主要目的：以持证商为Institut Biochimique SA的双氯芬酸依泊胺贴（规格：1.3%，10cm×14cm；商品名为：Flector）为参比制剂，以杭州端本医药科技有限公司研制的双氯芬酸依泊胺贴 [规格：每贴（14cm×10cm）含双氯芬酸依泊胺180mg，1.3%（每100g膏体中含双氯芬酸依泊胺1.3g）] 为受试制剂，评价两种制剂在中国健康受试者中外用条件下的生物等效性。次要目的： 1）评价受试制剂与参比制剂在中国健康受试者中的安全性； 2）评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性； 3）评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。

开始日期2024-05-06

申办/合作机构

杭州端本医药科技有限公司

CTR20232884

/ Completed临床3期

双氯芬酸依泊胺贴治疗局部软组织损伤（拉伤、扭伤、挫伤）引起的疼痛的有效性和安全性多中心、随机、双盲、阳性药、安慰剂平行对照临床试验

以氟比洛芬凝胶贴膏和安慰剂为对照，评价双氯芬酸依泊胺贴治疗局部软组织损伤（拉伤、扭伤、挫伤）引起的疼痛的有效性和安全性。

开始日期2023-11-15

申办/合作机构

南京海纳医药科技股份有限公司

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100 项与双氯芬酸依泊胺相关的临床结果

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100 项与双氯芬酸依泊胺相关的转化医学

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100 项与双氯芬酸依泊胺相关的专利（医药）

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项与双氯芬酸依泊胺相关的文献（医药）

2025-01-05·JOURNAL OF COMPUTATIONAL CHEMISTRY

CGPDTA: An Explainable Transfer Learning‐Based Predictor With Molecule Substructure Graph for Drug‐Target Binding Affinity

Article

作者: Fan, Qing ; Ning, Xiangzhen ; Zhang, Simeng ; Liu, Haichun ; Zhang, Yanmin ; Shen, Jun ; Han, Weijie ; Xu, Chengcheng ; Chen, Yadong ; Liu, Yingxu

ABSTRACT:

Identifying interactions between drugs and targets is crucial for drug discovery and development. Nevertheless, the determination of drug‐target binding affinities (DTAs) through traditional experimental methods is a time‐consuming process. Conventional approaches to predicting drug‐target interactions (DTIs) frequently prove inadequate due to an insufficient representation of drugs and targets, resulting in ineffective feature capture and questionable interpretability of results. To address these challenges, we introduce CGPDTA, a novel deep learning framework empowered by transfer learning, designed explicitly for the accurate prediction of DTAs. CGPDTA leverages the complementarity of drug–drug and protein–protein interaction knowledge through advanced drug and protein language models. It further enhances predictive capability and interpretability by incorporating molecular substructure graphs and protein pocket sequences to represent local features of drugs and targets effectively. Our findings demonstrate that CGPDTA not only outperforms existing methods in accuracy but also provides meaningful insights into the predictive process, marking a significant advancement in the field of drug discovery.

2023-10-01·Pain and therapy

Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study.

Article

作者: Trevisan, Carlo L M ; Carraro, Andrea ; Baldari, Gemma L A

INTRODUCTION:

The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain.

METHODS:

A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner's clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator's satisfaction with the treatment was also assessed. Subjects initially took 1-2 capsules of the study treatment and then one or two soft capsules every 4-6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period.

RESULTS:

A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated.

CONCLUSIONS:

The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects' overall satisfaction with treatment more than 90%.

TRIAL REGISTRATION:

EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018.

2022-11-01·Biomaterials advances

Effect of microneedles shape on skin penetration and transdermal drug administration

Article

作者: Palladino, Antonio ; De Martino, Selene ; Amendola, Eugenio ; Napolitano, Francesco ; Serpico, Luigia ; De Stefano, Luca ; Squillace, Antonino ; De Girolamo, Paolo ; Battisti, Mario ; Martone, Alfonso ; Dardano, Principia ; Dello Iacono, Stefania

Microneedle (MN) patches are highly efficient and versatile tools for transdermal drug administration, in particular for pain-free, self-medication and rapid local applications. Diffraction ultraviolet (UV) light lithography offers an advanced method in fabricating poly(ethylene glycol)-based MNs with different shapes, by changing both the UV-light exposure time and photomask design. The exposure time interval is limited at obtaining conical structures with aspect ratio < 1:3, otherwise MNs exhibit reduced fracture load and poor indentation ability, not suitable for practical application. Therefore, this work is focused on a systematic analysis of the MN's base shapes effects on the structural characteristics, skin penetration and drug delivery. Analyzing four different base shapes (circle, triangle, square and star), it has been found that the number of vertices in the polygon base heavily affects these properties. The star-like MNs reveal the most efficient skin penetration ability (equal to 40 % of -their length), due to the edges action on the skin during the perforation. Furthermore, the quantification of the drug delivered by the MNs through ex-vivo porcine skin shows that the amounts of small molecules released over 24 h by star-like MNs coated by local anesthetic (Lidocaine) and an anti-inflammatory (Diclofenac epolamine) drugs are 1.5× and 2× higher than the circular-MNs, respectively.

项与双氯芬酸依泊胺相关的新闻（医药）

2025-06-08

·信狐药迅

国内新药上市井喷！十款1类新药获批上市：6款化药+4款生物制品| 新获批(6.2-6.8）

每周药品注册获批数据，分门别类呈现，一目了然。(6.2-6.8）新药上市申请药品名称企业注册分类受理号复迈替尼片上海复星医药产业发展有限公司1CXHS2400049复迈替尼片上海复星医药产业发展有限公司1CXHS2400048复迈替尼片上海复星医药产业发展有限公司1CXHS2400047复迈替尼片上海复星医药产业发展有限公司1CXHS2400046注射用HR20013福建盛迪医药有限公司1CXHS2300113苹果酸法米替尼胶囊江苏恒瑞医药股份有限公司1CXHS2300110氘恩扎鲁胺软胶囊海创药业股份有限公司1CXHS2300107FCN-437c胶囊锦州奥鸿药业有限责任公司1CXHS2300103FCN-437c胶囊锦州奥鸿药业有限责任公司1CXHS2300102盐酸杰克替尼片苏州泽璟生物制药股份有限公司1CXHS2200054国;CXHS2200054阿利沙坦酯吲达帕胺缓释片深圳信立泰药业股份有限公司2.3CXHS2300079九价人乳头瘤病毒疫苗(大肠埃希菌)厦门万泰沧海生物技术有限公司2.2CXSS2400089九价人乳头瘤病毒疫苗(大肠埃希菌)厦门万泰沧海生物技术有限公司2.2CXSS2400088注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司1CXSS2400099注射用泽尼达妥单抗百济神州(苏州)生物科技有限公司1CXSS2400056怡培生长激素注射液厦门特宝生物工程股份有限公司1CXSS2400008怡培生长激素注射液厦门特宝生物工程股份有限公司1CXSS2400007怡培生长激素注射液厦门特宝生物工程股份有限公司1CXSS2400006怡培生长激素注射液厦门特宝生物工程股份有限公司1CXSS2400005怡培生长激素注射液厦门特宝生物工程股份有限公司1CXSS2400004注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白江苏泰康生物医药有限公司1CXSS2300099卡度尼利单抗注射液中山康方生物医药有限公司2.2CXSS2400042新药临床申请药品名称企业注册分类受理号DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500341WJ47156片上海君实生物医药科技股份有限公司1CXHL2500330WJ47156片上海君实生物医药科技股份有限公司1CXHL2500329SVHRSP注射液沈阳万锦医药科技有限公司1CXHL2500318RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500325RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500324RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500323NH104片江苏恩华药业股份有限公司1CXHL2500311NH104片江苏恩华药业股份有限公司1CXHL2500312CMCY2501片杭州中美华东制药有限公司2.4CXHL2500314重组带状疱疹疫苗(CHO细胞)长春百克生物科技股份公司1.3CXSL2500213注射用JS207上海君实生物医药科技股份有限公司1CXSL2500252注射用BC2027无锡智康弘义生物科技有限公司1CXSL2500245注射用SSGJ-705沈阳三生制药有限责任公司1CXSL2500247AZD0901阿斯利康全球研发(中国)有限公司1CXSL2500242XH001注射液北京新合睿恩生物医疗科技有限公司1CXSL2500215仿制药申请药品名称企业注册分类受理号二羟丙茶碱注射液湖北欣泽霏药业有限公司3CYHS2401037氟哌啶醇注射液裕松源药业有限公司3CYHS2400499帕拉米韦注射液河南润弘制药股份有限公司3CYHS2400380盐酸溴己新口服溶液福元药业有限公司3CYHS2400252盐酸溴己新口服溶液福元药业有限公司3CYHS2400253腺苷钴胺胶囊海南紫程众投生物科技有限公司3CYHS2400206氟哌啶醇片浙江京新药业股份有限公司3CYHS2400177肾上腺素注射液武汉久安药业有限公司3CYHS2400186奥沙西泮片成都苑东生物制药股份有限公司3CYHS2400144腺苷钴胺胶囊福建新迪医药科技有限公司3CYHS2400123腺苷钴胺胶囊福建省亿隆立康医药科技有限公司3CYHS2400050盐酸丙卡特罗口服溶液合肥国药诺和药业有限公司3CYHS2303630小儿复方氨基酸注射液(19AA-I)广州绿十字制药股份有限公司3CYHS2303617腺苷钴胺胶囊石药集团欧意药业有限公司3CYHS2303595盐酸多巴酚丁胺注射液成都百裕制药股份有限公司3CYHS2303576盐酸奈福泮注射液海南爱科制药有限公司3CYHS2303467门冬氨酸钾注射液昆明南疆制药有限公司3CYHS2303451生理氯化钠溶液广东科伦药业有限公司3CYHS2303441生理氯化钠溶液广东科伦药业有限公司3CYHS2303440葡萄糖酸钙注射液江西泰吉立生物医药科技有限公司3CYHS2303434地氯雷他定口服溶液江苏万高药业股份有限公司3CYHS2303404美索巴莫注射液江苏正大清江制药有限公司3CYHS2303401盐酸多巴酚丁胺注射液江苏联环药业股份有限公司3CYHS2303423复方聚乙二醇(3350)电解质散华益泰康药业股份有限公司3CYHS2303422美索巴莫注射液北京民康百草医药科技有限公司3CYHS2303372葡萄糖酸钙氯化钠注射液石家庄四药有限公司3CYHS2303292盐酸左西替利嗪口服溶液山东致泰医药技术有限公司3CYHS2303260盐酸左西替利嗪口服溶液山东致泰医药技术有限公司3CYHS2303259盐酸屈他维林片江苏联环药业股份有限公司3CYHS2303180盐酸二甲双胍缓释片浙江众延医药科技有限公司3CYHS2303145盐酸多巴胺注射液南京泽恒医药技术开发有限公司3CYHS2303141氯化钾口服溶液山东朗诺制药有限公司3CYHS2303094醋酸钠林格注射液浙江康吉尔药业有限公司3CYHS2303093复方醋酸钠林格注射液辽宁民康制药有限公司3CYHS2303076复方醋酸钠林格注射液辽宁民康制药有限公司3CYHS2303075托拉塞米注射液湖北亨迪药业股份有限公司3CYHS2303068托拉塞米注射液湖北亨迪药业股份有限公司3CYHS2303067重酒石酸去甲肾上腺素注射液成都旭阳永健医药科技有限公司3CYHS2303066重酒石酸去甲肾上腺素注射液成都旭阳永健医药科技有限公司3CYHS2303065美索巴莫注射液江苏神龙药业有限公司3CYHS2302977盐酸左西替利嗪口服溶液浙江恒研医药科技有限公司3CYHS2302933氯化钾颗粒石家庄四药有限公司3CYHS2302895注射用硫酸多黏菌素B四川汇宇海玥医药科技有限公司3CYHS2302839羧甲司坦口服溶液广州市联瑞制药有限公司3CYHS2302828氯化钾注射液成都华宇制药有限公司3CYHS2302703米诺地尔搽剂山东泰合医药科技有限公司3CYHS2302602米诺地尔搽剂山东泰合医药科技有限公司3CYHS2302599倍他米松磷酸钠注射液辰欣药业股份有限公司3CYHS2302577塞来昔布片江西施美药业股份有限公司3CYHS2302505塞来昔布片江西施美药业股份有限公司3CYHS2302504对乙酰氨基酚布洛芬片山东朗诺制药有限公司3CYHS2302481氯化钾注射液海南欧若拉生物技术有限公司3CYHS2302366氯化钾注射液广州合和医药有限公司3CYHS2302346氯化钾颗粒南京海纳制药有限公司3CYHS2302326腺苷钴胺胶囊北京星昊医药股份有限公司3CYHS2302331吸入用盐酸丙卡特罗溶液扬州中宝药业股份有限公司3CYHS2302217盐酸左西替利嗪口服溶液北京韩美生物科技有限公司3CYHS2302156倍他米松磷酸钠注射液汇禹远和(海南)药业有限公司3CYHS2301970聚乙二醇4000散福州基石医药科技有限公司3CYHS2301944羧甲司坦口服溶液宜昌人福药业有限责任公司3CYHS2301793门冬氨酸钾注射液海南倍特药业有限公司3CYHS2301779富马酸福莫特罗吸入溶液上海信谊金朱药业有限公司3CYHS2301674黄体酮注射液北京品尚品医药科技有限公司3CYHS2301325盐酸氨溴索口服溶液安徽海斯美医药有限公司3CYHS2301237布洛芬颗粒四川依科制药有限公司3CYHS2300517布洛芬混悬滴剂海南万玮制药有限公司3CYHS2300235甲硝唑凝胶无锡朗润医药有限公司3CYHS2201296国;CYHS2201296硝酸甘油注射液青海晨菲制药有限公司3CYHS2200378国;CYHS2200378硝酸甘油注射液青海晨菲制药有限公司3CYHS2200377国;CYHS2200377间苯三酚口崩片广州帝奇医药技术有限公司4CYHS2500887间苯三酚口崩片广州帝奇医药技术有限公司4CYHS2500886丙酸氟替卡松雾化吸入用混悬液深圳大佛药业股份有限公司4CYHS2403126甲磺酸溴隐亭片郑州泰丰制药有限公司4CYHS2402707氧(液态)重庆同辉科盛气体有限公司4CYHS2402634氧(气态)南阳市瑞源气体有限公司4CYHS2402607氧浙江三鑫特种气体有限公司4CYHS2402440氧(液态)浙江三鑫特种气体有限公司4CYHS2402439盐酸尼卡地平注射液济南良福精合医药科技有限公司4CYHS2402213多巴丝肼片重庆华邦制药有限公司4CYHS2401293普拉洛芬滴眼液广州大光制药有限公司4CYHS2401104注射用阿糖胞苷合肥亿帆生物制药有限公司4CYHS2401092注射用阿糖胞苷合肥亿帆生物制药有限公司4CYHS2401091碘普罗胺注射液上海司太立制药有限公司4CYHS2401095酒石酸溴莫尼定滴眼液浙江高跖医药科技股份有限公司4CYHS2401008沙库巴曲缬沙坦钠片湖南千金协力药业有限公司4CYHS2400792多巴丝肼片杭州泓友医药科技有限公司4CYHS2400673艾拉莫德片重庆圣华曦药业股份有限公司4CYHS2400614富马酸比索洛尔片山东新时代药业有限公司4CYHS2400582富马酸比索洛尔片山东新时代药业有限公司4CYHS2400581盐酸罗哌卡因注射液海南全星制药有限公司4CYHS2400565盐酸罗哌卡因注射液海南全星制药有限公司4CYHS2400564比索洛尔氨氯地平片山东齐都药业有限公司4CYHS2400558枸橼酸托法替布片浙江施强制药有限公司4CYHS2400546他达拉非片湖南威特制药股份有限公司4CYHS2400536他达拉非片湖南威特制药股份有限公司4CYHS2400535格列齐特缓释片山东汇泽生物制药有限公司4CYHS2400481枸橼酸钠血滤置换液福建盛迪医药有限公司4CYHS2400479门冬氨酸帕瑞肽注射液远大医药(中国)有限公司4CYHS2400456注射用盐酸表柔比星合肥亿帆生物制药有限公司4CYHS2400442尼莫地平注射液四川美大康佳乐药业有限公司4CYHS2400415硝酸异山梨酯注射液湖北民康药业集团有限公司4CYHS2400401硫酸氢氯吡格雷片天方药业有限公司4CYHS2400378比索洛尔氨氯地平片杭州沐源生物医药科技有限公司4CYHS2400367比索洛尔氨氯地平片浙江高跖医药科技股份有限公司4CYHS2400346他达拉非片广州白云山医药集团股份有限公司白云山制药总厂4CYHS2400337他达拉非片广州白云山医药集团股份有限公司白云山制药总厂4CYHS2400338盐酸达泊西汀片修正药业集团长春高新制药有限公司4CYHS2400327阿司匹林维生素C泡腾片湖南尚众合生物医药有限公司4CYHS2400313伏立康唑干混悬剂成都倍特药业股份有限公司4CYHS2400297他达拉非片石家庄龙泽制药股份有限公司4CYHS2400217注射用硫酸艾沙康唑华北制药股份有限公司4CYHS2400229注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400226他达拉非片石家庄龙泽制药股份有限公司4CYHS2400218多巴丝肼片武汉人福药业有限责任公司4CYHS2400184奥美沙坦酯氨氯地平片山西德元堂药业有限公司4CYHS2400183奥美沙坦酯氨氯地平片山西德元堂药业有限公司4CYHS2400182布洛芬缓释胶囊吉林省益浦生物科技有限公司4CYHS2400145左氧氟沙星氯化钠注射液成都克莱蒙医药科技有限公司4CYHS2400142左氧氟沙星氯化钠注射液成都克莱蒙医药科技有限公司4CYHS2400141左氧氟沙星氯化钠注射液成都克莱蒙医药科技有限公司4CYHS2400140阿帕他胺片成都苑东生物制药股份有限公司4CYHS2400138多巴丝肼片浙江赛默制药有限公司4CYHS2400107注射用米卡芬净钠齐鲁制药(海南)有限公司4CYHS2400099注射用米卡芬净钠齐鲁制药(海南)有限公司4CYHS2400098替米沙坦氨氯地平片(II)常州市阳光药业有限公司4CYHS2400117替米沙坦氨氯地平片常州市阳光药业有限公司4CYHS2400116盐酸咪达普利片国药集团容生制药有限公司4CYHS2400082间苯三酚注射液广州市联瑞制药有限公司4CYHS2400052卡前列素氨丁三醇注射液西藏海金药业有限公司4CYHS2400060马来酸氟伏沙明片上海雅培制药有限公司4CYHS2400035马来酸氟伏沙明片上海雅培制药有限公司4CYHS2400036注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400016注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400017替格瑞洛分散片天津力生制药股份有限公司4CYHS2303673泊沙康唑肠溶片上海智赋医药有限公司4CYHS2303639盐酸达泊西汀片湖南九典制药股份有限公司4CYHS2303598注射用头孢他啶阿维巴坦钠四川制药制剂有限公司4CYHS2303551氢溴酸伏硫西汀片湖南省湘中制药有限公司4CYHS2303482阿昔替尼片成都苑东生物制药股份有限公司4CYHS2303471甲钴胺片山东齐都药业有限公司4CYHS2303450托伐普坦片浙江华海药业股份有限公司4CYHS2303355甲钴胺片广东九明制药有限公司4CYHS2303340曲伏前列素滴眼液山东辰欣佛都药业股份有限公司4CYHS2303289尼莫地平注射液成都米子生物医药科技有限公司4CYHS2303268米氮平片宁波美舒医药科技有限公司4CYHS2303252米氮平片宁波美舒医药科技有限公司4CYHS2303250注射用硫酸艾沙康唑山东新华制药股份有限公司4CYHS2303229富马酸伏诺拉生片杭州民生药业股份有限公司4CYHS2303175富马酸伏诺拉生片杭州民生药业股份有限公司4CYHS2303174达可替尼片昆山龙灯瑞迪制药有限公司4CYHS2303142达可替尼片昆山龙灯瑞迪制药有限公司4CYHS2303143替米沙坦氨氯地平片山东齐都药业有限公司4CYHS2303131奥美沙坦酯氨氯地平片海南赛立克药业有限公司4CYHS2303130二十碳五烯酸乙酯软胶囊山东新华制药股份有限公司4CYHS2303097二十碳五烯酸乙酯软胶囊山东新华制药股份有限公司4CYHS2303096左炔诺孕酮片广州朗圣药业有限公司4CYHS2303011奥利司他胶囊大邦(湖南)生物制药有限公司4CYHS2303013奥利司他胶囊大邦(湖南)生物制药有限公司4CYHS2303012培哚普利氨氯地平片(III)浙江高跖医药科技股份有限公司4CYHS2302861盐酸左西替利嗪口服滴剂山东泰合医药科技有限公司4CYHS2302664盐酸文拉法辛缓释胶囊天津梅花生物医药科技有限公司4CYHS2302624达可替尼片重庆药友制药有限责任公司4CYHS2302557达可替尼片湖南科伦制药有限公司4CYHS2302120马来酸阿伐曲泊帕片江苏万邦生化医药集团有限责任公司4CYHS2301821达可替尼片瑞阳制药股份有限公司4CYHS2301795达可替尼片瑞阳制药股份有限公司4CYHS2301794尼莫地平注射液广东金城金素制药有限公司4CYHS2301733硫酸特布他林雾化吸入用溶液扬州中宝药业股份有限公司4CYHS2301152醋酸去氨加压素注射液四川奇裕医药科技有限公司4CYHS2301155醋酸去氨加压素注射液四川奇裕医药科技有限公司4CYHS2301156甲硝唑凝胶广州朗圣药业有限公司4CYHS2301007酮洛芬贴剂北京福元医药股份有限公司3CYHL2500071酮洛芬贴剂北京福元医药股份有限公司3CYHL2500070盐酸毛果芸香碱滴眼液苏州欧康维视生物科技有限公司3CYHL2500067双氯芬酸依泊胺贴深圳珐玛易药品科技有限公司3CYHL2500065酮洛芬凝胶贴膏北京阳光诺和药物研究股份有限公司3CYHL2500064进口申请药品名称企业注册分类受理号盐酸来罗西利片Genor Biopharma(USA), Inc.1JXHS2400020盐酸来罗西利片G1 Therapeutics, Inc.1JXHS2300028乌帕替尼缓释片AbbVie Deutschland GmbH & Co.KG2.4JXHS2400119盐酸伊普可泮胶囊Novartis Pharma Schweiz AG5.1JXHS2400074度伐利尤单抗注射液AstraZeneca UK Limited2.2JXSS2400067度伐利尤单抗注射液AstraZeneca UK Limited2.2JXSS2400066注射用罗特西普Celgene Corporation3.1JXSS2400036注射用罗特西普Celgene Corporation3.1JXSS2400035Brolucizumab注射液Novartis Europharm Ltd.3.1JXSS2300068Brolucizumab注射液Novartis Europharm Ltd.3.1JXSS2300067奥卡西平片Annora Pharma Private Limited5.2JYHS2300060奥卡西平片Annora Pharma Private Limited5.2JYHS2300059奥卡西平片Annora Pharma Private Limited5.2JYHS2300058替莫唑胺胶囊Amneal Pharmaceuticals of New York, LLC5.2JYHS2300028替莫唑胺胶囊Amneal Pharmaceuticals of New York, LLC5.2JYHS2300027吸入用硫酸沙丁胺醇溶液泰卫医药信息咨询(上海)有限公司5.2JXHS1900195国;JXHS1900195VSA001注射液Arrowhead Pharmaceuticals, Inc.1JXHL2500048DS-1062aASTRAZENECA AB1JXSL2500045AZD2936AstraZeneca AB1JXSL2500044AZD2936AstraZeneca AB1JXSL2500042TarlatamabAmgen Inc.2.2JXSL2500041TarlatamabAmgen Inc.2.2JXSL2500040TarlatamabAmgen Inc.2.2JXSL2500039中药相关申请药品名称企业注册分类受理号SOC201胶囊中国科学院上海药物研究所1.2CXZL2500017SOC201提取物中国科学院上海药物研究所1.2CXZL2500016开心散浙江康恩贝制药股份有限公司3.1CXZS2400039开心散山东润中药业有限公司3.1CXZS2400019注：橙色字体部分结论为不批准或收到通知件；

上市批准疫苗核酸药物申请上市

2025-03-19

·Business Wire

Virpax Pharmaceuticals Announces Reverse Stock Split

BERWYN, Pa.--(BUSINESS WIRE)--Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”) a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, today announced that it will effect a 1-for-25 reverse stock split (“reverse split”) of its common stock, par value $0.0001 per share (“Common Stock”), that will become effective at 12:01 a.m. Eastern Time on March 20, 2025. The Company’s Common Stock will continue to trade on the Nasdaq Capital Market (“Nasdaq”) under the symbol “VRPX” and will begin trading on a split-adjusted basis when the Nasdaq opens on March 21, 2025 (“Effective Time”). The new CUSIP number for the Common Stock following the reverse split will be 928251305. At a special meeting of stockholders held on January 15, 2025 (the “Special Meeting”), the Company’s stockholders granted the Company’s Board of Directors (the “Board”) the discretion to effect a reverse stock split of the Company’s Common Stock at a ratio of not less than 1-for-2 and not more than 1-for-240, with such ratio to be determined by the Board. Following the Special Meeting, the final ratio of 1-for-25 was recently approved by the Board. The 1-for-25 reverse stock split will proportionally reduce the number of outstanding shares of Common Stock from approximately 31,062,581 shares to approximately 1,242,504 shares and the ownership percentage of each shareholder will remain unchanged other than as a result of fractional shares. Proportional adjustments will be made to the number of shares of Common Stock issuable upon exercise or conversion of the Company’s outstanding equity awards and warrants, as well as the applicable exercise price. There will be no change to the total number of authorized shares of Common Stock as set forth in the Amended and Restated Certificate of Incorporation of the Company. Stockholders whose shares are held in brokerage accounts should direct any questions concerning the reverse stock split to their broker. All stockholders of record, whose shares are held with the Company’s transfer agent, VStock Transfer, may direct questions to VStock Transfer at (212) 828-8436 or action@vstocktransfer.com. The reverse split is intended to bring the Company into compliance with the minimum bid price requirement for maintaining the listing of its Common Stock on the Nasdaq Capital Market, and to make the bid price more attractive to a broader group of institutional and retail investors. The Nasdaq Capital Market requires, among other things, that a listed company’s common stock maintain a minimum bid price of at least $1.00 per share. The Company’s transfer agent, VStock Transfer, LLC, which is also acting as the paying agent for the reverse split, will provide instructions to stockholders regarding the process for exchanging stock certificates. Any person who would otherwise be entitled to a fractional share of Common Stock as a result of the reclassification and combination following the Effective Time (after taking into account all fractional shares of Common Stock otherwise issuable to such holder) shall be entitled to receive a cash payment equal to the number of shares of the Common Stock held by such stockholder before the reverse split that would otherwise have been exchanged for such fractional share interest multiplied by the average closing sales price of the Common Stock as reported on the Nasdaq for the ten days preceding the Effective Time. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com and follow us on Twitter, LinkedIn and YouTube. Forward-Looking Statements This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

上市批准

2025-02-27

·Business Wire

Virpax Reports Positive Results in Human Study for its Molecular Envelope Technology

BERWYN, Pa.--(BUSINESS WIRE)--Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, would like to congratulate Nanomerics on completing a human study using the Molecular Envelope Technology (MET) and showing no moderate to severe adverse events. Virpax uses MET in its Envelta (NES100) and NobrXiol. Envelta is an enkephalin drug product based on a type of nanotechnology delivery approach. The MET is designed to protect and help carry the drug to the brain with the goal of promptly suppressing pain by binding to the delta opioid receptors. Envelta has demonstrated analgesic potential in animal models without the development of opioid tolerance or reward seeking behavior. It is currently being developed in a cooperative research and development agreement with the National Center for Advancing Translational Sciences (NCATS), an institute/center of the National Institutes of Health (NIH), U.S. Department of Health and Human Services. In addition, Virpax uses MET with NobrXiol. NobrXiol is being developed for delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the MET as its delivery system to cross the blood brain barrier, propelling the cannabidiol nanoparticles through the nose to the brain via the olfactory nerve. The drug has received pre-Investigational New Drug (PIND) application guidance from the U.S. Food and Drug Administration (FDA) Nanomerics’s Phase I trial, the SUNLIGHT trial, involved 28 days of administration of OC134, powered by the MET and MET alone as eye drops to healthy volunteers. Dosing twice daily (12 h apart) of the healthy study participants with MET eye drops and OC134 eye drops commenced in December 2024 and was completed in January 2025. The SUNLIGHT trial was a phase I clinical trial; these trials are used to test for the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment (for example, by mouth, infusion into a vein, or injection) and how the treatment affects the body. All volunteers (n=10) completed the dosing schedule without dropouts and volunteers will report for follow up assessments in February 2025. There were no adverse events of moderate or severe severity reported during the clinical phase of the trial and there were no clinically significant individual changes from baseline or notable trends in safety assessments including safety bloods, vital signs, eye examination, 12 lead ECGs and urine analysis. The topical administration of MET and OC134 eye drops on 56 consecutive occasions were well tolerated by healthy volunteers under the condition of the trial. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com.and follow us on Twitter, LinkedIn and YouTube. About Nanomerics Nanomerics Ltd is a specialty pharmaceutical company with state-of-the-art laboratories based in London, UK. Nanomerics was founded to commercialise its biocompatible polymer technologies for drug delivery and other applications. Nanomerics' proprietary technology is based on world leading know-how and scientific leadership in polymer nanotechnology. Nanomerics creates uniquely differentiated, patented pharmaceutical assets, underpinned by high quality science. For example, the company's Molecular Envelope Technology (MET) is a unique patented biocompatible polymer that delivers a step change in target tissue bioavailability. The founding scientists, Professor Dame Ijeoma F. Uchegbu and Professor Andreas G. Schätzlein developed the technology at the Universities of Strathclyde and Glasgow and, latterly at the UCL School of Pharmacy. Pharmaceutical product candidates in development include the eye drops: OC134 for the treatment of moderate to severe allergic conjunctivitis, OC137 for the treatment of retinal diseases and OC135 for the treatment of glaucoma. For more information, please visit www.nanomerics.com Forward-Looking Statements This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

临床1期上市批准临床结果

100 项与双氯芬酸依泊胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	双氯芬酸依泊胺	M02AB	-

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
急性疼痛	美国	IBSA Institut Biochimique SA	2007-01-31

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
挫伤	临床3期	中国	南京海纳医药科技股份有限公司	2023-11-15
疼痛	临床3期	中国	南京海纳医药科技股份有限公司	2023-11-15
扭伤和拉伤	临床3期	中国	南京海纳医药科技股份有限公司	2023-11-15
软组织损伤	临床3期	美国	IBSA Institut Biochimique SA	2021-10-31
膝关节炎	临床前	美国	Virpax Pharmaceuticals, Inc.	2022-03-22

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临床结果

适应症

分期

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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


NCT02324270 (CTgov)	临床3期	急性疼痛 \| 踝损伤	658	Placebo	觸願選製衊齋獵齋簾製(憲築鑰憲積衊餘壓網襯) = 鏇糧壓築餘膚夢糧艱鏇襯糧製遞齋構膚壓選觸 (構遞餘膚廠構鹽簾襯鹽, 11.37) 更多	-	2020-06-24
NCT03145259 (CTgov)	早期临床1期	-	12	Diclofenac Epolamine (Diclofenac Epolamine Patches)	鬱鬱獵遞淵選簾願夢衊(壓齋糧齋鬱壓窪蓋觸構) = 選鏇選構鬱選繭獵願衊獵製艱淵製鹽構網淵衊 (遞積遞夢齋衊齋願鏇淵, 10.8) 更多	-	2020-06-16
NCT03145259 (CTgov)	早期临床1期	-	12	Diclofenac Sodium (Diclofenac Sodium Solution)	鬱鬱獵遞淵選簾願夢衊(壓齋糧齋鬱壓窪蓋觸構) = 蓋積餘鹹築鏇鏇鹽襯簾獵製艱淵製鹽構網淵衊 (遞積遞夢齋衊齋願鏇淵, 54.3) 更多	-	2020-06-16
NCT02132247 (CTgov)	临床4期	软组织损伤 \| 运动损伤	104	Flector (Flector Patch/Age 6-11)	鏇廠繭憲鏇憲鬱壓願齋(築淵範繭鑰淵鹽觸齋艱) = 淵衊網繭夢醖蓋衊築製鹽簾範鏇壓襯網範襯壓 (構衊壓糧顧襯夢鏇醖艱, 0.30) 更多	-	2018-05-11
NCT02132247 (CTgov)	临床4期	软组织损伤 \| 运动损伤	104	Flector (Flector Patch/Age 12-16)	鏇廠繭憲鏇憲鬱壓願齋(築淵範繭鑰淵鹽觸齋艱) = 齋醖網鬱築糧膚顧衊鹽鹽簾範鏇壓襯網範襯壓 (構衊壓糧顧襯夢鏇醖艱, 0.19) 更多	-	2018-05-11
NCT01054820 (CTgov)	临床4期	椎间盘疾病	123	Diclofenac Epolamine	願糧鹽餘壓夢鬱積膚蓋(壓築窪廠餘鑰齋鹽襯積) = 衊鑰繭廠獵襯餘構醖夢鹹鬱憲餘夢積艱繭餘願 (糧遞齋築築鏇鑰壓積襯, 1.30) 更多	-	2012-08-16