主要目的：评价单次皮下注射注射用醋酸丙氨瑞林微球在健康成年女性受试者中的安全性和耐受性。次要目的：评价单次皮下注射注射用醋酸丙氨瑞林微球在健康成年女性受试者中的药代动力学（PK）特征；评价单次皮下注射注射用醋酸丙氨瑞林微球在健康成年女性受试者中的药效动力学（PD）特征；评价注射用醋酸丙氨瑞林微球与注射用醋酸丙氨瑞林在健康女性受试者中的PK差异。

开始日期2024-04-26

申办/合作机构

上海丽珠制药有限公司

CTR20241125 / RecruitingN/A

前列腺癌患者单次皮下给予注射用醋酸亮丙瑞林微球（11.25mg）的随机、开放、平行设计的生物等效性试验

主要目的: 以上海丽珠制药有限公司生产的注射用醋酸亮丙瑞林微球（11.25 mg）为受试制剂，以注射用醋酸亮丙瑞林微球（11.25 mg，持证商：Takeda Pharmaceutical Company Limited）为参比制剂，按人体生物等效性试验的相关法规和指导原则要求，比较两种制剂在前列腺癌患者体内的药代动力学行为，考察两制剂的人体生物等效性。次要目的: 评价前列腺癌患者皮下给予注射用醋酸亮丙瑞林微球受试制剂和参比制剂后的安全性。

开始日期2024-04-18

申办/合作机构

上海丽珠制药有限公司

100 项与上海丽珠制药有限公司相关的临床结果

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0 项与上海丽珠制药有限公司相关的专利（医药）

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项与上海丽珠制药有限公司相关的文献（医药）

Huaxue Yu Shengwu Gongcheng

Liquid chromatography for purification of solid phase synthetic gonadorelin

作者: Wang, Linpeng ; Sang, Youmin ; Ji, Xiaotao ; Xiao, Jianguo ; Wan, Longyan ; Song, Chenghui ; Xuan, Jiangang ; Ruan, Zhenxing

In this paper, a purification route using the liquid chromatog. was established on gonadorelin synthesized by the solid phase peptide synthesis (SPPS) method using tBoc group for protecting α-amino acid.Two steps were included in the purification route.The first step was the ion exchange chromatog. (IEC).Two matrixes including CM 25 Sepharose Fast Flow and CMC were screened in order to optimize the separationCM 25 Sepharose Fast Flow was determined to be used for its higher recovery rate and higher resolutionThe medium was first equilibrated with pH value 6.0, 50 mmol/L^-1 NaAc buffer and eluted with pH value 6.0, 50 mmol /L^-1 NaAc, 500 mmol /L^-1 NaCl buffer.After this step, majority of nonpolar impurities and part of polar impurities were removed.The second step was reversed phase high performance liquid preparative chromatog. (RP-HPLC) on C₁₈ column.Several eluent systems containing TEAP or trifluoroacetic acid (TFA) were screened in order to optimize the separationThe system containing TFA was decided to be used for its higher recovery rate and higher resolutionAcetonitrile gradient elution was used.Mobile phase composition A was 0.1% TFA, 5% acetonitrile in water; Mobile phase composition B was 0.1% TFA, 80% acetonitrile in water.Acetonitrile gradient elution was used.Then the final product exceeded 98.5% of purity.The total yield was 72%.Those operation conditions during the isolation and purification process were also studied and optimized in this thesis.

Frontiers in Pharmacology

A single-dose, randomized, open-labeled, parallel-group study comparing the pharmacokinetics, pharmacodynamics and safety of leuprolide acetate microspheres 3.75 mg and Enantone® 3.75 mg in healthy male subjects

Article

作者: Zhang, Qiao ; Liu, Jian ; Zheng, Yunliang ; Xu, Nana ; Wan, Longyan ; Hu, Xingjiang ; Zhai, You ; Luo, Jindan ; Zhao, Qingwei

Leuprolide acetate microspheres developed by Shanghai Livzon Pharmaceutical Co., Ltd. (T) have been marketed in China for more than 10 years, benefiting a large number of patients, and will continue to play an important role in China. However, as a generic drug, it is unclear whether there is a difference in efficacy between T and the original product Enantone® (R). This study compared the differences in efficacy and safety of two 1-month depot formulations in 48 healthy Chinese male subjects by comparing multiple pharmacokinetic (PK) and pharmacodynamic (PD) parameters. The main research indicators were the PK parameters of leuprolide (Cmax, AUC0-t, AUC0-D7, and AUCD7-t) and the PD parameters of testosterone (Emax, AUEC0-t, AUEC0-D7, and AUECD7-t) after 42 days of administration. The Cmax, AUC0-t, AUC0-D7 and AUCD7-t of leuprolide were slightly higher in the T group than in the R group with 90% confidence intervals (CIs) of 94.43–118.53%, 109.13–141.88%, 109.53–139.54%, and 105.17–145.74%, respectively. No significant differences in the PD parameters (Emax, AUEC0-t, AUEC0-D7, and AUECD7-t) existed between the T and R groups, and 90% CIs were 62.80–93.57%, 88.17–110.55, 95.72%–118.50%, and 79.77–105.63, respectively. At 672 h (D28), the castration rate of T was 91.30% (21/23) and that of R was 60.87% (14/23). The PK characteristics were consistent and the inhibitory effects on testosterone levels were similar in both T and R groups; further, clinical safety was observed for both T and R formulations, suggesting that these two products can replace each other in clinical practice.Clinical Trial Registration:http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml, identifier CTR20200641.

Yaowu Shengwu Jishu

Purification of recombinant modified human serum albumin interferon 2b fusion protein

作者: Chen, Hui-min ; Ruan, Zhen-xing ; Cai, Yu ; Xiao, Jian-guo ; Zhang, Guo-hua ; Tang, Huo-long

The purification of recombinant modified human serum albumin-interferon α2b fusion protein(Ramsay-IFN-α2b) secretorily expressed by Pichia pastoris in high d. fermentation was studied.The recombinant Pichia pastoris strain PicZA/rmHSA-IFN-α2b/X33 was grown in 9-L fermentor and induced with methanol to express rmHSA-IFN-α2b.The supernatant was collected by centrifugation.RmHSA-IFN-α2b in the supernatant was purified by SP Sepharose^TM FF, Blue Sepharose^TM FF, and Q Sepharose^TM FF in sequence.The existence of rmHSA-IFN-α2b in the processes was determined by SDS-PAGE.The purity of the final product was detected by HPLC and SDS-PAGE.The specific activity of rmHSA-IFN-α2b was determined by Cytopathic effect inhibition assay.The expression of rmHSA-IFN-α2b reached 0.421 g/L of supernatant.The rmHSA-IFN-α2b in the supernatant was purified in three steps.The first step was SP Sepharose^TM FF, during which majority of yeast pigments and parts of other proteins were removed.The second step was Blue Sepharose^TM FF, during which parts of yeast protein were removed.The third step was Q Sepharose^TM FF, during which parts of yeast protein, solvent, and Endotoxin were removed.The purified rmHSA-IFN-α2b retaining its bioactivity was obtained.The final product exceeded 95% purity by HPLC and SDS-PAGE.The specific activity of rmHSA-IFN-α2b was 1.5*10⁶ IU/mg.The total purification recovery rate was 25.3%.The purification route of rmHSA-IFN-α2b secretorily expressed by Pichia pastoris in high d. fermentation is successfully constructed.The purification process is simple, well reproducible, and suitable for large-scale production of rmHSA-IFN-α2b.

项与上海丽珠制药有限公司相关的新闻（医药）

2024-10-20

·药通社

又双叒过评一家！最卷集采品种之一！

统计每周仿制药一致性评价通过、上市申请、临床申请及审批情况（10.12-10.18）注：周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。 1、仿制药一致性评价过评&驳回情况通过/视同通过一致性评价 66个（按受理号计算），首仿4个品种，4个受理号，分别为：注射用醋酸亮丙瑞林微球/上海丽珠制药有限公司；来特莫韦注射液/南京正大天晴制药有限公司；阿达帕林凝胶/苏州高迈药业有限公司；钆喷酸葡胺注射液/北京北陆药业股份有限公司。本周第十批集采报量目录已出，舒更葡糖钠注射液这个热门品种成了众所周知的“卷王”品种，而本周又有一家企业的舒更葡糖钠注射液过评了，该品种已达到20家企业过评，再加上原研企业，共计21家企业争夺6亿的市场。依据前几批国采时间点推测，一般想要参与集采报价的企业，品种需在报价日前5到10天过评，而从报量到报价大概需要60天左右。依据该产品现在仍在走流程的企业情况来看，这个品种的竞争只怕还得增加几家。注射用醋酸亮丙瑞林微球由上海丽珠制药首仿过评，亮丙瑞林微球是一个在国内市场规模有50亿以上的微球产品，原研武田制药曾经用该产品在FDA打开局面，2001年就达到了10亿美金的销量，而也有专业机构预测至2029年，全球醋酸亮丙瑞林市场规模将会达到238.22亿元。正大天晴的来特莫韦注射液首仿过评，今年4月，来特莫韦片同样由正大天晴首仿过评，正大天晴手上就有了该成分的两个剂型品种，这款“明显抗病毒药”未来可期。通知件有老面孔，乙酰半胱氨酸注射液，该成分制剂属实是命途多舛、举步维艰。 2、申请上市情况 3、临床申请&批准情况数据来源：药融云数据库投稿/内容沟通：华籍美人（Ww_150525）近期精华文章

一致性评价医药出海带量采购

2024-10-17

·米内网

【获批】50亿大品种，首家过评定了

精彩内容 10月16日，丽珠集团发布公告称，控股子公司上海丽珠制药的注射用醋酸亮丙瑞林微球通过了一致性评价。亮丙瑞林是内分泌治疗用药TOP1品种，2023年在中国公立医疗机构终端的销售额超过50亿元，丽珠集团是该品种首家过评企业。表1：最新过评产品情况来源：公司公告、米内网整理据悉，注射用醋酸亮丙瑞林微球的适应症包括子宫内膜异位症；对伴有月经过多、下腹痛、腰痛及贫血等的子宫肌瘤，可使肌瘤缩小和/或症状改善；雌激素受体阳性的绝经前乳腺癌；前列腺癌；中枢性性早熟等。米内网数据显示，目前已上市的亮丙瑞林制剂包括了武田药品的注射用醋酸亮丙瑞林微球、丽珠集团的注射用醋酸亮丙瑞林微球、北京博恩特药业的注射用醋酸亮丙瑞林缓释微球，仅丽珠集团通过了一致性评价。图1：亮丙瑞林的销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，亮丙瑞林的销售额在2022-2023年保持在50亿元水平，2024上半年止跌回升5.7%，潜力依然可期。目前，丽珠集团是亮丙瑞林的领军企业，2024上半年的市场份额为43.61%。公告中提到，丽珠集团针对注射用醋酸亮丙瑞林微球的一致性评价已累计投入的直接研发费用超过9000万元，本次通过一致性评价有利于进一步提升该药品的市场竞争力，巩固公司在国内微球制剂研发的优势地位。表2：丽珠集团目前已过评（含视同过评）的产品来源：米内网中国申报进度（MED）数据库目前，丽珠集团已过评（含视同过评）的产品有23个，其中苯磺酸氨氯地平胶囊、马来酸氟伏沙明片、盐酸哌罗匹隆片、注射用醋酸亮丙瑞林微球、注射用醋酸西曲瑞克、注射用丹曲林钠均为首家过评。资料来源：公司公告、米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至10月17日。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价

2024-10-16

·药融云

32亿+微球，国内首仿药企来袭！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 10月15日，据NMPA官网最新公示，上海丽珠的注射用醋酸亮丙瑞林微球一致性评价通过，是该品种首个过一致性评价的药企。据药融云数据库显示，注射用醋酸亮丙瑞林微球在2023年全国院内市场的销售额超32亿元。截图来源：NMPA官网亮丙瑞林的原研厂家是日本武田制药，1985年，通过TAP制药，武田与雅培推出药品“Lupron”。注射用醋酸亮丙瑞林微球是一种缓释制剂，它可恒定地向血液中释放醋酸亮丙瑞林，故能持续有效地降低卵巢和睾丸的反应，产生持续的垂体-性腺系统的抑制作用。据药融云数据库显示，注射用醋酸亮丙瑞林微球在2023年全国院内市场的销售额超32亿元。截图来源：药融云全国医院销售数据库国内现有两种亮丙瑞林微球制剂：注射用醋酸亮丙瑞林微球及注射用醋酸亮丙瑞林缓释微球，其中武田制药的注射用醋酸亮丙瑞林微球于2003年获准上市。据药融云数据库统计，当前国产微球上市品种仅9种，其中销量最高的就是亮丙瑞林微球，微球市场蕴含着巨大的潜力。截图来源：药融云中国药品批文数据库目前，注射用醋酸亮丙瑞林微球仅上海丽珠1家药企过评，此外上海丽珠现有醋酸奥曲肽、注射用醋酸亮丙瑞林微球、醋酸亮丙瑞林、注射用醋酸曲普瑞林微球等20个品种获批上市。 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“报告”，获取数十篇药融云出品独家报告后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，了解更多品牌升级详情！

一致性评价上市批准医药出海

100 项与上海丽珠制药有限公司相关的药物交易

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100 项与上海丽珠制药有限公司相关的转化医学

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