A Short-term Preoperative, Window-of-opportunity Study, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer

A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery. A total of three dedicated Formalin-fixed paraffin embedded (FFPE) samples (mandatory for all patients), along with two frozen biopsy (only for participants at Gustave Roussy), are planned to be collected at the time of inclusion from the biopsy sample and from the surgical specimen. Blood samples will also be collected throughout the study.

开始日期2025-09-23

申办/合作机构

Gustave Roussy, Cancer Campus, Grand Paris

[+1]

NCT06449027

/ Active, not recruiting临床3期

A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

开始日期2024-08-21

申办/合作机构

长春金赛药业有限责任公司

CTR20240920

/ Active, not recruiting临床3期

一项评价亮丙瑞林注射乳剂治疗绝经前乳腺癌的有效性、安全性和药代动力学的多中心、随机、开放Ⅲ期临床研究

以给药后第4周至48周血清E2浓度维持在绝经后水平（≤ 30 pg/mL）的抑制率为有效性评价的替代性指标，评估亮丙瑞林注射乳剂给药后治疗绝经前乳腺癌的疗效。

开始日期2024-08-21

申办/合作机构

FAREVA PAU

[+2]

100 项与甲磺酸亮丙瑞林相关的临床结果

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100 项与甲磺酸亮丙瑞林相关的转化医学

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100 项与甲磺酸亮丙瑞林相关的专利（医药）

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项与甲磺酸亮丙瑞林相关的文献（医药）

2024-10-01·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Review of drug-drug interactions in patients with prostate cancer

Review

作者: Ruplin, Andrew ; Segal, Eve ; McFarlane, Tom

Objective:

The objective of this review is to provide an overview of common drug-drug interactions (DDIs) associated with prostate cancer treatments and outline recommendations for managing polypharmacy.

Data sources:

A literature search of PubMed, Embase, and CINAHL was carried out to identify pharmacokinetic and pharmacodynamic changes caused by DDIs that are relevant for prostate cancer patients, DDIs between prostate cancer therapies and co-administered medications (both prescription and over-the-counter), and measures to prevent DDIs. Medication package inserts were used to identify the impact of DDI on the prostate cancer therapy and suggested interventions.

Data summary:

No DDIs are expected for the LHRH agonists leuprolide acetate, histrelin, goserelin, or leuprolide mesylate. However, DDIs have been reported for GnRH antagonists, anti-androgens, PARP inhibitors, and taxanes. Although there are no confirmed DDIs for sipuleucel-T to date, it is not generally recommended to use sipuleucel-T concurrently with immunosuppressive medications. Interventions to prevent DDIs include the use of software that can detect clinically significant DDIs, up-to-date medication reconciliation, the inclusion of dedicated clinical pharmacists in cancer treatment teams, and patient/caregiver education.

Conclusions:

Prostate cancer patients have a high risk of potential DDIs due to numerous new anti-cancer therapies, the increased use of treatment combinations, and the likelihood of comorbid conditions also requiring drug therapy. Drug-drug interaction screening software, up-to-date medication reconciliation, inclusion of oncology pharmacists on healthcare teams, and patient/caregiver education will aid the development of treatment plans that focus on achieving an optimal risk-benefit profile whilst reducing the risk of DDIs.

2022-09-01·Biomaterials

Suspension culture of human induced pluripotent stem cell-derived intestinal organoids using natural polysaccharides

Article

作者: Iwao, Takahiro ; Kanaki, Tatsuro ; Hayashi, Hisato ; Matsunaga, Tamihide ; Onozato, Daichi ; Ogawa, Isamu ; Anno, Shiho

Currently, there are many challenges in the culture of human induced pluripotent stem (iPS) cell-derived intestinal organoids (HIOs) for use in drug discovery, disease research, and regenerative medicine. For example, the main culture method, embedding culture, makes industrial large-scale culture difficult, and Matrigel, which is used for almost all HIO cultures, is not respected for its application in regenerative medicine. To overcome these challenges, we herein propose a new culture method using low concentrations of natural polysaccharides in a suspension culture. In the present study, five natural polysaccharides free from heterologous animal-derived components were used, and HIOs were successfully cultured in suspension with FP001 and FP003, which are microbial exopolysaccharide analogs of gellan gum. The fabricated HIOs were similar to living intestinal tracts with respect to their gene expression, microstructure, and protein expression. The observed activities of the drug metabolizing enzymes and drug transporters in the generated HIOs suggested that they have pharmacokinetic functions. We believe that suspension culture of HIOs using FP001 or FP003 can be widely applied to not only drug discovery research but also disease research and regenerative medicine.

2020-01-01·World journal of urology

A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients

Article

作者: Jievaltas, Mindaugas ; Mao, John ; DeGuenther, Mark ; Li, Yuhua ; Simpson, Kelle ; Patockova, Jitka ; Huang, Shih-Tsung ; Chien, Ben ; Hu, Chu-Hsuan ; Lee, Yisheng ; Mincik, Ivan ; Student, Vladimir ; Shore, Neal

OBJECTIVES:

To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer.

PATIENTS AND METHODS:

In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336.

RESULTS:

Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported.

CONCLUSIONS:

LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.

项与甲磺酸亮丙瑞林相关的新闻（医药）

2025-08-29

·EndPoints

Zydus to pursue PBC approval; Novocure terminates lung study

Plus news about Foresee Pharmaceuticals: ☑ Zydus Therapeutics’ PBC data: The drug saroglitazar met the primary endpoint in a Phase 2b/3 trial for a rare autoimmune disease that affects the bile ducts, the company announced Friday. The trial enrolled patients who had failed on ursodeoxycholic acid, the current standard of care in primary biliary cholangitis (PBC). There was a statistically significant difference in the percentage of patients who received saroglitazar and achieved a biochemical response compared to placebo, measured by multiple factors including the reduction of an enzyme that’s a predictor of PBC progression. Zydus said it will seek approval by the FDA in the first quarter of 2026. — Nicole DeFeudis 🛑 Novocure axes Phase 2 lung cancer trial: The biotech said it can meet the aims of the study, called LUNAR-4, but with the help of “real-world evidence.” The single-arm study was testing a type of alternating electrical field therapy, called tumor treating fields, in combination with Merck’s Keytruda in non-small cell lung cancer patients who had previously received a PD-1/PD-L1 inhibitor. The decision was not related to any safety concerns, Novocure said. — Ayisha Sharma ✅ A new formulation for Camcevi: Foresee Pharmaceuticals’ 21 mg dose of leuprolide mesylate with a schedule of once every three months was greenlit by the FDA for the treatment of advanced prostate cancer. The formulation, named Camcevi ETM , is a type of androgen deprivation therapy. Camcevi was approved at a dose of 42 mg, administered once every six months. — Ayisha Sharma

临床结果上市批准临床2期临床3期

2025-08-29

·PRNewswire

Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer

TAIPEI, Aug. 28, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer. "The approval of CAMCEVI ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients," said Dr. Ben Chien, founder, Chairman, and CEO of Foresee. "It is also a key step in our efforts to build Foresee as a profitable and growing business. We want to thank the team and all stakeholders for their tireless work, which has made this approval possible. The FDA approval was based on the successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with CAMCEVI ETM was demonstrated to be effective, safe, and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint. As it was the case for CAMCEVI 42 mg, we anticipate the commercial launch to take place after obtaining a J-code. The commercial market access strategy established by our partner will seek to find a balance between near term uptake and the optimization of mid/long term growth. CAMCEVI ETM is exclusively licensed to Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. for commercialization in the U.S. About Foresee Pharmaceuticals Co. Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August 25, 2025, while the EU regulatory review for the 3-month version of CAMCEVI is still ongoing. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床2期临床1期临床结果

2025-08-24

·信狐药迅

丹诺医药利福特尼唑、江苏恩华NH600001乳状注射液和爱科百发齐瑞索韦三个1类新药提交上市申请|新受理（8.18-8.24）

本周药品注册受理数据，分门别类呈现，一目了然。(8.18-8.24）新药上市申请药品名称企业注册分类受理号利福特尼唑胶囊丹诺医药(苏州)股份有限公司 1 CXHS2500103 NH600001乳状注射液江苏恩华药业股份有限公司 1 CXHS2500099 齐瑞索韦肠溶胶囊上海爱科百发生物医药技术股份有限公司 1 CXHS2500098 齐瑞索韦肠溶胶囊上海爱科百发生物医药技术股份有限公司 1 CXHS2500097 盐酸安罗替尼胶囊正大天晴药业集团股份有限公司 2.4 CXHS2500102 盐酸安罗替尼胶囊正大天晴药业集团股份有限公司 2.4 CXHS2500101 盐酸安罗替尼胶囊正大天晴药业集团股份有限公司 2.4 CXHS2500100 海曲泊帕乙醇胺片江苏恒瑞医药股份有限公司 2.4 CXHS2500096 贝莫苏拜单抗注射液正大天晴药业集团南京顺欣制药有限公司 2.2 CXSS2500085 新药临床申请药品名称企业注册分类受理号 RNK08954片珃诺生物医药科技(杭州)有限公司 1 CXHL2500886 RNK08954片珃诺生物医药科技(杭州)有限公司 1 CXHL2500885 IN10018片应世生物科技(深圳)有限公司 1 CXHL2500884 IN10018片应世生物科技(深圳)有限公司 1 CXHL2500883 YKYY013注射液北京悦康科创医药科技股份有限公司 1 CXHL2500882 LPM516000152盐酸盐胶囊烟台创和生物科技有限公司 1 CXHL2500881 LPM516000152盐酸盐胶囊烟台创和生物科技有限公司 1 CXHL2500880 BGT-004乳膏博骥源(上海)生物医药有限公司 1 CXHL2500878 BGT-004乳膏博骥源(上海)生物医药有限公司 1 CXHL2500877 HRS-7058片山东盛迪医药有限公司 1 CXHL2500876 HRS-7058片山东盛迪医药有限公司 1 CXHL2500875 HRS-7058胶囊山东盛迪医药有限公司 1 CXHL2500874 HRS-7058胶囊山东盛迪医药有限公司 1 CXHL2500873 CG-7321胶囊成都赛璟生物医药科技有限公司 1 CXHL2500872 CG-7321胶囊成都赛璟生物医药科技有限公司 1 CXHL2500871 YD6390片上海壹典医药科技开发有限公司 1 CXHL2500870 YD6390片上海壹典医药科技开发有限公司 1 CXHL2500869 YD6390片上海壹典医药科技开发有限公司 1 CXHL2500868 HRN77片北京华睿鼎信科技有限公司 1 CXHL2500867 HRN77片北京华睿鼎信科技有限公司 1 CXHL2500866 TSN1611片泰励生物医药(苏州)有限公司 1 CXHL2500865 TSN1611片泰励生物医药(苏州)有限公司 1 CXHL2500863 TH202216胶束注射液山东泰合医药科技有限公司 2.2 CXHL2500879 MIRSRT双释放缓释片吉林天衡药业有限公司 2.2 CXHL2500864 MIRSRT双释放缓释片吉林天衡药业有限公司 2.2 CXHL2500862 MIRSRT双释放缓释片吉林天衡药业有限公司 2.2 CXHL2500861 冻干结核病mRNA疫苗瑞佶(北京)生物科技有限公司 1.1 CXSL2500732 吸附无细胞百(二组分)白破联合疫苗(成人及青少年用) 长春百克生物科技股份公司 1.3 CXSL2500724 重组乙型肝炎疫苗(汉逊酵母,CpG和铝佐剂) 华普石家庄医药有限公司 1.3 CXSL2500710 LBM801 上海博赛美生物科技有限公司 1 CXSL2500734 SR604注射液上海莱士血液制品股份有限公司 1 CXSL2500733 GenSci134注射液长春金赛药业有限责任公司 1 CXSL2500731 GenSci134注射液长春金赛药业有限责任公司 1 CXSL2500730 GA001注射液健达九州(北京)生物科技有限公司 1 CXSL2500729 注射用GenSci143 长春金赛药业有限责任公司 1 CXSL2500728 SYS6010 石药集团巨石生物制药有限公司 1 CXSL2500722 注射用CS2009 申石生物医药(上海)有限公司 1 CXSL2500727 AZD0901 阿斯利康全球研发(中国)有限公司 1 CXSL2500726 AZD0901 阿斯利康全球研发(中国)有限公司 1 CXSL2500725 注射用SHR-A2102 苏州盛迪亚生物医药有限公司 1 CXSL2500718 注射用3H-10000 思康睿奇(上海)药业有限公司 1 CXSL2500717 HCB101注射液广州汉科生物有限公司 1 CXSL2500716 注射用SHR-9839 (sc) 苏州盛迪亚生物医药有限公司 1 CXSL2500713 注射用BL-B01D1 百时美施贵宝(中国)投资有限公司 1 CXSL2500712 注射用BL-B01D1 百时美施贵宝(中国)投资有限公司 1 CXSL2500711 GKL-006RTU注射液北京基因启明生物科技有限公司 1 CXSL2500721 重组人血小板生成素注射液沈阳三生制药有限责任公司 2.2 CXSL2500720 重组人血小板生成素注射液沈阳三生制药有限责任公司 2.2 CXSL2500719 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2500715 贝伐珠单抗注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2500714 仿制药申请药品名称企业注册分类受理号硫酸镁注射液成都华宇制药有限公司 3 CYHS2503089 氯化钾注射液山东新华制药股份有限公司 3 CYHS2503088 注射用氢化可的松琥珀酸钠西藏安星医药有限公司 3 CYHS2503087 注射用氢化可的松琥珀酸钠西藏安星医药有限公司 3 CYHS2503086 盐酸美金刚口腔崩解片江西施美药业股份有限公司 3 CYHS2503099 盐酸美金刚口腔崩解片江西施美药业股份有限公司 3 CYHS2503098 盐酸美金刚口腔崩解片江西施美药业股份有限公司 3 CYHS2503097 利伐沙班口崩片合肥恩瑞特药业有限公司 3 CYHS2503096 利伐沙班口崩片合肥恩瑞特药业有限公司 3 CYHS2503095 复方氨基酸注射液(18AA-X) 远大医学营养科学(武汉)有限公司 3 CYHS2503093 盐酸非索非那定口服混悬液杭州泓友医药科技有限公司 3 CYHS2503082 草酸艾司西酞普兰口服溶液浙江杭康药业有限公司 3 CYHS2503080 注射用哌拉西林钠/氯化钠注射液湖南科伦制药有限公司 3 CYHS2503074 注射用哌拉西林钠/氯化钠注射液湖南科伦制药有限公司 3 CYHS2503073 盐酸非索非那定片植恩生物技术股份有限公司 3 CYHS2503071 盐酸非索非那定片植恩生物技术股份有限公司 3 CYHS2503070 磷酸奥司他韦颗粒湖南欧亚药业有限公司 3 CYHS2503065 氯化钾注射液西安京西双鹤药业有限公司 3 CYHS2503058 硫酸镁注射液山西普恒制药有限公司 3 CYHS2503057 硫酸镁注射液山西普恒制药有限公司 3 CYHS2503055 左乙拉西坦微片海南元盈医药科技有限公司 3 CYHS2503054 左乙拉西坦微片海南元盈医药科技有限公司 3 CYHS2503053 己酮可可碱注射液丹东医创药业有限责任公司 3 CYHS2503052 盐酸伐地那非口崩片江苏东科康德药业有限公司 3 CYHS2503051 硝普钠注射液华润双鹤药业股份有限公司 3 CYHS2503066 聚普瑞锌颗粒北京韩美药品有限公司 3 CYHS2503026 乙酰半胱氨酸颗粒江西仁齐制药有限公司 3 CYHS2503020 复方聚乙二醇(3350)电解质口服溶液四川奇裕医药科技有限公司 3 CYHS2503045 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503040 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503039 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503038 卡格列净二甲双胍缓释片乐普药业股份有限公司 3 CYHS2503037 注射用氯解磷定广州瑞尔医药科技有限公司 3 CYHS2503035 联苯苄唑溶液浙江百代医药科技有限公司 3 CYHS2503029 注射用硫酸艾沙康唑湖北美林药业有限公司 4 CYHS2503091 苹果酸奈诺沙星氯化钠注射液海南广升誉制药有限公司 4 CYHS2503090 氧(液态) 湖南中益邦达能源科技有限公司 4 CYHS2503108 达格列净二甲双胍缓释片(IV) 石药集团欧意药业有限公司 4 CYHS2503107 达格列净二甲双胍缓释片(III) 石药集团欧意药业有限公司 4 CYHS2503106 达格列净二甲双胍缓释片(II) 石药集团欧意药业有限公司 4 CYHS2503105 达格列净二甲双胍缓释片(I) 石药集团欧意药业有限公司 4 CYHS2503104 达格列净二甲双胍缓释片(I) 石药集团欧意药业有限公司 4 CYHS2503103 阿帕他胺片成都康弘药业集团股份有限公司 4 CYHS2503102 二十碳五烯酸乙酯软胶囊山东益康药业股份有限公司 4 CYHS2503101 夫西地酸乳膏上海朝晖药业有限公司 4 CYHS2503100 铝碳酸镁咀嚼片山东司邦得制药有限公司 4 CYHS2503094 盐酸乙哌立松片湖南华纳大药厂股份有限公司 4 CYHS2503092 比索洛尔氨氯地平片山西同达药业有限公司 4 CYHS2503085 恩曲他滨丙酚替诺福韦片(II) 杭州民生药业股份有限公司 4 CYHS2503084 阿司匹林维生素C泡腾片浙江赛默制药有限公司 4 CYHS2503081 注射用头孢唑肟钠海南钧华医疗科技有限公司 4 CYHS2503079 美阿沙坦钾片江西远盛药业有限公司 4 CYHS2503078 美阿沙坦钾片江西远盛药业有限公司 4 CYHS2503077 注射用头孢唑肟钠海南钧华医疗科技有限公司 4 CYHS2503076 吸入用乙酰半胱氨酸溶液山东新华鲁抗医药有限公司 4 CYHS2503075 瑞维那新吸入溶液四川健林药业有限责任公司 4 CYHS2503072 乌帕替尼缓释片合肥英太制药有限公司 4 CYHS2503067 盐酸非索非那定片植恩生物技术股份有限公司 4 CYHS2503069 盐酸非索非那定片植恩生物技术股份有限公司 4 CYHS2503068 瑞巴派特片杭州奥默医药股份有限公司 4 CYHS2503083 苯磺酸美洛加巴林片杭州和康药业有限公司 4 CYHS2503060 苯磺酸美洛加巴林片杭州和康药业有限公司 4 CYHS2503059 富马酸伏诺拉生片江苏东科康德药业有限公司 4 CYHS2503056 盐酸尼卡地平注射液江西东抚制药有限公司 4 CYHS2503064 莫匹罗星软膏湖北长江瑞益医药科技有限公司 4 CYHS2503063 普乐沙福注射液湖北长联杜勒制药有限公司 4 CYHS2503061 卡铂注射液浙江华海药业股份有限公司 4 CYHS2503062 盐酸普罗帕酮片北京诚济制药股份有限公司 4 CYHS2503025 氧氟沙星滴耳液石家庄格瑞药业有限公司 4 CYHS2503024 苯磺酸美洛加巴林片南京万融健诚医药科技有限公司 4 CYHS2503023 来特莫韦注射液海南合瑞制药股份有限公司 4 CYHS2503022 富马酸伏诺拉生片药大制药有限公司 4 CYHS2503021 非奈利酮片海南海灵化学制药有限公司 4 CYHS2503019 富马酸伏诺拉生片药大制药有限公司 4 CYHS2503018 瑞维那新吸入溶液朗天药业(湖北)有限公司 4 CYHS2503017 培哚普利氨氯地平片(III) 浙江恒研医药科技有限公司 4 CYHS2503047 来特莫韦片海南合瑞制药股份有限公司 4 CYHS2503046 碘美普尔注射液重庆药友制药有限责任公司 4 CYHS2503044 碘美普尔注射液重庆药友制药有限责任公司 4 CYHS2503043 戊酸雌二醇片河南泰丰生物科技有限公司 4 CYHS2503042 左氧氟沙星片广州白云山医药集团股份有限公司白云山制药总厂 4 CYHS2503041 甲钴胺片淄博万杰制药有限公司 4 CYHS2503036 结构脂肪乳注射液(C6-24) 辰欣药业股份有限公司 4 CYHS2503034 阿仑膦酸钠维D3片(Ⅱ) 南京九霄药业有限公司 4 CYHS2503033 来特莫韦片华北制药股份有限公司 4 CYHS2503032 糠酸莫米松鼻喷雾剂长风药业股份有限公司 4 CYHS2503031 糠酸莫米松鼻喷雾剂长风药业股份有限公司 4 CYHS2503030 达格列净二甲双胍缓释片(III) 合肥合源药业有限公司 4 CYHS2503028 达格列净二甲双胍缓释片(I) 合肥合源药业有限公司 4 CYHS2503027 羟考酮纳洛酮缓释片江苏恩华药业股份有限公司 4 CYHS2503050 硫酸氨基葡萄糖胶囊扬州日兴生物科技股份有限公司 4 CYHS2503049 硫酸艾沙康唑胶囊福安药业集团庆余堂制药有限公司 4 CYHS2503048 甲磺酸亮丙瑞林注射乳剂长春金赛药业有限责任公司 3 CYHL2500148 PJ021注射液重庆派金生物科技有限公司 3.3 CXSL2500723 进口申请药品名称企业注册分类受理号尼拉帕利阿比特龙片 Janssen-Cilag International NV 2.4 JXHS2500089 尼拉帕利阿比特龙片 Janssen-Cilag International NV 2.4 JXHS2500088 玛巴洛沙韦干混悬剂 Roche Pharma (Schweiz) AG 5.1 JXHS2500090 注射用德曲妥珠单抗 Daiichi Sankyo Europe GmbH 2.2 JXSS2500110 阿伏利尤单抗注射液 AstraZeneca AB 3.1 JXSS2500109 他克莫司软膏 BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED 5.2 JYHS2500041 他克莫司软膏 BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED 5.2 JYHS2500040 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500228 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500227 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500226 LOXO-435片 Eli Lilly and Company 1 JXHL2500225 LOXO-435片 Eli Lilly and Company 1 JXHL2500224 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500223 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500222 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500221 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500220 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500219 Brenipatide注射液 Eli Lilly and Company 1 JXHL2500218 AZD2936 AstraZeneca AB 1 JXSL2500156 中药相关申请药品名称企业注册分类受理号卿芷软膏广州博济新药临床研究中心有限公司 1.1 CXZL2500067 盘龙七凝胶贴膏陕西盘龙药业集团股份有限公司 2.1;2.3 CXZL2500066 小儿连花清感颗粒石家庄以岭药业股份有限公司 1.1 CXZS2500034 一贯煎颗粒江苏康缘药业股份有限公司 3.1 CXZS2500036 保元汤颗粒山东齐都药业有限公司 3.1 CXZS2500035 注：绿色字体部分为潜在首仿品种；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

100 项与甲磺酸亮丙瑞林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L02AE02	-

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
晚期前列腺癌	以色列	逸达生物科技股份有限公司	2024-07-11
激素依赖性前列腺癌	欧盟	Accord Healthcare SLU	2022-05-24
激素依赖性前列腺癌	冰岛	Accord Healthcare SLU	2022-05-24
激素依赖性前列腺癌	列支敦士登	Accord Healthcare SLU	2022-05-24
激素依赖性前列腺癌	挪威	Accord Healthcare SLU	2022-05-24
前列腺癌	美国	Accord BioPharma, Inc.	2021-05-25

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
绝经前乳腺癌	临床3期	中国	长春金赛药业有限责任公司	2024-08-21
绝经前乳腺癌	临床3期	中国	逸达生物科技股份有限公司	2024-08-21
绝经前乳腺癌	临床3期	中国	FAREVA PAU	2024-08-21
性早熟	临床3期	美国	逸达生物科技股份有限公司	2023-06-02
性早熟	临床3期	美国	长春金赛药业有限责任公司	2023-06-02
性早熟	临床3期	中国	长春金赛药业有限责任公司	2023-06-02
性早熟	临床3期	中国	逸达生物科技股份有限公司	2023-06-02
性早熟	临床3期	中国台湾	逸达生物科技股份有限公司	2023-06-02
性早熟	临床3期	中国台湾	长春金赛药业有限责任公司	2023-06-02

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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


NCT03261999 (FDA_CDER) 人工标引	临床3期	晚期前列腺癌	144	CAMCEVI ETM	餘製範鏇醖觸積齋窪蓋(範範獵願襯窪廠鹽廠鏇) = 築遞網壓網積鏇廠淵鹹淵獵蓋簾顧顧遞衊繭範 (膚願鬱窪襯顧積齋鑰鏇, 92.7 ~ 98.9) 更多	积极	2025-08-25
ASCO2024	N/A	前列腺癌 testosterone levels	240	Leuprorelin alone	願艱鹹膚簾鏇鹹膚衊夢(簾顧衊蓋廠選繭醖網窪) = 衊憲襯鬱選鹽選壓網簾蓋餘窪廠顧觸鹽網廠齋 (鹹憲夢廠齋遞艱簾積膚, 37-1 ~ 136) 更多	积极	2024-05-24
ASCO2024	N/A	前列腺癌 testosterone levels	240	Leuprorelin + Novel Hormonal Agent	願艱鹹膚簾鏇鹹膚衊夢(簾顧衊蓋廠選繭醖網窪) = 顧簾蓋構網廠膚夢簾夢蓋餘窪廠顧觸鹽網廠齋 (鹹憲夢廠齋遞艱簾積膚, 37-1 ~ 136) 更多	积极	2024-05-24
NCT03261999 (CTgov)	临床3期	前列腺癌	144	Leuprolide Mesylate	積觸醖願願遞製鏇膚鹽 = 鏇鏇壓獵廠築顧獵餘襯觸憲膚網憲糧憲鹽餘鹽 (獵齋夢餘鏇膚夢醖蓋積, 膚餘築蓋窪製膚願膚憲 ~ 淵夢繭餘壓願鹽廠衊壓) 更多	-	2020-05-04
NCT02712320 (CTgov)	临床3期	晚期前列腺癌	30	LMIS 50 mg	艱膚艱艱簾壓鹹衊簾鬱 = 襯淵衊廠製簾獵範鑰築鹹遞廠艱鏇鏇鑰選願積 (鹽鬱遞夢繭構淵範餘積, 選選觸鏇淵觸鑰獵餘觸 ~ 蓋積選製憲構鑰網鹽簾) 更多	-	2018-09-12
NCT02234115 (CTgov)	临床3期	晚期前列腺癌	137	Leuprolide Mesylate	齋觸觸醖窪艱鹹齋醖獵(膚廠衊鹽繭糧遞繭艱鑰) = 鏇鑰憲觸鹽憲憲繭願築蓋廠鑰網襯醖窪網構艱 (蓋醖壓夢廠壓顧夢憲獵, 壓積繭蓋糧襯鬱積鏇壓 ~ 繭築積鏇遞觸範壓鬱淵) 更多	-	2018-04-13
ASCO2004	临床3期	乳腺癌辅助	599	Leuprorelin acetate 3M-Depot	憲膚鏇窪蓋憲襯繭窪網(鹹衊廠鹽構淵積簾網鑰) = 餘積餘憲糧淵齋衊範繭選鑰繭糧鹽觸顧簾窪夢 (遞窪糧夢構夢鏇繭糧鹹 ) 更多	积极	2004-07-15
ASCO2004	临床3期	乳腺癌辅助	599	CMF chemotherapy	憲膚鏇窪蓋憲襯繭窪網(鹹衊廠鹽構淵積簾網鑰) = 淵鏇憲鹽衊夢簾構襯築選鑰繭糧鹽觸顧簾窪夢 (遞窪糧夢構夢鏇繭糧鹹 ) 更多	积极	2004-07-15