Acoramidis

上海，2025年11月6日——在第八届中国国际进口博览会上，“维立西呱VICTOR研究结果中国首发仪式”在拜耳展台隆重举行。该研究于2025年欧洲心脏病学会（ESC）大会上荣耀发布，为心衰患者的规范治疗提供了坚实的循证医学证据，开启了心衰治疗的新篇章。 拜耳维立西呱VICTOR研究中国重磅发布 心力衰竭是心血管疾病最后的战场。尽管以“新四联”为代表的标准治疗（GDMT）极大改善了患者预后，但临床实践中患者仍面临高死亡率、高住院率的严峻挑战，存在显著的残余风险。VICTOR研究的突破性在于，它首次在“病情相对稳定”、已接受充分标准治疗的HFrEF患者中，验证了维立西呱在降低心血管死亡和全因死亡方面的获益。 中国科学院院士葛均波教授 中国科学院院士葛均波教授担任VICTOR研究的中国Leading PI，他表示，“VICTOR研究的结果为临床医生提供了强有力的新证据，改变了我们对稳定期心衰患者的管理策略，即推动治疗转向更加主动的全程风险管理，这最终将为患者带来显著的生存获益和生活质量提升。研究的顺利开展与成果的获得，离不开全国48家研究中心研究团队的辛勤付出和医药企业的专业支持。期待未来能与拜耳这样的创新医药企业继续深入合作，将更多突破性疗法带给中国患者，共同携手推动中国心血管疾病防治水平的提升。” 复旦大学附属中山医院周京敏教授 复旦大学附属中山医院周京敏教授作为作为中国VICTOR研究组长单位的执行PI对VICTOR研究结果进行了深入解读。研究结果显示，维立西呱能够降低心血管死亡相对风险17%，并降低全因死亡相对风险16%，尤其可降低心源性猝死风险达25%，且中位获益时间仅为5.4个月，提示其早期使用维立西呱即可发挥保护作用。周京敏教授介绍，“VICTOR研究传递出一个关键信息：对于看似“稳定”的HFrEF患者，其猝死及远期死亡风险依然严峻。稳定期不应被视为治疗的‘终点’，而应成为我们主动干预、进一步改善预后的‘关键窗口期’。这提示临床医生应转变观念，对稳定期患者进行更积极、主动的干预，从而进一步优化心衰的全程管理。” 拜耳集团处方药事业部全球执行副总裁兼中国区总裁，及拜耳中国区总裁周晓兰表示：“作为一家创新的生命科学企业，拜耳始终致力于将全球领先的突破性疗法引入中国，并深度支持本土临床研究，以切实满足中国患者的健康需求。面对超过千万的中国心衰患者，VICTOR研究这一里程碑结果的发布，既是维立西呱临床价值的重要探索，更是拜耳以创新践行‘共享健康’企业使命的核心体现。‘健康中国’战略目标的实现需要汇聚各方智慧，拜耳期待在研发、诊疗、疾病教育等各个环节，与社会各界深化合作，共同构建一个以患者为中心的创新生态系统，携手迎接中国心血管事件‘拐点’的早日到来。” 拜耳集团处方药事业部高级副总裁，核心产品业务总经理杨灏介绍，“从拥有百年历史的拜阿司匹灵®，到抗高血压药物拜新同®，口服抗凝药拜瑞妥®，慢性心衰治疗药物唯可同®,到今年中美同步递交心衰适应症的糖尿病相关慢性肾脏病治疗药物可申达®，以及在研的口服XIa因子抑制剂Asundexian和治疗ATTR-CM（蛋白淀粉样变性心肌病）的创新药物Acoramidis，拜耳以强大的产品线，构建起从抗血小板、降压、抗凝、心衰治疗到心肾共护的全程心血管疾病管理体系，应对中国慢病管理的巨大挑战。与此同时，我们积极携手学会等专业学术机构，支持房颤中心、心衰中心、胸痛中心等三大核心项目建设，持续推动中国心血管诊疗规范化，将循证医学证据和指南推荐转化为可落地的临床实践。” 关于拜耳 拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2024财年，拜耳的员工人数约为93,000名，销售额为466亿欧元。不计特殊项目的研究开发投入为62亿欧元。更多信息请见www.bayer.com。 前瞻性声明 本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站http://www.bayer.com/上公开的拜耳各项报告。本公司没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。

The much-ballyhooed competition between BridgeBio and Alnylam has been less of a tug-of-war and more of a rising-tide-lifts-all-boats scenario. That’s because both companies are hitting the milestones they each laid out for the respective launches of their transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) treatments, and that’s likely to continue, even as other companies attempt to enter the market, analysts tell Endpoints News . For BridgeBio, the commercial success of Attruby — combined with two late-stage rare disease wins this week — underscore the company’s increasingly diverse portfolio. Alnylam, meanwhile, is headed toward its long-stated goal of becoming profitable by the end of this year. “We’re definitely, I’d say, poised to achieve this goal that we set out for ourselves back in 2021,” Alnylam CEO Yvonne Greenstreet told Endpoints News . Attruby and Alnylam’s Amvuttra, which both received approval for ATTR-CM within the last year, continue to record strong sales and quarter-over-quarter growth. Amvuttra generated $685 million in sales in the third quarter, up from $492 million in the second quarter, and Attruby pulled in $108.1 million compared to $71.5 million in Q2. But the raw sales numbers don’t tell the whole story. Amvuttra costs more than twice as much as Attruby. Amvuttra is also covered by Medicare Part B, while Attruby is covered by Part D. Part B drugs are typically more expensive because they’re administered in doctors’ offices, and clinicians have a different set of incentives to prescribe them. Attruby is also a small molecule drug, which is typically cheaper to manufacture than other drugs. (Amvuttra is an RNA silencer.) What’s really driving the growth for both drugs is a significant increase in the number of patients being diagnosed, according to TD Cowen analyst Ritu Baral. Some investors theorized that ATTR-CM was underdiagnosed. Even after the first ATTR-CM drug was approved in 2019 — Pfizer’s Vyndamax/Vyndaqel franchise — it was primarily prescribed to patients with severe symptoms. That created an opening for both drugs to record strong early sales despite near-simultaneous launches, Baral said. But investor skepticism also drove the idea there would be stiff competition, she added. The market potential “just wasn’t recognized by the investors, where it was by the doctors,” Baral said. Most analysts say the key metric to watch is related to underdiagnoses. The goal is to grow the number of “first-line” individuals on a drug rather than simply count the patients who switch from Vyndamax/Vyndaqel. That’s happening, according to William Blair analyst Myles Minter, because there are so many undiagnosed patients. “The moment that I start hearing all these companies going, ‘Hey, the majority of our patients are switches,’ then I’ll start to get worried,” he said. “Because then you’re just fighting for a smaller piece of the pie.” In a third-quarter earnings call, BridgeBio CEO Neil Kumar said his “best guess” of Attruby’s first-line market share is “well in the 20s” in terms of percentage of market share. Kumar said he couldn’t give a precise figure, because Alnylam and Pfizer hadn’t yet reported their earnings. (Pfizer is set to report on Tuesday.) Alnylam did not break down the first-line and “switch” figures in Thursday’s earnings call, but Greenstreet told Endpoints that Amvuttra is “highly competitive” in that “first-line” segment. Despite the strong sales figures for each drug, BridgeBio and Alnylam’s stock prices both dropped on Thursday after Alnylam reported its quarterly results. BridgeBio $BBIO shares closed down 4.9%, while Alnylam $ALNY fell about 6.7%. It’s unclear why this happened. More than a handful of analysts, including Cantor Fitzgerald’s Olivia Brayer, put out notes to investors saying investor expectations have become inflated, particularly for Alnylam. Some are “starting to question” how much upside is left in Alnylam’s stock, given the company likely won’t launch another drug for several years, Brayer wrote. Leerink analyst Mani Foroohar agreed, saying investors seemed to want accelerating sales growth rather than the stable, linear growth Alnylam has shown so far. “As investor expectations got really, really high, driven by technical as well as fundamental reasons, it became tougher and tougher to hit that bar,” he told Endpoints. BridgeBio is more insulated from this dynamic, he added, because the company is closer to launching other drugs. The rare disease wins this week point to at least two new drugs coming to market sometime in 2027. Baral noted that the stock drops may have been influenced by other incentives. Attruby and Amvuttra sales are intensely scrutinized every quarter when doing so may not be warranted, given the “explosive” market that’s unfolded in the last 12 months. “Everybody’s pushing their narrative, and Alnylam has frequently been a stock that has been controversial,” Baral said. “Let’s put it that way.”