲妥珠单抗）、奥康泽®等产品稳居细分市场领先地位，持续贡献稳定现金流。 2026年上半年，H药汉斯状®（斯鲁利单抗）于中国境内新增胃癌围术期适应症，填补了全球临床空白；于欧盟新增获批一线治疗鳞状非小细胞肺癌、食管鳞癌、非鳞状非小细胞肺癌三项适应症；截至目前，H药已在全球约50个国家和地区上市，并被纳入英国、德国、意大利、西班牙和瑞典等12个国家医保或公共支付体系。汉倍优（帕妥珠单抗）接连在欧盟、中国获批上市，与汉曲优®、汉奈佳®、复妥宁®等乳腺癌领域创新产品协同放量。复迈宁®（芦沃美替尼片）新增获批2岁及2岁以上经系统治疗后复发/难治的朗格汉斯细胞组织细胞增生症（LCH）儿童及青少年适应症，填补国内临床空白。 与此同时，公司多款创新药品上市申请获受理，高效推进重点管线的国际多中心临床研究，为后续商业化增长持续注入动力。ALK抑制剂SAF-189（丁二酸复瑞替尼胶囊）用于非小细胞肺癌的上市申请已获国家药监局受理；复迈宁®治疗丛状神经纤维瘤的I型神经纤维瘤病成人适应症上市申请获国家药监局受理并纳入优先审评；BCMA×CD3双特异性抗体纬利妥米单抗（GR1803）用于多发性骨髓瘤的上市申请已获受理。重点在研资产HLX43、HLX22国际多中心研究同步推进，覆盖中美欧澳日等多个国家和地区，其中，HLX43作为潜在同类最优的广谱抗肿瘤PD-L1ADC，在非小细胞肺癌等多个实体瘤中已展现出“高效、低毒”的初步临床疗效。 在免疫炎症领域，公司加强自研的同时通过BD合作持续丰富管线，获授予偌考奇拜单抗（抗IL-17A单抗）于中国境内及港澳台地区的开发、生产及商业化权利；补体抑制剂 FXS6837用于治疗IgA肾病等补体异常激活相关肾小球疾病于中国境内启动IIb期临床试验；DPP1抑制剂FXS7553针对非囊性纤维化支气管扩张症及慢阻肺的两项适应症于中国境内均处于II期临床阶段。 神经退行性疾病领域诊疗一体化布局不断夯实。甘露特钠胶囊于中国境内的上市后确证性临床稳步推进，截至2026年7月31日累计入组超1,000例，超过计划入组例数的50%。帕金森病在研药物HT001已在澳大利亚启动I期临床。与此同时，“磁波刀”临床应用与相关诊断试剂的研发有序推进。 复星医药坚持以循证医学为导向，报告期内，复星医药的3个在研创新药管线的临床研究成果入选2026 ASCO年会口头报告，包括复迈宁®NF1成人III期研究、斯鲁利单抗注射液胃癌围术期III期研究及HLX43非小细胞肺癌临床研究；另有10项研究入选2026 ASCO年会壁报展示，其中包括复妥宁®两项Ⅲ期研究数据、HLX43在鼻咽癌中的研究等。在《柳叶刀》《自然医学》等全球顶级期刊及全球行业学术会议持续输出高质量临床成果，为产品的国际注册与商业拓展提供坚实学术支撑。 深度国际化 全球化能力加速创新价值兑现 作为国内较早实现全球化布局的制药企业，复星医药正从“产品出海”向“体系出海”持续升级，在研发、注册、生产、商业化等维度持续深化国际化能力，加速创新药品在全球商业化的价值兑现。 对外授权方面，控股子公司复宏汉霖就斯鲁利单抗注射液先后与卫材、雅培达成战略合作：授予卫材在日本及约定领域的开发、生产及独家商业化权利；授予雅培在亚洲、中东、非洲及东欧共42个国家和地区的独家商业化许可，加速自主创新成果的全球化落地，惠及广大患者。 许可引进方面，复星医药与AriBio就阿尔茨海默病在研药物AR1001达成全球独家选择权合作，在原有中国及东南亚区域权益基础上，有权进一步拓展至美国、欧洲、日本等全球核心市场，并将作为该产品对应区域的上市许可持有人。目前AR1001用于治疗早期阿尔茨海默病的国际多中心III期临床试验已完成最后一位患者的最后一次访视，顶线数据将于2026年内公布。 复星医药依托多年全球合规生产经验，持续推进国际化战略。生物药生产基地已实现全球市场供货常态化，供货范围覆盖中国、欧洲、加拿大、拉丁美洲、东南亚、印度等市场。截至报告期末，已建成84,000升产能，其中已商业化运行的产能为48,000升。 复星医药控股子公司Gland Pharma作为印度首家获美国FDA批准的注射剂生产企业，具备西林瓶、冻干、安瓿、预充式注射器等复杂剂型的一站式开发与制造能力。近期与全球领先药企达成55个SKU无菌注射剂战略供应协议，进一步印证了其在高壁垒复杂制剂领域的技术积淀与客户黏性。这一平台也为复星医药的全球化布局提供了不可多得的战略性资源，在出海进程中形成了独具差异化的竞争优势。 凭借创新与全球化的核心竞争力，复星医药持续巩固行业领先地位，MSCI ESG评级提升至AAA级[1]。在国内，连续八年稳居工信部 “中国医药工业百强榜单”前十；在全球，创新管线规模进入全球第一梯队，入选Citeline“全球TOP25管线规模制药企业”前20。 陈玉卿 复星医药董事长 “ 2026年上半年，面对充满挑战的行业变局，复星医药以战略聚焦应对外部不确定性，业绩稳健增长。我们坚定践行创新与国际化，聚焦肿瘤、免疫炎症、神经退行性疾病核心领域，依托全球化布局与BD双向赋能，锻造商业化能力。中国创新药全球化机遇当前，我们蓄力长远，坚定迈向高质量发展。 ” [1] 本文中对MSCI Solutions LLC或相关实体（“MSCI”）数据、标识、商标、服务标志或指数名称的使用，不构成MSCI对本集团的赞助、认可、推荐或推广。MSCI的服务和数据归MSCI或其信息提供者所有，按现有状态提供，不作任何保证。MSCI的名称和标识是MSCI的商标或服务标志 Fosun Pharma Announces 2026 Interim Results Globalization Accelerates Value Realization of Innovative Drugs (August 25, 2026, Shanghai, China) — On August 25, Fosun Pharma (“the Company”, stock code: 600196.SH; 02196.HK) announced its interim results for 2026. In the first half of 2026 (“the Reporting Period”, or 1H2026), the Company recorded revenue of RMB 20.442 billion, a year‑on‑year increase of 4.75%, or 7.17% at constant exchange rates. Profit attributable to shareholders of the listed company, net of non‑recurring gains and losses, stood at RMB 1.144 billion, up 19.09% year‑on‑year. Profit growth outpaced revenue growth, reflecting sustained improvement in earnings quality. Net cash generated from operating activities reached RMB 2.424 billion, rising 13.59% year‑on‑year. Innovation and globalization stand as the dual core engines driving business performance. Revenue from Innovative Drugs hit RMB 4.911 billion, representing a 13.84% year‑on‑year increase and accounting for 33.21% of pharmaceutical‑segment revenue, 2.17 percentage points higher than the same period last year. Business revenue from regions outside Chinese mainland and other countries totaled RMB 6.379 billion, growing 16.45% year‑on‑year and making up 31.21% of total revenue, a year‑on‑year uplift of 3.14 percentage points. The Group’s revenue mix continues to improve. Focusing on Core Therapeutic Areas and Accelerating Clinical Translation of Innovative Drugs Guided by clinical‑value‑driven innovation, Fosun Pharma prioritises three core therapeutic areas: oncology, immunology and inflammation, and neurodegenerative diseases. It also expands into CVRM (cardiovascular, renal and metabolic), anti‑infectives, rare diseases and other segments. Leveraging an open‑innovation framework that combines in‑house R&D, two‑way licensing and fund‑incubation models, the Company accelerates clinical translation and pushes forward its innovation‑led transformation. In 1H2026, Fosun Pharma's total R&D investment amounted to RMB 3.247 billion, up 25.66% year-on-year. Among this, R&D investment related to Innovative Drugs accounted for 81.61% of total R&D investment, primarily directed towards pipelines such as HLX43, HLX22, GR1803, FXR0906, as well as next-generation small molecule drugs, radiopharmaceuticals, and other cutting-edge technology platforms. During the reporting period, Fosun Pharma's Innovative Drugs entered a period of intensive approvals and value realization, with a total of 20 indications of 7 Innovative Drugs were approved for launch both domestically and overseas. In solid tumor areas including lung cancer, breast cancer, and gastrointestinal tumors, the Company has established differentiated competitive advantages through multi-product synergy and global commercialization. Han Li Kang (Rituximab), Han Qu You (trastuzumab), and Akynzeo® continue to maintain leading positions in their respective market segments, consistently contributing stable cash flow. During H1 2026, Han Si Zhuang (Serplulimab) gained approval in China for the perioperative treatment of gastric cancer, filling a global unmet clinical need. In the EU, it obtained three additional first‑line approvals for squamous non‑small‑cell lung cancer, esophageal squamous‑cell carcinoma and non‑squamous non‑small‑cell lung cancer. To date, serplulimab has been launched in approximately 50 countries and regions worldwide and is reimbursed under national health‑insurance or public‑reimbursement schemes in 12 markets including the United Kingdom, Germany, Italy, Spain and Sweden. Han Bei You (Pertuzumab) received successive marketing approvals in the EU and China. It works in synergy with breast‑cancer portfolio assets including Han Qu You, Han Nai Jia and Fu Tuo Ning to drive commercial uptake. Fu Mai Ning (luvometinib tablets) secured a new indication for pediatric and adolescent patients aged two years and older with relapsed/refractory Langerhans‑cell histiocytosis (LCH) following systemic therapy, addressing an unmet clinical need in China. With regulatory applications accepted for multiple innovative drugs and international multi-center clinical trials for key pipelines moving forward efficiently, Fosun Pharma continues to fuel its long-term commercial growth. ‑ The NDA for SAF‑189 (foritinib succinate capsules), an ALK inhibitor for non‑small‑cell lung cancer, has been accepted by the NMPA. ‑ The NDA of Fu Mai Ning  for adult patients with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1 (NF1) has been accepted and granted priority review by the NMPA. ‑ The NDA for Velinotamig (GR1803), a BCMA × CD3 bispecific antibody for multiple myeloma, has been accepted. Lead pipeline candidates HLX43 and HLX22 are progressing in international multi‑center trials across China, the US, Europe, Australia, Japan and other geographies. As a potential best‑in‑class pan‑tumor PD‑L1‑targeting ADC, HLX43 has demonstrated promising preliminary clinical efficacy featuring high potency and favorable safety profiles across multiple solidtumors types including non‑small‑cell lung cancer. In the immunology and inflammation field, the Company strengthened its in-house R&D while continuously enriching its pipeline through BD collaborations, obtaining the rights to develop, manufacture, and commercialize roconkibart (anti-IL-17A monoclonal antibody) in Chinese mainland, Hong Kong SAR, Macau SAR, and Taiwan region. The complement inhibitor FXS6837 for the treatment of IgA nephropathy and other glomerular diseases associated with complement dysregulation initiated Phase 2b clinical trials in Chinese Mainland. The DPP1 inhibitor FXS7553 is in Phase 2 clinical stage in Chinese Mainland for two indications: non-cystic fibrosis bronchiectasis and COPD. In the neurodegenerative diseases field, the integrated diagnosis and treatment layout continues to strengthen. The post-marketing confirmatory clinical trial for Sodium Oligomannate Capsules in Chinese mainland is progressing steadily; as of July 31, 2026, cumulative enrollment exceeded 1,000 cases, reaching over 50% of the planned enrollment target. HT001, an investigational drug for Parkinson’s disease, has initiated Phase 1 clinical trials in Australia. Parallel work is underway on the clinical deployment of magnetic‑resonance‑guided focused‑ultrasound therapy and the R&D of companion diagnostic reagents. Rooted in evidence‑based medicine, Fosun Pharma presented three oral abstracts at the 2026 ASCO Annual Meeting, including the Phase 3 study of Fu Mai Ning in adult NF1 patients, the Phase 3 study of serplulimab injection in the perioperative setting for gastric cancer, and the clinical study of HLX43 in non-small cell lung cancer. 10 studies were selected for poster presentations at the 2026 ASCO Annual Meeting, including data from two Phase 3 studies of Fu Tuo Ning and a study of HLX43 in nasopharyngeal carcinoma. The Company continues to deliver high-quality clinical outcomes in top-tier global journals such as The Lancet and Nature Medicine, as well as at global industry academic conferences, providing solid academic support for international registration and commercial expansion of its products. Deep Globalization: Global Capabilities Accelerate Value Delivery of Innovation Among China’s early‑movers in global pharmaceutical expansion, Fosun Pharma is evolving from mere product exports toward system‑level global deployment. It strengthens cross‑border capabilities across R&D, regulatory affairs, manufacturing and commercialization to maximize the global value of its innovative assets. In terms of out-licensing, Shanghai Henlius, a subsidiary of Fosun Pharma, has entered strategic partnerships with Eisai and Abbott for serplulimab. Eisai obtains development, manufacturing and exclusive commercialization rights for Japan and agreed territories. Abbott receives exclusive commercial‑license rights covering 42 countries and regions across Asia, the Middle East, Africa and Eastern Europe. These collaborations accelerate global roll‑out of home‑grown innovations for patients worldwide. In terms of in-licensing, Fosun Pharma entered into a global exclusive option agreement with AriBio for AR1001, an investigational drug for Alzheimer's disease. Building on the existing rights in China and Southeast Asia, Fosun Pharma is entitled to further expand its right to global core markets including the US, Europe, and Japan, with the Company serving as the marketing authorization holder for the product in the corresponding territories. The international multi-center Phase 3 clinical trial of AR1001 for the treatment of early Alzheimer's disease has completed the last patient's last visit, with top-line results to be announced within 2026. Drawing on years of global GMP‑compliant manufacturing experience, Fosun Pharma presses ahead with its internationalization drive. Its biotech manufacturing site supplies products routinely to global markets including China, Europe, Canada, Latin America, Southeast Asia and India. As of period‑end, installed biologic capacity totaled 84,000 liters, of which 48,000 liters are commercially operational. Fosun Pharma's subsidiary Gland Pharma, as the first injectable manufacturer in India to receive U.S. FDA approval, possesses one-stop development and manufacturing capabilities for complex dosage forms including vials, lyophilized products, ampoules, and pre-filled syringes. Gland Pharma recently entered into a strategic supply agreement with a global leading pharmaceutical company for 55 SKUs of sterile injectable, further validating its technological expertise and customer stickiness in the high-barrier complex formulation segment. This platform also provides Fosun Pharma with a unique strategic resource for its globalization layout, creating a differentiated competitive advantage in the process of going global. Bolstered by its innovation and globalization strengths, Fosun Pharma keeps elevating its industry standing and has achieved an MSCI ESG rating upgrade to AAA[1]. Domestically, it has ranked among the top 10 of MIIT’s China Top 100 Pharmaceutical Enterprises for eight consecutive years. Globally, its innovative‑pipeline scale places it within the world’s top tier, ranking top 20 in Citeline's Global Top 25 Pipeline Scale Pharmaceutical Companies. “Amidst challenging industry dynamics, Fosun Pharma responded to external uncertainties with strategic focus, achieving steady revenue growth.” Chen Yuqing, Chairman of Fosun Pharma, said, “We stay firmly committed to innovation and globalization. Concentrating on oncology, immuno-inflammation and neurodegenerative diseases, we leverage our global footprint and two‑way BD synergies to build stronger commercial capabilities. Amid global‑expansion opportunities for China’s innovative drugs, we take a long‑term view and advance resolutely toward high‑quality development.” [1] The use by Fosun Pharma of any MSCI Solutions LLC and related entities (“MSCI”) data, and the use of MSCI logos, trademarks, service marks or product names, do not constitute a sponsorship, endorsement, recommendation, or promotion of Fosun Pharma by MSCI. MSCI ESG Ratings are solely the opinion of MSCI Solutions. MSCI services and data are the property of MSCI or its information providers, are provided ‘as-is’ and without warranty, and MSCI disclaims all liability, including for any damages. 联系方式 媒体：pr@fosunpharma.com 投资人：ir@fosunpharma.com