Pimurutamab(Shanghai Henlius Biotech, Inc.)

SHANGHAI, April 28, 2026 /PRNewswire/ -- On 28 April, Fosun Pharma ("the Company", stock code: 600196.SH; 02196.HK) announced its results for the first quarter of 2026 (the reporting period). During the reporting period, the Company achieved a total revenue of RMB 10,073 million, representing a year-on-year increase of 6.93%. Regarding R&D investment, the Company firmly implemented its innovation transformation strategy. During the reporting period, the R&D expenditure increased to RMB 897 million, increased by 1.59% YoY. While increasing the R&D intensity, the Company maintained a positive growth trend in profit. Net profit attributable to shareholders of the list company after deducting extraordinary gain or loss was RMB 501 million, up 21.96% year-on-year. Net profit attributable to shareholders of the listed company was RMB 871 million, increased by 13.87% YoY. Net cash flows generated from operating activities was RMB 1,149 million, up 8.8% YoY. In the first quarter of 2026, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma firmly continued to advance its innovation transformation, promoted the deep synergy between innovation and R&D and global operations, and further enhanced the foundation for high-quality development. Driven by the continuous increase in R&D investment, the Company's transformation of innovative achievements continues to materialize. During the reporting period, the NDA for 4 Innovative Drugs were accepted by the NMPA or the U.S. FDA, and 14 clinical trials for Innovative Drugs (calculated by approval) were approved by domestic and overseas regulatory authorities, covering core therapeutic areas such as oncology. In the Pharma R&D Annual Review 2026 white paper released by the world-known consulting firm Citeline, Fosun Pharma ranked among the global top 20, gained international professional recognition for its innovative R&D strength and pipeline quality. Deepening Core Technology Platforms to Consolidate Advantages in Oncology and Other Fields Fosun Pharma has established an open-ended R&D system that combines in-house R&D, co-development, licensing, fund incubation, and industrial investment, also focused on strengthening core technology platforms such as antibodies/ADC, small molecules, and cell therapy, continuously consolidating its innovation moat in core therapeutic areas including oncology. In the field of antibody/ADC technology platform, Shanghai Henlius, a subsidiary of Fosun Pharma, has steadily advanced the approvals and clinical progress of several self-developed biological drugs. Notably, denosumab injection (HLX14) secured approval in Canada in March 2026, covering all indications of the reference product approved locally, achieving a global commercialization breakthrough in areas such as osteoporosis, bone metastasis from tumors, and giant cell tumor of bone. The NDA for bevacizumab injection (HLX04) was accepted in the U.S., marking a new milestone in the Company's international registration capabilities for biosimilars. HLX43, an antibody-drug conjugate targeting PD-L1, is expected to create synergy with HLX07 or serplulimab injection for the treatment of advanced colorectal cancer and other solid tumors. HLX3901, a tetraspecific antibody of DLL3×DLL3×CD3×CD28, received approval for clinical trial, demonstrating significant potential in refractory solid tumors through multi-target synergistic activation of immune cells. In the field of small molecule innovative drug platform, in January 2026, the NDA for foritinib succinate capsules (SAF-189), Fosun Pharma's Class 1 innovative drug, was accepted by the NMPA, intended for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), expected to provide a new option for precision treatment of lung cancer. In February 2026, the NDA for the self-developed MEK 1/2 inhibitor luvometinib tablets (Trade name in Chinese mainland: Fu Mai Ning) for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) have been accepted and granted in the priority review by the NMPA. This marks a critical step toward full-age coverage following its approval for pediatric and adolescent NF1 patients in May 2025, also brings new hope to a large number of adult NF1 patients in China who lack effective drug treatments. Additionally, the NDA for methoxyetomidate hydrochloride injection (ET-26), a Class 1 innovative drug self-developed by the subsidiary Avanc Pharma for anesthesia induction and short-term surgical anesthesia, was also accepted. In the field of prospective layout of early-stage pipeline, several new molecules have been approved for the clinical trials: FXB0871, a PD-1-targeted IL-2 fusion protein, was approved for clinical trials in locally advanced or metastatic solid tumors. Based on the ATTENUKINE™ platform, FXB0871 is expected to achieve high efficacy and low toxicity. FXS0683, a next-generation Bcl-2 inhibitor, was approved for Phase I clinical trials in hematological malignancies. Innovative molecule including HLX97 (a KAT6A/B small molecule inhibitor) and HLX3901 (tetra specific antibody of DLL3×DLL3×CD3×CD28) were approved for clinical trials, widely covering refractory solid tumors such as breast cancer and small cell lung cancer. Meanwhile, HLX22 (anti-HER2 monoclonal antibody) entered phase II clinical trials for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in combination with HLX87. HLX43 (PD-L1 ADC) in combination with HLX07 or serplulimab injection, and HLX701 (CD47 fusion protein), among others, have entered Phase I clinical trials, further enhancing the Company's layout in the fields of tumor immunology and targeted therapy. Expanding Global Commercialization Network and Enhancing Academic Influence During the reporting period, Fosun Pharma's global registration and commercialization network continued to expand. The overseas registration of products like denosumab and bevacizumab progressed steadily. The Company reached deep collaborations with global partners such as Eisai and Abbott to accelerate the market coverage of innovative products in Japan, Asia-Pacific, Middle East, Africa, and Eastern Europe. In the academic field, several innovation achievements were presented at top international conferences such as AACR and ASCO. The Phase III study data of luvometinib tablets for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) was selected for a rapid oral abstract session at 2026 ASCO, the study results will be released for the first time during the meeting. At the 2026 AACR Annual Meeting, Shanghai Henlius, a Fosun Pharma's subsidiary, presented preclinical data for the novel trispecific T-cell engager HLX3902 and the tetraspecific antibody HLX3901, demonstrating best-in-class treatment potential, building a solid foundation for the future clinical development. AI Embracement: Driving Digital Transformation via FoSTRAID Fosun Pharma continues to deepen its digitalization and AI strategic layout, and systematically advances the platformisation, engineering and scaled implementation of AI capabilities focusing on core aspects such as new drug R&D, clinical research, products and services, and operation management. On this basis, the fully AI- embracing strategy centered on FoSTRAID (Fosun Pharma Strategic Transformation via AI & Data science) was further defined and steadily advanced. By integrating resources, a digital-intelligence architecture that promotes synergistic development across "foundation — platform — data — agent — scenario — mechanism" has been established. The self-developed PharmAID® Pharmaceutical Intelligence Platform deeply applies large language models, fine-tuned with professional medical corpora and R&D data. It integrates full-cycle of decision-making tools including competitor analysis, clinical competitive performance evaluation, NDA approval prediction, and peak sales estimation, comprehensively applied in key scenarios such as target discovery, molecular optimization, clinical writing, intelligence retrieval, and literature interpretation, providing systematic and data-driven support for drug R&D decision-making. Looking ahead, Fosun Pharma will continue to adhere to the dual drivers of innovation and globalization, deepen its core technology platforms, promote the implementation of AI strategy and accelerate the transformation of its pipeline and global market access. The Company remains committed to providing high-quality healthcare products and services to patients worldwide, striving to become a leading global healthcare innovation integrator. - 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

（2026年4月28日，中国上海）4月28日，复星医药（600196.SH；02196.HK）公布2026年第一季度业绩报告。报告期内，公司实现营业收入100.73亿元，同比增长6.93%；研发投入方面，公司坚定贯彻创新转型战略。报告期内，公司研发费用提升至8.97亿元，同比增加1.59亿元。在提高研发强度的基础上，公司利润依旧保持良好增长趋势。一季度归属于上市公司股东的扣除非经常性损益的净利润5.01亿元，同比增长21.96%；归属于上市公司股东的净利润8.71亿元，同比增长13.87%；经营活动产生的现金流量净额11.49亿元，同比增长8.8%。 2026年一季度，复星医药在“创新引领、深度国际化、全面拥抱AI”战略的引领下，坚定推进创新转型，创新研发与国际化布局协同推进，高质量发展基础进一步夯实。得益于研发投入的持续提升，公司创新成果转化持续落地，报告期内，共有4款创新药品上市申请获中国国家药监局或美国FDA受理，14项（按批件数）创新药品临床试验获境内外监管机构批准，涵盖肿瘤等核心治疗领域。由全球知名咨询机构Citeline发布的《2026年医药研发年度回顾》白皮书（Pharma R&D Annual Review 2026）中，复星医药位列全球20强，创新研发实力与管线质量获得国际专业认可。 深耕核心技术平台，夯实肿瘤等领域优势 目前，复星医药已形成自主研发、合作开发、许可引进、基金孵化、产业投资相结合的开放式研发体系，重点强化抗体/ADC、小分子、细胞治疗等核心技术平台，持续巩固在肿瘤等核心治疗领域的创新护城河。 抗体/ADC技术平台方面，复星医药控股子公司复宏汉霖自主研发的多款生物药上市及临床进展稳步推进。其中，地舒单抗注射液（HLX14）于2026年3月在加拿大成功获批上市，涵盖原研产品在当地获批的全部适应症，在骨质疏松、肿瘤骨转移、骨巨细胞瘤等领域实现全球商业化突破。贝伐珠单抗注射液（HLX04）美国上市申请获受理，标志着公司生物类似药国际化注册能力再上新台阶。靶向 PD-L1 的抗体偶联药物 HLX43与HLX07、斯鲁利单抗等形成协同，用于晚期结直肠癌等实体瘤治疗，拓展精准治疗场景。HLX3901作为 DLL3×DLL3×CD3×CD28 四特异性抗体获批临床，多靶点协同激活免疫细胞，在难治性实体瘤中展现出良好潜力。 小分子创新药平台方面，2026年1月，复星医药1类新药丁二酸复瑞替尼胶囊（SAF-189）的上市申请获国家药监局受理，拟用于间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC），有望为肺癌精准治疗提供新选择。2026年2月，复星医药自主研发的MEK 1/2抑制剂芦沃美替尼片（中国境内商品名：复迈宁）用于治疗伴有症状、无法手术的丛状神经纤维瘤（PN）的Ⅰ型神经纤维瘤病（NF1）成人患者的药品上市申请获国家药监局受理并已获纳入优先审评程序，标志着该创新药在继2025年5月获批用于儿童及青少年NF1患者后，向覆盖全年龄段患者的目标迈出关键一步，也为国内大量缺乏有效药物治疗的成人NF1患者带来了新的曙光。此外，控股子公司奥鸿药业研发的1类新药盐酸莫托咪酯注射液（ET-26）拟用于麻醉诱导和短时手术麻醉的上市申请亦获受理。 早期管线前瞻布局方面，多款新分子获批临床。其中，PD-1靶向型IL-2融合蛋白FXB0871获批开展用于局部晚期或转移性实体瘤的临床试验，基于ATTENUKINE™技术平台，有望实现高疗效、低毒性；新一代Bcl-2抑制剂FXS0683获批用于血液系统恶性肿瘤的I期临床；HLX97（KAT6A/B小分子抑制剂）以及HLX3901（DLL3×DLL3×CD3×CD28四特异性抗体）等创新分子相继获批临床，广泛覆盖乳腺癌、小细胞肺癌等难治性实体瘤。此外，HLX22（抗HER2单抗）联合HLX87进入II期临床，用于一线治疗HER2阳性复发或转移性乳腺癌；HLX43（PD-L1 ADC）联合HLX07或斯鲁利单抗注射液、HLX701（CD47融合蛋白）等进入I期临床，进一步夯实公司在肿瘤免疫与靶向治疗领域的布局。 全球商业化网络进一步拓展 学术影响力持续提升 报告期内，复星医药全球化注册与商业化网络持续拓展，地舒单抗、贝伐珠单抗等产品海外注册稳步推进，与卫材、Abbott等全球伙伴达成深度合作，加速创新产品在日本及亚太、中东、非洲、东欧等市场覆盖。 在学术领域，公司多项创新成果亮相 AACR、ASCO 等国际顶级学术会议，其中，芦沃美替尼片治疗伴有症状、无法手术的丛状神经纤维瘤I型（NF1）成人患者的Ⅲ期研究数据成功入选2026 ASCO快速口头报告，研究成果将于会议期间首次公布；在2026年美国癌症研究协会（AACR）年会上，控股子公司复宏汉霖公布了新型三特异性T细胞衔接器HLX3902及四特异性抗体HLX3901的临床前研究数据，展现出同类最优治疗潜力，为后续临床开发奠定坚实基础。 全面拥抱 AI 以 FoSTRAID 驱动数智化转型 复星医药持续深化数字化与AI战略布局，围绕新药研发、临床研究、产品服务及运营管理等核心环节，系统推进AI能力的平台化、工程化和规模化落地。在此基础上，公司进一步明确并推进以 FoSTRAID（Fosun Pharma Strategic Transformation via AI & Data Science）为核心的全面拥抱AI战略，通过整合资源，构建“基座—平台—数据—智能体—场景—机制”协同推进的数智化架构。 复星医药自主研发的PharmAID医药智能平台深度应用大语言模型，针对专业医药语料和研发数据进行微调，已集成竞品分析、临床竞争性能评估、上市时间预测、峰值销售测算等全环节决策工具，应用于靶点发现、分子优化、临床写作、情报检索、文献解读等关键场景，以期为药物研发决策提供系统化、数据驱动支撑。 展望未来，复星医药将继续坚持创新与全球化双引擎驱动，深耕核心技术平台，推进 AI 战略落地，加速管线转化与全球准入，持续为全球患者提供高品质医药健康产品与服务，致力于成为全球领先的医疗创新整合者。 联系方式 媒体：pr@fosunpharma.com 投资人：ir@fosunpharma.com