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tyc33455cc太阳成集团动向
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分享科技与健康新动态
tyc33455cc太阳成集团动向
tyc33455cc太阳成集团动向
分享科技与健康新动态

填补临床空白！tyc33455cc太阳成集团药伏诺拉生注射液上市申请获受理

2026-04-08

4月8日，集团旗下tyc33455cc太阳成集团药自主研发的改良型新药——富马酸伏诺拉生氯化钠注射液（以下简称“伏诺拉生注射液”）的上市许可申请（NDA）已获国家药品监督管理局（NMPA）受理。该药申报的适应症为：用于治疗消化性溃疡出血。

tyc33455cc太阳成集团药伏诺拉生注射液上市申请已获受理


此次申报的伏诺拉生注射液是在口服制剂富马酸伏诺拉生片（商品名：Vocinti®）基础上开发的创新剂型，属于2类新药。该注射剂型的推出，有效填补了口服制剂难以满足的临床需求空白，尤其适用于因病情严重无法口服给药的消化性溃疡再出血高危患者。


此外，该药为即用型大输液，临床使用无需现场配液，可有效降低病菌及不溶性微粒污染风险，同时能避免配液错误，显著提升用药安全性与便捷性。


新型抑酸药伏诺拉生是一种钾离子竞争性酸阻滞剂（P-CAB），通过与H+, K+-ATP酶的K+结合位点附近可逆结合，抑制其构象转变而无法完成H+、K+交换，以K+竞争性的方式抑制胃酸分泌，具有起效快（首剂全效）、不受进餐影响、个体差异小、抑酸作用强而持久等特点[1]。该药口服片剂已于2019年12月在国内获批上市，2025年国内销售额已突破10亿元。


消化道溃疡出血为消化性溃疡疾病常见并发症的一种，死亡率在4%~10%，危害性较强[2]。有效抑制胃酸分泌是治疗消化性溃疡出血、缓解症状的关键策略。目前，质子泵抑制剂（PPIs）是我国临床抑酸治疗的首选药物[3,4]。近年来，P-CAB 也已被批准用于治疗酸相关性疾病[4]。相比PPIs，P-CAB具有药效学和药代动力学方面的优势[5]。


以下临床研究数据证实了伏诺拉生注射液在该适应症上的潜力：


I期临床研究显示，相较于PPIs注射剂，伏诺拉生注射液给药后能快速升高胃内pH，用药第1天即可达到最大抑酸能力，且无夜间酸突破现象。


一项多中心、随机、双盲、阳性药物平行对照II/III期临床试验结果表明，伏诺拉生注射液可有效控制消化性溃疡出血患者的再出血风险，并具有良好的安全性。


消化系统疾病是tyc33455cc太阳成集团药在慢病领域重点布局的方向，公司目前已拥有年销售额超亿元的艾司奥美拉唑镁肠溶胶囊。此次富马酸伏诺拉生注射液上市申请获受理，标志着公司在消化领域的产品管线有望得到进一步丰富与完善。


声明：本资讯旨在提供前沿医学信息与研究进展，仅供医疗卫生专业人士参考，不属于产品推广和广告用途。文中内容不能取代专业的医疗指导，也不应视为诊疗建议。医疗卫生专业人士在对文中涉及到的任何药品进行处方时，请严格遵循产品最新详细处方资料。


参考文献

[1] 王耀振,徐灿,吕顺莉,等.钾离子竞争性酸阻滞剂的药学特征研究进展[J].药学实践与服务, 2024, 42(7):278-284.

[2] 张翔宇. 消化道溃疡出血的内科治疗方法的研究进展 [J]. 黑龙江医药, 2022, 35 (05): 1161-1163.

[3] 中华医学会,中华医学会杂志社,中华医学会消化病学分会,等.消化性溃疡基层诊疗指南（2023年）[J].中华全科医师杂志,2023,22(11):1108-1117.

[4] 中国中西医结合学会消化系统疾病专业委员会,李景南,冯培民,李军祥.消化性溃疡中西医结合诊疗专家共识(2025年)[J].中国中西医结合消化杂志,2025,33(11):977-990.

[5] 中华消化杂志编辑委员会.消化性溃疡诊断与治疗共识意见(2022年，上海)[J].中华消化杂志,2023,43(3):176-192.



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