Omecamtiv mecarbil是一种在研的选择性小分子心肌肌球蛋白激活剂，作为同类首创的靶向肌节的在研新药^{1<\/sup>，可直接靶向作用于心脏的收缩机制，在收缩过程中结合并增加与肌动蛋白相互作用的心肌肌球蛋白头部区域的数量。Omecamtiv mecarbil旨在增加每个心动周期中的肌动蛋白-肌球蛋白活性横桥的数量，从而在射血分数降低的心力衰竭（HFrEF）患者中增强受损的心肌收缩力。临床前研究显示，omecamtiv mecarbil可增强心肌收缩力，且不增加心肌细胞内的钙浓度或心肌耗氧量^{2-4<\/sup>。<\/p> \n}}

Omecamtiv mecarbil的开发项目正在评估其治疗HFrEF的潜力。omecamtiv mecarbil的第一个3期临床试验GALACTIC-HF的积极结果证明了在采用标准治疗的患者中，与安慰剂相比，omecamtiv mecarbil治疗在降低心血管死亡或心力衰竭事件（心力衰竭住院和其他心力衰竭紧急治疗）的主要复合终点风险方面具有统计学意义。没有观察到心血管死亡的次要终点减少。不良事件和研究药物的中止治疗在各治疗组之间平衡。FDA已接受了基于GALACTIC-HF结果的Omecamtiv mecarbil的新药申请，并指定《处方药使用者付费法案(PDUFA)》目标评审日期为2023年2月28日。<\/p> \n

心力衰竭是多种原因导致心脏结构和\/或功能的异常改变，使心室收缩和\/或舒张功能发生障碍，从而引起的一组复杂临床综合征，主要表现为呼吸困难、疲乏和液体潴留（肺淤血、体循环淤血及外周水肿）等，也是各种心脏疾病的严重表现或晚期阶段^{5<\/sup>。据估计，全球心力衰竭患者约6400万^{6<\/sup>。在中国25岁以上人群的患病率为1.1%，这意味着中国25岁以上人群中患者人数估计超过1200万，且患病率随着年龄增加而上升^{7<\/sup>。<\/p> \n}}}

根据左室射血分数（LVEF），分为射血分数降低的心衰（HFrEF，LVEF≤40%）、射血分数改善的心衰（HFimpEF，既往LVEF≤40%，随访LVEF>40%）、射血分数轻度降低的心衰（HFmrEF，LVEF 41%-49%）和射血分数保留的心衰（HFpEF，LVEF ≥50%）^{8<\/sup>。在中国队列中观察到HFrEF的患者5年死亡率明显高于其他类型^{9<\/sup>。<\/p> \n}}

虽然心衰的防治已经取得了很大进步，但整体预后仍不理想。有数据显示，中国心衰患者出院后30天和1年的再住院率为19%和53%，而出院后30天和1年死亡率分别为14%和29%^{10<\/sup>。考虑到心衰患者的数量，反复住院和最终死亡都给家庭和医疗系统都带来明显的负担。<\/p> \n}

箕星是一家总部位于中国上海的生物制药公司，致力于将创新科学和药物带给罹患严重危及生命健康疾病的中国患者。箕星由RTW Investments, LP于2019年投资创立，与全球多家生物技术公司开展合作，通过开发和商业化独特创新的治疗药物，应对心血管和眼科疾病领域尚未满足的医疗需求。凭借强劲且不断壮大的产品管线、经验丰富的管理团队和以患者为中心的理念，箕星将为大中华地区的患者群体带来持久而深远的影响。更多信息请访问：www.jixing.com<\/span><\/a>。<\/p> \n

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7.         Wang H, Chai K, Du M, et al. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021;14(10):e008406.<\/span><\/p> <\/td> \n <\/tr> \n
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9.         Chen SQ, Huang ZD, Liang Y, et al. Five-year mortality of heart failure with preserved, mildly reduced, and reduced ejection fraction in a 4880 Chinese cohort. ESC Heart Fail. 2022;9(4):2336-2347.<\/span><\/p> <\/td> \n <\/tr> \n
10.      Lan T, Liao Y, Zhang J, et al. Mortality and readmission rates after heart failure: A systematic review and meta-analysis. Therapeutics and Clinical Risk Management. 2021;17: 1307–1320.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n
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