A Phase I Clinical Trial in Healthy and Overweight/Obese Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids

This trial is conducted in China. The aim of the trial is to investigate safety, tolerability, and pharmacokinetics of the Mulberry Twig Alkaloids tablets (WH006) in healthy ，overweight and obesity subjects.

开始日期2024-05-13

申办/合作机构

北京五和博澳药业股份有限公司

[+1]

CTR20241722

/ Recruiting临床1期

桑枝总生物碱片 I 期临床人体耐受性及药代动力学试验

主要目的评价WH006 在健康受试者中，嚼服与餐后吞服两种给药方式，单次给药后的药代动力学特征；评价 WH006 在健康受试者中单次给药剂量递增的安全性和耐受性；评价 WH006 在健康受试者、肥胖/超重受试者中多次给药剂量递增的安全性和耐受性，确定 WH006 多次给药的最大耐受剂量（MTD）及后续推荐剂量（RD）。次要目的评价 WH006 在健康受试者、肥胖/超重受试者中，多次给药的伴随药代动力学特征。

开始日期2024-05-13

申办/合作机构

北京五和博澳药业股份有限公司

CTR20220482

/ Recruiting临床4期

评价桑枝总生物碱片治疗2型糖尿病的有效性和安全性的IV期临床试验

1)评价桑枝总生物碱片单药或联合其他降糖药物（此处并非严格意义上的联合用药，而是指在其他降糖药血糖控制不佳的基础上加用本品，并经临床医生根据药物作用的机理进行充分判断）治疗2型糖尿病的有效性； 2)观察受试者长期用药后的安全性； 3）探索桑枝总生物碱片治疗不同中医证候2型糖尿病的有效性和安全性（2型糖尿病中医证候分型仅在参加单位为中医院的中心进行）。

开始日期2022-05-19

申办/合作机构

北京五和博澳药业股份有限公司

[+1]

100 项与桑枝总生物碱相关的临床结果

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100 项与桑枝总生物碱相关的转化医学

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100 项与桑枝总生物碱相关的专利（医药）

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项与桑枝总生物碱相关的文献（医药）

2025-06-01·Phytomedicine

Mulberry twig (Sangzhi) alkaloids induce pancreatic α-to-β-cell phenotypic conversion in type 2 diabetic mice

Article

作者: Yang, Jin ; Wei, Rui ; Hong, Tianpei ; Li, Jian ; Cui, Xiaona ; Le, Yunyi ; Wang, Dandan ; Liao, Xinyue ; Yin, Deshan ; Li, Fei ; Wei, Tianjiao

BACKGROUNDPancreatic β-cell regeneration represents a promising therapeutic strategy for diabetes, yet safe and effective treatments remain elusive.PURPOSEWe aimed to investigate whether and how mulberry twig (Sangzhi) alkaloids (SZ-A), a newly approved anti-diabetic Chinese medicine, promoted β-cell regeneration.METHODSDiabetic db/db mice and pancreatic α-cell lineage-tracing mice were treated with SZ-A, acarbose, or vehicle daily via intragastric gavage. Blood glucose and plasma insulin levels were measured. The areas of islets, α-cells and β-cells were quantified. Cell transdifferentiation was assessed by double-immunostaining of glucagon or α-cell lineage-tracing marker with β-cell-specific markers. Mouse α-cells were incubated with SZ-A or its three main components, and the mRNA levels of cell transdifferentiation-related genes were detected. RNA-sequencing was performed to screen potential targets. The activities of five mitochondrial complexes were detected following treatment, and specific inhibitor was utilized to validate the involvement.RESULTSBoth SZ-A and acarbose improved glycemic control, but only SZ-A enlarged islet and β-cell areas in the diabetic mice. SZ-A induced α-to-β-cell conversion, as indicated by glucagon and insulin double-immunostaining and confirmed by α-cell lineage-tracing. In cultured α-cells, SZ-A and its main component 1-deoxynojirimycin (DNJ) downregulated the expressions of α-cell-specific markers, while upregulated the expressions of β-cell-specific markers. DNJ-induced differentially expressed genes were enriched in the mitochondrial protein complex term. DNJ inhibited mitochondrial complex I activity, and the complex inhibitor induced α-to-β-cell conversion.CONCLUSIONSZ-A, especially its main component DNJ, induces α-to-β-cell transdifferentiation via inhibiting mitochondrial complex I. Our finding provides a potential strategy for β-cell regeneration and diabetes treatment.

2024-11-01·Phytomedicine

Accelerating diabetic wound healing with Ramulus Mori (Sangzhi) alkaloids via NRF2/HO-1/eNOS pathway

Article

作者: Rui, Shunli ; Deng, Wuquan ; Chen, Qiu ; Ma, Yu ; Xiao, Fugang ; Huang, Guangbin ; Hao, Wei ; Armstrong, David G ; Zhang, Xiaoshi ; Armstrong, David G. ; Wu, Xiaohua

Diabetic foot ulcers (DFUs) represent a severe complication of diabetes mellitus. Ramulus Mori (Sangzhi) alkaloids (SZ-A), an approved oral medication for type 2 diabetes, have not been explored for their potential to enhance the processes involved in diabetic wound healing. This study aims to investigate SZ-A's role in diabetic wound healing mechanisms. The in vivo experimentation involves dividing the subjects into NC and SZ-A groups, with SZ-A dosed at 200 and 400 mg/kg, to assess the therapeutic efficacy of SZ-A. The results of the animal studies show that SZ-A intervention accelerates the processes of diabetic angiogenesis and wound healing in a manner dependent on its concentration. Additionally, a pathological model using advanced glycation end products (AGEs) in HUVECs demonstrates SZ-A's cytoprotective effect. In vitro, SZ-A intervention significantly increases cell proliferation, migration and tube formation, protecting HUVECs from oxidative stress injury induced by AGEs. Mechanistically, SZ-A exerts a protective effect on HUVECs from oxidative stress damage through the activation of the NRF2/HO-1/eNOS signaling pathway. The findings suggest that SZ-A exhibits considerable potential as a promising candidate for treating DFUs, which will aid in more effectively integrating plant-based therapies into clinical settings.

2024-06-01·Phytomedicine

Morus alba L. (Sangzhi) alkaloids mitigate atherosclerosis by regulating M1/M2 macrophage polarization

Article

作者: Zhang, Binbin ; Shi, Junping ; Zhuang, Zhenjie ; Yu, Zhenqiu ; Wang, Mingwei ; Zhang, Yuanyuan ; Zhuge, Fen ; Li, Jie ; Peng, Dandan ; Zhou, Run

BACKGROUNDAtherosclerosis (AS) is an important cause of cardiovascular disease, posing a substantial health risk. Recognized as a chronic inflammatory disorder, AS hinges on the pivotal involvement of macrophages in arterial inflammation, participating in its formation and progression. Sangzhi alkaloid (SZ-A) is a novel natural alkaloid extracted from the mulberry branches, has extensive pharmacological effects and stable pharmacokinetic characteristics. However, the effects and mechanisms of SZ-A on AS remain unclear.PURPOSETo explore the effect and underlying mechanisms of SZ-A on inflammation mediated by macrophages and its role in AS development.METHODSAtherosclerosis was induced in vivo in apolipoprotein E-deficient mice through a high-fat and high-choline diet. We utilized macrophages and vascular endothelial cells to investigate the effects of SZ-A on macrophage polarization and its anti-inflammatory properties on endothelial cells in vitro. The transcriptomic analyses were used to investigate the major molecule that mediates cell-cell interactions and the antiatherogenic mechanisms of SZ-A based on AS, subsequently validated in vivo and in vitro.RESULTSSZ-A demonstrated a significant inhibition in vascular inflammation and alleviation of AS severity by mitigating macrophage infiltration and modulating M1/M2 macrophage polarization in vitro and in vivo. Moreover, SZ-A effectively reduced the release of the proinflammatory mediator C-X-C motif chemokine ligand (CXCL)-10, predominantly secreted by M1 macrophages. This reduction in CXCL-10 contributed to improved endothelial cell function, reduced recruitment of additional macrophages, and inhibited the inflammatory amplification effect. This ultimately led to the suppression of atherogenesis.CONCLUSIONSZ-A exhibited potent anti-inflammatory effects by inhibiting macrophage-mediated inflammation, providing a new therapeutic avenue against AS. This is the first study demonstrating the efficacy of SZ-A in alleviating AS severity and offers novel insights into its anti-inflammatory mechanism.

项与桑枝总生物碱相关的新闻（医药）

2025-02-15

·赛柏蓝

中药新药销售额TOP10

编者按：本文来自药智网，作者何非非；赛柏蓝授权转载，编辑凯西 2016-2024年，共有29个中药新药（不含中药提取物）获批上市，其中27个已进入国家医保乙类目录。但是，商业化成为中药新药另一座难以翻越的大山。这29款中药新药中，仅2个品种年销售额超过1亿元，与西药（化学药和生物药）创新药前十品种相比，中药创新药的销售额尚不足其十分之一。表1 中药新药销售额TOP10 注：1.统计品种为2016年-2024年获NMPA批准的中药创新药（不含改良型新药）；累计销售额为2016-2023年的销售额。 01 2个品种，销售额过亿中药是我国传统文化的瑰宝，具有悠久的历史传承与使用经验。近年来，一系列旨在促进中医药高质量发展的政策措施相继出台，涵盖新的注册分类、医保支付政策的优化以及监管力度的加强等多个维度，为中药创新奠定了基础。 2016-2024年，共有29个中药新药（不含中药提取物）获批上市。从获批时间来看，大部分品种上市时间不足5年（24个），上市5-8年的有5个。图1 历年获批的中药新药数量从销售额来看，2023年国内医院和零售合计销售额超过1亿的中药创新药品种有2个，分别为：聚协昌（北京）药业的金花清感颗粒和石家庄以岭药业的连花清咳片。另外，还有多个品种上市后累计销售额不足100万。另外，五和博澳药业的降糖天然药物桑枝总生物碱片在2023年销售额0.96亿元，还处于增长趋势，有望成为下一个过亿品种。该药于2020年获批上市，是近15年来中国首个获批上市的降血糖中药新药，也是全球唯一的植物组分天然降糖药。五和博澳又启动了桑枝总生物碱片的减重I期临床试验，未来销售前景可观。 02 销售额低迷背后虽然中药创新药在商业化上取得了一定成绩，但对比化药和生物药创新药，销售额仍有不少距离。表2 国内上市1类新药销售总额TOP10 对比表1和表2，化药销售额冠军安罗替尼2023年销售额36.6亿元，TOP10门槛为14亿元。而中药新药销售额榜首金花清感颗粒2023年销售额2.59亿元，TOP10门槛仅一千万元，不足化药和生物药的十分之一。而对比中药销售额TOP10，中药创新药依然难以上榜。图2 2023年中药医院销售额TOP10 中药新药销售额低迷，背后究竟隐藏着怎样的行业逻辑？又该如何破局？中国医药健康发展促进专委会主任委员、北京盛世康来中药营销策划公司董事长申勇认为中药创新药销量不佳有多方面的原因：其一，生不逢时的市场困局。除金花清感颗粒外，大部分中药创新药上市时间都在2019-2021年，恰逢疫情期间。除金花清感颗粒、连花清咳片等抗疫品种外，多数产品因疫情期间，医院推广受阻，导致销量低迷。其二，集采“黑天鹅”。以桑枝生物碱片为例，这款中药创新药在研发时对标的是拜唐苹，一款年销售额高达20多亿的西药。但上市时恰逢拜唐苹被纳入集采，价格从60元一盒降至6元，市场空间被严重压缩。其三，企业的“顶层设计”问题。有部分企业虽已拿到创新药批文，但从公司整体战略考虑现有产品的市场，暂未将此新药作为主推品种。其四，红海竞争。还有部分品种受“竞争因素”影响，推广起来难度较大。例如补肾、风湿骨病等传统中药市场已成红海。新品若缺乏差异化卖点，即便获批，也难以撼动老牌企业的市场地位。其五，产品生命周期差异。西药靠“新颖性”快速占领市场，可在短期内快速放量，但在之后可能被更新的疗法迭代。而中药因理论复杂、疗效反馈周期长，前5年起步较慢，但中药生命周期也更长，5年后依然有很大的增长潜力。因此，申勇建议中药创新药研发时，应紧盯市场变化，避开已成红海竞争的领域、集采高风险领域、以及“降压、降糖、肝病”等中药无竞争优势的领域。应聚焦“西药无解、中医有术”的特色领域，例如黄斑变性、妇科、儿科领域，研发与销售协同，才能做出市场需要的产品。 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

上市批准

2025-02-14

·五和博澳药业

广西壮族自治区主席蓝天立莅临广西五和博澳调研考察

2025年2月11日下午，广西壮族自治区主席蓝天立一行莅临广西五和博澳药业有限公司（以下简称“广西五和博澳”）调研考察。自治区政府秘书长钟得志，河池市市长王军、市委副书记孔建忠、市委常委常务副市长黄贤昌、副市长曹崇俊等陪同调研。广西五和博澳药业有限公司总经理杨俊东对调研组的到来表示热烈欢迎。调研组先后参观了广西五和博澳的企业展厅和桑枝总生物碱提取车间，深入了解了公司桑枝总生物碱原料药的加工生产流程。在参观过程中，蓝天立主席认真听取了公司的汇报，对公司在天然药物研发和产业化方面取得的成绩表示高度肯定。蓝天立主席指出，广西五和博澳作为行业内的领军企业，要不断优化研发体系，提升天然药物创制和高端创新制剂研发、产业化的核心竞争力，推动桑蚕经济向高附加值的健康产业转型升级。广西五和博澳是北京五和博澳药业股份有限公司中西合璧中国原创天然药物“桑枝总生物碱”的原料药生产基地和“现代天然药物”成果转化平台，是国家高新技术企业、广西瞪羚企业、广西壮族自治区制造业单项冠军企业、自治区农业产业化重点龙头企业。公司基于国家重大专项标志性成果的辐射，利用宜州丰富的桑资源，开发现代天然药物，打造生物医药高端切入的桑资源综合开发健康产业链。未来将继续加大研发投入，提升创新能力，推动更多科技成果转化为实际生产力。公司将致力于推动桑蚕经济向高附加值的健康产业转型升级，为广西的经济发展和生态文明建设贡献更多力量。广西五和博澳供稿扫码关注我们查看更多精彩内容

2025-02-14

·五和博澳药业

解读天然降糖药物在《中国糖尿病防治指南》2024版的收录

中国医学科学院药物研究所与北京五和博澳药业股份有限公司联合开发的原创天然降糖药物“桑博恩®桑枝总生物碱片”2020年上市以来，守正创新，躬行不辍，不断累计高质量循证医学证据，已经纳入5本指南推荐，1个专家共识和2本医学教材。在最新的《中国糖尿病防治指南（2024版）》,桑枝总生物碱更是创新性的被“高血糖治疗药物”和“中医药防治糖尿病”两个章节同时收录。《中国糖尿病防治指南2024版》高血糖治疗药物和中医药防治糖尿病章节桑枝总生物碱作为中药提取物物质基础明确，质量可控，非传统中药，凭借明确的糖苷酶抑制作用，在诊疗路径中推荐用于二联治疗。《中国糖尿病防治指南2024版》诊疗路径桑枝总生物碱IIIa期临床研究显示治疗24周，整体人群可降低HbA1c0.93% ，“中医药防治糖尿病--2型糖尿病”章节列明中医药具有“单独”降糖能力。《中国糖尿病防治指南2024版》中医药防治糖尿病章节桑枝总生物碱口服后除在胃肠道发挥糖苷酶抑制作用，还可吸收入血广泛分布在肾脏，肝脏，主动脉血管和脂肪等糖脂代谢组织发挥多重药理作用，通过多项研究证实，可直接干预、间接作用于2型糖尿病（T2DM）患者多重病理生理机制，显示了其在代谢疾病领域广泛的应用前景。 “桑博恩®桑枝总生物碱片”三种生物碱参考文献： 1.中国糖尿病防治指南（2024版） 2.Qu L, et al. Diabetes Care. 2021 Apr 8;dc202109. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

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100 项与桑枝总生物碱相关的药物交易

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