主要目的：（1）评价健康受试者在空腹条件下单次、多次服用XT1061的安全性和耐受性；（2）评价健康受试者在空腹条件下单次、多次服用XT1061的药代动力学影响；（3）评价食物对XT1061在健康受试者体内的药代动力学的影响。次要目的：（1）初步探索健康受试者在空腹条件下单次服用XT1061的代谢转化研究；（2）评估高脂饮食对健康受试者服用XT1061的安全性的影响。

开始日期2023-07-18

申办/合作机构

西安新通药物研究股份有限公司

[+1]

NCT06280534 / Recruiting临床1期

Randomized, Double-blind, Single Center Phase Ia Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects

A Randomized, Double-Blind, Single-Center Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effects of Single and Multiple Doses of XT1061 in Healthy Subjects.

开始日期2023-07-18

申办/合作机构

西安新通药物研究股份有限公司

NCT06122454 / Recruiting临床1/2期

A Single-center, Randomized, Open-label, Active-controlled Phase Ic/IIb Study to Evaluate the Efficacy，Safety and Pharmacokinetics of Hepenofovir Fumarate Tablets in Patients With CHB

The goal of this a clinical trial is to learn about the efficacy，safety and Pharmacokinetics of Hepenofovir Fumarate Tablets（HTS） in patients with CHB. The main questions it aims to answer are：
Evaluate the efficacy and safety of multiple doses of continuous administration of HTS in patients with chronic hepatitis B, and compare it with Tenofovir alafenamide Fumarate tablets（TAF）.
To evaluate the pharmacokinetic characteristics of HTS in patients with chronic hepatitis B after multiple oral administration.
To evaluate the pharmacodynamic changes of HTS in patients with chronic hepatitis B after multiple consecutive administrations, and compare it with TAF.
Positive control drug：Tenofovir alafenamide Fumarate tablets（25mg/d） Test drug：Hepenofovir Fumarate Tablets（10mg/d、20mg/d、40mg/qod） Test process：This study was divided into 4 groups, with the specific list shown below. The initial plan was to include 12 subjects in each group, stratified by HBeAg status, with 4 subjects negative for HBeAg and 8 subjects positive for HBeAg. A total of 48 subjects were included in this trial, and they were randomly assigned to multiple doses at a ratio of 1:1:1:1. The dosing period was 24 weeks. However, after enrolling 37 subjects (29 positive for HBeAg and 8 negative for HBeAg), the protocol was adjusted (V4.0): the remaining 11 subjects would be included, all of whom were over 30 years old with ALT < ULN and met all the inclusion criteria but none of the exclusion criteria. The random assignment was: 7 subjects positive for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 2:2:2:1; and 4 subjects negative for HBeAg were randomly assigned to HTS 10mg/day, 20mg/day, 40mg/qod and TAF 25mg/day groups at a ratio of 1:1:1:1.

开始日期2022-11-10

申办/合作机构

西安新通药物研究股份有限公司

[+1]

100 项与西安新通药物研究股份有限公司相关的临床结果

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0 项与西安新通药物研究股份有限公司相关的专利（医药）

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项与西安新通药物研究股份有限公司相关的文献（医药）

2024-06-14·Journal of Liquid Chromatography & Related Technologies

Optimization of extracting technology of iridoid glycosides and phenylethanoid glycosides from Pedicularis decora Franch. by G1-entropy-coupled response surface methodology and rapid identification by UPLC-Q/TOF-MS

作者: Sun, Wenjun ; Wang, Yaxuan ; Li, Yunzhe ; Gao, Xin ; Liu, Xia ; Gao, Fang ; Nan, Guanjun ; Pan, Xiaoyan ; Bai, Lu

Quality control and clarifying ingredients are the foundation of pharmacodynamic material basis research.Pedicularis decora Franch.(P. decora) is clin. used to treat Alzheimer disease and exerts significant antioxidative, anti-inflammatory and neuroprotective effects.However, there is little systematic research on the extraction and composition and the current research on P. decora focused on the quality control and extraction with aucubin as only quality marker.It reported that Iridoid glycosides (IGs) and phenylpropanoid glycosides (PeGs), which are characteristic components of the Pedicularis species, have been reported to have various anti-Alzheimer activity.This study focused on the extraction and rapid qual. anal. of IGs and PeGs in P. decora.First, HPLC-UV method was established to detect five IGs and PeGs analytes simultaneously and assess the effect of the extraction technol.Then, the G1-entropy method with the Box-Behnken response surface design methodol. was used to optimized extraction technol.The optimum conditions were determined to be reflux with 55% methanol aqueous solutions, at 75 °C for 50 min.Finally, by establishing UPLC-Q/TOF-MS, 15 IGs and 15 PeGs in P. decora were rapidly identified and characterized for the first time.The results will provide a reverence of a higher quality standard and the pharmacodynamic material basis research.

2024-03-14·Journal of Medicinal Chemistry1区 · 医学

Discovery of Highly Potent Small-Molecule PD-1/PD-L1 Inhibitors with a Novel Scaffold for Cancer Immunotherapy

1区 · 医学

Article

作者: Xu, Yongling ; Ren, Weijie ; Liu, Beibei ; Wang, Hongxia ; Zou, Yi ; Guo, Weibo ; Xu, Yungen ; Huang, Jingling ; Yan, Wenxin ; Du, Huijie ; Wu, Shiqi ; Zhu, Qihua ; Wang, Jie ; Qin, Long ; Gu, Hongfeng ; Zhang, Chi

Inhibition of the PD-1/PD-L1 interaction through small-molecule inhibitors is a promising therapeutic approach in cancer immunotherapy. Herein, we utilized BMS-202 as the lead compound to develop a series of novel PD-1/PD-L1 small-molecule inhibitors with a naphthyridin scaffold. Among these compounds, X14 displayed the most potent inhibitory activity for the PD-1/PD-L1 interaction (IC₅₀ = 15.73 nM). Furthermore, X14 exhibited good binding affinity to both human PD-L1 (K_D = 14.62 nM) and mouse PD-L1 (K_D = 392 nM). In particular, X14 showed favorable pharmacokinetic properties (oral bioavailability, F = 58.0%). In the 4T1 (mouse breast cancer cells) syngeneic mouse model, intragastric administration of X14 at 10 mg/kg displayed significant antitumor efficacy (TGI = 66%). Mechanistic investigations revealed that X14 effectively enhanced T-cell infiltration within the tumor microenvironment. Our study demonstrates that compound X14 exhibits potential as a candidate compound for the development of orally effective small-molecule inhibitors targeting PD-1/PD-L1.

2024-01-01·Journal of Separation Science

Rapid analysis of the chemical constituents in Qiangli Dingxuan tablets using ultra‐performance liquid chromatography coupled with quadrupole time‐of‐flight tandem mass spectrometry

Article

作者: Gao, Xin ; Li, Yunzhe ; Wang, Yaxuan ; Niu, Xiaofeng ; Li, Xiaohui ; Bai, Lu ; Sun, Wenjun

Qiangli Dingxuan (QLDX) tablet is a widely recognized traditional Chinese medicine formula that has been extensively used in China for decades to treat vertigo, tinnitus, and dizziness owing to its outstanding therapeutic outcomes. However, the complexity of the chemical components in this tablet makes it challenging to separate and identify these components. This study presented an effective and sensitive strategy for the rapid separation and simultaneous structural identification of QLDX tablet components using ultra‐performance liquid chromatography with quadrupole time‐of‐flight tandem mass spectrometry and the UNIFI platform. Based on retention times, accurate masses, fragment ions, related literature, and authentic standards, 119 compounds were identified or tentatively characterized; these included 9 iridoids, 12 lignans, 21 phenylpropanoids, 27 flavonoids, 7 phthalides, and 43 others. Among them, 36 were confirmed using reference standards. The representative compounds with various chemical structures were studied by analyzing their fragmentation patterns and characteristic ions. In conclusion, this study established a rapid approach for characterizing the chemical constituents in QLDX tablet. The proposed approach provides a basis for qualitative analysis and quality control in the manufacturing process and is beneficial for advancing investigations into the efficacy and mechanism of action of this tablet.

298

项与西安新通药物研究股份有限公司相关的新闻（医药）

2024-10-29

·同写意

高活性、低脱靶基因编辑工具enCas12Ultra，有望打破Cas9国际专利垄断

信使RNA临床申请核酸药物基因疗法细胞疗法

2024-10-29

·医药观澜

抗乙肝1类新药获中国国家药监局批准上市

10月28日，中国国家药监局（NMPA）宣布批准新通药物全资子公司葛蓝新通制药申报的1类创新药甲磺酸普雷福韦片（曾用名：甲磺酸帕拉德福韦片）上市申请，用于治疗成人慢性乙型肝炎。根据新通药物公开资料，这是一种治疗慢性乙肝的肝靶向核苷类药物。慢性乙型病毒性肝炎是由乙型肝炎病毒（HBV）引起的、以肝脏炎症为主要表现的传染病。HBV是一个双链DNA病毒，其复制转录过程在人体肝细胞内完成。病毒复制的逆转录过程需要病毒基因整合到人体肝细胞核中，形成病毒核心颗粒，成熟的病毒核心颗粒在细胞质中进一步组装成为成熟病毒释放至肝细胞外，引发肝脏炎性病变。核苷（酸）类药物通过抑制病毒DNA聚合酶以阻止病毒持续复制。据新通药物此前招股书介绍，普雷福韦基于肝靶向创新药物研发平台开发，在阿德福韦结构基础上引入芳基磷酸环二酯结构，形成肝靶向阿德福韦前药。该产品在血液和胃肠道中稳定，只有药物进入肝脏后，被肝脏中特异性高表达的CYP3A4酶氧化后开环，再经β消除，才会释放出活性产物单磷酸化阿德福韦。后者是一种单磷酸腺苷的无环核苷（酸）类似物，其在体内细胞激酶作用下进一步磷酸化生成活性代谢产物阿德福韦二磷酸，它与天然底物脱氧腺苷三磷酸竞争，抑制HBV的DNA聚合酶（逆转录酶），且可以通过整合到病毒DNA链使得DNA复制终止，从而抑制乙肝病毒复制。在已完成的1期、2期和3期临床试验的核心临床阶段中的数据显示，普雷福韦片抑制乙肝病毒DNA复制率、乙肝e抗原（HBeAg）转阴率及肝功复常率等疗效指标与当前一线用药对比的疗效相当。在临床试验中，未观察到核苷（酸）类药物常见的对肾脏、骨骼的不良影响。相比于对照药，甲磺酸帕拉德福韦片在肾脏和骨骼等方面的安全性更佳，对血脂影响更低，长期用药心脑血管疾病隐患小。慢性乙型肝炎病毒（HBV）感染有着显著的发病率和死亡率，是全球公共卫生面临的紧迫挑战。希望普雷福韦在中国的获批，能为患者带来新的治疗选择。参考资料： [1]国家药监局批准甲磺酸普雷福韦片上市. Retrieved Oct 28, 2024. From https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20241028144038195.html [2]新通药物招股书. Retrieved Apr 13, 2023. From http://listing.sse.com.cn/renewal/xmxq/index.shtml?auditId=1062&anchor_type=0 内容来源于网络，如有侵权，请联系删除。

上市批准寡核苷酸核酸药物

2024-10-29

·GBIHealth

逾22亿美元，诺华获Monte Rosa旗下分子胶产品全球独家权益；新通药物慢性乙肝新药甲磺酸普雷福韦片获NMPA批准

药械追踪 No.1 / 阿斯利康本瑞利珠单抗获欧盟批准，用于罕见病EGPA 近日，阿斯利康宣布Fasenra（本瑞利珠单抗）已在欧盟（EU）获批，作为成人复发性或难治性嗜酸性肉芽肿性多血管炎（EGPA）患者的附加治疗药物。 III期MANDARA研究的积极数据支持了此次批准。EGPA（旧称Churg-Strauss综合征）是一种可累及全身多个系统的罕见自身免疫性疾病。本瑞利珠单抗目前已在包括美国、日本、欧盟和中国在内的80多个国家获批，除EGPA外还覆盖了慢性阻塞性肺病（COPD）、重度嗜酸性粒细胞性哮喘（SEA）等适应证。 ->点击文末阅读原文，解锁完整双语新闻 No.2/ 默沙东PD-1抑制剂可瑞达在欧洲新增两项妇癌适应证批准 10月29日，默沙东（NYSE：MRK）宣布，PD-1抑制剂可瑞达（帕博利珠单抗）已获欧盟批准两项妇科肿瘤新适应证，分别为：与卡铂和紫杉醇联用，一线治疗适合系统治疗的原发性晚期或复发性子宫内膜癌成人患者；与放化疗（CRT）联用，用于既往未接受过确定性治疗的III-IVA期（FIGO 2014分期）局部晚期宫颈癌成人患者。这两项适应证此前分别在2024年6月和1月获得了美国FDA的批准；本次获批后，可瑞达获欧盟批准的适应证达到30项。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 新通药物慢性乙肝新药甲磺酸普雷福韦片获NMPA批准 2024年10月28日，中国国家药品监督管理局（NMPA）宣布批准新通药物子公司西安葛蓝新通制药有限公司申报的1类创新药甲磺酸普雷福韦片（商品名：新舒沐）上市，该药品适用于治疗成人慢性乙型肝炎。根据新通药物公开资料，普雷福韦是一种肝靶向核苷类药物，通过抑制乙肝病毒（HBV）DNA聚合酶以阻止其持续复制。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 / 逾22亿美元，诺华获Monte Rosa旗下分子胶产品权益 10月28日，Monte Rosa（Nasdaq: GLUE）宣布，与诺华达成许可协议，授予后者包括MRT-6160在内的靶向VAV1的分子胶降解剂（MGD）全球独家开发和商业化权益。根据协议条款，诺华已同意向Monte Rosa支付1.5亿美元的预付款。从Ⅱ期研究开始，Monte Rosa有资格获得高达21亿美元的开发、监管和销售里程碑付款，以及美国以外的分层特许权使用费。净销售额。 Monte Rosa将共同资助Ⅲ期临床开发，并将分摊与MRT-6160在美国制造和商业化相关的利润和损失。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

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药物(靶点)	适应症	全球最高研发状态

甲磺酸普雷福韦 ( RT )	慢性乙型肝炎更多	批准上市
磷苯妥英钠 ( SCNA )	癫痫更多	申请上市
三氟柳 ( COX-1 )	-	临床3期
MB-07133 ( DNA polymerase )	不可切除的肝细胞癌更多	临床2期
百痛舒软胶囊	原发性痛经更多	临床2期