以浙江麒正药业有限公司生产并提供的哌柏西利片（规格： 125mg）为受试制剂，原研 Pfizer Europe MA EEIG 持证、 Pfizer Manufacturing Deutschland GmbH 生产的哌柏西利片（规格： 125mg，商品名： IBRANCE®）为参比制剂，在空腹与餐后及空腹（抗酸剂条件）状态下评价受试制剂和参比制剂在健康受试者中的生物等效性。

开始日期2024-10-12

申办/合作机构

浙江麒正药业有限公司

CTR20250438

/ CompletedN/A

甲磺酸仑伐替尼胶囊在中国健康受试者中单中心、随机、开放、单次给药、两周期、两序列、自身交叉的空腹及餐后状态下生物等效性试验

主要目的：以浙江麒正药业有限公司提供的甲磺酸仑伐替尼胶囊（规格：4mg）为受试制剂，原研 Eisai Europe Limited 持证的甲磺酸仑伐替尼胶囊（规格：4mg，商品名：乐卫玛 ®）为参比制剂，在空腹及餐后状态下评价受试制剂和参比制剂在健康受试者中的生物等效性。次要目的：观察空腹及餐后状态下受试制剂和参比制剂在健康受试者中的安全性。

开始日期2024-09-25

申办/合作机构

浙江麒正药业有限公司

CTR20242369

/ CompletedN/A

浙江麒正药业有限公司研制的磷酸芦可替尼片与原研参比制剂在中国健康受试者中进行的单中心、随机、开放、两制剂、空腹和餐后、单次给药、两周期、双交叉设计的生物等效性研究

以浙江麒正药业有限公司研制的磷酸芦可替尼片（规格：20 mg）为受试制剂，持证商为Novartis Europharm Limited的磷酸芦可替尼片（商品名：Jakavi，规格：20 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

开始日期2024-07-16

申办/合作机构

浙江麒正药业有限公司

100 项与浙江奥翔药业股份有限公司相关的临床结果

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0 项与浙江奥翔药业股份有限公司相关的专利（医药）

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项与浙江奥翔药业股份有限公司相关的文献（医药）

2024-08-21·CRYSTAL GROWTH & DESIGN

Exploring the Structural Landscape for a Thrombopoietin Receptor Agonist Avatrombopag Maleate: An Innovative Trihydrate Forms with Improved Solubility Found

作者: Liu, Shuna ; Dai, Chunguang ; Chen, Linshen ; Zheng, Zhiguo ; Liu, Jiyong ; Shi, Dier ; Yu, Kaxi ; Hu, Xiurong

Avatrombopag maleate (AVAT), a second-generation oral thrombopoietin (TPO) receptor agonist, is currently in development for the therapeutic management of thrombocytopenia.The present study introduces a novel comparative anal. that elucidates the intricate relationship between the crystallog. structures and the diverse physicochem. properties inherent to the complex polymorphic forms of the Avatrombopag (AVA) maleic salt.Seven solid-state forms, including two polymorphic forms (AVAT-B, AVAT-C), a new trihydrate (AVAT-3H), and four solvates (AVAT-A, AVAT-dimethyl sulfoxide (AVAT-DMSO), AVAT-dimethylformamide (AVAT-DMF), and AVAT-tetrahydrofuran (AVAT-THF)), were synthesized and analyzed in detail.Although the powder diffraction patterns for polymorphs AVAT-A, AVAT-B, and AVAT-C have been previously reported, our study marks the inaugural report of their crystallog. structures.Trihydrate and three new solvates were initially identified and subjected to a comprehensive characterization through thermal anal., X-ray diffraction, etc.Thermal stability and transformation in aqueous solutions for different forms were conducted.Surprisingly, it was found that all five other solid forms except AVAT-B would be transformed to AVAT-3H when suspended in aqueous solutionAll solvates retained their original framework structure after the removal of part of the solvent and could not lose all solvents until decompositionAVAT trihydrate did not lose water upon storage under ambient conditions.Furthermore, the solubility profiles of AVAT-B, AVAT-C, and AVAT-3H were meticulously determinedBy integrating the distinct mol. conformations with the resp. intermol. and intramol. interactions as well as the packing arrangements, we were able to elucidate the underlying factors influencing their phase behavior.The insights gained from this anal. were instrumental in simulating crystal growth, thereby facilitating a comprehensive understanding of the specific interactions that govern the phase behavior of these compounds

2024-01-01·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

A first-in-human study of Brozopentyl Sodium, following single and multiple ascending intravenous infusion in Chinese healthy volunteers

Article

作者: Sheng, Xiao-Yan ; Zhao, Xia ; Zheng, Zhi-Guo ; Li, Yun-Feng ; Jia, Bo ; Cui, Yi-Min ; Wei, Lu-Hua ; Xie, Ran

BACKGROUND:

Brozopentyl Sodium (BZP), a novel agent for ischemic stroke, has shown promising results in preclinical pharmacological studies, prompting the initiation of the first-in-human investigation.

PURPOSE:

This study aimed to assess the safety, tolerability, and pharmacokinetic (PK) characteristics of BZP in Chinese healthy volunteers.

METHODS:

The study consisted of two parts. Part I was a single-center, randomized, single-blinded, placebo-controlled, single-ascending study with six BZP dose cohorts (SAD: 25, 50, 100, 200, 300, and 400 mg). Part II was a single-center, randomized, single-blinded, placebo-controlled, multi-dose- and dose-elevated study with three BZP dose cohorts (MAD: 50, 100, and 200 mg). Doses were administered once daily on days 1 and 7 and twice daily on days 2-6. The PK properties of BZP and its bioactive metabolites, BNBP, were assessed. Safety and tolerability evaluations were also conducted.

RESULTS:

In the SAD study, BZP reached peak plasma concentrations (T_max) at the end of administration, with median T_max values ranging from 1 to 1.03 h, while BNBP reached T_max between 1.25 to 1.38 h. The terminal half-lives (T_1/2) were approximately 8 h for BZP and 15 h for BNBP. In the MAD study, steady-state plasma concentrations of BZP were reached by day 5. There was minimal accumulation of both BZP and BNBP after 7 days of administration. The area under the plasma concentration-time curve from 0 to time of the last measurable concentration (AUC_0-t) and maximum plasma drug concentration (C_max) showed dose-proportional increases for BZP but not for BNBP in both study parts. Single and multiple doses of BZP demonstrated a good safety profile and were well-tolerated.

CONCLUSION:

BZP displayed safety, good tolerability and predictable PK characteristics following both single and multiple ascending intravenous administrations. These findings provide a basis for further clinical development of BZP for ischemic stroke patients.

2018-09-01·Journal of pharmaceutical and biomedical analysis3区 · 医学

Quantitation of polymorphic impurity in entecavir polymorphic mixtures using powder X-ray diffractometry and Raman spectroscopy

3区 · 医学

Article

作者: Kang, Yanlei ; Hu, Xiurong ; Shao, Zhanying ; Yu, Dongdong ; Wang, Qiang

Entecavir was used for the treatment of chronic hepatitis B through inhibiting hepatitis B virus. The anhydrous form of entecavir (ENT-A) often appeared as impurity polymorph in the manufacturing process of entecavir monohydrate (ENT-H) such as granulation, drying and compression. Since different crystal forms might affect drug bioavailability and therapeutic effect, it was vital to control the ENT-A content of the drug product. The work aimed to develop useful methods to assess ENT-A weight percentage in ENT-H. Powder X-ray diffractometry (PXRD) and Raman spectrometric methods were applied. Binary mixtures with different ratios of pure ENT-H and pure ENT-A were scanned using PXRD and Raman to obtain spectra. Then peak heights and peak areas versus weight percentage were used to construct calibration curves. The best linear regression analysis data for PXRD and Raman method were found to be R² = 0.9923 and R² = 0.9953, in the weight ratio range of 2.1-20.2% w/w% of ENT-A in binary mixtures. Limit of detection (LOD) of ENT-A was 0.38% and limit of quantitation (LOQ) was 1.15% for PXRD method. LOD and LOQ for Raman method were 0.48% and 1.16%. The results showed that PXRD and Raman methods: both were precise and accurate, and could be used for measurement of ENT-A content in the selected weight percentage range. Partial least squares (PLS) algorithm with four data pre-processing methods: including multiplicative scatter correlation (MSC), standard normal variate (SNV), first and second derivatives were applied and evaluated using prediction errors. The best performance of PLS was R² = 0.9958 with RMSEC (0.44%) and RMSEP (0.65%). Multivariate analysis for Raman spectra showed similar good results with univariate analysis, and would be an advantageous method when there were overlapped peaks in the spectra. In summary, the proposed PXRD and Raman method could be developed for the quality control of ENT-H. And Raman was a more promising method in industrial practice due to its slightly better precision, accuracy and time-saving advantage.

项与浙江奥翔药业股份有限公司相关的新闻（医药）

2025-04-13

·蒲公英Ouryao

【出海新进展】4药品出口海外！

来源：企业公告编辑：wangxinglai2004近日，四药企分别发布了产品海外上市进展公告，具体为甘李药业制剂获巴基斯坦注册批件、浙江奥翔药业原料药获CEP证书、健友生化制剂获FDA批件和浙江东邦药业原料药获韩国注册证书。甘李药业制剂获巴基斯坦注册批件一、药物基本情况药品名称：BASAGINE 药品通用名：甘精胰岛素注射液适应症：糖尿病剂型：注射剂规格：3ml：100IU/ml（卡式瓶）批件号：Reg. No. 120504申请人：甘李药业股份有限公司二、药物其他相情况甘精胰岛素注射液属于长效胰岛素类似物产品，又称基础胰岛素类似物，每天注射一次，注射起效后作用时间可持续24小时。甘精胰岛素具有作用时间长、血药浓度无峰值、平稳地降低患者血糖的作用，有较好的疗效和安全性，因此甘精胰岛素注射液成为糖尿病治疗中尤为重要的基础胰岛素类似物。截至公告发布日，在巴基斯坦境内甘精胰岛素注射液的主要供货商为赛诺菲。赛诺菲作为原研厂家，其甘精胰岛素产品2024年的全球销售额约17.6 亿美元，截至2024 年9月30日，甘李药业在甘精胰岛素项目中累计投入研发费用9.06亿元人民币。浙江奥翔药业原料药获CEP证书一、药物基本情况药品名称：盐酸毛果芸香碱剂型：原料药持有人：浙江奥翔药业股份有限公司证书编号：CEP 2023-367-Rev 00 发证机构：欧洲药品质量管理局（EDQM）二、药物其他相情况盐酸毛果芸香碱最早用于治疗口干症，剂型为片剂。随后盐酸毛果芸香碱被开发为其它剂型，如凝胶剂、滴眼液等，用于治疗开角型青光眼、闭角型青光眼以及高眼压症等。 2021年，艾伯维（Abbvie）旗下公司艾尔建研制的盐酸毛果芸香碱滴眼液（规格1.25%）获美国FDA批准上市，是全球首款用于治疗老视的药物。盐酸毛果芸香碱是M-胆碱受体激动剂，可激活平滑肌的毒蕈碱受体，通过虹膜括约肌的收缩，使瞳孔收缩，以增加焦深，改善近中视力，同时保持瞳孔对光的反应，另外其还可收缩睫状肌，增强适应力，从而达到治疗成人老视的效果。健友生化制剂获FDA批件一、药物基本情况药品名称：利拉鲁肽注射液适应症：作为饮食和运动的辅助手段，改善成人和10岁及以上的儿童2型糖尿病患者的血糖控制。降低伴有心血管疾病的2型糖尿病成人患者的主要心血管不良事件的风险。剂型：注射液规格：18 mg/3 mL (6 mg/mL) ANDA号：218115 申请人：南京健友生化制药股份有限公司二、药物其他相情况利拉鲁肽注射液原研药品，由NOVO NORDISK INC持有，2010年01月25日前经FDA批准在美国上市。经查询，除原研厂家以外，美国境内仅有1家HIKMA PHARMACEUTICALS USA INC同规格的利拉鲁肽注射液获批上市。截至目前公司在利拉鲁肽注射液研发项目上已投入研发费用约人民币5,737.31万元。浙江东邦药业原料药获韩国注册证书一、药物基本情况企业名称：浙江东邦药业有限公司地址：中国浙江省台州市临海市台州湾经济技术开发区东海第五大道21号产品名称：头孢妥仑匹酯 DMF注册号：20250326-209-J-1841 发证机构：韩国食品药品监督管理局（韩国MFDS）二、药物其他相情况头孢妥仑匹酯为第三代头孢类抗菌药物，用于治疗敏感菌引起的呼吸道、泌尿系统、胆道、皮肤软组织感染等。据相关数据显示，2023年度头孢妥仑匹酯制剂全国销售额约为1.36亿元。

上市批准

2025-04-11

·GlobeNewswire-Health Care

Algernon Pharmaceuticals Receives Notice of Allowance from European Patent Office for Repirinast for Kidney Disease

April 08, 2025 -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that it has received a notice of allowance from the European Patent Office (EPO) for patent application 19827430.0 for its lead chronic kidney disease (CKD) program drug NP-251 (Repirinast). The invention claims the use of Repirinast, either alone or in combination with telmisartan, for the treatment or prophylaxis of renal fibrosis or kidney disease. The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The Company has previously announced the allowance of this patent application in the U.S., Japan and China. The patent is currently pending in Canada. Repirinast is the Company’s lead candidate for the treatment of CKD based on data showing it reduced fibrosis by 51% with statistical significance and showed an additive benefit to telmisartan in a unilateral ureteral obstruction (UUO) mouse model. Algernon’s intellectual property strategy for its repurposed drug program includes protecting its compounds by filing patent applications including method of use, dosing, and formulations, and for new composition of matter patents based on novel salt forms. “This is our first patent issued by the EPO and marks another key milestone for the Company,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. The Company also announces a grant of 50,000 restricted share units (each, an "RSU") and 50,000 stock options to consultants of the Company. Each RSU entitles the recipient to receive one common share of the Company or a cash payment equal to the equivalent of one common share of the Company on vesting. The stock options are exercisable at $0.09 for five years from the date of grant. Both the RSUs and stock options vest on the date of grant. The RSUs and stock options are subject to approval by regulatory authorities. Repirinast was originally developed by Mitsubishi Tanabe Pharma (“Mitsubishi”) and was sold and marketed in Japan under the brand name RometTM for the treatment of Asthma. RometTM was marketed for over 25 years in Japan. Mitsubishi discontinued manufacturing and sales of the drug in 2013. Accordingly, Algernon has retained Zhejiang Ausun Pharmaceutical in Zhejiang, China to manufacture a cGMP Repirinast supply. Mast cells are recruited to sites of cellular damage, and degranulation of mast cells leads to release of a myriad of proinflammatory chemical mediators which lead to tissue damage in a self-propagating cascade. NP-251 binds to receptors on mast cells and prevents their degranulation, which the Company believes could help prevent fibrosis in multiple organ classes including the kidneys. Algernon Pharmaceuticals is a Canadian clinical stage drug development company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals is also the parent company of a private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of DMT for stroke and traumatic brain injury. The content above comes from the network. if any infringement, please contact us to modify.

上市批准专利到期

2025-02-27

·分子科学

重磅药芦可替尼：年销近50亿美元，国内15家药企抢滩仿制

引言芦可替尼作为一款重磅级JAK抑制剂，通过其独特的作用机制和多样化的适应症布局，在全球市场取得了显著成功。从最初用于治疗骨髓增殖性肿瘤，到后来拓展至移植物抗宿主病和皮肤病领域，芦可替尼展现出强大的治疗潜力和市场价值。本文将从药物背景、市场表现、研发创新和未来前景等方面，系统梳理这款年销售额近50亿美元的明星药物在全球及中国市场的发展现状。 “ 药物背景芦可替尼（又称鲁索利替尼，Ruxolitinib）是一种小分子选择性JAK1/JAK2抑制剂，由美国Incyte公司开发。它通过抑制JAK-STAT信号通路中的关键激酶JAK1和JAK2，调控细胞因子和生长因子的信号转导，从而发挥治疗作用。这一独特的作用机制使其在治疗骨髓增殖性肿瘤（如真性红细胞增多症和骨髓纤维化）以及免疫介导的疾病（如特应性皮炎）中具有显著的临床效果。芦可替尼 Ruxolitinib 2009年，Incyte与诺华（Novartis）达成协议，将美国以外市场的商业化权利授予后者（商品名：Jakavi），而Incyte则负责芦可替尼在美国的开发和商业化，商品名为Jakafi。该药于2011年11月首次在美国获批，2023年全球销售额突破43亿美元，跻身重磅药物行列。在中国市场，磷酸芦可替尼片（商品名：捷恪卫）2017年3月通过优先审评获批上市。2023年4月和2024年6月，磷酸芦可替尼片分别在国内获批新适应症，用于治疗对糖皮质激素或其他系统治疗应答不充分的12岁及以上急性移植物抗宿主病（急性GVHD）患者和慢性移植物抗宿主病（cGVHD）患者。目前已获批适应症： • 乳膏剂：特应性皮炎、手部湿疹、面部非节段性白癜风 • 片剂：骨髓纤维化、真性红细胞增多症、移植物抗宿主病（GVHD） “ 市场表现凭借出色的临床表现和持续扩展的适应症，芦可替尼的全球销售规模节节攀升。 2024年，诺华财报显示其芦可替尼片剂及乳膏剂型销售额达19.36亿美元，同比大幅增长15%；Incyte公司芦可替尼产品线（包括片剂及乳膏剂型）贡献29.25-29.75亿美元，同比增长5%-6%。两家公司合计，2024年芦可替尼全球销售额突破49亿美元，再创历史新高。在中国市场，自2017年上市以来累计销售额已超30亿元。2023年在公立医疗机构和实体药店终端实现7.58亿元销售额，2024年上半年继续保持约10%的增速，预计全年销售将超过8亿元。 “ 研发创新在产品创新方面，芦可替尼走出了独特的发展路径。除常规的口服片剂外，考虑到JAK抑制剂全身给药的安全性问题，其创新性地开发了外用乳膏剂型。 2022年7月，其乳膏剂型Opzelura获FDA批准用于治疗非节段性白癜风，成为全球首个获批的白癜风局部用药。此前，该剂型已获批用于特应性皮炎的治疗。 Opzelura在2023年实现3.38亿美元销售额，被誉为"最近推出的最好的皮肤病学产品之一"。目前，康哲药业已获得Opzelura在中国大陆、港澳台及东南亚市场的独家开发和商业化权益，并已向中国药监局（NMPA）提交了治疗白癜风的上市申请，该申请已于2024年9月获受理并处于审评阶段。除已获批的骨髓纤维化、移植物抗宿主病、特应性皮炎和白癜风外，芦可替尼还在积极推进斑秃、银屑病、淋巴瘤等新适应症的研究，进一步扩展其治疗领域。 “ 市场前景随着诺华的芦可替尼化合物专利CN201310058988.2（CN103214483B）将于2026年12月到期，国内企业积极布局仿制药赛道。截至目前，已有15家企业进入该领域，包括成都苑东生物、浙江麒正药业、浙江华海制药、浙江海正药业、成都倍特药业、哈尔滨三联药业、杭州中美华东制药、重庆华邦制药、南京正大天晴制药、南京正科医药等。其中，成都苑东生物已于2024年11月率先获批5mg片剂，成为国内首家仿制药上市企业。芦可替尼市场前景广阔，但也面临挑战。一方面，凭借其临床疗效，通过拓展适应症、开发新剂型和探索联合疗法，芦可替尼的市场空间有望持续扩大，尤其在新兴市场具有巨大的渗透潜力。另一方面，随着专利到期，仿制药的上市以及国内药企的集中涌入将加剧市场竞争，带来价格压力。然而，国内改良型新药和仿制药市场的成熟将吸引更多企业加入，这种良性竞争既能促进芦可替尼在国内的普及，也能让更多患者获得可负担的治疗方案。

财报上市批准医药出海

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