Elranatamab

核心摘要：2026年5月，全球医药行业呈现“MNC靠并购买未来，中国药企靠数据要席位”的鲜明特征。礼来、诺和诺德凭借GLP-1药物现金流开启“扫货模式”；恒瑞医药刷新BD出海纪录，百济神州实现持续盈利，科伦博泰ADC数据惊艳ASCO，标志着中国创新药从“跟跑”进入“并跑”阶段。 一、MNC巨头：现金为王，并购重构管线 1. 礼来（Eli Lilly）：业绩与并购双引擎 业绩狂飙：2026年Q1营收198亿美元（+56%），净利润激增168%。核心驱动力为替尔泊肽（Mounjaro/Zepbound），合计销售额约128亿美元。公司上调全年营收指引至820-850亿美元。 并购加码：手握巨额现金，2026年并购总额已超200亿美元。5月以最高2.02亿美元收购Engage Biologics；4月以最高3亿美元收购ADC企业CrossBridge Bio，布局下一代双载药技术。战略重心转向体内CAR-T（如收购Kelonia）及ADC实体瘤赛道。 2. 诺和诺德（Novo Nordisk）：口服制剂放量 营收结构变化：Q1销售额968亿丹麦克朗。口服减重片剂Wegovy自1月上市后快速放量，Q1贡献约22.56亿丹麦克朗，目前在美国已惠及超100万患者。 竞争压力显现：若剔除一次性会计转回，调整后销售额实际面临下滑压力。礼来口服GLP-1小分子药物Foundayo（orforglipron）于4月获FDA批准，对诺和诺德的口服制剂形成直接竞争。 3. 辉瑞（Pfizer）与罗氏（Roche）：战略“瘦身”与聚焦 辉瑞：Q1营收144.51亿美元，重申全年指引。战略上“做减法”，一次性删减7款非核心管线；重点推进ADC药物Padcev（膀胱癌新适应症获FDA受理，PDUFA日期2026年8月）及双抗Elrexfio。 罗氏：同步进行管线重构，新增12个项目并剔除9个项目，聚焦肿瘤免疫与神经科学。 二、国产创新药：ASCO亮剑与BD出海 1. 恒瑞医药：BD刷新纪录，ASCO数据爆发 152亿美元战略合作：与百时美施贵宝（BMS）达成潜在总额约152亿美元的战略合作，刷新出海纪录。合作包含4项恒瑞管线+4项BMS管线+5项共同开发管线，首付款及近期里程碑达9.5亿美元。 ASCO数据矩阵：携91项研究亮相ASCO（6项口头报告），ADC管线全面爆发： SHR-A1811（HER2 ADC）：一线治疗HER2+结直肠癌，ORR达81.3%。 SHR-A2009（HER3 ADC）：后线治疗EGFRm NSCLC，PFS/OS显著优于化疗。 SHR-A2102（Nectin-4 ADC）：在肌层浸润性膀胱癌中ORR超越同类竞品。 口服GLP-1进展：HRS-7535的3期研究（OUTSTAND-1）达主要终点，计划递交NDA。 2. 百济神州：持续盈利，实体瘤突破 业绩里程碑：Q1营收15亿美元（+35%），GAAP净利润2.3亿美元，实现持续盈利。核心产品泽布替尼（Zanubrutinib）全球收入11亿美元（+39%），美国市场占比近70%。 ASCO新机制：首次公布GPC3/4-1BB双抗（BGB-B2033）I期数据，在肝细胞癌（HCC）中确认ORR为20.3%，展示出差异化免疫激活潜力。 3. 科伦博泰：ADC+IO全球首创数据 OptiTROP-Lung05研究：在ASCO公布TROP2 ADC（SKB264）联合帕博利珠单抗（K药）一线治疗NSCLC的III期数据。这是全球首个ADC+IO一线治疗肺癌的阳性结果，PFS风险比（HR）低至0.35，ORR达70.2%（vs K药单药42.0%），确立其在TROP2靶点的全球第一梯队地位。 三、行业风向：ADC并购潮与高层变动 1. ADC赛道白热化 吉利德（Gilead）：以最高50亿美元收购德国公司Tubulis，扩充ADC管线及平台技术。 礼来与恒瑞：均通过并购（CrossBridge）或BD（BMS合作）加码ADC布局，该领域已成为大药企必争之地。 2. 高层变动与战略调整 赛诺菲（Sanofi）：在CEO变动后，战略重心进一步向免疫学与罕见病倾斜，削减部分糖尿病管线投入。 恒瑞医药：孙飘扬回归后持续推进“二次创业”，2025年创新药收入占比首破58%，2026年Q1进一步升至61.69%，完成从仿制药向创新药的艰难转身。 ______ 免责声明：本文内容基于2026年5月及此前公开信息（包括公司财报、ASCO年会摘要、SEC filing）整理，仅供行业参考，不构成任何投资或医疗建议。医药研发存在较高不确定性，具体商业进展以公司官方公告为准。数据来源包括但不限于：礼来、诺和诺德、辉瑞、恒瑞医药、百济神州、科伦博泰官方披露及ASCO官方议程。

Bristol Myers Squibb (NYSE: BMY) reported that mezigdomide, its oral cereblon E3 ligase modulator (CELMoD), cut the risk of disease progression or death by 52% versus carfilzomib and dexamethasone alone in relapsed or refractory multiple myeloma, delivering the first Phase III readout for any CELMoD agent and handing BMS a potential new commercial pillar as its immunomodulatory drug franchise faces generic erosion from lenalidomide biosimilars. The data were the subject of a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) summit meeting. The SUCCESSOR-2 trial is a seamless Phase II/III, multicenter, randomized, open-label study that enrolled 479 patients with relapsed or refractory multiple myeloma, randomized to mezigdomide plus carfilzomib and dexamethasone (MeziKd, n\=288) or carfilzomib and dexamethasone alone (Kd, n\=191). The population was heavily pretreated and largely refractory to current standards: 92.1% were triple-class-exposed, 85.8% were refractory to an anti-CD38 monoclonal antibody, and 75.8% were refractory to lenalidomide — the very drug class from which mezigdomide descends. The primary endpoint was met decisively. Median progression-free survival reached 18 months with MeziKd versus 8.3 months with Kd (HR: 0.48; 95% CI reported; p \< 0.0001), a hazard ratio that corresponds to a 52% reduction in the risk of progression or death at a median follow-up of 10.6 months. Overall response rate was 80.2% with MeziKd versus 53.4% with Kd, and complete response or better was achieved in 26.7% versus 8.9%. Median overall survival had not yet been reached in either arm. The results were presented as a late-breaking oral at Bristol Myers Squibb ASCO 2026 (#LBA7506). The safety profile carries a meaningful hematologic burden. Grade 3–4 treatment-emergent adverse events occurred in 83.7% of MeziKd patients versus 56.5% on Kd. Neutropenia was the dominant toxicity, appearing in 61.1% of the MeziKd arm versus 9.1% on Kd, and Grade 3–4 infections occurred in 34.0% versus 15.6%. BMS described the profile as consistent with mezigdomide’s known safety profile, and notably 52.4% of MeziKd patients remained on treatment at data cutoff versus 31.4% on Kd, suggesting tolerability sufficient for continued dosing in a substantial proportion of patients. Competitive context and outlook The SUCCESSOR-2 trial results arrive at a moment when the relapsed refractory multiple myeloma treatment landscape is undergoing rapid reorganization. Bispecific T-cell engagers — including Janssen’s Tecvayli (teclistamab), Janssen’s Talvey (talquetamab), and Pfizer’s Elrexfio (elranatamab) — have reshaped late-line practice since 2023, while the CAR-T therapies Janssen and Legend Biotech’s Carvykti (ciltacabtagene autoleucel) and BMS’s own Abecma (idecabtagene vicleucel) have moved into earlier relapse settings following label expansions in 2024. Against this backdrop, mezigdomide’s oral administration, outpatient delivery, and activity in a predominantly anti-CD38-refractory and lenalidomide-refractory population position it as a chemotherapy-free oral option that does not require the manufacturing lead times of CAR-T or the step-up hospitalization protocols associated with bispecifics. CELMoD therapy in RRMM builds on the mechanistic foundation established by lenalidomide and pomalidomide but with substantially greater potency. Mezigdomide is optimized for maximal and rapid degradation of Ikaros and Aiolos transcription factors, proteins essential for myeloma cell survival, and preclinical data suggest it also reinvigorates exhausted T cells — a property that may become clinically relevant as the field increasingly uses it alongside immunotherapy backbones. The carfilzomib and dexamethasone combination was a deliberate design choice: Kd is an established standard of care in second- and third-line RRMM, making it a credible comparator and the PFS improvement over it directly interpretable for practicing oncologists. Cross-trial comparisons are limited by differences in patient populations, prior therapy exposure, and follow-up duration, but the 18-month median PFS in a population that was more than 85% anti-CD38-refractory compares favorably to historical benchmarks for pomalidomide-based triplets in similar settings. The ORR of 80.2% and the complete response rate of 26.7% are also notable in a population where most patients had already received two or more prior lines including an IMiD and an anti-CD38 antibody. BMS has indicated it will share the SUCCESSOR-2 data with health authorities, and a regulatory submission appears imminent. A second ongoing Phase III trial, SUCCESSOR-1, is evaluating mezigdomide in a separate RRMM combination, broadening the potential label scope. The company has framed mezigdomide as the centerpiece of its next-generation targeted protein degradation platform, which also encompasses ligand-directed degraders and degrader antibody conjugates — modalities that have not yet generated pivotal data but represent BMS’s long-term bet on cereblon biology beyond the IMiD era. For BMS, the commercial stakes are substantial. Revlimid (lenalidomide) generic entry has been eroding one of the company’s most durable revenue streams, and pomalidomide faces its own competitive pressure from bispecifics in later lines. Mezigdomide, if approved, would enter a market where oral convenience, outpatient administration, and activity in anti-CD38-refractory disease are genuine differentiators — though the neutropenia rate will require careful management and may limit use in older or frailer patients without growth factor support. The next milestone is a regulatory filing, with the timeline to be confirmed following health authority discussions. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.