Arlocabtagene autoleucel

近期，百时美施贵宝（BMS）举办了第三届“创至新 · 合致远”中国合作周，并宣布正式启用其在中国的首个创新中心。这一坐落于北京亦庄的创新中心将与其位于上海静安的研发创新中心协同，聚焦肿瘤、血液、免疫、心血管及神经科学五大核心领域，和蛋白质降解、放射性药物、细胞疗法三大治疗模态，推进“开放创新和生态合作”的进程。百时美施贵宝执行副总裁、首席医学官兼研发负责人Cristian Massacesi在接受医趋势专访时阐述了这个中心的战略定位：“百时美施贵宝中国创新中心不仅是一个开放创新的物理空间，更将成为我们与中国医疗健康产业生态圈合作伙伴‘共创价值’的创新枢纽。” 如何定义“创新枢纽”？在Cristian看来，其核心在于通过“双向赋能”实现“双向创新”。一方面，与全球同步，将更多“First-in-Class同类首创”及“Best-in-Class同类最佳”产品及适应症引入中国。同时参与中国多层次医疗保障体系的建设，提升患者对创新药的可及，并助力推动相关疾病领域从诊到治标准化路径的建立与规范。另一方面，通过战略合作，孵化本土创新，推动中国原创成果转化，并反哺全球市场。这种双向模式，既是BMS在中国的布局正从“引入创新产品”到“融入创新策源地”的生动实践，也是跨国药企中国战略升级的一个标志性观察窗。百时美施贵宝执行副总裁、首席医学官兼研发负责人Cristian Massacesi01、重塑产品组合2025年8月，Cristian加入BMS，成为其全球研发掌舵者。不久后，BMS在摩根大通（JPM）医疗健康年会上释放了公司研发策略正从“以资产为中心”转向“以疾病为中心”的信号。为什么要“以疾病为中心”？“当前，约有90%的药物在进入首次人体试验后，最终未能获得监管批准。这反映了药物开发模式所存在的现实挑战。”Cristian坦言。他对此给出的解题思路是：“BMS将继续在深耕的疾病领域优先布局具有变革潜力的创新疗法。力求更高的成功率、实现可持续的患者价值、承担明智的风险。” “我们的全球研发战略聚焦于危及生命的疾病领域，优先布局那些有望重塑业务格局且成功率最高的前沿科学。”他进一步表示：“但如果某一科学领域存在巨大未被满足的需求，而潜在疗法又有机会给患者带来真正的价值，即便成功率相对较低，我们也会选择性地在高价值机遇中承担风险。” 他强调，对BMS来说，顶尖科学和卓越执行是驱动研发成功率，推进“极具差异化优势、涵盖多款重磅药物的研发管线”的关键。据了解，2026年，BMS将发布至少10项关键III期数据。其中包括近期公布的mezigdomide III期SUCCESSOR-2研究达到主要终点。该结果进一步验证了靶向蛋白降解平台（TPD）和CELMoD的价值。TPD是BMS深耕超过20年的差异化研究平台。目前，已有多个在研的蛋白降解药物进入临床阶段，覆盖三种不同技术路径，包括CELMoD、配体导向降解剂（LDD）以及降解剂抗体偶联物（DAC）。其中，CELMoD是TPD平台下高度差异化的一类治疗模态，也是目前研发进展最快的方向之一。BMS在CELMoD的布局中有mezigdomide，iberdomide，golcadomide三款药物。其中，iberdomide用于治疗多发性骨髓瘤的适应症已被中国国家药监局药品审评中心（CDE）纳入优先审评，mezigdomide则于今天（5月9日）被CDE正式授予突破性治疗药物。接下来，BMS还将发布mezigdomide的关键数据以及milvexian、admilparant、arlo-cel和RYZ101的注册性研究数据。此外，Sotyktu和Cobenfy更多新适应症的关键数据结果也将出炉。这些成果有望重塑BMS的产品组合。02、中国角色的关键时刻在跨国药企的全球化叙事中，中国在过去很长一段时间内都被定格在“市场+产能”的二元角色中。但得益于国家的政策支持，中国生物医药产业经过过去十年的转型，创新能力正在持续跃升，创新药研发进入密集收获期。包括BMS在内的跨国药企也随之开始对中国角色有了新的定义—— 将资源筹码逐步押在中国日益成熟的创新生态上。让中国在全球创新中，成为有科学能力的“合伙人”（Capability Partner）。BMS在北京亦庄启用的中国创新中心正是这一逻辑的有力注脚。研发方面，BMS将借助这一创新中心，以“科学”与“合作”进一步驱动创新药物在中国的研发进程。“BMS始终以患者为先。对于任何有潜力惠及中国患者的产品或适应症，我们都会尽最大努力将中国纳入其全球开发路径，并与全球团队同步推进。目前，中国在全球重点临床研究中的参与度持续提升，并且比以往更早进入开发流程。”Cristian表明，持续扩大在中国的临床研究布局，正帮助BMS进一步加速推进全球管线开发，也让更多中国患者更早获益于创新的治疗选择。2025年7月，BMS“免疫双子星”双免疫治疗方案获中国国家药品监督管理局批准，用于一线非小细胞肺癌，纳武利尤单抗成为中国目前唯一实现“新辅助-围术期-一线-二线”治疗全程覆盖的PD-1抑制剂。而上文提到的用于治疗多发性骨髓瘤的iberdomide新药上市申请则已于2025年12月在中国递交，仅与美国市场间隔三个工作日。这些正是中国深度参与全球研发的成果体现。与此同时，更深层的合作也正在发生。BMS已在中国与百利天恒合作开发ADC，与环码生物在环状RNA领域展开探索，与药明巨诺进行细胞疗法技术许可，与和铂医药合作开发下一代多特异性抗体等等。这些合作不再是简单的“产品引进”，而是将中国的创新能力嵌入BMS全球研发链条。“独行快，众行远，”Cristian引用这句中国俗语总结BMS的合作哲学：通过与整个医疗健康产业生态圈建立更广泛的合作，实现“创至新，合致远”。在这个瞬息万变的时代，跨国药企的竞争已从“管线规模”转向“生态能力”—— 谁能构建最开放的创新网络，谁就能将科学突破最快转化为患者价值。03、让患者有治疗的选择“BMS产品管线的优势包括：跨阶段的广度、靶点数量的深度，以及治疗模态的多样性。”Cristian概括道，“我们正在核心治疗领域持续推进这些布局。”而在BMS聚焦的五大核心领域中，神经科学对Cristian来说具有特殊的意义。“我的父亲因路易体痴呆离世，且在早期曾被误诊。”Cristian在采访中分享了他的个人经历。这段经历坚定了他要为神经退行性疾病研发出创新药物的决心。正因高度重视这一赛道，在此次中国行中，他专程拜访了上海市精神卫生中心，传递了其个人和BMS对神经科学的战略雄心。BMS拥有神经科学领域极具竞争力的管线之一。未来12到24个月，BMS正迎来神经精神病学管线的“数据爆发期”。随着ADEPT项目中的三项注册性研究在内的多项关键数据的陆续发布，被寄予厚望的KarXT（毒蕈碱受体激动剂）有望释放出强劲潜力 —— 这是35年来首个全新机制抗精神病药，2024年已获批精神分裂症适应症。目前，BMS中国研发团队正积极参与其针对阿尔茨海默病和I型双相情感障碍的关键性III期临床研究。神经科学之所以被视为未来最具潜力、也是最难攻克的领域之一，在于其疾病机制的错综复杂。在药物研发中，有着传统开发模式的几乎所有痛点：周期长、成功率低、研发成本攀升。“新数字化工具、人工智能（AI）以及真实世界数据（RWD）正在帮助我们提高临床研究的成功率。”Cristian对此表示：“从研发到商业化，BMS正在全业务范围内推进AI应用与整合，以释放效率，提升生产力、质量和整体体验，并加速业务增长。在此基础上，还将进一步发挥自身在AI领域的优势，把前沿探索转化为可规模化应用的行业最佳实践，最终惠及全球患者。”提升研发成功率从本质上是为了让科学跑在疾病的前面。采访最后，Cristian描绘了一个令人憧憬的未来：“生物学能让我们捕捉到最早的信号——远在症状显现之前。凭借更精准的生物标志物、尖端前沿的工具以及多样化的治疗方案，早期个性化干预将不再是遥不可及的梦想，而是触手可及的现实。”“我希望未来，患者不会再听到‘没有治疗选择’。”返回搜狐，查看更多

Bristol-Myers Squibb held its BMY Q1 2026 earnings conference call on April 30, 2026, with management highlighting a late-stage pipeline approaching a cluster of pivotal readouts across cardiovascular disease, fibrotic lung disease, neuroscience, and hematology. The key near-term catalysts include milvexian in AFib and secondary stroke prevention, admilparant in IPF, Cobenfy in Alzheimer’s disease psychosis, and the company’s CELMoD protein degradation platform in relapsed or refractory multiple myeloma. Management framed these readouts as central to defining BMS’s growth profile into the next decade. Key Strategic Signals CELMoD Platform: The iberdomide new drug application was accepted by the US FDA with Breakthrough Therapy Designation and Priority Review, carrying a PDUFA date of August 17, 2026. Separately, mezigdomide hit a positive interim progression-free survival endpoint in the SUCCESSOR-2 Phase III trial ahead of schedule, with full data to be presented at ASCO. Chief Medical Officer Cristian Massacesi said the company intends to position both iberdomide and mezigdomide as replacements for Revlimid (lenalidomide) and Pomalyst (pomalidomide) in second-line relapsed or refractory multiple myeloma (RRMM), with longer-term ambitions to pair them with T-cell redirecting therapies and cell therapy. Admilparant: The company’s LPA1 inhibitor admilparant is advancing through Phase III trials in idiopathic pulmonary fibrosis (IPF), with a readout guided for the second half of 2026, and progressive pulmonary fibrosis (PPF), with data expected in early 2027. Massacesi cited Phase II results showing greater than 60% improvement versus placebo in lung function decline at the 60 milligram twice-daily dose, a clear dose-response relationship across tested doses, and ongoing Data Monitoring Committee reviews recommending continuation without safety flags. The company is running both Phase III studies with two doses — 60 milligram and 120 milligram — providing two shots at demonstrating efficacy. Management described admilparant as first-in-class for both indications with a tolerability profile meaningfully differentiated from current antifibrotics, where approximately 50% to 60% of patients discontinue therapy within 12 months. Non-Obstructive HCM: Massacesi announced that BMS is planning a new, more focused Phase III study in non-obstructive hypertrophic cardiomyopathy (HCM) for Camzyos (mavacamten), informed by learnings from the ODYSSEY trial. He said the company now has a clearer understanding of which patient subpopulations and disease subtypes are most likely to benefit from myosin inhibition, and that trial details would be registered on ClinicalTrials.gov. This represents a strategic attempt to recover a previously failed indication through refined patient selection. Analyst Pressure Points Milvexian Trial Design and Subgroup Risk: Analysts from Wolfe Research and UBS pressed management on whether the milvexian AFib trial — the Librexia program — could produce a partial or ambiguous result, and whether historically lower stroke event rates in contemporary AFib trials could delay the readout into 2027. Massacesi acknowledged the study is event-driven and that the company remains blinded, but said the predefined event count for both efficacy and safety is accruing as planned and that a year-end readout remains the base case. He declined to specify a bleeding reduction threshold required for commercial success, and analysts noted the non-inferiority margins of 0.84 to 1.3 on efficacy leave meaningful room for interpretation if the efficacy result lands close to the boundary. Cobenfy ADEPT Program Heterogeneity: Analysts at Jefferies questioned why BMS added mandatory biomarker confirmation of Alzheimer’s diagnosis to the ADEPT-4 trial design — requiring plasma or imaging confirmation — when ADEPT-2 was already enrolling without that requirement. Massacesi said the decision was made to reduce patient population heterogeneity and increase confidence that enrolled patients have confirmed Alzheimer’s disease, while acknowledging that the biomarker screening requirement increases operational complexity and screening failures. He framed ADEPT-2 and ADEPT-4 as parallel shots on goal, with the company requiring at least two positive studies for a regulatory filing. BMS has since added ADEPT-5 to the program, giving it four trials in Alzheimer’s disease psychosis (ADP). Forward-Looking Catalysts H2 2026 — Milvexian Phase III Readouts (AFib and SSP): Both the Librexia AFib trial, enrolling 20,500 patients in a head-to-head comparison against apixaban, and the secondary stroke prevention (SSP) trial are on track for year-end readouts. The AFib study is powered to demonstrate non-inferiority on stroke prevention and superiority on bleeding, with the bleeding endpoint split between measured bleeds and clinically relevant non-major bleeds. Chief Commercialization Officer Adam Lenkowsky said payers are not anchored to a specific percentage bleeding reduction threshold but are seeking a clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations. BMS would be the only company with a Factor XIa inhibitor approved in both AFib and SSP if successful. H2 2026 — Admilparant IPF Phase III Readout: The IPF data readout is the catalyst Massacesi described as among the most critical of the year. Both Phase III studies stratify patients by prior antifibrotic use — pirfenidone or nintedanib — allowing for analysis as an add-on or monotherapy, and the DMC has continued both studies without modification. Management said the Phase III population was designed to closely mirror the Phase II population to maximize translation of the earlier efficacy signal. Pipeline Context: Pumitamig and the CELMoD Depth During the Bristol-Myers Squibb Q1 earnings transcript, analysts also asked about pumitamig, BMS’s PD-1 x VEGF bispecific antibody developed in partnership with BioNTech. Massacesi said the company is presenting Phase II non-small cell lung cancer (NSCLC) data as an oral presentation at ASCO — the first global dataset following earlier China-specific data — and that seven pivotal Phase III studies across indications are all actively recruiting. He framed pumitamig’s strategy as “replace and expand,” targeting replacement of PD-1 and PD-L1 inhibitors while extending into novel combinations. BMS has initiated combination studies pairing pumitamig with Iza-bren (izalontamab brengitecan), its EGFR-HER3 antibody-drug conjugate (ADC), and with navlimetostat, a PRMT5 inhibitor, reflecting a deliberate effort to build pumitamig as a combinability backbone across tumor types. On the CELMoD platform, CEO Christopher Boerner highlighted golcadomide as an underappreciated asset, citing high-quality data accruing ahead of ASCO presentations. He also noted that earlier-stage degraders — BCL6-LDD and AR-LDD — are advancing behind the lead programs, indicating a platform depth that extends well beyond the two assets closest to approval. During the Bristol-Myers Squibb earnings call, Massacesi also confirmed that Arlo-cel, a GPRC5D-targeted CAR-T in RRMM, is expected to produce a pivotal readout later in 2026. In autoimmune disease cell therapy, BMS outlined a three-modality immune reset strategy: zola-cel, an autologous CD19 CAR-T in pivotal studies for lupus and scleroderma; an allogeneic CAR-T now in the clinic; and an mRNA-based in vivo CAR-T platform acquired through Orbital, which could improve scalability by enabling patients to generate CAR-T cells in vivo. Across the BMY Q1 2026 earnings discussion, Christopher Boerner framed the company’s R\&D productivity agenda around two quantified targets: a 50% reduction in lead molecule identification time and a 30% reduction in late-stage development cycle times versus a few years ago, supported by AI partnerships with Faro and Evinova. He said business development remains a capital allocation priority and that BMS is size-agnostic in evaluating opportunities, with a preference for assets in therapeutic areas where the company can add clinical and commercial value. 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