东方证券发布研报称，自体CAR-T凭借优异的疗效具备极大的吸引力，2025年全球销售额已接近60亿美 元。近期TCE优异的数据引起市场对自体CAR-T前景的担忧，主要因为疗效接近的情况下自体CAR-T复 杂的制备和使用过程，以及高昂的成本带来的价格劣势格外突出。in vivo CAR-T是解决以上问题极具 潜力的方向，目前整体处于临床早期，初步数据已经验证疗效，安全性有望优于自体CAR-T，MNC已 下场达成众多大额合作交易或收购，国内企业布局数量众多，未来有望达成多项交易。 CAR-T是血液瘤疗效天花板和单次给药即可"治愈"的代名词，全球已有15款自体CAR-T获批，2025年销 售额已达59亿美元(同比+30%)。ASH2025大会披露了BCMATCE(T细胞接合器)特立妥单抗联合达雷妥 尤单抗治疗复杂/难治性多发性骨髓瘤(R/RMM)的MajesTEC-3研究数据，疗效表现不弱于CARVYKTI， PFS率甚至更优，同时安全性良好，这使得自体CAR-T复杂的生产、使用过程和高昂的成本、价格等劣 势凸显，亟需新的突破。 2025年以来，已发生超10项in vivo CAR-T相关交易，阿斯利康、艾伯维、B ...

根据IQVIA MIDASTM的资料(IQVIA是全球医药健康产业专业信息和战略咨询服务提供商)，2024年 度，达雷妥尤单抗于全球範围内的销售额约为128.8亿美元。 HLX15(重组抗CD38全人单克隆抗体)(HLX15)是本公司自主研发的达雷妥尤单抗生物类似药，拟用于多 发性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞 表面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用 (ADCC)和抗体依赖 的细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单 抗还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的 1期临床研究已成功完成。 2026年2月，HLX15-SC用于多发性骨髓瘤治疗的 1期临床试验申请(IND)获国家药品监督管理局(NMPA) 批准。2025年2月，本公司与Dr. Reddy's Laboratories Ltd.的全资附属公司Dr. Redd ...

复宏汉霖(02696)发布公告，近日，本公司自主研发的HLX15-SC(重组抗CD38全人单克隆抗体注射液-皮 下注射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获美国食品药品管理局(FDA)批 准。 HLX15(重组抗CD38全人单克隆抗体)(HLX15)是本公司自主研发的达雷妥尤单抗生物类似药，拟用于多 发性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞 表面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖 的细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单 抗还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 2026年2月，HLX15-SC用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局(NMPA) 批准。2025年2月，本公司与Dr.Reddy's Laborat ...

Core Viewpoint - Recently, Fosun Pharma announced that its subsidiary, Fuhong Hanlin, received approval from the National Medical Products Administration to conduct Phase I clinical trials for HLX15-SC, a recombinant anti-CD38 fully human monoclonal antibody injection for the treatment of multiple myeloma [1] Group 1: Clinical Development - Fuhong Hanlin plans to conduct relevant clinical research for HLX15 in China once conditions are met [1] - HLX15 is a biosimilar to Daratumumab, with both subcutaneous (HLX15-SC) and intravenous (HLX15-IV) formulations intended for the treatment of multiple myeloma [1] Group 2: Financial Investment - As of January 2026, the company's cumulative R&D investment is approximately 192 million yuan [1] - According to the latest data, the global sales of Daratumumab formulations are expected to reach approximately 12.882 billion USD in 2024 [1]

HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发性骨髓 瘤(「MM」)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表面 表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的细 胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗还 可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作用。 2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 格隆汇2月12日丨复宏汉霖(02696.HK)宣布，近日，公司自主研发的HLX15-SC(重组抗CD38全人单克隆 抗体注射液－皮下注射)(「HLX15-SC」)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监 督管理局(NMPA)批准。 ...

根据IQVIA MIDASTM的资料(IQVIA是全球医药健康产业专业信息和战略谘询服务提供商)，2024年 度，达雷妥尤单抗于全球范围内的销售额约为128.8亿美元。 据悉，HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发 性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表 面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的 细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗 还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 复宏汉霖(02696)公布，近日，公司自主研发的HLX15-SC(重组抗CD38全人单克隆抗体注射液-皮下注 射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局(NMPA)批准。 ...

根据IQVIA MIDAS的资料(IQVIA是全球医药健康产业专业信息和战略谘询服务提供商)，2024年度，达 雷妥尤单抗于全球范围内的销售额约为128.8 亿美元。 智通财经APP讯，复宏汉霖(02696)公布，近日，公司自主研发的HLX15-SC (重组抗CD38全人单克隆抗 体注射液-皮下注射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局 (NMPA)批准。 据悉，HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发 性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表 面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的 细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗 还可通过降低髓源性抑制细胞和消耗CD38 表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月， HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 ...

Core Insights - The global pharmaceutical industry is witnessing a significant shift in the rankings of best-selling drugs, with several products surpassing $10 billion in sales for 2025 [1][2]. Group 1: Sales Performance - Novo Nordisk's semaglutide briefly topped the sales chart in Q1 2025 but was ultimately surpassed by Eli Lilly's tirzepatide, with both drugs exceeding $30 billion in sales [1][3]. - Tirzepatide achieved a remarkable year-on-year sales growth of 121%, while semaglutide's growth was only 13% [3]. - The sales figures for semaglutide in the first half of 2025 reached $16.683 billion, maintaining its position as a top-selling drug [3]. Group 2: Competitive Landscape - The GLP-1 drug class is experiencing intense competition, with both tirzepatide and semaglutide being key players [4][5]. - The market is dominated by Novo Nordisk and Eli Lilly, but Chinese pharmaceutical companies are also making significant strides in this area [5][6]. - New GLP-1 drugs are under development, including Novo Nordisk's CagriSema and Eli Lilly's retatrutide, which shows potential for greater weight loss than tirzepatide [5]. Group 3: Oncology and Autoimmune Drugs - The PD-1 inhibitor pembrolizumab (Keytruda) remains a top seller in oncology, with sales reaching $31.68 billion in 2025, despite falling to third place [7]. - Nivolumab (Opdivo) also crossed the $10 billion mark, achieving sales of $10.29 billion [8]. - In the autoimmune disease sector, drugs like dupilumab and risankizumab achieved sales of $17.8 billion and $17.562 billion, respectively [8]. Group 4: Anticoagulants - The anticoagulant apixaban continues to show strong sales growth, with BMS reporting $14.443 billion in sales, a year-on-year increase of 8% [9]. - Pfizer's reported revenue from apixaban reached $8 billion, making it their second-largest selling product [9].

Core Insights - The pharmaceutical industry is witnessing a significant shift in the rankings of top-selling drugs, with several products surpassing $10 billion in sales for 2025 [1][2] - The competition in the GLP-1 drug category is intensifying, with new entrants like semaglutide and tirzepatide rapidly gaining market share [3][4] Group 1: Top-Selling Drugs - Tirzepatide from Eli Lilly has achieved sales of $365.07 billion, making it the top-selling drug of 2025 [2][3] - Semaglutide from Novo Nordisk follows closely with sales of $361 billion, having briefly surpassed Merck's pembrolizumab (Keytruda) in Q1 2025 [1][3] - Pembrolizumab (Keytruda) recorded sales of $316.8 billion, maintaining a strong position despite falling to third place [7][8] Group 2: Market Dynamics - The sales growth of tirzepatide is remarkable, with a year-on-year increase of 121%, while semaglutide's growth is only 13% [3] - The competitive landscape for GLP-1 drugs is evolving, with multiple companies, including domestic Chinese firms, entering the market with biosimilars and new formulations [4][6] - Novo Nordisk and Eli Lilly are both developing next-generation GLP-1 drugs, with Novo Nordisk's CagriSema and Eli Lilly's retatrutide showing promising clinical results [5] Group 3: Other Notable Drugs - Other significant drugs include nivolumab (Opdivo) from Bristol-Myers Squibb, which achieved sales of $102.87 billion, and daratumumab (Darzalex) with sales of $143.51 billion [8][9] - Apixaban (Eliquis), a leading anticoagulant, continues to grow, with Bristol-Myers Squibb reporting sales of $144.43 billion, reflecting an 8% increase [9]

Core Insights - Major multinational pharmaceutical companies are showing robust revenue growth and increased sales of core products as they release their 2025 performance results [1][2] - Johnson & Johnson leads with nearly $94.2 billion in revenue, while Eli Lilly's weight loss drug, tirzepatide, shows a remarkable 45% year-over-year growth [1][2] Group 1: Revenue Performance - Johnson & Johnson reported total revenue of $94.193 billion for 2025, marking a 6% increase year-over-year [2] - Roche follows with revenue of $74.428 billion, while Eli Lilly, Merck, Pfizer, and AbbVie each exceeded $60 billion in revenue [2] - Eli Lilly's revenue reached $65.179 billion, a 44.7% increase, driven by strong sales of tirzepatide, which generated $36.5 billion [6] Group 2: Product Performance - Johnson & Johnson's innovative pharmaceuticals and medical technology segments both achieved revenue growth, with $60.401 billion and $33.792 billion respectively, both up by approximately 6% [2] - The CAR-T therapy, ciltacabtagene autoleucel, contributed significantly to Johnson & Johnson's growth, with revenue of $1.887 billion, a 95.9% increase [2] - Eli Lilly's tirzepatide sales reached $36.5 billion, with the weight loss version generating $13.542 billion, a 175% increase [6] Group 3: Market Trends and Challenges - The pharmaceutical industry faces a looming "patent cliff," with an estimated $236 billion in revenue at risk from patent expirations between 2025 and 2030 [8] - Companies are increasingly engaging in business development transactions to replenish their R&D pipelines, with Chinese innovative pharmaceutical companies gaining prominence [8][9] - In 2025, Chinese companies achieved record-breaking business development deals, totaling $135.655 billion, with significant collaborations involving major multinational firms [9]