1) 通过初步剂量持续时间-效应的探索研究测定醋丙甲泼尼龙乳膏参比制剂（规格：0.1%、Leo Pharma A/S持证、商品名：Advantan®）在中国健康受试者中的剂量持续时间-效应关系，确定后续体内生物等效性试验中的剂量持续时间（ED50）和预期满足AUEC值的D2/D1最小比值的受试者比例； 2) 结合初步剂量持续时间-效应探索研究结果，设计合适的研究条件，以广东华润顺峰药业有限公司提供的醋丙甲泼尼龙乳膏（规格：0.1%（15 g））为受试制剂、以Leo Pharma A/S持证的醋丙甲泼尼龙乳膏（规格：0.1%、商品名：Advantan®）为参比制剂进行人体生物等效性试验，通过比较两制剂的药效学参数，评价两制剂的生物等效性。 3) 以广东华润顺峰药业有限公司提供的醋丙甲泼尼龙乳膏（规格：0.1%（15 g））为受试制剂，以Leo Pharma A/S持证的醋丙甲泼尼龙乳膏（规格：0.1%；商品名：Advantan®）为参比制剂，研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂的安全性。

开始日期2024-08-02

申办/合作机构

广东华润顺峰药业有限公司

CTIS2024-511390-30-00

/ Recruiting临床3期

Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Cream (Test) vs. Advantan(R) 0.1% Cream (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis - 22-01/MPA-C

开始日期2023-08-17

申办/合作机构

Dermapharm AG

CTR20192503

/ Completed临床3期

0.1%MPA乳膏治疗湿疹有效性和安全性多中心、随机、双盲、阳性药平行对照临床研究

评价MPA乳膏治疗湿疹的有效性和安全性

开始日期2019-11-21

申办/合作机构

天津药业研究院股份有限公司

100 项与醋丙甲泼尼龙相关的临床结果

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100 项与醋丙甲泼尼龙相关的转化医学

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100 项与醋丙甲泼尼龙相关的专利（医药）

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项与醋丙甲泼尼龙相关的文献（医药）

2025-05-01·Clinical Gastroenterology and Hepatology

Daily or Twice Daily Treatment With Topical Steroids Results in Similar Responses in Eosinophilic Esophagitis

Article

作者: Reed, Craig C ; Lee, Christopher J. ; Dellon, Evan S. ; Thel, Hannah L ; Borinsky, Stephanie A ; Borinsky, Stephanie A. ; Kaakati, Rayan N ; McCallen, Justin ; Gee, Timothy S. ; Thel, Hannah L. ; LaFata, Sean S ; Eluri, Swathi ; Barlowe, Trevor ; Ocampo, Adolfo A. ; Dellon, Evan S ; Cameron, Brenderia A ; Gee, Timothy S ; Cameron, Brenderia A. ; Redd, Walker D ; Lee, Christopher J ; Xue, Angela Z ; LaFata, Sean S. ; Kiran, Akshatha ; Cotton, Cary C. ; Xue, Angela Z. ; Kaakati, Rayan N. ; Cotton, Cary C ; Ocampo, Adolfo A ; Reed, Craig C. ; Redd, Walker D.

BACKGROUND & AIMS:

Few data compare topical corticosteroid (tCS) dosing regimens and outcomes. We aimed to compare treatment outcomes in patients with eosinophilic esophagitis (EoE) by once or twice daily dosing regimens.

METHODS:

We conducted a retrospective cohort study using the UNC EoE Clinicopathologic Database of newly diagnosed patients with EoE treated with a tCS who had a follow-up endoscopy with biopsy. Baseline data and outcomes were extracted. Bivariate and multivariate analyses compared patients at baseline and following initial tCS given as a once or twice daily dose.

RESULTS:

A total of 522 patients met inclusion criteria, 122 patients on once daily dosing (72% male; 91% white) and 400 patients on twice daily dosing (66% male; 89% white). Patients on twice daily dosing were older (28.8 ± 18.2 vs 24.3 ± 18.0; P = .01) and reported more heartburn (40% vs 25%; P = .004). On bivariate analysis, global symptomatic response (78% vs 76%; P = .82), posttreatment eosinophil count (20.8 ± 27.2 vs 25.6 ± 39.4; P = .21), posttreatment EoE Endoscopic Reference Score (2.2 ± 1.8 vs 2.2 ± 2.0; P = .92), and histologic response (<15 eos/hpf; 56% vs 58%; P = .66) did not differ by dosing frequency. Candida was less frequent with daily dosing (2% vs 8%; P = .04). In multivariate analysis, the odds of histologic response did not differ by dose groups (adjusted odds ratio, 1.03; 95% confidence interval, 0.67-1.60).

CONCLUSIONS:

EoE outcomes did not differ by daily or twice daily dosing regimens. These results inform tCS dosing regimens and reassure that both are effective.

2025-02-01·Dermatology and Therapy

Baricitinib Provides Significant Improvements in Quality of Life and Functioning in Adults with Moderate-to-Severe Atopic Dermatitis with Baseline Body Surface Area ≤ 40% and Severe Itch

Article

作者: Liu, Chunyuan ; Kleyn, C Elise ; Otero-Asman, Joaquin R ; Reguiai, Ziad ; Augustin, Matthias ; Izu-Belloso, Rosa ; Grond, Susanne ; Nomura, Toshifumi ; Silvia Sabatino ; Napolitano, Maddalena

INTRODUCTION:

Patients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.

MATERIALS:

BREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks. Patients eligible for enrollment had to have BSA ≥ 10%. This post-hoc analysis focused on placebo and BARI 4 mg for patients with BSA ≤ 40% and itch NRS ≥ 7. QoL impairment was measured using a Dermatology Life Quality Index (DLQI) of ≤ 5, and functioning outcomes were assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported descriptively. Last observation carried forward (LOCF) data were reported, excluding data collected after the first rescue therapy date or permanent study drug discontinuation. Non-responder imputation was used to account for missing data.

RESULTS:

At BL, patients with BSA ≤ 40% and itch NRS ≥ 7 had high QoL impairment. The mean DLQI score at BL for patients who received BARI 4 mg and placebo indicates a very large effect of AD on patients' QoL. Patients who received BARI and placebo experienced a significant itch burden and reported a similar itch NRS. At week 16, 61.5% of patients treated with BARI 4 mg indicated that it had no to only a small effect on their QoL (DLQI ≤ 5), versus 24.1% for patients receiving placebo (p < 0.01). A decrease in WPAI work impairment score of - 41.6 for BARI patients and - 7.0 for placebo patients was observed at week 16 (p < 0.01). Patients receiving BARI also observed a noticeable improvement in WPAI daily activity impairment of - 30.4 from baseline at week 16 compared to patients on placebo, who achieved - 12.2 (p < 0.01).

CONCLUSION:

Despite having high QoL impairment at baseline, patients with itch-dominant AD treated with BARI 4 mg showed marked benefits in QoL, daily life activity, and work function compared to placebo after 16 weeks of treatment. Limitations include the small sample size analyzed.

2024-12-01·BMJ Open

Effectiveness of potent topical corticosteroids versus mild ones in primary care for children with moderate flare-ups of atopic dermatitis; results of a randomised controlled trial

Article

作者: van Halewijn, Karlijn F ; Elshout, Gijs ; Bohnen, Arthur M ; Pasmans, Suzanne G M A ; Bindels, Patrick J E

Objective:

To assess the effectiveness of a potent topical corticosteroid (TCS) as an initial treatment in primary care for children with moderate flare-ups of atopic dermatitis (AD), compared to starting on a mild TCS.

Design:

An observational prospective cohort study with an embedded pragmatic multicentre open-label randomised controlled trial.

Setting:

A total of 53 general practices in the southwest of the Netherlands took part in the study.

Participants:

209 children aged 3 months to 17 years diagnosed with AD (International Classification of Primary Care codes S87 or S88) who visited their general practitioner (GP) for AD or received repeat prescriptions for AD in the previous 12 months were included in the cohort study through the general practices. Finally, 32 patients (15%) were randomised and assigned to the trial (13 girls; 19 boys; median age 4.0 years).

Interventions:

If cohort participants experienced a moderate flare-up (ie, need to intensify topical treatment from the child’s and/or parents’ point of view of AD and a three-item severity score from three to<6 scored by their GP) during cohort follow-up, they were randomised to either the intervention group, a strong TCS (class III, fluticasone propionate 0.05%), or the control group, a mild TCS (class I, hydrocortisone acetate 1%).

Primary and secondary outcome measures:

We measured outcomes at baseline and at 1, 4 and 24 weeks. The primary outcome was AD-related symptoms (Patient-Oriented Eczema Measure (POEM) score) measured over 24 weeks of follow-up. Secondary outcomes included the Eczema Area and Severity Index, the Investigators Global Assessment, quality of life (QoL), Patient Global Assessment, Numeric Itch Intensity Score and TCS use.

Results:

The primary outcome showed a significant difference in the POEM scores over 24 weeks of follow-up between the intervention group (n=17) and the control group (n=15) (3.3 vs 9.4, p=0.023). The potent TCS also significantly improved the POEM at 1 week (5.5 vs 12.0, p=0.042) and 4 weeks (4.3 vs 12.7, p=0.030). Improvement in the QoL was significant at 4 weeks (1.0 vs 4.5, p=0.014) and 24 weeks (0.0 vs 2.0, p=<0.000).

Conclusion:

Despite the small sample size, the data suggests a clinical benefit from starting with a potent TCS rather than a mild TCS when a flare-up of AD is moderate.

Trial registration:

The Netherlands National Trial Register: NTR6679.

项与醋丙甲泼尼龙相关的新闻（医药）

2023-11-20

·信狐药迅

鞍石生物肺癌新药伯瑞替尼上市，德恩鲁胺、艾玛昔替尼不批准 | 新获批（11.13-11.19）

每周药品注册受理数据，分门别类呈现，一目了然。（11.13-11.19）新药上市申请药品名称企业名称分类受理号伯瑞替尼肠溶胶囊北京浦润奥生物科技有限责任公司1CXHS2200047伯瑞替尼肠溶胶囊北京浦润奥生物科技有限责任公司1CXHS2200048奥雷巴替尼片广州顺健生物医药科技有限公司2.4CXHS2200039德恩鲁胺软胶囊海创药业股份有限公司1CXHS2300040替戈拉生片山东罗欣药业集团股份有限公司2.4CXHS2300034盐酸氨溴索无水吞服颗粒山东科成医药科技有限公司2.2CXHS2200023硫酸艾玛昔替尼片瑞石生物医药有限公司1CXHS2300052人生长激素注射液中山未名海济生物医药有限公司3.4CXSS2200056人生长激素注射液中山未名海济生物医药有限公司3.4CXSS2200057赫基仑赛注射液合源生物科技(天津)有限公司1CXSS2200093新药临床申请药品名称企业名称分类受理号OQL036上海岸阔医药科技有限公司1CXHL2300930OQL036上海岸阔医药科技有限公司1CXHL2300931SRSD101注射液靖因药业(上海)有限公司1CXHL2300932康替唑胺片上海盟科药业股份有限公司2.4CXHL2300928注射用醋酸丙氨瑞林微球上海丽珠制药有限公司2.2CXHL2300953ALMB-0166注射液上海恩乐迈生物科技有限公司1CXSL2300580IBI356信达生物制药(苏州)有限公司1CXSL2300566SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2300587VT-101注射液江苏万戎生物医药科技有限公司1CXSL2300558异体内皮祖细胞(EPCs)注射液呈诺再生医学科技(北京)有限公司1CXSL2300561注射用JSKN003江苏康宁杰瑞生物制药有限公司1CXSL2300582注射用RC108荣昌生物制药(烟台)股份有限公司1CXSL2300591注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2300583自体抗CLL-1嵌合抗原受体T细胞注射液广州百暨基因科技有限公司1CXSL2300555阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2300581仿制药申请药品名称企业名称分类受理号他达拉非片成都锦华药业有限责任公司4CYHS2200229他达拉非片成都锦华药业有限责任公司4CYHS2200230吡仑帕奈片江苏康缘药业股份有限公司4CYHS2101605吸入用异丙托溴铵溶液天津梅花生物医药科技有限公司4CYHS2300030吸入用硫酸沙丁胺醇溶液朗天药业(湖北)有限公司4CYHS2200535复方电解质注射液河北仁合益康药业有限公司4CYHS1700313对乙酰氨基酚注射液南京卡文迪许生物工程技术有限公司3CYHS2300609尼莫地平口服溶液浙江国镜药业有限公司3CYHS2200017左氧氟沙星滴眼液苏州弘森药业股份有限公司4CYHS2300099左氧氟沙星滴眼液苏州弘森药业股份有限公司4CYHS2300100左氧氟沙星滴眼液苏州弘森药业股份有限公司4CYHS2300101布洛芬注射液成都苑东生物制药股份有限公司3CYHS2200644普瑞巴林胶囊浙江诺得药业有限公司4CYHS2200494氨甲环酸注射液湖北多瑞药业有限公司3CYHS2200931注射用头孢美唑钠湖南恒生制药股份有限公司3CYHS2200210注射用头孢美唑钠湖南恒生制药股份有限公司3CYHS2200212注射用尼可地尔重庆莱美药业股份有限公司3CYHS2301393注射用尼可地尔重庆莱美药业股份有限公司3CYHS2301394注射用帕瑞昔布钠无锡凯夫制药有限公司4CYHS2200343注射用帕瑞昔布钠无锡凯夫制药有限公司4CYHS2200344注射用阿莫西林钠克拉维酸钾(10:1)深圳华润九新药业有限公司3CYHS2200375注射用阿莫西林钠克拉维酸钾(10:1)深圳华润九新药业有限公司3CYHS2200376玻璃酸钠滴眼液海南斯达制药有限公司4CYHS2302603玻璃酸钠滴眼液海南斯达制药有限公司4CYHS2302605盐酸莫西沙星滴眼液陕西博森生物制药股份集团有限公司4CYHS2200621盐酸莫西沙星滴眼液合肥华威药业有限公司4CYHS2200145盐酸达泊西汀片海南卓力制药有限公司4CYHS2200501磷酸奥司他韦干混悬剂宏越科技(湖州)有限公司3CYHS2200589维A酸外用乳重庆华邦制药有限公司3CYHL2300105胞磷胆碱钠注射液广州绿十字制药股份有限公司3CYHS2200408艾地骨化醇软胶囊大连美创药业有限公司4CYHS2200939艾地骨化醇软胶囊南京海融医药科技股份有限公司4CYHS2200324艾地骨化醇软胶囊南京海融医药科技股份有限公司4CYHS2200325艾塞那肽注射液成都圣诺生物制药有限公司4CYHS2200215葡萄糖酸钙氯化钠注射液山东齐都药业有限公司3CYHS2201300葡萄糖酸钙氯化钠注射液山东齐都药业有限公司3CYHS2201301达格列净片阿斯利康药业(中国)有限公司4CYHS2200657达格列净片阿斯利康药业(中国)有限公司4CYHS2200658酒石酸溴莫尼定滴眼液沈阳兴齐眼药股份有限公司4CYHS2302515醋丙甲泼尼龙乳膏广东华润顺峰药业有限公司3CYHL2300104进口申请药品名称企业名称分类受理号克拉屈滨片Merck Europe B.V.5.1JXHS2101019左乙拉西坦片上海诺华贸易有限公司5.2JXHS1900066左乙拉西坦片上海诺华贸易有限公司5.2JXHS1900065拉法姆林注射液Nabriva Therapeutics Ireland DAC5.1JXHS2101081拉法姆林片Nabriva Therapeutics Ireland DAC5.1JXHS2101082AUP1602-CAurealis Therapeutics AG1JXSL2300161PF-06940434注射液Pfizer Inc.1JXSL2300159度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2300025度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2300024度普利尤单抗注射液Sanofi-aventis groupe3.1JXSS2300007度普利尤单抗注射液Sanofi-aventis groupe3.1JXSS2300008中药相关申请药品名称企业名称分类受理号小儿豉翘清热糖浆济川药业集团有限公司2.2CXZS2300003藿夏感冒颗粒石家庄以岭药业股份有限公司1.1CXZL2300059连榆烧伤膏扬子江药业集团江苏制药股份有限公司2.3CXZL2300052骨性关节炎软膏义乌市振伟中草药科技开发有限公司1.1CXZL2300053注：灰色字体部分结论为不批准或收到通知件；

上市批准申请上市

2023-08-28

·信狐药迅

康方生物新药IL-12/23依若奇单抗，珠海联邦利拉鲁肽上市申请 | 新受理（8.21-8.27）

每周药品注册受理数据，分门别类呈现，一目了然。(8.21-8.27）新药上市申请药品名称企业名称分类受理号IMP4297胶囊上海君派英实药业有限公司1CXHS2300073IMP4297胶囊上海君派英实药业有限公司1CXHS2300074SHR0302片江苏恒瑞医药股份有限公司1CXHS2300071依若奇单抗注射液中山康方生物医药有限公司1CXSS2300069利拉鲁肽注射液珠海联邦制药股份有限公司3.3CXSS2300067氟唑帕利胶囊江苏恒瑞医药股份有限公司2.4CXHS2300070注射用替奈普酶世贸天阶制药(江苏)有限责任公司3.4CXSS2300068注射用醋酸曲普瑞林微球丽珠医药集团股份有限公司2.4CXHS2300072注射用重组人促卵泡激素北京双鹭药业股份有限公司3.3CXSS2300070新药临床申请药品名称企业名称分类受理号ABSK051注射液无锡和誉生物医药科技有限公司1CXHL2300898ACE-86225106片优领医药科技(上海)有限公司1CXHL2300907ACE-86225106片优领医药科技(上海)有限公司1CXHL2300908ANS014004片北京鞍石生物科技有限责任公司1CXHL2300903ANS014004片北京鞍石生物科技有限责任公司1CXHL2300904ASKC202片江苏奥赛康药业有限公司1CXHL2300901ASKC202片江苏奥赛康药业有限公司1CXHL2300902CRTE7A2-01 TCR-T细胞注射液北京可瑞生物科技有限公司1CXSL2300572CVL237片甫康(上海)健康科技有限责任公司1CXHL2300899EB070注射液北京东方百泰生物科技股份有限公司1CXSL2300573GH21胶囊勤浩医药(苏州)有限公司1CXHL2300913GH21胶囊勤浩医药(苏州)有限公司1CXHL2300914GKL-006注射液北京基因启明生物科技有限公司1CXSL2300567HP518片海创药业股份有限公司1CXHL2300900HRS-8080片山东盛迪医药有限公司1CXHL2300905HRS-8080片山东盛迪医药有限公司1CXHL2300906HS-10511片上海翰森生物医药科技有限公司1CXHL2300909HS-10511片江苏豪森药业集团有限公司1CXHL2300910HS-10511片江苏豪森药业集团有限公司1CXHL2300911IBI356信达生物制药(苏州)有限公司1CXSL2300566LM-101注射液礼新医药科技(上海)有限公司1CXSL2300564NCR300注射液安徽中盛溯源生物科技有限公司1CXSL2300562QL2111注射液齐鲁制药有限公司3.4CXSL2300571SCG101自体T细胞注射液星汉德生物医药(大连)有限公司1CXSL2300577SYS6011石药集团巨石生物制药有限公司1CXSL2300563SZJK-0421片深圳济康医药科技有限公司1CXHL2300917TB-B002D注射液深圳市图微安创科技开发有限公司1CXHL2300912ZX2021注射液江苏中新医药有限公司1CXSL2300574ZX2021注射液江苏中新医药有限公司1CXSL2300575司美格鲁肽注射液华润双鹤药业股份有限公司2.2CXHL2300915司美格鲁肽注射液华润双鹤药业股份有限公司2.2CXHL2300916异体内皮祖细胞(EPCs)注射液呈诺再生医学科技(北京)有限公司1CXSL2300561注射用DR10624浙江道尔生物科技有限公司1CXSL2300559注射用DR10624浙江道尔生物科技有限公司1CXSL2300560泽贝妥单抗注射液浙江博锐生物制药有限公司2.2CXSL2300568泽贝妥单抗注射液浙江博锐生物制药有限公司2.2CXSL2300569痘苗病毒致炎兔皮提取物注射液威世药业(如皋)有限公司2.2CXSL2300570重组抗CTLA-4全人单抗注射液上海复宏汉霖生物制药有限公司3.3CXSL2300576仿制药申请药品名称企业名称分类受理号丁溴东莨菪碱注射液呋欧医药科技(湖州)有限公司3CYHS2302236乙酰半胱氨酸注射液福安药业集团庆余堂制药有限公司3CYHS2302272他达拉非片四川依科制药有限公司4CYHS2302218他达拉非片河北瑞森药业有限公司4CYHS2302219依帕司他片乐普制药科技有限公司3CYHS2302233利伐沙班片江西同和药业股份有限公司4CYHS2302258利伐沙班片江西同和药业股份有限公司4CYHS2302259利伐沙班片江西同和药业股份有限公司4CYHS2302260卡前列素氨丁三醇注射液北京仁众药业有限公司4CYHS2302262吸入用异丙托溴铵溶液浙江金华康恩贝生物制药有限公司4CYHS2302237吸入用盐酸丙卡特罗溶液扬州中宝药业股份有限公司3CYHS2302217地夸磷索钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2302234地氯雷他定口服溶液浙江高跖医药科技股份有限公司3CYHS2302256复方奥美拉唑干混悬剂浙江同伍生物医药有限公司3CYHS2302229复方奥美拉唑干混悬剂浙江同伍生物医药有限公司3CYHS2302230头孢地尼颗粒广州江正医药科技有限公司4CYHS2302270孟鲁司特钠咀嚼片山东丹红制药有限公司4CYHS2302242孟鲁司特钠咀嚼片山东丹红制药有限公司4CYHS2302243富马酸酮替芬口服溶液海口天行健药物研究有限公司3CYHS2302211尼莫地平口服溶液海南全星制药有限公司3CYHS2302210左乙拉西坦氯化钠注射液贵州阜康仁制药有限公司3CYHS2302205左卡尼汀片辽宁诺维诺制药股份有限公司3CYHL2300107普拉洛芬滴眼液合肥利民制药有限公司4CYHS2302244比索洛尔氨氯地平片江西施美药业股份有限公司4CYHS2302271比索洛尔氨氯地平片福建海西新药创制股份有限公司4CYHS2302208氟[18F]洛贝平注射液北京欣翮医药科技有限公司3CYHS2302261氟哌噻吨美利曲辛片植恩生物技术股份有限公司4CYHS2302252氟比洛芬凝胶贴膏武汉法玛星制药有限公司4CYHS2302265氨氯地平贝那普利胶囊杭州沐源生物医药科技有限公司3CYHS2302279氯化钾注射液广东科伦药业有限公司3CYHS2302275氯化钾注射液广东科伦药业有限公司3CYHS2302276氯化钾注射液南京赛瑞谱顿制药有限公司3CYHS2302235氯化钾注射液黑龙江博宇制药有限公司3CYHS2302209氯化钾注射液海南景泽康生物科技有限公司3CYHS2302201法莫替丁注射液成都米子生物医药科技有限公司3CYHS2302251法莫替丁注射液江苏瑜兴医药科技有限公司3CYHS2302215注射用乳糖酸克拉霉素广东金城金素制药有限公司3CYHL2300106注射用培美曲塞二钠福建基诺厚普生物科技有限公司4CYHS2302213注射用头孢唑肟钠海南合瑞制药股份有限公司4CYHS2302263注射用头孢唑肟钠海南合瑞制药股份有限公司4CYHS2302264注射用尼可地尔重庆莱美药业股份有限公司3CYHS2302247注射用尼可地尔重庆莱美药业股份有限公司3CYHS2302248注射用氯诺昔康东阳祥昇医药科技有限公司4CYHS2302214注射用氯诺昔康华东医药(西安)博华制药有限公司4CYHS2302216注射用硼替佐米瑞阳制药股份有限公司4CYHS2302231注射用硼替佐米山西普德药业有限公司4CYHS2302212注射用紫杉醇(白蛋白结合型)正大天晴药业集团股份有限公司4CYHS2302255玻璃酸钠滴眼液山东华鲁制药有限公司4CYHS2302277甲氨蝶呤注射液浙江华海药业股份有限公司4CYHS2302253甲磺酸艾立布林注射液正大天晴药业集团股份有限公司4CYHS2302221盐酸屈他维林注射液成都倍特药业股份有限公司4CYHS2302232盐酸左沙丁胺醇雾化吸入溶液海南葫芦娃药业集团股份有限公司3CYHS2302228盐酸拉贝洛尔注射液南京斯泰尔医药科技有限公司3CYHS2302203盐酸普萘洛尔注射液北京布霖生物科技有限公司3CYHS2302250盐酸纳洛酮注射液湖北津药药业股份有限公司3CYHS2302206盐酸纳洛酮注射液湖北津药药业股份有限公司3CYHS2302207盐酸肾上腺素注射液成都欣捷高新技术开发股份有限公司3CYHS2302227硫代硫酸钠注射液成都倍特药业股份有限公司3CYHS2302223硫酸镁注射液福建天泉药业股份有限公司3CYHS2302238硫酸镁注射液福建天泉药业股份有限公司3CYHS2302240碘普罗胺注射液杭州沐源生物医药科技有限公司4CYHS2302202碳酸氢钠林格注射液武汉福星生物药业有限公司3CYHS2302204碳酸氢钠注射液石家庄四药有限公司3CYHS2302249磷酸奥司他韦干混悬剂广东红珊瑚药业有限公司3CYHS2302274磷酸奥司他韦干混悬剂恒昌(广州)新药研究有限公司3CYHS2302257磷酸奥司他韦胶囊安徽省先锋制药有限公司4CYHS2302239磷酸奥司他韦胶囊安徽省先锋制药有限公司4CYHS2302241福多司坦口服溶液江苏联环药业股份有限公司3CYHS2302224立他司特滴眼液山东辰欣佛都药业股份有限公司3CYHL2300103米诺地尔外用溶液江苏睿实生物科技有限公司3CYHS2302267米诺地尔外用溶液江苏睿实生物科技有限公司3CYHS2302268维A酸外用乳重庆华邦制药有限公司3CYHL2300105脑脊髓手术用灌流液山东齐都药业有限公司3CYHS2302269蒙脱石混悬液南京海纳制药有限公司4CYHS2302254西格列汀二甲双胍缓释片越洋医药开发(广州)有限公司3CYHS2302225醋丙甲泼尼龙乳膏广东华润顺峰药业有限公司3CYHL2300104重酒石酸去甲肾上腺素注射液武汉久安药业有限公司3CYHS2302220间苯三酚注射液成都天台山制药股份有限公司4CYHS2302222阿仑膦酸钠片浙江花园药业有限公司4CYHS2302266阿戈美拉汀片杭州领业医药科技有限公司4CYHS2302278阿替洛尔片上海理想制药有限公司3CYHS2302245阿替洛尔片上海理想制药有限公司3CYHS2302246阿瑞匹坦注射液江苏康禾生物制药有限公司3CYHS2302273进口申请药品名称企业名称分类受理号AZD5305AstraZeneca AB1JXHL2300197AZD5305AstraZeneca AB1JXHL2300198AZD5305AstraZeneca AB1JXHL2300199AZD5305AstraZeneca AB1JXHL2300200AZD5335AstraZeneca AB1JXSL2300158BI685509片Boehringer Ingelheim International GmbH1JXHL2300193BI685509片Boehringer Ingelheim International GmbH1JXHL2300194BI685509片Boehringer Ingelheim International GmbH1JXHL2300195JNJ-77242113-AAC片Janssen Research & Development, LLC1JXHL2300196JNJ-77242113-AAC片Janssen Research & Development, LLC1JXHL2300191JNJ-77242113-AAC片Janssen Research & Development, LLC1JXHL2300192替尔泊肽注射液Eli Lilly and Company2.4JXHS2300079替尔泊肽注射液Eli Lilly and Company2.4JXHS2300080替尔泊肽注射液Eli Lilly and Company2.4JXHS2300081替尔泊肽注射液Eli Lilly and Company2.4JXHS2300082磷酸奥司他韦干混悬剂Lupin Inc.5.2JYHS2300107中药相关申请无。不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请高管变更

2019-04-09

·BioSpace

Medigene AG: Medigene sells remaining rights and inventories of Veregen® to Aresus Pharma

Aresus takes over Veregen® business including API stock and intends to invest in expanding Veregen® into indications and markets Planegg (pta/08.04.2019/16:25) Aresus takes over Veregen® business including API stock and intends to invest in expanding Veregen® into indications and markets Sale of non-core product Veregen® completes Medigene’s transformation into a pure immunotherapy company Medigene AG (FSE: MDG1, Prime Standard) sells its remaining rights to the dermatological drug Veregen® and its complete stock of the corresponding active pharmaceutical ingredient (API) to the pharmaceutical company Aresus Pharma GmbH (“Aresus”), Munich, Germany. In the course of the sale, all existing relevant contracts with distribution partners and external service providers will be transferred from Medigene to Aresus. Medigene had sold the US rights to the drug at the end of 2017 to the US company Fougera Pharmaceuticals Inc. With this sale of its last product from its “non-core business”, Medigene AG completes the transformation into a pure immunotherapy company. Prof. Dolores Schendel, Chief Executive Officer and CSO of Medigene AG , comments: “Since Medigene’s refocusing on cellular immunotherapy, the skin drug Veregen® no longer fits into our strategic position. We are very pleased that following the sale of US rights, we will now be able to hand over the remaining rights to this product to a company lead by dermatology product and clinical trial specialists. This will now allow us to focus fully on the advancement of our immuno-oncological cell therapies.” Dr. Francisco Harrison, Director of Aresus Pharma GmbH: “We are excited to built-up Aresus as a dynamic dermatology company focusing on the further commercialization and clinical research of Veregen®. This product has various potentials to be explored and we intend to invest in expanding Veregen® into further indications and markets.” Medigene will receive up to approximately EUR 7.75 million from Aresus for the remaining Veregen® rights and all existing API stock. Therefrom, Medigene receives EUR 300.000 upfront and the balance within the next ten years as annual revenue-based earn-out payments from 2021 onwards. These expected payments are recognized as receivables and discounted in accordance with International Financial Reporting Standards (IFRS) and due to the measurement method of the receivable at the date of the transaction. Therefore, Medigene’s EBITDA will be affected by a non-cash effective loss between EUR 4 and 5 Mio. In the future, this non-cash effective loss will be compensated by corresponding interest income as the payment period becomes continuously shorter. Medigene will update its financial guidance with respect to revenue and EBITDA with issuing its quarterly statement. The closing of the transaction including the transfer of rights is planned for mid-April 2019. Veregen® is an ointment for the local treatment of external genital and perianal warts (Condylomata acuminata). About Aresus Pharma: Aresus Pharma GmbH is a new company, that will focus on the further global commercialization and clinical development of Veregen®. The company founders Mr. Sven Schimansky-Wabra and Dr. Francisco Harrison are an experienced team with a sound background in dermatology and clinical research who have an additional company portfolio for the development and commercialization of other semi-solid products as well as a company that specializes in regulatory affairs services. More information at: About the Aresus founders: Dr Francisco Harrison is an MD, who built a global CRO company over a span of 25 years. Up to 2012, Harrison Clinical Research Group, today operating under Synteract, covered all clinical phases and employed over 500 people in 16 countries. Later, Harrison established a new group of service companies for the Life Science community under the HCSTH holding: Idea Regulatory in the regulatory area, Rephine for quality assurance and Hureka Resources providing healthcare investment advice and management. The new venture Aresus Pharma will be devoted to prescription dermatological products of natural origin. More information at: Sven Schimansky-Wabra has been working in the pharmaceutical sector since 2004, starting his career at Schering, later Intendis Dermatologie and Bayer. In 2012, he left Bayer to set up Skin Care Pharma. Skin Care developed Skinatan®, the generic version of Advantan®, and brought it successfully through the approval studies. Furthermore, Sven Schimansky-Wabra is also involved in the company Degode-Dermago Development where he had developed Beloren®, a generic version of Skinoren®. More information at: Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with the focus on T cell receptor-modified T cells (TCR-Ts) and has projects currently in preclinical and clinical development. For more information, please visit This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Contacts Medigene AG Julia Hofmann, Dr. Robert Mayer Tel.: +49 - 89 - 20 00 33 - 33 01 email: investor@medigene.com Aresus Pharma GmbH Email: info@aresus.de

免疫疗法高管变更引进/卖出并购

100 项与醋丙甲泼尼龙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07203	醋丙甲泼尼龙	D07AC14	DB14643

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
银屑病	澳大利亚	Leo Pharma, Inc.	1994-07-11
湿疹	瑞士	LEO Pharmaceutical Products OOO	1991-12-19
特应性皮炎	瑞士	LEO Pharmaceutical Products OOO	1991-12-19

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
神经性皮炎	临床3期	中国	天津药物研究院药业有限责任公司	2013-10-30

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临床结果

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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


NCT02798523 (CTgov)	临床1期	-	33	Methylprednisolone sodium succinate(Solu-Medrol) (Up to 2 Hours Post Infusion)	膚膚鑰憲壓夢齋顧壓範 = 願壓鬱網築醖積鏇襯網壓選簾糧夢顧繭遞憲範 (遞衊繭築繭醖鹹製夢獵, 醖簾鏇鏇獵餘繭蓋鹽繭 ~ 鏇構鹹鹽糧製壓顧構選) 更多	-	2023-06-22
				Methylprednisolone sodium succinate(Solu-Medrol)+Topical methylprednisolone (Advantan emulsion 0 /1%) (Up to 4 Hours Post Infusion)	膚膚鑰憲壓夢齋顧壓範 = 醖衊選鹹繭觸獵獵鏇憲壓選簾糧夢顧繭遞憲範 (遞衊繭築繭醖鹹製夢獵, 蓋鬱糧憲構鏇壓築獵膚 ~ 網顧餘網構艱廠鹹觸鹹) 更多