A Multicenter, Randomized, Outcomes Assessor Blind, Parallel Controlled Trial to Evaluate the Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After Coronary Artery Bypass Grafting

The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.
The main question it aims to answer is:
Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .
Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.
Participants will
1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG.
2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG.
3. Protocol-driven CCTA at Week 24 after CABG.

开始日期2025-06-01

申办/合作机构-

ISRCTN44436843

/ Recruiting临床3期IIT

The LACunar Intervention Trial 3 (LACI-3). Assessment of efficacy and safety of cilostazol and isosorbide mononitrate to prevent adverse outcomes in patients with cerebral small vessel disease (lacunar) ischaemic stroke.

开始日期2025-03-03

申办/合作机构

The University of Edinburgh

[+1]

NCT06715007

/ RecruitingN/AIIT

Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases

Cerebral small vessel disease (cSVD) is a common accompaniment of aging. Recent small subcortical (or lacunar) infarcts (i.e. symptomatic cSVD) and white matter hyperintensities are typical cSVD lesions on neuroimaging. cSVD causes about a quarter of ischaemic strokes and related with cognitive dysfunction. However, few studies are available so far to especially explore the treatment of cSVD. Endothelial dysfunction plays an important part in cSVD. Cilostazol and isosorbide mononitrate have endothelial protective function. We designed this prospective cohort study in China, aiming to evaluate the effect of different antiplatelet agents (e.g. Cilostazol) on cSVD and retina in patients with cSVD (recent small subcortical infarcts or WMH, respectively).

开始日期2024-12-20

申办/合作机构

常州市第二人民医院

100 项与单硝酸异山梨酯相关的临床结果

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100 项与单硝酸异山梨酯相关的转化医学

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100 项与单硝酸异山梨酯相关的专利（医药）

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1,810

项与单硝酸异山梨酯相关的文献（医药）

2025-09-01·INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS

A Matched Case-Control Study of the Relationship Between Radiation Dose to the Internal Mammary Lymph Nodes and Clinical Outcomes in Patients With and Without Internal Mammary Lymph Node Relapses

Article

作者: Lohrisch, Caroline ; Gondara, Lovedeep ; Nichol, Alan ; Swift, Carrie-Lynne ; Chng, Nicholas ; Narinesingh, Dylan ; Chang, Jee Suk ; Musoke, Richard ; Wade, Louise ; Speers, Caroline

PURPOSE:

The Early Breast Cancer Trialists' Collaborative Group's 2023 meta-analysis of radiation therapy to regional nodes in early breast cancer demonstrated a significant improvement in overall survival (OS) without an associated improvement in locoregional recurrence in the trials comparing internal mammary node (IMN) irradiation versus none. We aimed to study cases with IMN relapse (IMNR) and controls without IMNR to examine the link between IMNR and OS.

METHODS AND MATERIALS:

Patients treated curatively between 2005 and 2014, who subsequently developed IMNR, were identified in a population-based database. The IMNR cases were matched 1:2 to controls without IMNR using patient and tumor characteristics. The internal mammary vessels in the first 3 intercostal spaces were outlined on planning computed tomography scans as the IMN clinical target volume, and the mean equivalent doses in 2-Gy fractions to the IMNs were calculated. Multivariable Fine and Gray competing-risk regression and Cox regression were used to evaluate the effect of the baseline patient, tumor, and treatment variables, including therapeutic IMN irradiation with ≥40 Gy on IMNR and OS.

RESULTS:

Seventy cases were matched with 140 controls. Median follow-up was 9.1 years, median tumor size was 25 mm, and N-stages were: 37% N0, 33% N1, and 30% N2-3. The medians of the IMN doses were 4.1 Gy for cases and 13.7 Gy for controls (P < .001). On multivariable analysis, worse IMNR was associated with mastectomy (hazard ratio [HR], 2.11; P = .02), and better IMNR was associated with therapeutic IMN irradiation (HR, 0.36; P = .009); worse OS was associated with larger tumor size (HR, 1.02; P = .006), ≥10 positive axillary nodes (HR, 3.15; P = .04), and triple-negative subtype (HR, 2.92; P = .03), and better OS was associated with therapeutic IMN irradiation (HR, 0.49; P = .02).

CONCLUSIONS:

We demonstrated that therapeutic IMN irradiation with ≥40 Gy was associated with both a lower risk of IMNR and improved OS.

2025-09-01·CANCER CAUSES & CONTROL

Leveraging technology and standardized institutional practices to mitigate disparities in breast cancer radiation therapy

Article

作者: Oyeniyi, Jacob F ; Jawad, Maha Saada ; Dilworth, Joshua T ; Loving, Bailey A ; Almahariq, Muayad F

OBJECTIVES:

Disparities in various dimensions, including racial, in breast cancer treatment and outcomes are well established. A recent multi-institutional study reported a higher mean heart dose (MHD) in Black and minority women compared to White women who underwent left-sided breast/chest wall irradiation which translated into excess cardiac events and mortality. We evaluated the MHD of women treated in our institution and investigated whether institution-wide measures including the use of readily available but inconsistently adopted technologies can mitigate this disparity.

METHODS:

We identified 509 female patients treated with left-sided breast/chest wall irradiation with/without regional nodal irradiation (RNI). Details regarding cardiac dosimetry, deep-inspiratory breath-hold (DIBH) such as active breathing coordinator (ABC) use, breast size, internal mammary nodal (IMN) irradiation, and whether the treatment plan met boarding pass requirements and was peer reviewed were noted. MHD differences across racial groups were analyzed using Kruskal-Wallis test, while UVA and MVA linear regression analyses assessed influence of various factors on MHD.

RESULTS:

MHD(Gy) was similar across racial groups; 1.38, 1.35, and 1.39 (p = 0.6) in Black, White, and other racial groups, respectively. Utilization of hypofractionation, cavity boosts, RNI, IMN irradiation, meeting boarding pass requirements, and peer review were similar. ABC usage (%) was 83/75/62 (p = 0.005), while median breast size(cc) was 1504/1904/1331 (p = 0.001) in White/Black/other women, respectively. On UVA and MVA, MHD differed with IMN treatment, boost and ABC use but not racial groups and varying breast sizes.

CONCLUSION:

Despite anatomical differences such as breast size, achieving similar cardiac dose is feasible across racial groups by uniformly utilizing appropriate technology such as ABC, with standardized boarding pass constraints, and peer review of all cases. Further studies to identify factors that may cause varied cardiac morbidity rates despite similar cardiac dosimetry among racial groups are warranted.

2025-08-08·ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY

Wedge fragments: no significant impact on bone healing in femoral shaft fractures treated with intramedullary nailing.

Article

作者: Yoon, Yong-Cheol ; Jang, Myung Jin ; Song, Hyung Keun ; Jeun, Jigang

INTRODUCTION:

Intramedullary nailing (IMN) is the treatment of choice for femoral shaft fractures with wedge-shaped fragments. However, the management of wedged fragments remains controversial. This study investigated whether wedged fragments affect bone union rates in patients treated with IMN. The primary hypothesis was that wedged fragments would not significantly affect bone union when proper IMN principles were followed.

MATERIALS AND METHODS:

Between March 2014 and June 2023, 162 patients were diagnosed with femoral shaft fractures (AO/OTA 32-B type) accompanied by wedge fractures. The surgeries involved the use of a reconstruction antegrade nail with a greater trochanteric entry point. Closed reduction was performed, and recon-type screws were used for proximal fixation of the femoral neck and head and at least two screws distally. The wedged fragments were not manipulated further. We analyzed the characteristics of the wedged fragments, including size, displacement, angle, and reversal morphology, and assessed the main fracture gap size in relation to bone union outcomes.

RESULTS:

The study included 95 of the 162 patients, of whom 82 (86.3%) achieved bone union and 13 (13.7%) experienced nonunion. Demographic and preoperative variables showed no significant differences between the union and nonunion groups. Postoperative radiographic analysis of the wedged fragments revealed no significant differences in fragment size, angle, displacement, or presence of reversed fragments. However, the main fracture gap size significantly differed, averaging 5.2 mm in the union group and 15.6 mm in the nonunion group(p = 0.01). Complications included superficial infections in four patients and malrotation in three, which were managed conservatively.

CONCLUSIONS:

Wedge fragments in femoral shaft fractures do not significantly affect bone union with IMN. Instead, the size of the main fracture gap is critical for healing. Surgery should focus on stable fixation and minimization of the main fracture gap rather than manipulating the wedged fragments.

项与单硝酸异山梨酯相关的新闻（医药）

2025-08-25

·国家药品监督管理局

2025年08月25日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CXHS2400035地罗阿克片轩竹生物科技股份有限公司国药准字H202500552025年08月19日2CXHS2400036地罗阿克片轩竹生物科技股份有限公司国药准字H202500562025年08月19日3CXHS2400092注射用苯磺酸瑞马唑仑宜昌人福药业有限责任公司国药准字H202000062025年08月19日4CXHS2400093注射用苯磺酸瑞马唑仑宜昌人福药业有限责任公司国药准字H202270872025年08月19日5CXSS2300039口服六价重配轮状病毒减毒活疫苗（Vero细胞）武汉生物制品研究所有限责任公司国药准字S202500472025年08月19日6CXSS2400011绒促卵泡激素α N01注射液苏州晟济药业有限公司国药准字S202500492025年08月19日7CXSS2400012绒促卵泡激素α N01注射液苏州晟济药业有限公司国药准字S202500502025年08月19日8CXSS2400043鼻喷流感减毒活疫苗长春百克生物科技股份公司国药准字S202500462025年08月19日9CXSS2400044吸附破伤风疫苗北京科兴中维生物技术有限公司国药准字S202500482025年08月19日10CYHS2101727国二氟泼尼酯滴眼液津药和平（天津）制药有限公司国药准字H202551632025年08月19日11CYHS2301541利丙双卡因乳膏华润双鹤药业股份有限公司国药准字H202550852025年08月19日12CYHS2301548米诺地尔搽剂华润三九医药股份有限公司国药准字H202551362025年08月19日13CYHS2302005盐酸左西替利嗪口服溶液海南斯达制药有限公司国药准字H202551372025年08月19日14CYHS2302311注射用培美曲塞二钠北京双鹭药业股份有限公司国药准字H202550862025年08月19日15CYHS2302312注射用培美曲塞二钠北京双鹭药业股份有限公司国药准字H202550872025年08月19日16CYHS2302643米诺地尔搽剂山东新华制药股份有限公司国药准字H202551382025年08月19日17CYHS2302644米诺地尔搽剂山东新华制药股份有限公司国药准字H202551392025年08月19日18CYHS2303019复方甘草酸苷片浙江美迪深生物医药有限公司国药准字H202551402025年08月19日19CYHS2303040重酒石酸去甲肾上腺素注射液嘉实（湖南）医药科技有限公司国药准字H202551412025年08月19日20CYHS2303041重酒石酸去甲肾上腺素注射液嘉实（湖南）医药科技有限公司国药准字H202551422025年08月19日21CYHS2303133复方甘草酸苷片成都倍特药业股份有限公司国药准字H202551432025年08月19日22CYHS2303249维生素B₁₂滴眼液中山万汉制药有限公司国药准字H202550882025年08月19日23CYHS2303462环硅酸锆钠散时森海（杭州）医药科技有限公司国药准字H202551152025年08月19日24CYHS2303490吸入用复方异丙托溴铵溶液扬州中宝药业股份有限公司国药准字H202551642025年08月19日25CYHS2303518盐酸西替利嗪口服溶液重庆健能医药开发有限公司国药准字H202551442025年08月19日26CYHS2303519盐酸西替利嗪口服溶液重庆健能医药开发有限公司国药准字H202551452025年08月19日27CYHS2303570克拉霉素干混悬剂山东淄博新达制药有限公司国药准字H202551162025年08月19日28CYHS2303614拉考沙胺口服溶液岳阳新华达制药有限公司国药准字H202550892025年08月19日29CYHS2303680沙格列汀二甲双胍缓释片（I）山东齐都药业有限公司国药准字H202550902025年08月19日30CYHS2400001左氧氟沙星片湖北唯森制药有限公司国药准字H202551652025年08月19日31CYHS2400002硫辛酸片浙江花园药业有限公司国药准字H202550912025年08月19日32CYHS2400003硫辛酸片浙江花园药业有限公司国药准字H202550922025年08月19日33CYHS2400027富马酸伏诺拉生片双鹤药业（海南）有限责任公司国药准字H202551662025年08月19日34CYHS2400028富马酸伏诺拉生片双鹤药业（海南）有限责任公司国药准字H202551672025年08月19日35CYHS2400097盐酸尼卡地平注射液齐鲁制药（海南）有限公司国药准字H202550932025年08月19日36CYHS2400168、CYHB2500973左氧氟沙星注射液湖北科伦药业有限公司国药准字H202551682025年08月19日37CYHS2400169、CYHB2500972左氧氟沙星注射液湖北科伦药业有限公司国药准字H202551692025年08月19日38CYHS2400196吗啉硝唑氯化钠注射液贵州科伦药业有限公司国药准字H202551702025年08月19日39CYHS2400201注射用磷酸特地唑胺上海谷方盟医药科技有限公司国药准字H202550942025年08月19日40CYHS2400232注射用尼可地尔朗天药业（湖北）有限公司国药准字H202551712025年08月19日41CYHS2400317吲哚布芬片金鸿药业股份有限公司国药准字H202551722025年08月19日42CYHS2400331吡拉西坦注射液西安达莫制药有限公司国药准字H202550952025年08月19日43CYHS2400332吡拉西坦注射液西安达莫制药有限公司国药准字H202550962025年08月19日44CYHS2400347结构脂肪乳注射液(C₆ ~₂₄)四川科伦药业股份有限公司国药准字H202550972025年08月19日45CYHS2400372、CYHB2501431苯磺酸左氨氯地平片吉林天衡英睿制药有限公司国药准字H202551172025年08月19日46CYHS2400409盐酸艾司洛尔氯化钠注射液海南爱科制药有限公司国药准字H202551182025年08月19日47CYHS2400445盐酸多奈哌齐片山东新时代药业有限公司国药准字H202550982025年08月19日48CYHS2400446盐酸多奈哌齐片山东新时代药业有限公司国药准字H202550992025年08月19日49CYHS2400462舒更葡糖钠注射液乳源东阳光药业有限公司国药准字H202551732025年08月19日50CYHS2400511硫酸镁注射液江苏迪赛诺制药有限公司国药准字H202551742025年08月19日51CYHS2400516盐酸左沙丁胺醇雾化吸入溶液海南斯达制药有限公司国药准字H202551462025年08月19日52CYHS2400590沙库巴曲缬沙坦钠片重庆圣华曦药业股份有限公司国药准字H202551472025年08月19日53CYHS2400591沙库巴曲缬沙坦钠片重庆圣华曦药业股份有限公司国药准字H202551482025年08月19日54CYHS2400593甲钴胺片山东鲁宁药业有限公司国药准字H202551192025年08月19日55CYHS2400677氯化钾缓释片天津力生制药股份有限公司国药准字H202551492025年08月19日56CYHS2400678氯化钾缓释片天津力生制药股份有限公司国药准字H202551502025年08月19日57CYHS2400702复方氨基酸注射液（18AA-Ⅶ-SF）广东赛烽医药科技有限公司国药准字H202551002025年08月19日58CYHS2400703盐酸奥布卡因滴眼液广州大光制药有限公司国药准字H202551202025年08月19日59CYHS2400727二羟丙茶碱注射液山东睿亿医药有限公司国药准字H202551512025年08月19日60CYHS2400728二羟丙茶碱注射液辽宁海神联盛制药有限公司国药准字H202551522025年08月19日61CYHS2400747长链脂肪乳注射液（OO）四川科伦药业股份有限公司国药准字H202551212025年08月19日62CYHS2400748长链脂肪乳注射液（OO）四川科伦药业股份有限公司国药准字H202551222025年08月19日63CYHS2400784比索洛尔氨氯地平片浙江花园药业有限公司国药准字H202551012025年08月19日64CYHS2400805复方氨基酸注射液（18AA-Ⅸ-SF）广东赛烽医药科技有限公司国药准字H202551022025年08月19日65CYHS2400806左氧氟沙星滴眼液河北合渡药业有限公司国药准字H202551532025年08月19日66CYHS2400808、CYHB2500206醋酸加尼瑞克注射液海南中和药业股份有限公司国药准字H202551232025年08月19日67CYHS2400810注射用氟氧头孢钠浙江惠迪森药业有限公司国药准字H202551242025年08月19日68CYHS2400908、CYHB2501156硫酸镁钠钾口服用浓溶液云鹏医药集团有限公司国药准字H202551752025年08月19日69CYHS2400909莫匹罗星软膏深圳市泰力生物医药有限公司国药准字H202551252025年08月19日70CYHS2400924左甲状腺素钠片北京福元医药股份有限公司国药准字H202551262025年08月19日71CYHS2400930草酸艾司西酞普兰滴剂广州一品红制药有限公司国药准字H202551542025年08月19日72CYHS2401056硫酸镁钠钾口服用浓溶液浙江凯润药业股份有限公司国药准字H202551032025年08月19日73CYHS2401114硫酸镁钠钾口服用浓溶液广东大冢制药有限公司国药准字H202551042025年08月19日74CYHS2401147、CYHB2401912二甲硅油乳剂丽彩甘肃西峰制药有限公司国药准字H202551552025年08月19日75CYHS2401149、CYHB2401913二甲硅油乳剂丽彩甘肃西峰制药有限公司国药准字H202551562025年08月19日76CYHS2401150、CYHB2401914二甲硅油乳剂丽彩甘肃西峰制药有限公司国药准字H202551572025年08月19日77CYHS2401196氧（液态）吉林杭氧气体有限公司国药准字H202551272025年08月19日78CYHS2401267盐酸屈他维林注射液北京新美泰克医药科技有限公司国药准字H202551282025年08月19日79CYHS2401282他达拉非片重庆康刻尔制药股份有限公司国药准字H202551582025年08月19日80CYHS2401283他达拉非片重庆康刻尔制药股份有限公司国药准字H202551592025年08月19日81CYHS2401292盐酸达泊西汀片苏州特瑞药业股份有限公司国药准字H202551052025年08月19日82CYHS2401342磷酸奥司他韦胶囊陕西步长高新制药有限公司国药准字H202551292025年08月19日83CYHS2401354骨化三醇软胶囊浙江浙北药业有限公司国药准字H202551302025年08月19日84CYHS2401399盐酸奥布卡因滴眼液浙江视方极医药科技有限公司国药准字H202551062025年08月19日85CYHS2401408盐酸贝尼地平片石家庄四药有限公司国药准字H202551762025年08月19日86CYHS2401412非布司他片四川依科制药有限公司国药准字H202551072025年08月19日87CYHS2401413非布司他片四川依科制药有限公司国药准字H202551082025年08月19日88CYHS2401415单硝酸异山梨酯片珠海润都制药股份有限公司国药准字H202551602025年08月19日89CYHS2401417枸橼酸西地那非片南京正科医药股份有限公司国药准字H202551092025年08月19日90CYHS2401418枸橼酸西地那非片南京正科医药股份有限公司国药准字H202551102025年08月19日91CYHS2401420枸橼酸西地那非片南京正科医药股份有限公司国药准字H202551112025年08月19日92CYHS2401428沙库巴曲缬沙坦钠片山东新华制药股份有限公司国药准字H202551312025年08月19日93CYHS2401462、CYHB2402100酒石酸溴莫尼定滴眼液浙江恒研医药科技有限公司国药准字H202551122025年08月19日94CYHS2401474二羟丙茶碱注射液峨眉山通惠制药有限公司国药准字H202551612025年08月19日95CYHS2401487氨磺必利注射液南京正科医药股份有限公司国药准字H202551132025年08月19日96CYHS2401526阿司匹林肠溶片江苏济茗医药有限公司国药准字H202551772025年08月19日97CYHS2401563甲巯咪唑片江苏德源药业股份有限公司国药准字H202551322025年08月19日98CYHS2401580吸入用异丙托溴铵溶液广州大光制药有限公司国药准字H202551782025年08月19日99CYHS2401589枸橼酸托法替布缓释片华润双鹤利民药业（济南）有限公司国药准字H202551142025年08月19日100CYHS2401637硫酸氨基葡萄糖胶囊山西复盛公大药厂有限公司国药准字H202551332025年08月19日101CYHS2401669依折麦布阿托伐他汀钙片（II）成都倍特药业股份有限公司国药准字H202551792025年08月19日102CYHS2401670依折麦布阿托伐他汀钙片（Ⅰ）成都倍特药业股份有限公司国药准字H202551802025年08月19日103CYHS2401840盐酸奥洛他定滴眼液江西马应龙美康药业有限公司国药准字H202551812025年08月19日104CYHS2402027、CYHB2501104左卡尼汀注射液东阳祥昇医药科技有限公司国药准字H202551342025年08月19日105CYHS2402032地夸磷索钠滴眼液四川美大康华康药业有限公司国药准字H202551352025年08月19日106CYHS2403642氧麻栗坡县民华燃气有限公司国药准字H202551622025年08月19日107JXHS2400103盐酸阿曲生坦片北京诺华制药有限公司国药准字HJ202500992025年08月19日108JXSS2400026注射用德达博妥单抗第一三共（中国）投资有限公司国药准字SJ202500212025年08月19日109JYHB2500274丁丙诺啡透皮贴剂萌蒂（中国）制药有限公司————2025年08月20日110JYHB2500275丁丙诺啡透皮贴剂萌蒂（中国）制药有限公司————2025年08月20日111JYHB2500276丁丙诺啡透皮贴剂萌蒂（中国）制药有限公司————2025年08月20日112JYHS2200067国注射用亚锡喷替酸北京瑞杰传思咨询有限公司国药准字HJ202500972025年08月19日113JYHS2300095枸橼酸西地那非片亚宝药业集团股份有限公司国药准字HJ202500932025年08月19日114JYHS2300096枸橼酸西地那非片亚宝药业集团股份有限公司国药准字HJ202500942025年08月19日115JYHS2300097枸橼酸西地那非片亚宝药业集团股份有限公司国药准字HJ202500952025年08月19日116JYHS2300118吗替麦考酚酯胶囊晖致医药有限公司国药准字HJ202500982025年08月19日117JYHS2300127枸橼酸西地那非片熙德隆药业（北京）有限公司国药准字HJ202500962025年08月19日

疫苗申请上市高管变更

2025-08-14

·PRNewswire

Navamedic ASA: Financial report for the 2nd quarter and first half of 2025

OSLO, Norway, Aug. 14, 2025 /PRNewswire/ -- In the first half of 2025, Navamedic ASA (OSE: NAVA), a Nordic pharma company and trusted supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies, delivered revenues of NOK 269.3 million, down from NOK 277.2 million in 2024. Excluding the milestone license fee from Orion corporation of NOK 22.7 million in 2024, revenues grew by 5.8 per cent YoY, gross margin improved to 37.3 per cent, compared to 37.0 per cent in Q2 2024 and EBITDA amounted to NOK 22.9 million compared to EBITDA of NOK 18.4 million in 2024. The performance was primarily driven by the Hospital area, particularly the antibiotics portfolio. Recent tender wins have driven sales growth for the antibiotics portfolio, which is up 48.4% YoY. "Having invested in various strategic growth initiatives over the last year, we are encouraged by the results in the second quarter of 2025. Excluding the Orion license fee last year, the 5.8 per cent revenue growth was positively impacted by Nordic tender wins for our antibiotics portfolio. Furthermore, several products, including Imdur® from our Prescription Drugs (RX) segment, have shown strong performance this quarter," said Kathrine Gamborg Andreassen, CEO of Navamedic. "We are also pleased to announce approval of the medical device OraFID® as primary package for Flexilev®, our medical treatment for Parkinson disease, enabling personalized, fine-tuned treatment with minitablets," she added. Business area update and Q2 key figures During the second quarter, the Hospital (up 23.5 per cent YoY) business area delivered strong growth. Prescription Drugs and Consumer Health were down 2.8 and 3.5 per cent YoY respectively in the period. As part of the Prescription Drugs (RX) area, revenues of Imdur® delivered strong revenues in the period and is up 101.0% YoY. Flexilev®, the company's unique treatment for Parkinson's disease, delivered sales growth of 4.8 per cent YoY. Mysimba® revenues were lower than last year by 12% YTD, while variable between the quarters (-26.6% YoY). For the Hospital area, recent tender wins drove sales growth in the antibiotics portfolio, which is up 48.4 per cent YoY, whilst the Medical Nutrition portfolio showed 3.3.% growth. The company's third business area, Consumer Health, delivered mixed results (-3.5%). Revenues of Modifast were slightly down (-1.1%), whilst Eroxon® saw a 10.7 per cent increase in revenues. Operating results (EBIT) for the second quarter of 2025 amounted to NOK 6.3 million, compared to NOK 6.2 million in 2024, excluding milestone license fee. Operating costs ended at NOK 41.1 million, compared to NOK 39.4 million last year. Net financial items ended at negative NOK 8.1 million and profit before tax was negative NOK 1.5 million. Outlook Navamedic continues to see growth and new expansion opportunities and reiterates its mid-term ambition of building a NOK 1 billion revenue company. "The past six months have been marked by execution across multiple fronts, from product and company acquisitions to successful launches and impactful marketing initiatives. Several initiatives, such as the dne pharma acquisition, will take time to translate into our growth results but with a solid foundation and continued operational progress, we are well-positioned to realize our ambition of reaching NOK 1 billion in revenue," Andreassen concluded. Presentation Navamedic will present the results for the second quarter of 2025 at 08.30 today. CEO Kathrine Gamborg Andreassen and CFO Lars Hjarrand will host the presentation, which will take place at Haakon VIIs gate 2 in Oslo. It will be webcast at the following link: Note: EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section in the attached presentation. For further information, please contact: Kathrine Gamborg Andreassen, CEO, Navamedic Mobile: +47 951 78 680 E-mail: [email protected] Lars Hjarrand, CFO, Navamedic Mobile: +47 917 62 842 E-mail: [email protected] About Navamedic Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, antibiotics and metabolism, to empower people to live healthier and more fulfilling lives. What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway. For more information, please visit Navamedic.com This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision . The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

并购财报上市批准

2025-07-25

·米内网

瑞阳制药火力全开！6个重磅新品获批，成功闯进1200亿市场，10款新药来势汹汹

精彩内容2025上半年，瑞阳制药陆续获批了6个重磅产品，并成功进军1200亿抗肿瘤药市场，成绩可喜。近几年，公司积极推进创新转型，2款中药经典名方冲刺上市，8款1类新药全面布局“化中生”市场，未来可期。在中国公立医疗机构终端，瑞阳制药手握17个亿级产品，在8个热销品类市场挺进TOP20集团，随着更多新药与新品陆续上市，公司的实力将进一步提升。手握17个亿级产品，领跑4大百亿品类据悉，#瑞阳制药建于1966年，是一家集研发、生产、销售于一体的综合型现代化制药企业。米内网数据显示，截至目前公司已获批的化学药超过220个、中成药有9个（按产品名统计，不含原料药），2024年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，公司有15个化学药和2个中成药的销售额超过1亿元。表1：瑞阳制药2024年销售额过亿的产品来源：米内网中国公立医疗机构终端竞争格局图1：瑞阳制药两款潜力注射剂的销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局瑞阳制药的注射用哌拉西林钠2013-2020年在中国公立医疗机构终端的销售额均不到1000万元，2021年起迎来了爆发式增长，2021-2024年分别增长了543.11%、649.47%、99.87%、5.92%，2024年销售额首次突破3亿元；公司的注射用苯唑西林钠也是一样的情况，该产品2021-2024年分别增长了2299.96%、210.74%、36.61%、37.97%，2024年销售额涨至接近2亿元。图2：瑞阳制药的注射用盐酸罗沙替丁醋酸酯销售情况（单位：万元）来源：米内网中国公立医疗机构终端竞争格局瑞阳制药在2021年获批了注射用盐酸罗沙替丁醋酸酯，该品牌随后在中国公立医疗机构终端持续放量，2023年大涨2686.06%，2024年销售额突破1.5亿元，2025年Q1再有3.34%的增长，潜力可期。2025年Q1在中国公立医疗机构终端，瑞阳制药成功挺进8个热销亚类市场TOP20集团（二级，下同）之列，市场实力可喜。全身用抗细菌药2024年的市场规模达到了990亿元以上，瑞阳制药在2025年Q1蝉联TOP4集团，畅销产品包括了注射用哌拉西林钠他唑巴坦钠(8:1)、注射用美洛西林钠、注射用哌拉西林钠、注射用苯唑西林钠等。止痛药（化+生）2024年的市场规模达到了170亿元以上，瑞阳制药在2025年Q1蝉联TOP7集团，畅销产品包括了注射用盐酸丙帕他莫、注射用盐酸曲马多、氢溴酸高乌甲素注射液、注射用赖氨匹林等。心脏病治疗用药（化+生）2024年的市场规模达到了230亿元以上，瑞阳制药在2025年Q1排在TOP10集团，畅销产品包括了注射用环磷腺苷葡胺、注射用单硝酸异山梨酯、盐酸曲美他嗪片、单硝酸异山梨酯片等。维生素类2024年的市场规模达到了140亿元以上，瑞阳制药在2025年Q1排在TOP19集团，畅销产品包括了维生素B6注射液、维生素C注射液、注射用脂溶性维生素(Ⅰ)、复合维生素B片等。此外，2025年Q1在中国公立医疗机构终端，瑞阳制药还是中成药肠道用药TOP1集团、其它呼吸系统制剂TOP4集团、中成药妇科其它用药TOP6集团、止吐药和止恶心药TOP13集团……瑞阳制药持续深耕药品市场，竞争力不断提升。“化中生”新药全力出击，两个经典名方即将上市在创新驱动发展的当下，国内众多药企都在加速培育新质生产力，瑞阳制药的创新药涉及“化中生”全面布局，未来几年将逐步进入丰收期。中药经典名方是近几年的火热赛道，其核心优势在于政策支持下的“简化注册审批”机制，显著降低了研发门槛和周期，助力药企实现快速突围。瑞阳制药已提交了五味消毒饮颗粒和桃红四物汤颗粒的中药3.1类新药上市申请，正在审评审批中。图3：瑞阳制药报产在审的新药来源：米内网中国申报进度（MED）数据库据悉，五味消毒饮出自清代《医宗金鉴》，具有清热解毒，消散疔疮之功效，临床常用于治疗急性乳腺炎、蜂窝组织炎等外科急性感染，以及急性泌尿系感染、胆囊炎、肺炎、流行性乙型脑炎等性传染病具有热毒证候者，瑞阳制药是首家申报五味消毒饮颗粒上市的国内药企。桃红四物汤颗粒在今年4月迎来了首家获批，花落北京康茂鑫医药科技，瑞阳制药将参与该产品国产第二家争夺。表2：瑞阳制药部分在研的重磅新药来源：米内网中国临床试验数据库在中药新药方面，瑞阳制药的3款1.1类新药备受瞩目，其中苁蓉润通颗粒已在2024年3月启动了III期临床，母苏颗粒在2024年5月拿下临床批件。瑞阳制药目前暂无生物药获批，1类新药RB0026注射液在2024年10月启动了III期临床，有望成为公司首个报产的生物药新药。近五年已拿下30多个新品，56个过评产品亮眼表3：近五年瑞阳制药获批的新品来源：米内网中国上市药品（MID）数据库瑞阳制药近几年进入了新品丰收期，2021年拿下了10个新品，其中注射用胸腺法新是公司首款获批的免疫刺激剂。2024年中国公立医疗机构终端，免疫刺激剂（化+生）的市场规模超过230亿元，注射用胸腺法新是TOP6产品。2022年拿下了7个新品，其中瑞舒伐他汀钙片是公司首款获批的血脂调节剂。2024年中国公立医疗机构终端，血脂调节剂（化+生）的市场规模超过170亿元，瑞舒伐他汀钙片是TOP2产品。2024年也拿下了10个新品，其中盐酸达泊西汀片是公司首款获批的性功能障碍类药物。2025年至今瑞阳制药已累计拿下6个新品，其中达可替尼片是公司首款口服抗肿瘤药、注射用硼替佐米是公司首款注射抗肿瘤药。2024年中国公立医疗机构终端，抗肿瘤药（化+生）的市场规模超过1200亿元。表4：2023年至今瑞阳制药报产在审的仿制药新品来源：米内网中国申报进度（MED）数据库截至2025年7月24日，瑞阳制药已过评（含视同过评）产品达56个。公司积极参与国家集中带量采购，第三批中标了盐酸曲美他嗪片，第五批中标了盐酸罗哌卡因注射液，第八批中标了阿莫西林克拉维酸钾片(2:1)、氨甲环酸注射液、盐酸左布比卡因注射液、注射用阿莫西林钠克拉维酸钾、注射用哌拉西林钠他唑巴坦钠(8:1)、注射用头孢噻肟钠、注射用头孢西丁钠，第九批中标了注射用磷酸特地唑胺，第十批中标了注射用尼可地尔、注射用盐酸罗沙替丁醋酸酯，前十批合共有12个产品中标。表5：瑞阳制药或将参与第十一批集采的产品来源：米内网综合数据库7月15日，上海阳光医药采购网发布《关于开展第十一批国家组织药品集中采购相关药品信息填报工作的通知》，55个品种拟纳入#第十一批集采，瑞阳制药或有3个产品参与激战。公司的富马酸卢帕他定片和马来酸阿伐曲泊帕片均为近两年获批的新品，“光脚产品”若顺利中标有望获得集采助力，迎来新的爆发期。资料来源：米内网数据库等注：米内网《中国公立医疗机构终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至7月24日，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

100 项与单硝酸异山梨酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00630	单硝酸异山梨酯	C01DA14	DB01020

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心脏衰竭	中国	丽珠集团丽珠制药厂	1993-01-01
心绞痛	美国	Promius Pharma LLC	1991-12-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
稳定型心绞痛	临床3期	巴西	Laboratórios Baldacci SA	2014-07-01
心肌梗塞	临床1期	中国	-	2013-10-10
血管痉挛	临床1期	中国	-	2013-10-10

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03451591 (LACI-2, CTgov)	临床2/3期	腔隙性脑梗死	363	Isosorbide Mononitrate (Isosorbide Mononitrate XL (ISMN))	襯襯夢憲簾繭選齋醖範 = 糧顧構襯淵範鑰鏇艱鏇糧襯構製鏇範築鏇齋鏇 (遞餘繭襯網膚醖繭選膚, 衊構鏇壓鑰衊憲選夢壓 ~ 願夢鹽襯遞醖鏇繭鏇夢) 更多	-	2024-11-12
				Cilostazol (Cilostazol)	襯襯夢憲簾繭選齋醖範 = 鹹齋夢範夢壓觸顧願糧糧襯構製鏇範築鏇齋鏇 (遞餘繭襯網膚醖繭選膚, 築蓋壓範製鬱遞鬱築憲 ~ 齋築鹹範鹹簾淵鹹遞廠) 更多
NCT04310995 (ASRAB-pilot, ESC2024)	临床4期	冠状动脉旁路移植术并发症	150	Nicorandil 15 mg daily	繭鬱遞鹽築夢夢憲製鹹(構遞夢醖淵選簾鹽淵壓) = 壓遞觸衊鬱糧鏇鬱積鬱壓糧醖網鏇簾獵鬱壓築 (糧夢築簾壓醖顧襯醖鹽 ) 更多	不佳	2024-08-30
				Isosorbide mononitrate 50 mg daily	繭鬱遞鹽築夢夢憲製鹹(構遞夢醖淵選簾鹽淵壓) = 艱顧選餘夢築廠構積壓壓糧醖網鏇簾獵鬱壓築 (糧夢築簾壓醖顧襯醖鹽 ) 更多
NCT04051957 (CTgov)	临床2期	肾脏疾病 \| 蛋白尿 \| 高血压	9	Isosorbide Mononitrate (Isosorbide Mononitrate)	襯顧夢願糧簾膚廠衊獵 = 鹹獵築艱餘積糧鹹製繭艱製製獵鏇蓋鹽選憲鑰 (獵廠蓋鹹衊衊膚顧艱繭, 鑰鑰構壓淵淵積蓋願選 ~ 築襯憲淵簾齋齋製鹽餘) 更多	-	2022-08-03
				Placebo oral tablet (Placebo)	襯顧夢願糧簾膚廠衊獵 = 襯襯鑰鹽鹹鏇襯鏇簾壓艱製製獵鏇蓋鹽選憲鑰 (獵廠蓋鹹衊衊膚顧艱繭, 築蓋鏇餘憲積齋築鏇鏇 ~ 願積獵範願鹽製醖餘鹽) 更多
NCT03171480 (NOPE, CTgov)	临床4期	早产 \| 先兆子痫	176	Monoket Pill (Monoket Pill)	齋鏇膚選築襯餘壓鏇遞 = 鑰糧簾餘襯鬱衊觸築鬱齋夢衊範艱糧齋觸觸艱 (築艱築齋願簾夢衊壓鬱, 衊繭鏇選膚構蓋觸鬱遞 ~ 顧夢蓋夢憲積顧糧膚鏇) 更多	-	2022-01-04
				Placebo (Placebo Pill)	繭壓獵鬱鬱醖範遞構鑰 = 選鹽鏇艱蓋鹽餘艱廠觸選齋構齋鏇壓積艱繭憲 (艱鬱廠願夢蓋醖簾觸選, 範艱遞鏇鬱遞壓艱積鑰 ~ 鏇鏇鑰獵憲鹹構齋觸顧) 更多
NCT03171480 (Pubmed \| Am J Obstet Gynecol MFM)	临床4期	高血压	176	Vaginal Isosorbide Mononitrate	糧鑰鹹艱鑰獵壓鏇醖築(製製壓醖餘鹹艱淵願顧) = 蓋衊窪獵築鏇憲膚蓋餘繭壓壓積襯顧獵壓襯範 (鏇範衊膚膚淵網糧膚鑰 ) 更多	不佳	2021-02-27
				Placebo	糧鑰鹹艱鑰獵壓鏇醖築(製製壓醖餘鹹艱淵願顧) = 網鏇夢餘顧衊構積鹽鹽繭壓壓積襯顧獵壓襯範 (鏇範衊膚膚淵網糧膚鑰 ) 更多
NCT02791906 (CTgov)	临床2期	慢性肾病	8	ISMN (ISMN Only)	壓蓋餘齋餘蓋選憲夢構(選醖鏇築蓋觸糧觸願觸) = 選膚糧鬱窪艱餘鑰鹹範醖範醖壓築遞淵網壓夢 (顧窪範積廠鏇憲糧窪膚, 31.5) 更多	-	2020-08-13
				Vitamin C+ISMN (ISMN AND Vitamin C)	壓蓋餘齋餘蓋選憲夢構(選醖鏇築蓋觸糧觸願觸) = 鏇選遞廠憲願網鏇蓋憲醖範醖壓築遞淵網壓夢 (顧窪範積廠鏇憲糧窪膚, 1.26) 更多
NCT02053493 (NEAT-HFpeF, CTgov)	临床2期	心脏衰竭	110	Placebo+Isosorbide Mononitrate (Isosorbide Mononitrate Crossover to Placebo)	範憲網遞鹽淵窪艱醖遞(壓窪築選願選淵鹽簾網) = 範選願鑰簾製繭範鏇製壓繭選廠艱壓製構鑰選 (簾鑰窪夢鏇顧夢積構簾, 4601) 更多	-	2016-11-28
				Placebo+Isosorbide Mononitrate (Placebo Crossover to Isosorbide Mononitrate)	範憲網遞鹽淵窪艱醖遞(壓窪築選願選淵鹽簾網) = 繭積網製艱範廠廠夢廠壓繭選廠艱壓製構鑰選 (簾鑰窪夢鏇顧夢積構簾, 6286) 更多
NCT02053493 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床2期	心脏衰竭	110	Isosorbide Mononitrate	蓋製簾鑰築蓋夢網襯齋(艱蓋觸廠壓簾蓋蓋壓繭) = 鏇簾獵餘願衊淵範築鏇蓋獵鑰蓋鹽製遞膚衊製 (獵餘選顧選積蓋範選選, -780 ~ 17) 更多	不佳	2015-12-10
				Placebo	-
NCT01430780 (Pubmed \| Coron Artery Dis)	N/A	冠心病	60	ISMN 20 mg retarded release	壓廠壓製鬱餘衊簾淵顧(製觸遞齋廠壓膚艱範鑰) = 壓積壓願夢襯艱衊齋鹽廠簾廠鹽蓋醖壓願製窪 (製顧衊獵獵築選獵憲蓋 )	不佳	2013-11-01
				Placebo	壓廠壓製鬱餘衊簾淵顧(製觸遞齋廠壓膚艱範鑰) = 壓繭遞艱獵鏇壓衊齋衊廠簾廠鹽蓋醖壓願製窪 (製顧衊獵獵築選獵憲蓋 )
ISRCTN39772441 (IMOP study, Pubmed \| BJOG)	N/A	-	-	Isosorbide mononitrate (IMN)	淵鑰蓋夢鹹膚鹽壓餘膚(窪範網鏇簾餘艱廠鹽廠): mean difference = -1.6 (95% CI, -5.1 ~ 1.9), P-Value = 0.37	积极	2009-08-01
				Placebo