Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients

A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.

开始日期2020-10-13

申办/合作机构

Recordati Rare Diseases

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100 项与 Udonitrectag lysine 相关的临床结果

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100 项与 Udonitrectag lysine 相关的转化医学

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100 项与 Udonitrectag lysine 相关的专利（医药）

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项与 Udonitrectag lysine 相关的文献（医药）

2026-04-14·CURRENT DRUG METABOLISM

Absorption, Distribution, Metabolism, and Excretion of [14C]MT-8, A Derivative of Procyanidin B3 in Sprague-Dawley Rats

Article

作者: Xu, Haibo ; Diao, Xingxing ; Zhang, Heyanhao ; Zhao, Yuqing ; Chen, Lijuan ; Tang, Chongzhuang ; Chang, Jun ; Chen, Shuoyue ; Li, Zhiqiang ; Gao, Yang ; Bao, Yuanwu ; Wang, Linwei

Introduction/Objectives::

Procyanidins are abundant dietary flavonoids with diverse pharmacological activities; however, their Absorption, Distribution, Metabolism, and Excretion (ADME) remain incompletely characterized. MT-8, a procyanidin B3 derivative with an ethyl group at the C8 position of the A-ring, is a promising preclinical candidate for cerebral ischemia treatment and is currently in the Investigational New Drug (IND) application stage. This study aimed to systematically characterize the ADME profile of MT-8 in male Sprague-Dawley (SD) rats following intravenous administration to provide a reference for ADME studies of procyanidin-related compounds.

Methods::

A single intravenous dose of 24 mg/kg (100 μCi/kg) [¹⁴C]MT-8 was administered to male SD rats. Given the observed instability of MT-8 in plasma due to catechol oxidation, 10 mM tris(2-carboxyethyl) phosphine hydrochloride (TCEP) was employed as a stabilizer in all sample preparations. Pharmacokinetics, tissue distribution, mass balance, metabolite profiling, and metabolic enzyme phenotyping were comprehensively evaluated.

Results::

Pharmacokinetic analysis revealed rapid elimination of [¹⁴C]MT-8-related substances, with a terminal half-life of 1.77 hours. The blood-to-plasma radioactivity ratio (1.68) indicated preferential distribution into blood cells. Tissue distribution revealed the highest radioactivity concentrations in the small intestine, kidneys, and liver. Mass balance analysis showed total radioactive recovery of 95.49% within 168 hours, with clearance of >90% of drug-related substances within 24 hours, predominantly via feces (85.57%) and bile (62.78% in bile duct-cannulated rats), with only 9.91% in urine. Metabolite profiling identified 32 metabolites in plasma, urine, feces, and bile, with methylation and glucuronidation as the major metabolic pathways. In vitro phenotyping referred to catechol-O-methyltransferase (COMT) involvement in methylation and UDP-glucuronosyltransferase 1A1 (UGT1A1) and 1A9 (UGT1A9) in glucuronidation.

Discussion::

After verifying the mechanism of the instability of MT-8 in plasma, we tracked the in vivo disposition of MT-8 via radioisotope labeling technique and acquired credible pharmacokinetic, mass balance, tissue distribution, and metabolite identification results. Phenotypes of two enzymes were determined to further the investigation of the methylation and glucuronidation process of in vivo clearance of MT-8.

Conclusion::

Collectively, MT-8 undergoes rapid clearance, broad distribution, extensive metabolism, and predominant biliary/fecal excretion. These findings provide critical support for MT-8’s IND application and subsequent clinical development.

2016-09-02·Journal of enzyme inhibition and medicinal chemistry2区 · 医学

Synthesis of mono Mannich bases of 2-(4-hydroxybenzylidene)-2,3-dihydroinden-1-one and evaluation of their cytotoxicities

2区 · 医学

ArticleOA

作者: Gul, Halise Inci ; Yamali, Cem ; Sakagami, Hiroshi ; Tugrak, Mehtap

Chalcones and Mannich bases are a group of compounds known for their cytotoxicities. In this study restricted chalcone analogue, compound 2-(4-hydroxybenzylidene)-2,3-dihydroinden-1-one MT1, was used as a starting compound to synthesize new mono Mannich bases since Mannich bases may induce more cytotoxicity than chalcone analogue that they are derived from by producing additional alkylating center for cellular thiols. In this study, cyclic and acyclic amines were used to synthesize Mannich bases. All compounds were tested against Ca9-22 (gingival carcinoma), HSC-2, HSC-3 and HSC-4 (oral squamous cell carcinoma) as tumour cell lines and HGF (gingival fibroblasts), HPC (pulp cells) and HPLF (periodontal ligament fibroblasts) human normal oral cells as non tumour cell lines. Cytotoxicity, selectivity index (SI) values and potency selectivity expression (PSE) values expressed as a percentage were determined for the compounds. According to data obtained, the compound MT8 with the highest PSE value bearing N-methylpiperazine moiety seems to be a good candidate to develop new cytotoxic compounds and is suited for further investigation.

JOURNAL OF ENDOCRINOLOGICAL INVESTIGATION

Inhibition of endolysosomal two-pore channel 2 (TPC2) induces osteoblast differentiation and matrix mineralization while targeting autophagy

Article

作者: Giampietri, Claudia ; Mancini, Rita ; Keller, Marco ; Bracher, Franz ; Del Fattore, Andrea ; De-Eknamkul, Wanchai ; Meucci, Martina ; Rossi, Michela ; Battafarano, Giulia ; Liguoro, Domenico ; Riminucci, Mara ; Umehara, Kaoru ; Riccioli, Anna ; Palmisano, Biagio ; Grimm, Christian ; Palombi, Fioretta ; Montaseri, Azadeh ; Filippini, Antonio

Abstract:

Purpose:

Endolysosomal two-pore channels (TPCs) are non-selective cation channels that control the release of Ca 2+ and Na + from the endolysosomal lumen. TPCs also reportedly play a role in autophagy. Interestingly, autophagy regulates bone cell differentiation and function. This study aimed to provide an in-depth insight into TPC2’s action in the autophagy pathway to control osteoblast differentiation and function.

Methods:

Primary human mesenchymal stem cells (hMSCs) and human osteoblast-like cells (Saos-2) were used to assess osteoblastogenesis and bone mineralization, respectively. MSCs were treated with different pharmacological TPC2 inhibitors including naringenin, tetrandrine, MT-8 and SG-094 during their differentiation process. Finally, formation of osteoblasts and in vitro bone mineralization were evaluated by alkaline phosphatase, alizarin red S and Von Kossa staining. Western blot analysis was performed to investigate the expression of autophagy-related molecules.

Results:

The inhibition of TPC2 activity stimulates osteoblast differentiation from hMSCs and bone mineralization by Saos-2 cells. Interestingly, TPC2 inhibition reduces beclin-1 and LC3-II expression while that of the mammalian target of rapamycin (mTOR), the master regulator of autophagy, increases. Inhibition of mTOR activity by rapamycin reverses osteoblast differentiation induced by TPC2 inhibitor SG-094.

Conclusion:

Inhibition of TPC2 channel activity increases osteoblast differentiation and bone mineralization in vitro and interferes with the completion of autophagy, upregulating phosphorylated mTOR.

项与 Udonitrectag lysine 相关的新闻（医药）

2025-10-29

·mimetech.eu

EMA Grants PRIME Designation to MimeTech S.r.l. for Investigational Drug Udonitrectag Lysine in the Treatment of Diabetic Foot Ulcers (DFU)

We are proud to announce that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to our investigational drug, Udonitrectag lysine, for the treatment of diabetic foot ulcers (DFU). Existing measures for the treatment of diabetic foot ulcers achieve complete healing in only 30–60% of cases within six months, with 40% one-year recurrence and amputation rates around 20–30% in complicated ulcers. This represents a significant unmet medical need for innovative medicines capable of providing a clinically meaningful and durable improvement in healing and limb salvage. Evidence from a 6-week, randomised, single-blind, comparative Phase 1/2 study in 24 patients with slow-healing diabetic foot ulcers testing Udonitrectag lysine in addition to standard of care versus standard of care alone suggests that a potentially clinically meaningful treatment effect addressing this unmet medical need can be achieved. PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary programme is based on enhanced interaction and early dialogue with developers of promising medicines to optimise development plans and accelerate evaluation, helping these medicines reach patients earlier. “Receiving PRIME designation is an important recognition of the potential of Udonitrectag lysine to make a real difference for patients affected by diabetic foot ulcers,” said Federico Cozzolino, CEO of MimeTech S.r.l. “We look forward to working closely with EMA to advance the development of this innovative therapy and to bring it as soon as possible to patients in need.”

2023-04-07

·国家药品监督管理局政务服务门户

2023年04月07日化妆品决定书送达信息发布

2022年10月1日起，行政相对人可登录化妆品智慧申报审评系统，在申请单管理模块中查看电子文书，按照相关提示自行打印。序号受理编号产品名称注册人1JHZTZX2300201玛蒂德肤新活亮肤美白面膜玛蒂德肤2JHZTZX2300202雅诗敦金睿御龄莹润亮白手霜诺奥思3JHZTZX2300203雅诗敦盈润焕白淡斑精华滚珠诺奥思4JHZTZX2300204资生堂新透白美肌集中焕白眼霜株式会社资生堂5JHZTZX2300205资生堂时光琉璃御藏防晒隔离乳株式会社资生堂6JHZTZX2300206怿馨晶钻燕窝护肤水（株）伊思韩佛7JHZTZX2300207怿馨晶钻燕窝面霜（株）伊思韩佛8JHZTZX2300208怿馨晶钻燕窝乳液（株）伊思韩佛9JHZTZX2300209美伊娜多月华妆前修护底霜（滋润型）SPF12 PA+日本美伊娜多化妆品株式会社10JHZTZX2300210奥碧虹无瑕晶透裸妆粉饼01株式会社奥碧虹11JHZTZX2300211奥碧虹无瑕晶透裸妆粉饼00株式会社奥碧虹12JHZTZX2300212姿露得修复防晒乳霜韩国新药株式会社13JHZTZX2300213森颜树语水漾滋润粉底乳 1号韩国珂朵玛药妆研制公司14JHZTZX2300214森颜树语滋润细腻粉饼 1号韩国珂朵玛药妆研制公司15JHZTZX2300215森颜树语水润丝柔亮肤隔离霜韩国珂朵玛药妆研制公司16JHZTZX2300216森颜树语水润遮瑕调整肤色裸妆霜韩国珂朵玛药妆研制公司17JHZTZX2300217森颜树语保湿无瑕BB霜 2号韩国珂朵玛药妆研制公司18JHZTZX2300218森颜树语保湿无瑕BB霜 1号韩国珂朵玛药妆研制公司19JHZTZX2300219森颜树语水漾滋润粉底乳 2号韩国珂朵玛药妆研制公司20JHZTZX2300220香蕉船运动系列防晒乳液 SPF 50+ PA++++倍儿乐公司21JHZTZX2300221奥蜜思水凝精华粉底液 N03奥蜜思株式会社22JHZTZX2300222奥蜜思水凝精华粉底液 N01奥蜜思株式会社23JHZTZX2300223奥蜜思水凝精华粉底液 PN02奥蜜思株式会社24JHZTZX2300224奥蜜思水凝精华粉底液 N02奥蜜思株式会社25JHZTZX2300225奥蜜思净妍修色妆前乳奥蜜思株式会社26JHZTZX2300226奥蜜思芯悠日间精华乳奥蜜思株式会社27JHZTZX2300227奥蜜思柔光丝绒粉饼 N02奥蜜思株式会社28JHZTZX2300228奥蜜思柔光丝绒粉饼 N01奥蜜思株式会社29JHZTZX2300229奥蜜思柔光丝绒粉饼 PN02奥蜜思株式会社30JHZTZX2300230奥蜜思丝绒保湿妆前乳奥蜜思株式会社31JHZTZX2300231奥蜜思凝时粉底液 N02奥蜜思株式会社32JHZTZX2300232奥蜜思凝时粉底液 N01奥蜜思株式会社33JHZTZX2300233奥蜜思凝时粉底液 PN02奥蜜思株式会社34JHZTZX2300234奥蜜思水原力润白洁面乳奥蜜思株式会社35JHZTZX2300235奥蜜思水原力润白保湿液（滋润型）奥蜜思株式会社36JHZTZX2300236奥蜜思水原力润白保湿液（清爽型）奥蜜思株式会社37JHZTZX2300237奥蜜思水原力润白水（滋润型）奥蜜思株式会社38JHZTZX2300238奥蜜思水原力润白水（清爽型）奥蜜思株式会社39JHZTZX2300239奥蜜思芯悠肌活精华面膜奥蜜思株式会社40JHZTZX2300240奥蜜思盈光精华粉底液 N02奥蜜思株式会社41JHZTZX2300241奥蜜思盈光精华粉底液 N01奥蜜思株式会社42JHZTZX2300242奥蜜思盈光精华粉底液 PN02奥蜜思株式会社43JHZTZX2300243奥蜜思净白精华奥蜜思株式会社44JHZTZX2300244奥蜜思新定格美肌防晒粉饼 N02奥蜜思株式会社45JHZTZX2300245奥蜜思新定格美肌防晒粉饼 N01奥蜜思株式会社46JHZTZX2300246奥蜜思新定格美肌防晒粉饼 PN02奥蜜思株式会社47JHZTZX2300247奥蜜思倍护防晒乳奥蜜思株式会社48JHZTZX2300248普柔玛丝特染发膏 R-8/7（配合普蓉斯绨双氧乳6%）朋友株式会社49JHZTZX2300249普柔玛丝特染发膏 V-8/7（配合普蓉斯绨双氧乳6%）朋友株式会社50JHZTZX2300250普柔玛丝特染发膏 A-7/6（配合普蓉斯绨双氧乳6%）朋友株式会社51JHZTZX2300251普柔玛丝特染发膏 C-8/8（配合普蓉斯绨双氧乳6%）朋友株式会社52JHZTZX2300252普柔玛丝特染发膏 AO-8（配合普蓉斯绨双氧乳6%）朋友株式会社53JHZTZX2300253普柔玛丝特染发膏 C-9/9（配合普蓉斯绨双氧乳6%）朋友株式会社54JHZTZX2300254普柔玛丝特染发膏 C-10/10（配合普蓉斯绨双氧乳6%）朋友株式会社55JHZTZX2300255普柔玛丝特染发膏（一） G-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社56JHZTZX2300256普柔玛丝特染发膏（一） LT/SH（配合普蓉斯绨双氧乳 9%）朋友株式会社57JHZTZX2300257普柔玛丝特染发膏（一） MT-8/7（配合普柔双氧乳 6%）朋友株式会社58JHZTZX2300258普柔玛丝特染发膏（一） N-10/10（配合普柔双氧乳 6%）朋友株式会社59JHZTZX2300259普柔玛丝特染发膏（一） N-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社60JHZTZX2300260普柔玛丝特染发膏（一） R-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社61JHZTZX2300261普柔玛丝特染发膏（一） V-6/5（配合普柔双氧乳 6%）朋友株式会社62JHZTZX2300262普柔玛丝特染发膏（一） A-8/7（配合普柔双氧乳 6%）朋友株式会社63JHZTZX2300263普柔玛丝特染发膏（一） A-9/8（配合普柔双氧乳 6%）朋友株式会社64JHZTZX2300264普柔玛丝特染发膏（一） A-10/9（配合普柔双氧乳 6%）朋友株式会社65JHZTZX2300265普柔玛丝特染发膏（一） A-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社66JHZTZX2300266普柔玛丝特染发膏（一） C-7/7（配合普柔双氧乳 6%）朋友株式会社67JHZTZX2300267普柔玛丝特染发膏（一） MT-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社68JHZTZX2300268普柔玛丝特染发膏（一） N-3/2（配合普柔双氧乳 6%）朋友株式会社69JHZTZX2300269普柔玛丝特染发膏（一） N-6/5（配合普柔双氧乳 6%）朋友株式会社70JHZTZX2300270普柔玛丝特染发膏（一） N-7/6（配合普柔双氧乳 6%）朋友株式会社71JHZTZX2300271普柔玛丝特染发膏（一） M-10/10（配合普柔双氧乳 6%）朋友株式会社72JHZTZX2300272普柔玛丝特染发膏（一） MT-6/5（配合普柔双氧乳 6%）朋友株式会社73JHZTZX2300273普柔玛丝特染发膏（一） MT-7/6（配合普柔双氧乳 6%）朋友株式会社74JHZTZX2300274普柔玛丝特染发膏（一） SV-6（配合普柔双氧乳 2%）朋友株式会社75JHZTZX2300275普柔玛丝特染发膏（一） N-8/7（配合普柔双氧乳 6%）朋友株式会社76JHZTZX2300276普柔玛丝特染发膏（一） N-9/8（配合普柔双氧乳 6%）朋友株式会社77JHZTZX2300277普柔玛丝特染发膏（一） E SG-6（配合普柔双氧乳 2%）朋友株式会社78JHZTZX2300278普柔玛丝特染发膏（一） E NA-3（配合普柔双氧乳 2%）朋友株式会社79JHZTZX2300279普柔玛丝特染发膏（一） E BE-8（配合普柔双氧乳 2%）朋友株式会社80JHZTZX2300280普柔玛丝特染发膏 M-10/10（配合普蓉斯绨双氧乳6%）朋友株式会社81JHZTZX2300281普柔玛丝特染发膏亮丽系列 M-10/13（配合普蓉斯绨双氧乳6%）朋友株式会社82JHZTZX2300282普柔玛丝特染发膏 MT-6/5（配合普蓉斯绨双氧乳6%）朋友株式会社83JHZTZX2300283普柔玛丝特染发膏 MT-7/6（配合普蓉斯绨双氧乳6%）朋友株式会社84JHZTZX2300284普柔玛丝特染发膏 N-5/4（配合普蓉斯绨双氧乳6%）朋友株式会社85JHZTZX2300285普柔玛丝特染发膏 R-7/6（配合普蓉斯绨双氧乳6%）朋友株式会社86JHZTZX2300286普柔玛丝特染发膏（一） A-7/6（配合普柔双氧乳 6%）朋友株式会社87JHZTZX2300287普柔玛丝特染发膏（一） BB-1（配合普柔双氧乳 2%）朋友株式会社88JHZTZX2300288普柔玛丝特染发膏（一） CB-5（配合普柔双氧乳 2%）朋友株式会社89JHZTZX2300289普柔玛丝特染发膏（一） EG-6（配合普柔双氧乳 2%）朋友株式会社90JHZTZX2300290普柔玛丝特染发膏（一） C-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社91JHZTZX2300291普柔玛丝特染发膏（一） R-9/8（配合普柔双氧乳 6%）朋友株式会社92JHZTZX2300292普柔玛丝特染发膏（一） MT-9/8（配合普柔双氧乳 6%）朋友株式会社93JHZTZX2300293普柔玛丝特染发膏 CB-5（配合普蓉斯绨双氧乳6%）朋友株式会社94JHZTZX2300294普柔玛丝特染发膏 EG-6（配合普蓉斯绨双氧乳6%）朋友株式会社95JHZTZX2300295普柔玛丝特染发膏 G-8/7（配合普蓉斯绨双氧乳6%）朋友株式会社96JHZTZX2300296普柔玛丝特染发膏 G-9/9（配合普蓉斯绨双氧乳6%）朋友株式会社97JHZTZX2300297普柔玛丝特染发膏 HY-9（配合普蓉斯绨双氧乳6%）朋友株式会社98JHZTZX2300298普柔玛丝特染发膏 M-8/7（配合普蓉斯绨双氧乳6%）朋友株式会社99JHZTZX2300299普柔玛丝特染发膏 M-9/9（配合普蓉斯绨双氧乳6%）朋友株式会社100JHZTZX2300300普柔玛丝特染发膏（一） V-10/12（配合普蓉斯绨双氧乳 9%）朋友株式会社101JHZTZX2300301欧蕙精致妆容遮瑕镜垫粉底液 02LG生活健康股份有限公司102JHZTZX2300302欧蕙精致妆容遮瑕镜垫粉底液 01LG生活健康股份有限公司103JHZTZX2300303彤人秘潭滋润面霜KGC韩国人参公社104JHZTZX2300304彤人秘雪亮白眼部精华KGC韩国人参公社105JHZTZX2300305彤人秘雪亮白精华液KGC韩国人参公社106JHZTZX2300306彤人秘雪集中亮白精华液KGC韩国人参公社107JHZTZX2300307彤人秘津肌底修护眼部精华KGC韩国人参公社108JHZTZX2300308彤人秘津肌底修护眼霜KGC韩国人参公社109JHZTZX2300309彤人秘润保湿紧致眼霜KGC韩国人参公社110JHZTZX2300310彤人秘潭精华露KGC韩国人参公社111JHZTZX2300311彤人秘贤精华露KGC韩国人参公社112JHZTZX2300312彤人秘映润光气垫霜23号色KGC韩国人参公社113JHZTZX2300313彤人秘美活力面膜KGC韩国人参公社114JHZTZX2300314彤人秘美亮白面膜KGC韩国人参公社115JHZTZX2300315彤人秘映润光气垫霜21号色KGC韩国人参公社116JHZTZX2300316彤人秘美石榴面膜KGC韩国人参公社117JHZTZX2300317欧缇丽尊贵璀璨时光精华欧缇丽公司118JHZTZX2300318欧缇丽白藜芦醇提升紧致丝绒面霜欧缇丽公司119JHZTZX2300319欧缇丽白藜芦醇提升紧致晚霜欧缇丽公司120JHZTZX2300320欧缇丽尊贵璀璨时光奢颜面霜欧缇丽公司121JHZTZX2300321EDVIEW 凝时焕白倍润保湿霜爱博集团有限公司122JHZTZX2300322EDVIEW 凝时焕白多效赋活精华面霜爱博集团有限公司123JHZTZX2300323EDVIEW 凝时焕白多效赋活柔肤乳爱博集团有限公司124JHZTZX2300324EDVIEW 凝时焕白多效赋活抗皱眼霜爱博集团有限公司125JHZTZX2300325EDVIEW 凝时焕白多效焕颜精华液爱博集团有限公司126JHZTZX2300326EDVIEW 凝时焕白多效赋活柔肤水爱博集团有限公司127JHZTZX2300327普瑞迷露丝滑提拉眼颈霜百佩莱株式会社128JHZTZX2300328普瑞迷露水光润肌霜百佩莱株式会社129JHZTZX2300329向我来富乐霓爽肤水胜利集团130JHZTZX2300330保妮肌漂冽世她BB霜日本生物制剂韩国有限公司131JHZTZX2300331保妮肌漂冽世她面膜日本生物制剂韩国有限公司132JHZTZX2300332保妮肌漂冽世她护手霜日本生物制剂韩国有限公司133JHZTZX2300333向我来啊密韩呼面霜胜利集团134JHZTZX2300334向我来爱斯精华液胜利集团135JHZTZX2300335向我来美益泽乳液胜利集团136JHZTZX2300336向我来富乐霓乳液胜利集团137JHZTZX2300337向我来美益泽爽肤水胜利集团138JHZTZX2300338贝佳斯活力亮采净透白皙精华液贝佳斯有限公司139JHZTZX2300339贝佳斯赋活青春无瑕护手霜贝佳斯有限公司140JHZTZX2300340贝佳斯妍白修颜紧致精华液贝佳斯有限公司141JHZTZX2300341YACYURE雪肌净白润肤乳吉珀可莱集团(日本)142GHZTZ2202851奇妙时光水润防晒乳上海乐达通实业有限公司143GHZTZ2203144婉黛风嫒缇熙染发膏0号（配合婉黛风嫒缇熙双氧乳3%使用）玫丽盼（浙江）化妆品有限公司144GHZTZ2203413本叮叮儿童防晒喷雾广州原生萃集生物科技有限公司145GHZTZ2203514珍草堂温顺染发膏34.66(植物调理型）北京九州益华化妆品有限公司146GHZTZ2203515珍草堂温顺染发膏36.45(植物调理型）北京九州益华化妆品有限公司147GHZTZ2203516珍草堂温顺染发膏35.06(植物调理型）北京九州益华化妆品有限公司148GHZTZ2203517珍草堂温顺染发膏318.3(植物调理型）北京九州益华化妆品有限公司149GHZTZ2203518珍草堂温顺染发膏37.06(植物调理型）北京九州益华化妆品有限公司150GHZTZ2203519珍草堂温顺染发膏32.0（植物调理型）北京九州益华化妆品有限公司151GHZTZ2203520珍草堂温顺染发膏33.0（植物调理型）北京九州益华化妆品有限公司152GHZTZ2203521珍草堂温顺染发膏34.05(植物调理型）北京九州益华化妆品有限公司153GHZTZ2203821TVLV 美白精华液汕头市欧之曼生物科技有限公司154GHZTZ2203889阿美妍水感清透防晒喷雾阿美妍生物科技（杭州）有限公司155GHZTZ2203890MD摇一摇防晒乳广东敏达药妆医药有限公司156JHZTZ2200158诺珊娜水润美白约会精华乳圣妮娜国际有限公司157JHZTZ2200574华伦天奴光影奢润轻垫粉底液 LN 2华伦天奴158JHZTZ2200575华伦天奴光影奢润轻垫粉底液 LIGR 2华伦天奴159JHZTZ2200576华伦天奴光影奢润轻垫粉底液 LA 1华伦天奴160JHZTZ2200577华伦天奴光影奢润轻垫粉底液 LN 1华伦天奴

申请上市ASH会议

2022-09-29

·国家药品监督管理局政务服务门户

2022年09月29日化妆品批准证明文件（GHZJ)待领取信息发布

序号产品名称注册证号注册人受理编号备注1爱玛美白身体匀嫩霜国妆特进字J20191455爱玛实业有限公司GHZJ2200049交回旧证2碧格伦焕白防护精华国妆特进字J20200007杰邦国际商务集团股份有限公司GHZJ2200050交回旧证3缪缪游转幻境女士身体乳国妆特进字J20200021科蒂有限公司GHZJ2200051(1)交回旧证4古驰丝润气垫粉底液03国妆特进字J20210372科蒂有限公司GHZJ2200051(2)交回旧证5古驰丝润气垫粉底液04国妆特进字J20210373科蒂有限公司GHZJ2200051(3)交回旧证6古驰丝润气垫粉底液06国妆特进字J20210374科蒂有限公司GHZJ2200051(4)交回旧证7古驰丝润气垫粉底液05国妆特进字J20210375科蒂有限公司GHZJ2200051(5)交回旧证8古驰丝润气垫粉底液02国妆特进字J20210379科蒂有限公司GHZJ2200051(6)交回旧证9古驰丝润气垫粉底液01国妆特进字J20210380科蒂有限公司GHZJ2200051(7)交回旧证10普柔玛丝特染发膏 C-9/9（配合普蓉斯绨双氧乳6%）国妆特进字J20170074朋友株式会社GHZJ2200052(1)交回旧证11普柔玛丝特染发膏 C-10/10（配合普蓉斯绨双氧乳6%）国妆特进字J20170079朋友株式会社GHZJ2200052(2)交回旧证12普柔玛丝特染发膏 G-8/7（配合普蓉斯绨双氧乳6%）国妆特进字J20170082朋友株式会社GHZJ2200052(3)交回旧证13普柔玛丝特染发膏 G-9/9（配合普蓉斯绨双氧乳6%）国妆特进字J20170084朋友株式会社GHZJ2200052(4)交回旧证14普柔玛丝特染发膏 R-7/6（配合普蓉斯绨双氧乳6%）国妆特进字J20170092朋友株式会社GHZJ2200052(5)交回旧证15普柔玛丝特染发膏 AO-8（配合普蓉斯绨双氧乳6%）国妆特进字J20170094朋友株式会社GHZJ2200052(6)交回旧证16普柔玛丝特染发膏 N-5/4（配合普蓉斯绨双氧乳6%）国妆特进字J20170095朋友株式会社GHZJ2200052(7)交回旧证17普柔玛丝特染发膏 C-8/8（配合普蓉斯绨双氧乳6%）国妆特进字J20170096朋友株式会社GHZJ2200052(8)交回旧证18普柔玛丝特染发膏 R-8/7（配合普蓉斯绨双氧乳6%）国妆特进字J20170115朋友株式会社GHZJ2200052(9)交回旧证19普柔玛丝特染发膏 HY-9（配合普蓉斯绨双氧乳6%）国妆特进字J20171382朋友株式会社GHZJ2200052(10)交回旧证20普柔玛丝特染发膏 A-7/6（配合普蓉斯绨双氧乳6%）国妆特进字J20190955朋友株式会社GHZJ2200052(11)交回旧证21普柔玛丝特染发膏 EG-6（配合普蓉斯绨双氧乳6%）国妆特进字J20190956朋友株式会社GHZJ2200052(12)交回旧证22普柔玛丝特染发膏 M-9/9（配合普蓉斯绨双氧乳6%）国妆特进字J20190957朋友株式会社GHZJ2200052(13)交回旧证23普柔玛丝特染发膏亮丽系列 M-10/13（配合普蓉斯绨双氧乳6%）国妆特进字J20190958朋友株式会社GHZJ2200052(14)交回旧证24普柔玛丝特染发膏 MT-6/5（配合普蓉斯绨双氧乳6%）国妆特进字J20190959朋友株式会社GHZJ2200052(15)交回旧证25普柔玛丝特染发膏 MT-7/6（配合普蓉斯绨双氧乳6%）国妆特进字J20190960朋友株式会社GHZJ2200052(16)交回旧证26普柔玛丝特染发膏 M-10/10（配合普蓉斯绨双氧乳6%）国妆特进字J20190961朋友株式会社GHZJ2200052(17)交回旧证27普柔玛丝特染发膏 CB-5（配合普蓉斯绨双氧乳6%）国妆特进字J20192169朋友株式会社GHZJ2200052(18)交回旧证28普柔玛丝特染发膏 M-8/7（配合普蓉斯绨双氧乳6%）国妆特进字J20192170朋友株式会社GHZJ2200052(19)交回旧证29普柔玛丝特染发膏（一） V-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211281朋友株式会社GHZJ2200052(20)交回旧证30普柔玛丝特染发膏（一） N-9/8（配合普柔双氧乳 6%）国妆特进字J20211282朋友株式会社GHZJ2200052(21)交回旧证31普柔玛丝特染发膏（一） N-7/6（配合普柔双氧乳 6%）国妆特进字J20211283朋友株式会社GHZJ2200052(22)交回旧证32普柔玛丝特染发膏（一） N-6/5（配合普柔双氧乳 6%）国妆特进字J20211284朋友株式会社GHZJ2200052(23)交回旧证33普柔玛丝特染发膏（一） MT-8/7（配合普柔双氧乳 6%）国妆特进字J20211285朋友株式会社GHZJ2200052(24)交回旧证34普柔玛丝特染发膏（一） C-7/7（配合普柔双氧乳 6%）国妆特进字J20211296朋友株式会社GHZJ2200052(25)交回旧证35普柔玛丝特染发膏（一） LT/SH（配合普蓉斯绨双氧乳 9%）国妆特进字J20211297朋友株式会社GHZJ2200052(26)交回旧证36普柔玛丝特染发膏（一） MT-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211298朋友株式会社GHZJ2200052(27)交回旧证37普柔玛丝特染发膏（一） R-9/8（配合普柔双氧乳 6%）国妆特进字J20211299朋友株式会社GHZJ2200052(28)交回旧证38普柔玛丝特染发膏（一） N-8/7（配合普柔双氧乳 6%）国妆特进字J20211300朋友株式会社GHZJ2200052(29)交回旧证39普柔玛丝特染发膏（一） G-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211301朋友株式会社GHZJ2200052(30)交回旧证40普柔玛丝特染发膏（一） A-8/7（配合普柔双氧乳 6%）国妆特进字J20211302朋友株式会社GHZJ2200052(31)交回旧证41普柔玛丝特染发膏（一） A-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211303朋友株式会社GHZJ2200052(32)交回旧证42普柔玛丝特染发膏（一） C-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211304朋友株式会社GHZJ2200052(33)交回旧证43普柔玛丝特染发膏（一） R-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211305朋友株式会社GHZJ2200052(34)交回旧证44普柔玛丝特染发膏（一） V-6/5（配合普柔双氧乳 6%）国妆特进字J20211306朋友株式会社GHZJ2200052(35)交回旧证45普柔玛丝特染发膏（一） A-10/9（配合普柔双氧乳 6%）国妆特进字J20211307朋友株式会社GHZJ2200052(36)交回旧证46普柔玛丝特染发膏（一） N-10/10（配合普柔双氧乳 6%）国妆特进字J20211308朋友株式会社GHZJ2200052(37)交回旧证47普柔玛丝特染发膏（一） N-3/2（配合普柔双氧乳 6%）国妆特进字J20211309朋友株式会社GHZJ2200052(38)交回旧证48普柔玛丝特染发膏（一） N-10/12（配合普蓉斯绨双氧乳 9%）国妆特进字J20211310朋友株式会社GHZJ2200052(39)交回旧证49普柔玛丝特染发膏（一） A-9/8（配合普柔双氧乳 6%）国妆特进字J20211312朋友株式会社GHZJ2200052(40)交回旧证50普柔玛丝特染发膏（一） MT-9/8（配合普柔双氧乳 6%）国妆特进字J20211313朋友株式会社GHZJ2200052(41)交回旧证

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适应症	最高研发状态	国家/地区	公司	日期
角膜炎	临床2期	美国	Recordati Rare Diseases, Inc.	2020-10-13
角膜炎	临床2期	法国	Recordati Rare Diseases, Inc.	2020-10-13
角膜炎	临床2期	德国	Recordati Rare Diseases, Inc.	2020-10-13
角膜炎	临床2期	匈牙利	Recordati Rare Diseases, Inc.	2020-10-13
角膜炎	临床2期	意大利	Recordati Rare Diseases, Inc.	2020-10-13
角膜炎	临床2期	西班牙	Recordati Rare Diseases, Inc.	2020-10-13
角膜炎	临床2期	英国	Recordati Rare Diseases, Inc.	2020-10-13
糖尿病足溃疡	临床2期	-	MimeTech SRL	-
神经营养性角膜炎	临床2期	-	MimeTech SRL	-
镰状细胞血症	临床申请	-	MimeTech SRL	-

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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


NCT04276558 (CTgov)	临床2期	神经营养性角膜炎	108	Vehicle+Udonitrectag (Dose 1 - 0.5 µg/Day)	構鑰醖選壓齋夢齋製鑰 = 餘糧顧範顧夢醖齋鑰淵艱齋壓襯醖鑰夢壓餘積 (顧襯願選顧憲構築蓋夢, 願構築窪夢夢淵鑰襯簾 ~ 餘壓餘願壓積餘構選獵) 更多	-	2025-05-14
				Vehicle+Udonitrectag (Dose 2 - 2.5 µg/Day)	構鑰醖選壓齋夢齋製鑰 = 艱廠憲製淵膚製願遞繭艱齋壓襯醖鑰夢壓餘積 (顧襯願選顧憲構築蓋夢, 廠積鏇獵鏇範選構鏇選 ~ 淵衊蓋蓋製製蓋積鏇餘) 更多