A Randomized, Double-Blind, Placebo-controlled, Clinical Trial to Evaluate the Efficacy and Safety of Combination of Recombinant Human Insulin Enteric-coated Capsule in the Treatment of Subjects with Type 2 Diabetes Mellitus (T2DM) with Inadequate Glycemic Control on Oral Antihyperglycemic Agents(AHA)

开始日期2020-09-24

申办/合作机构-

CTR20170470 / Completed

重组人胰岛素注射液在人体随机、开放、单剂量、两制剂、双周期、双交叉的生物等效性研究

研究江苏万邦生化医药股份有限公司生产的重组人胰岛素注射液在中国健康男性志愿者中的单次给药药动学、药效学特征，并与Humulin R的药动学和药效学特征进行比较。

开始日期2017-11-21

申办/合作机构

江苏万邦生化医药集团有限责任公司

CTR20170414 / Completed临床3期

多中心、随机、阳性药物平行对照临床研究评价重组人胰岛素注射液治疗糖尿病的有效性和安全性

以重组人胰岛素注射液（优泌林，3ml：300单位）为对照，评价重组人胰岛素注射液（3 ml：300单位）治疗糖尿病的有效性和安全性

开始日期2017-07-18

申办/合作机构

江苏万邦生化医药集团有限责任公司

100 项与重组人胰岛素 (江苏万邦生化医药集团) 相关的临床结果

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100 项与重组人胰岛素 (江苏万邦生化医药集团) 相关的转化医学

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100 项与重组人胰岛素 (江苏万邦生化医药集团) 相关的专利（医药）

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项与重组人胰岛素 (江苏万邦生化医药集团) 相关的文献（医药）

2024-11-01·Journal of Biotechnology

Enhanced activation of signaling pathway by recombinant human adiponectin from genome-edited chickens

Article

作者: Yoo, Eunhui ; Han, Jae Yong ; Choi, Hee Jung

Adiponectin (ADPN) exerts various cellular and metabolic functions by activating signaling pathways, including extracellular signal-regulated protein kinases 1 and 2 (ERK1/2) pathways, the protein kinase B (Akt) pathway, and the p38 mitogen-activated protein kinase (MAPK) pathway. However, generating functional recombinant human adiponectin (hADPN) in bacterial or mammalian cells is challenging. Although ADPN agonist peptides have been developed, problems like stability, solubility, and affinity for receptors remain. Recently, a genome-edited chicken bioreactor system was established, ensuring efficient ADPN production with optimal post-transcriptional modifications. We assessed the ability of egg white (EW)-derived hADPN, commercial hADPN, various ADPN agonist peptides, and globular ADPN on activation of the ERK1/2, Akt, and p38 MAPK pathways. EW-derived hADPN, abundant in hexamers and high molecular weight multimers, significantly phosphorylated ERK1/2 in serum-starved HEK293 cells after 15 min of treatment. Comparative analysis revealed that EW-derived hADPN and commercial hADPN induced greater phosphorylation of ERK1/2, Akt, and p38 MAPK than ADPN agonist peptides and globular ADPN, with EW-derived hADPN showing the highest activation. In summary, the finding that EW-derived hADPN strongly activates the ERK1/2, Akt, p38 MAPK signaling pathways highlights that an ADPN production system based on genome-edited chickens is an advantageous alternative to existing methods.

2024-09-01·The Bone & Joint Journal

Dysregulated neutrophil extracellular traps and haemostatic biomarkers as diagnostic tools and therapeutic targets in periprosthetic joint infection

Article

作者: Medina, Pilar ; Fuertes, Manuel ; Plana, Emma ; Oto, Julia ; Baixauli, Francisco ; Herranz, Raquel ; Verger, Patricia ; Amaya, José V.

AimsBacterial infection activates neutrophils to release neutrophil extracellular traps (NETs) in bacterial biofilms of periprosthetic joint infections (PJIs). The aim of this study was to evaluate the increase in NET activation and release (NETosis) and haemostasis markers in the plasma of patients with PJI, to evaluate whether such plasma induces the activation of neutrophils, to ascertain whether increased NETosis is also mediated by reduced DNaseI activity, to explore novel therapeutic interventions for NETosis in PJI in vitro, and to evaluate the potential diagnostic use of these markers.MethodsWe prospectively recruited 107 patients in the preoperative period of prosthetic surgery, 71 with a suspicion of PJI and 36 who underwent arthroplasty for non-septic indications as controls, and obtained citrated plasma. PJI was confirmed in 50 patients. We measured NET markers, inflammation markers, DNaseI activity, haemostatic markers, and the thrombin generation test (TGT). We analyzed the ability of plasma from confirmed PJI and controls to induce NETosis and to degrade in vitro-generated NETs, and explored the therapeutic restoration of the impairment to degrade NETs of PJI plasma with recombinant human DNaseI. Finally, we assessed the contribution of these markers to the diagnosis of PJI.ResultsPatients with confirmed PJI had significantly increased levels of NET markers (cfDNA (p < 0.001), calprotectin (p < 0.001), and neutrophil elastase (p = 0.022)) and inflammation markers (IL-6; p < 0.001) in plasma. Moreover, the plasma of patients with PJI induced significantly more neutrophil activation than the plasma of the controls (p < 0.001) independently of tumour necrosis factor alpha. Patients with PJI also had a reduced DNaseI activity in plasma (p < 0.001), leading to a significantly impaired degradation of NETs (p < 0.001). This could be therapeutically restored with recombinant human DNaseI to the level in the controls. We developed a model to improve the diagnosis of PJI with cfDNA, calprotectin, and the start tail of TGT as predictors, though cfDNA alone achieved a good prediction and is simpler to measure.ConclusionWe confirmed that patients with PJI have an increased level of NETosis in plasma. Their plasma both induced NET release and had an impaired ability to degrade NETs mediated by a reduced DNaseI activity. This can be therapeutically restored in vitro with the approved Dornase alfa, Pulmozyme, which may allow novel methods of treatment. A combination of NETs and haemostatic biomarkers could improve the diagnosis of PJI, especially those patients in whom this diagnosis is uncertain.Cite this article: Bone Joint J 2024;106-B(9):1021–1030.

2024-09-01·Journal of Diabetes Science and Technology

Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches

Article

作者: Rosu-Myles, Michael ; Klein, Agnes V. ; Loo, Shih-Miin ; Lu, Huixin ; Walrond, Lisa ; Green, Nancy ; Girard, Michel ; Zhang, Xu ; Lorbetskie, Barry ; Sauvé, Simon ; Bigelow, Stewart

Background: For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification. Methods: To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies—including human insulin, insulin analogs, and porcine insulin—by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods. Results: We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs—insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content. Conclusions: Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.

项与重组人胰岛素 (江苏万邦生化医药集团) 相关的新闻（医药）

2022-10-19

·GBIHealth

拜耳组织构架调整；传奇生物CAR-T初步销售净额；东阳光门冬胰岛素注射液获批上市

‍‍*点击图片了解详情药讯精选GBI NEWS传奇生物CAR-T西达基奥仑赛初步销售净额5500万美元10月19日，金斯瑞生物科技股份有限公司发布公告称，子公司传奇生物旗下CAR-T产品西达基奥仑赛（商品名：Carvykti）截至2022年9月30日的销售净额约为5500万美元。贸易销售净额系基于杨森向传奇生物提供的数据，传奇生物尚未独立核实该销售数字的准确性。根据传奇生物的会计政策及国际财务报告准则，传奇生物不会将杨森报告的贸易销售净额确认为收益。西达基奥仑赛是一款具有两种靶向B细胞成熟抗原（BCMA）单域抗体的嵌合抗原受体T细胞（CAR-T）细胞治疗，2022年2月及4月先后于美国和欧盟获批上市，是全球第二款靶向BCMA的CAR-T疗法。2017年12月，杨森斥资6亿美元获西达基奥仑赛全球独家许可进行开发和商业化。2022年9月，西达基奥仑赛在日本获批上市，用于治疗复发或难治性多发性骨髓瘤（R/R MM）成人患者。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯东阳光门冬胰岛素注射液国内获批上市宜昌东阳光长江药业股份有限公司公告称，其自主开发的门冬胰岛素注射液（规格3ml: 300单位（笔芯））已获国家药监局批准上市。门冬胰岛素注射液属于速效胰岛素类似物，比人胰岛素起效更迅速，能更好地控制餐后血糖，降低低血糖发生风险，同时注射时间更灵活，适用于接受口服降糖药物治疗但血糖控制仍然不佳的患者，是目前主流胰岛素强化治疗方案的常用药物。东阳光药正积极布局糖尿病治疗领域。除此次获批的门冬胰岛素注射液外，其自主开发的重组人胰岛素注射液、甘精胰岛素注射液已获批上市，门冬胰岛素30注射液以及精蛋白重组人胰岛素注射液（预混30R）正处于境内生产注册审评阶段；荣格列净及利拉鲁肽则处于III期临床阶段。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯复宏汉霖汉贝泰新增适应证获批，用于治疗复发性胶质母细胞瘤10月19日，上海复宏汉霖生物技术股份有限公司宣布，全资附属公司上海复宏汉霖生物制药有限公司自主开发的贝伐珠单抗生物类似药汉贝泰新增适应证补充申请已获国家药监局批准，此次获批的适应证为复发性胶质母细胞瘤。汉贝泰于2021年11月在中国境内获批上市。截至公告日，汉贝泰在中国境内获批的适应证为：①转移性结直肠癌；②晚期、转移性或复发性非小细胞肺癌；③复发性胶质母细胞瘤。此外，2022年8月及10月，汉贝泰新增肝细胞癌、宫颈癌及上皮性卵巢癌、输卵管癌或原发性腹膜癌适应证的补充申请先后获CDE受理。除汉贝泰外，中国境内已上市的贝伐珠单抗有Roche Pharma（Schweiz）Ltd.的安维汀、齐鲁制药有限公司的安可达、信达生物制药（苏州）有限公司的达攸同等。**戳文末“阅读原文”定制/订阅医疗行业新闻资讯企业动态GBI NEWS拜耳南中国女性健康治疗领域将成立深圳大区据悉，拜耳南中国女性健康治疗领域将成立深圳大区，负责深圳市场及粤东部分市场的产品推广职能。拜耳表示，此举是为了进一步践行处方药中国TNN战略，最大化支持女性健康治疗领域的快速成长，并基于产品线策略及区域布局考量。现任南中国女性健康治疗领域粤桂大区广州3组高级地区经理罗江，将晋升为南中国女性健康治疗领域深圳大区大区经理，直接向南中国女性健康治疗领域总监肖露汇报。现南中国女性健康治疗领域深圳1组、深圳2组及广州4组将划分加入深圳大区架构，相应经理将向深圳大区大区经理罗江汇报。粤桂大区高级区域推广经理李昭将同时支持粤桂大区及深圳大区相关业务工作，汇报线保持不变。现粤桂大区其余团队及人事汇报线保持不变，向粤桂大区高级大区经理韦志云汇报。以上人事变动将于2022年11月1日生效。GBI既往报道，拜耳已于今年调整了中国区组织架构，自6月1日起在中国设立肿瘤事业部，并将心血管和糖尿病业务合并更名为代谢治疗领域。**戳文末“阅读原文”定制/订阅新闻资讯传奇生物创始人范晓虎离职后就任西交大研究院院长自3月底从传奇生物离职的范晓虎公布最新动向，就任西安交通大学基因与细胞治疗研究院院长。范晓虎是传奇生物创始人和前首席科学官（CSO），曾先后在西安交通大学、日本广岛大学获得医学、应用免疫学博士学位，后又赴加拿大多伦多大学儿童医院完成博士后工作。2014年，范晓虎加入金斯瑞生物，担任抗体蛋白质工程部负责人；2015年子公司传奇生物成立，主攻CAR-T细胞疗法，范晓虎出任CSO并参与西达基奥仑赛的研发。2022年3月，范晓虎从传奇生物离职，8月被老东家金斯瑞生物起诉，案由为侵犯商业秘密纠纷。案件于8月8日开庭，8月26日再次开庭。据业内消息，此次诉讼纠纷可能与双方签订的竞业禁止协议或保密协议相关。**戳文末“阅读原文”定制/订阅新闻资讯研报首发《高值创新药医保报销风险管理——国际经验：创新型支付协议从概念到案例》报告由清华大学医院管理研究院教授兼研究员、GBI首席顾问陈怡博士撰写，报告在汇总相关国际文献基础上，梳理了创新型市场准入协议（Market Access Agreement, MAA）的发展背景、协议类别、实施条件、评估标准、案例和发展趋势，旨在帮助行业同仁系统地认识国际实践经验，并对未来如何建立适合我国的高值药品准入支付方式解决思路带来启示与思考。滑动查看报告目录扫描二维码或点击“阅读原文”解锁完整版报告精彩内容。点击阅读原文获取完整版报告

免疫疗法细胞疗法基因疗法抗体生物类似药

100 项与重组人胰岛素 (江苏万邦生化医药集团) 相关的药物交易

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