Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

2026 年上半年，国内医药行业处在转型升级关键周期，医保控费、集采常态化、汇率波动多重因素交织，行业整体经营承压，药企普遍面临增长考验。在此背景下，复星医药（600196.SH；02196.HK）交出一份韧性十足的中期成绩单：报告期实现营业收入 204.42 亿元，同比增长 4.75%，恒定汇率口径下营收同比增长 7.17%；归母扣非净利润 11.44 亿元，同比增长 19.09%，利润增速显著跑赢营收增速，盈利质量持续改善；经营活动产生的现金流量净额 24.24 亿元，同比增长 13.59%，主业现金流稳健夯实企业持续研发与扩张的底盘。拆解这份业绩，创新产品进入集中兑现周期、全球化布局成效显著，成为公司穿越行业周期的两大核心驱动力。创新药层面，公司持续加码研发投入，2026 年上半年研发总投入 32.47 亿元，同比增长 25.66%；其中创新药品相关研发投入达 26.50 亿元，占集团研发总投入 81.61%，资源重点向肿瘤、免疫炎症、神经退行性疾病三大核心治疗领域倾斜，同步布局 CVRM、抗感染、罕见病赛道，夯实抗体 ADC、新一代小分子，拓展核药、小核酸等前沿技术平台。投入迎来密集产出，报告期复星医药创新药品步入密集收获期，共有7 个创新药品合计 20 项适应症于境内外获批上市，多款产品实现临床空白填补。H药汉斯状®（斯鲁利单抗注射液）国内新增胃癌围术期适应症，填补全球临床空白；欧盟一次性获批一线治疗三项肺癌适应症，截至目前该产品已经登陆全球50个国家和地区，纳入12个国家医保或公共支付体系。汉倍优®帕妥珠单抗）在中国、欧盟两地同步获批上市，与汉曲优®、汉奈佳®、复妥宁®构建起乳腺癌领域产品矩阵；复迈宁®（芦沃美替尼片）新增2岁及以上儿童青少年朗格汉斯细胞组织细胞增生症适应症，补齐国内该领域治疗缺口，成人 I 型神经纤维瘤病适应症上市申请获受理并纳入优先审评。与此同时，ALK 抑制剂丁二酸复瑞替尼胶囊、BCMA×CD3 双特异性抗体纬利妥米单抗（GR1803）等多款创新药上市申请获国家药监局受理；HLX43、HLX22 等重点管线高效推进国际多中心临床研究，覆盖中美欧澳日等国家及地区，其中 PDL1 ADC候选药物 HLX43 展现“高效、低毒”初步临床疗效。报告期内，公司3项在研管线入选2026 ASCO年会口头报告、10项研究入选壁报展示，高质量临床数据为产品全球注册、商业化拓展提供学术支撑。从经营数据看，创新业务拉动效应持续放大。2026上半年，复星医药创新药品收入49.11亿元，同比增长13.84%，占制药业务收入比重达33.21%，较上年同期提升2.17个百分点。全球化布局成为对冲国内行业压力、打造第二增长引擎的关键抓手，公司正从 “产品出海”向着研发、注册、生产、商业化一体化的体系出海升级。2026 年上半年，中国大陆以外地区业务收入63.79亿元，同比增长16.45%，占总营收比重达31.21%，同比提升3.14 个百分点，海外业务已经成为稳定增长极。双向 BD 合作持续落地，验证自研创新资产的全球价值。对外授权方面，复宏汉霖将斯鲁利单抗注射液分别授予卫材日本区域开发商业化权益、授予雅培亚洲、中东、非洲、东欧合计42个国家和地区独家商业化权益。许可引进方面，复星医药与 AriBio 达成阿尔茨海默病在研药物AR1001全球独家选择权合作，该药国际多中心III期临床试验已完成最后一例受试者的最后一次访视，顶线数据预计2026年内公布；同时引进BCMA×CD3双特异性抗体纬利妥米单抗（GR1803）、偌考奇拜单抗（抗IL-17A单抗）等高价值管线，补强血液瘤、免疫炎症领域布局，构建 “自主研发+双向BD”的开放式创新生态。全球制造供应链底座持续加固。生物药基地建成总产能84000升，商业化运行产能48000升，实现全球多区域常态化供货；2026年8月初，控股子公司Gland Pharma宣布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。复星医药董事长陈玉卿表示：“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，业绩实现稳健增长。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 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。”

Globalization Accelerates Value Realization of Innovative Drugs SHANGHAI, Aug. 25, 2026 /PRNewswire/ -- 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 solid tumors 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." - END - About Fosun Pharma Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem. Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia. Looking ahead, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health. For more information about the Group, please visit the company website: SOURCE Fosun Pharma 21% more press release views with Request a Demo