Xanomeline Tartrate/Trospium Chloride

百时美施贵宝公司（BMS; NYSE: BMY）公布了2025年第二季度财务业绩，总收入按固定汇率计算（下文所有增长数据均采用此口径）同比增长持平，达到122.7亿美元。每股收益（GAAP）受到重创，同比下降22%，但这主要是由于公司在6月与德国BioNTech（Nasdaq: BNTX）达成合作，为其PD-L1×VEGF-A双特异性抗体BNT327（由Biotheus发现）支付了15亿美元的预付款。实际上，由于传统产品组合的销售好于预期，BMS上调了全年营收预期，目前预计营收将达到465亿至475亿美元（此前为458亿至468亿美元）。而非GAAP每股收益预期因对BioNTech及其他投资而略有下调，调整为6.35至6.65美元（此前为6.70至7.00美元）。首席执行官Christopher Boerner博士强调，公司的新增长产品组合在2025年第二季度实现了17%的同比增长，达到66亿美元，这主要得益于公司的免疫肿瘤学（IO）产品组合。主要产品销售业绩包括：靶向CD19嵌合抗原受体（CAR）T细胞疗法Breyanzi（lisocabtagene maraleucel），销售额同比增长122%至3.44亿美元；贫血治疗药物Reblozyl（luspatercept），销售额同比增长33%至5.68亿美元；用于治疗有症状的梗阻性肥厚型心肌病（obstructive HCM）的药物Camzyos（mavacamten），销售额同比增长86%至2.6亿美元；程序性死亡-1（PD-1）抑制剂Opdivo（nivolumab），销售额同比增长7%至25.6亿美元。精神分裂症治疗药物Cobenfy（xanomeline/trospium chloride）也实现了强劲上市，仅在美国市场就创造了3500万美元的销售额。在传统产品组合中，与辉瑞公司在全球范围内合作销售的非专利血液稀释剂Eliquis（apixaban）销售额持续增长，同比增长6%至36.8亿美元。在此期间，Opdivo的皮下注射版本Qvantig也已推出。在财报电话会议上，CEO Boerner强调，公司正处于一个关键时期，通过战略合作和关键数据发布，其增长轨迹将加速。除了与BioNTech的合作，BMS在7月还宣布与贝恩资本（Bain Capital）成立一家“NewCo”合资公司，将包括afimetoran（TLR7/8）以及靶向TYK2、IL-2-CD25、IL-10和IL-18的产品在内的五种免疫学资产授权给该实体。BMS持有这家新公司约20%的股份。在临床试验进展方面，Boerner表示：“我们正在进入一个数据丰富的时期。仅在接下来的12到24个月里，我们预计将有7项注册性资产和7项重要的生命周期管理机会。”在未来12个月内的关键数据发布中，Cobenfy治疗阿尔茨海默病精神病的III期临床试验将是其中之一。在即将到来的产品管线事件方面，同类首创的TYK2抑制剂Sotyktu（deucravacitinib）已获批用于治疗中度至重度斑块状银屑病，目前已在全球（包括中国）提交了用于治疗活动性银屑病关节炎这一新适应证的申请，美国食品药品监督管理局（FDA）已将2026年3月6日定为《处方药使用者付费法案》（PDUFA）的目标决策日。全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

After four failed phase 3 trials, Bristol Myers Squibb CEO Chris Boerner said a new chief medical officer represents "an opportunity for a refresh." Bristol Myers Squibb had a strong quarter, with key drugs old and new coming in either above or in line with Wall Street’s expectations.The New Jersey pharma’s $12.3 billion revenues in the second quarter handily beat analysts’ consensus by 7.7%. As a result, the company raised its full-year revenue outlook by $700 million at the midpoint, to a new range between $46.5 billion and $47.5 billion.Both legacy products, such as blood cancer drug Revlimid and Pfizer-partnered blood thinner Eliquis, and newer drugs, including heart disease med Camzyos and cell therapy Breyanzi, outperformed expectations during the period. Most notably, despite a 38% year-over-year decline, Revlimid’s $838 million haul during the quarter landed a surprising 40% above consensus.But investors’ attention remains focused on the schizophrenia drug Cobenfy, despite its small $35 million contribution to BMS’ top line in the second quarter.The number slightly beat analysts’ projection of $32 million, as BMS continues to see prescription growth. Still, the sales are far from the multibillion-dollar territory that BMS and industry watchers believe the novel antipsychotic could reach. Cobenfy is now tracking over 2,000 total weekly scripts in the U.S., BMS Chief Commercialization Officer Adam Lenkowsky told investors on a call Thursday.“As we previously communicated, we knew it was going to take time to change what’s been decades of entrenched prescribing behavior; and indeed, I think that’s been the case,” Lenkowsky said.BMS is expanding its community field force to increase reach and frequency because “it takes multiple calls to change physician behavior,” he said. Addressing a common question from doctors about how to switch from traditional meds, BMS is introducing peer-to-peer assistance and running a phase 4 switch study, which is expected to read out this year.Lenkowsky described a phased approach to Cobenfy’s expansion: first in the community setting, then to hospitals and, ultimately, new indications.However, Cobenfy recently failed as an adjunctive treatment in patients with inadequately controlled schizophrenia. BMS, having observed a numerical improvement and a positive sign through a post-hoc subgroup analysis of the Arise trial, has said it would talk with the FDA about a potential path forward.That discussion has not yet happened, and BMS continues to analyze the data, BMS’ chief medical officer, Samit Hirawat, M.D., said on Thursday’s call.Meanwhile, investors are shifting their focus to Cobenfy’s opportunity in Alzheimer’s disease psychosis, with Adept-2, the first of three phase 3 trials, on track to report data this year. BMS needs at least two positive studies to be able to file for an approval there.Cobenfy is a combination of xanomeline and trospium chloride. Xanomeline has shown some benefits for treating psychosis symptoms in Alzheimer’s, but as one analyst noted on Thursday’s call, xanomeline on its own demonstrated a clear problem with patient dropouts in an earlier trial. Hirawat argued that people should not draw direct conclusions from that case, because BMS’ trials mark “a huge difference” from the xanomeline study conducted 30 years ago.Counting Cobenfy’s Arise trial flop, all four of BMS’ pivotal data readouts so far this year have been negative. The other three setbacks were Opdualag in adjuvant melanoma, Camzyos in non-obstructive hypertrophic cardiomyopathy and, more recently, Reblozyl in myelofibrosis-associated anemia. Clinical failures of those growth products don’t look very promising for a company that’s bracing itself for a major loss-of-exclusivity phase. But BMS CEO Chris Boerner appeared less concerned.“First, as we look back at the studies that haven’t gone the way we had anticipated, there are two things I think are important to keep in mind,” Boerner said on the investor call. “The first is that when you look at those studies in totality, while they were meant to answer important scientific questions or clinical practice questions, they collectively have relatively limited impact on the long-term growth of the company.”“What is more important is whether or not those studies have any implications going forward,” the chief executive continued. “And we don’t see any read-forward from those studies to future opportunities.”That said, BMS is bringing on a new chief medical officer as of Aug. 1: Cristian Massacesi, M.D., formerly AstraZeneca’s chief medical officer and oncology chief development officer.“In many respects, not just with respect to the early pipeline, but really across drug development, there’s going to be a focus that we have on execution,” Boerner said of Massacesi’s appointment.While Hirawat has laid the foundation for some R&D initiatives at BMS, “anytime you bring somebody in from outside the company, you would expect that they would bring a different approach, a different level of energy, a different way of thinking,” Boerner continued. “So, I think there’s an opportunity for a refresh there as well.”