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An Update on the Clinical Pipelines of New Antibacterial Drugs Developed in China
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作者 Xinyi Yang Congran Li +8 位作者 Xiukun Wang Zhonghui Zheng Peiyi Sun Chunjie Xu Luni Chen Jiandong Jiang Staffan Normark Birgitta Henriques-Normark Xuefu You 《Engineering》 SCIE EI CAS CSCD 2024年第7期52-68,共17页
Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being dis... Antibacterial resistance is a global health threat that requires further concrete action on the part of all countries.In this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and developed.Although several high-quality reviews on clinical antibacterial drug pipelines from a global perspective were published recently,none provides comprehensive information on original antibacterial drugs at clinical stages in China.In this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since 2019.Information was obtained by consulting official websites,searching commercial databases,retrieving literature,asking personnel from institutions or companies,and other means,and a considerable part of the data covered here has not been included in other reviews.As of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and updated.Among them,two new antibacterial drugs that belong to traditional antibiotic classes were approved by the National Medical Products Administration(NMPA)in China in 2019 and 2021,respectively,and 18 antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in phase-1.Most of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial protein.Overall,despite there being 17 antibacterial clinical candidates,our analysis indicates that there are still relatively few clinically differentiated antibacterial agents in stages of clinical development in China.Hopefully,Chinese pharmaceutical companies and institutions will develop more innovative and clinically differentiated candidates with good market potential in the future research and development(R&D)of original antibacterial drugs. 展开更多
关键词 Antimicrobial resistance new antibiotics Clinical pipelines WHO priority pathogens National Mega-Project for Innovative drugs
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The brain-derived neurotrophic factor in neuronal plasticity and neuroregeneration: new pharmacological concepts for old and new drugs 被引量:7
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作者 Solomon Habtemariam 《Neural Regeneration Research》 SCIE CAS CSCD 2018年第6期983-984,共2页
Neurotrophins:Neurotrophins are peptides or proteins that are known to regulate neuronal viability,development,and function Beyond synaptic plasticity,neurotrophins protect neurons from apoptosis and also promote neu... Neurotrophins:Neurotrophins are peptides or proteins that are known to regulate neuronal viability,development,and function Beyond synaptic plasticity,neurotrophins protect neurons from apoptosis and also promote neurogenesis to recover neuronal defici even in adulthood. 展开更多
关键词 The brain-derived neurotrophic factor in neuronal plasticity and neuroregeneration new pharmacological concepts for old and new drugs
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New drugs for the treatment of metastatic colorectal cancer 被引量:1
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作者 Sara Cherri Michela Libertini Alberto Zaniboni 《World Journal of Gastrointestinal Oncology》 SCIE 2021年第11期1551-1560,共10页
Colorectal cancer(CRC)represents one of the most frequent malignancies in terms of incidence and mortality,thus representing the third leading cause of cancer death worldwide.In the last decade,few drugs have enriched... Colorectal cancer(CRC)represents one of the most frequent malignancies in terms of incidence and mortality,thus representing the third leading cause of cancer death worldwide.In the last decade,few drugs have enriched the treatment landscape of metastatic CRC and have significantly affected prognosis.Unlike other neoplasms,metastatic CRC patients who have exhausted treatment options often still maintain a good performance status.There are many challenges to increasing potential treatment options,notably a better understanding of disease biology and the mechanisms of resistance underlying cancer treatment failure.The development of new drugs for metastatic CRC certainly represents one of the most important challenges in medical oncology.This article discusses the main limitations in the development of new drugs and potential future scenarios.In particular,we addressed three questions:(1)The main limitations of targeted therapy in the treatment of metastatic CRC(mCRC);(2)New target armamentarium that could escape primary and secondary resistance and lead to more personalized mCRC therapy;and(3)Future directions. 展开更多
关键词 Colon cancer Colon rectal cancer new drugs drug resistance Metastatic colorectal cancer
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Literature Review on the Development of New Drugs Based on TRIZ 被引量:1
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作者 Bu Hemeng Xue Aoming Zhang Fang 《Asian Journal of Social Pharmacy》 2021年第1期60-67,共8页
Objective To promote the application of TRIZ theory in the new drug R&D and the innovative development of medical devices.Methods TRIZ can be literally translated as“theory of inventive problem resolving”,focusi... Objective To promote the application of TRIZ theory in the new drug R&D and the innovative development of medical devices.Methods TRIZ can be literally translated as“theory of inventive problem resolving”,focusing on clarifying and solving contradictions in the system.This article introduces the TRIZ theory and the general process of new drug development.It collects literature in the field of new drug development and medical devices and refers to ideas for solving problems in some successful cases of applying TRIZ theory in other fields.Results and Conclusion After summarizing the general ideas of TRIZ to solve the problems,it is concluded that attention should be paid to applying TRIZ theory in the development of new drug and medical devices. 展开更多
关键词 TRIZ new drug BIOPHARMACEUTICAL pharmaceutical technology medical device
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PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF NEW DRUGS FROM CLINICAL PHARMACOLOGY STUDIES
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作者 Jan Koch-Weser M.D. 《中国临床药理学杂志》 CAS 1988年第2期101-104,共4页
The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years ... The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac- 展开更多
关键词 PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF new drugs FROM CLINICAL PHARMACOLOGY STUDIES
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New strategies against drug resistance to herpes simplex virus 被引量:16
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作者 Yu-Chen Jiang Hui Feng +1 位作者 Yu-Chun Lin Xiu-Rong Guo 《International Journal of Oral Science》 SCIE CAS CSCD 2016年第1期1-6,共6页
Herpes simplex virus (HSV), a member of the Herpesviridae family, is a significant human pathogen that results in mucocutaneous lesions in the oral cavity or genital infections. Acyclovir (ACV) and related nucleos... Herpes simplex virus (HSV), a member of the Herpesviridae family, is a significant human pathogen that results in mucocutaneous lesions in the oral cavity or genital infections. Acyclovir (ACV) and related nucleoside analogues can successfully treat HSV infections, but the emergence of drug resistance to ACV has created a barrier for the treatment of HSV infections, especially in immunocompromised patients. There is an urgent need to explore new and effective tactics to circumvent drug resistance to HSV. This review summarises the current strategies in the development of new targets (the DNA helicase/primase (H/P) complex), new types of molecules (nature products) and new antiviral mechanisms (lethal mutagenesis of Janus-type nucleosides) to fight the drug resistance of HSV. 展开更多
关键词 new strategies drug resistance herpes simplex virus Janus-type nucleoside analogues lethal mutagenesis
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The synthesis of potential anticancer drugs related to mitoxantrone
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作者 ZhengWei JamesLBloomer 《中国抗生素杂志》 CAS CSCD 北大核心 2001年第2期112-117,共6页
ABSTRACT In an attempt at a rational design for anticancer drugs, two new potential anticancer compounds related to mitoxantrone were prepared. Compounds 4. 1.4-dihydroxy-6-aminoethyl-9.10-anthracenedione was synthesi... ABSTRACT In an attempt at a rational design for anticancer drugs, two new potential anticancer compounds related to mitoxantrone were prepared. Compounds 4. 1.4-dihydroxy-6-aminoethyl-9.10-anthracenedione was synthesized in 6 steps starting with 4-methyl-phthalic acid, and compound 5, 2(4-aminobutyl)-l 4-dihvdroxv-9,10-anthracenedione was synthesized in 5 steps from N-3-bromopropylphthalimide. 展开更多
关键词 ANTICANCER drugs MITOXANTRONE new COMPOUNDS
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Opinion on pharmacology research and new drug development from precision medicine
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作者 Michael SPEDDING James BARRETT Ying ZHAO 《中国药理学与毒理学杂志》 CAS CSCD 北大核心 2017年第8期779-785,共7页
Since President Obama announced the Precision Medicine Initiative from a national strategy perspective in his State of the Union address,precision medicine has rapidly become a world-wide hotspot and drawn global atte... Since President Obama announced the Precision Medicine Initiative from a national strategy perspective in his State of the Union address,precision medicine has rapidly become a world-wide hotspot and drawn global attention in the medical field.Precision medicine aims at applying genetic information of individual diseases to guide his or her diagnosis and treatment. 展开更多
关键词 Opinion on pharmacology research and new drug development from precision medicine
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Reference of New Zealand’s Drug Shortage Management Measures
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作者 Zhang Jie Zhang Fang 《Asian Journal of Social Pharmacy》 2020年第2期68-72,共5页
Objective To provide a scientific reference for China’s drug shortage and supply mechanism by conducting a specific study on New Zealand’s management measures for dealing with the shortage of drugs.Methods Through r... Objective To provide a scientific reference for China’s drug shortage and supply mechanism by conducting a specific study on New Zealand’s management measures for dealing with the shortage of drugs.Methods Through reviewing the official website of the New Zealand Pharmaceutical Management Agency(PHARMAC)and relevant literature,the specific measures to deal with drug supply and shortage in New Zealand were sorted out,and then some countermeasures were put forward for our domestic drug supply.Results and Conclusion PHARMAC worked closely with the pharmaceutical suppliers and signed contracts to maintain their relationship.A sound drug supply mechanism has been established to respond to various supply issues.At present,there are some problems in drug supply in China,such as the lack of timely publicity of shortage information,the lack of management team for supply,and the lack of alternative drug supply mechanism.China should learn from the PHARMAC to establish a supply contract management team to promote the transparency of drug shortage information and seek alternative drug supply actively. 展开更多
关键词 new Zealand drug shortage drug supply supply contract
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Regulation of “Checkpoint Molecule” Sheds New Light on Anti-Cancer Drug Development
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作者 YAN Fusheng 《Bulletin of the Chinese Academy of Sciences》 2018年第4期220-222,共3页
The rivalry between T cells and tumor cells somewhat mimics the scene of 'Tom and Jerry,' an animated series in which Tom (a house cat) rarely succeeds in catching Jerry (a mouse), mainly because of Jerry’s c... The rivalry between T cells and tumor cells somewhat mimics the scene of 'Tom and Jerry,' an animated series in which Tom (a house cat) rarely succeeds in catching Jerry (a mouse), mainly because of Jerry’s cleverness and cunning abilities. In a way, tumor cells are like Jerry, in terms of their crafty and sneaky features. 展开更多
关键词 REGULATION of PD SHEDS new LIGHT on ANTI-CANCER drug Development CHECKPOINT MOLECULE
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New Developments in Drug Therapy and Research of Cerebral Vasospasm
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作者 Eleftherios Archavlis Peter Ulrich Mario Carvi YNievas 《Open Journal of Modern Neurosurgery》 2013年第4期72-93,共22页
In this manuscript a comprehensive coverage of recent developments in the drug therapy of vasospasm while providing the background information that neuroscientists need to understand its rationale. The range of new ag... In this manuscript a comprehensive coverage of recent developments in the drug therapy of vasospasm while providing the background information that neuroscientists need to understand its rationale. The range of new agents available for treatment of cerebral vasospasm is expanding rapidly along with rapid advances in pharmacology and physiology that are uncovering the mechanisms of this disease. Although there are many publications for treatment of cerebral vaso-spasm, most are focusing on different aspects of vasospasm treatment and many have limited value due to insufficient quality. Moreover, the complexity of this, in many cases deleterious condition, is enormous and the information needed to understand drug effects is accordingly often not readily available in a single source. A number of pharmacological and medical therapies are currently in use or being investigated in an attempt to reverse cerebral vasospasm, but only a few have proven to be useful. Current research efforts promise the eventual production of new medical therapies. At last, recommendations for the use of different treatment stages based on currently available clinical data are provided. 展开更多
关键词 Cerebral Vasospasm drug Therapy Subarachnoid Hemorrhage Delayed Cerebral Ischemia new Developments TREATMENT
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Real-World Evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China
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作者 Lan Yipeng Huang Zhe 《Asian Journal of Social Pharmacy》 2021年第3期203-208,共6页
Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European ... Objective To analyze the application of real-world evidence(RWE)in the field of medicine in European Union,and provide suggestions for RWE supporting the review and approval of new drugs in China.Methods The European Medicines Agency(EMA)and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE.Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun.The decision-making process includes three stages such as new drug research and development,review,and approval.However,there are some challenges in data quality,research methods,evidence sufficiency,and research process of RWE supporting the European Union in reviewing and approving new drugs.At present,RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs.At the same time,RWE also can promote the development and application of Traditional Chinese Medicine(TCM)and help find out the potential value of TCM such as new indications. 展开更多
关键词 real-world evidence new drug review and approval European Union ENLIGHTENMENT
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A New Anticancer Drug
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《Bulletin of the Chinese Academy of Sciences》 2002年第2期73-73,共1页
After some six years of hard work, a research team headed by Prof. Liu Zhivu (Z.Y. Liu) at the Shanghai Institute of Organic Chemistry, CAS, has scored major progress in independently generating a novel cancer killer ... After some six years of hard work, a research team headed by Prof. Liu Zhivu (Z.Y. Liu) at the Shanghai Institute of Organic Chemistry, CAS, has scored major progress in independently generating a novel cancer killer called epothilone. Their findings have been granted three patents, and their research paper Total Synthesis of Epothilone: A Thorough Stereospecific Expoxidation of the 3-0-(4-methoxy) Benzyl Ether of Epothilone C has been accepted for publication in the Chemistry - European Journal. 展开更多
关键词 CAS A new Anticancer drug
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Application Research of Earned Value Management in New Drug Research and Development Projects
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作者 Wang Wanting Xing Hua 《Asian Journal of Social Pharmacy》 2020年第1期16-21,共6页
Objective To help investors assess and control the costs of new drug development and reduce the risks of new drug development projects.Methods Cost analysis and financial forecasting were carried out with the integrat... Objective To help investors assess and control the costs of new drug development and reduce the risks of new drug development projects.Methods Cost analysis and financial forecasting were carried out with the integrated approach of earned value management.According to the principle of earned value management deviation analysis,the basic process of the new drug research and development project was combined with the hypothesis method from the research of Tufts Drug Development Research Center.Results and Conclusion If the project progress check was carried out in the clinical trial,the project costs were found overspent,the efficiency was low,the project progress was faster,and the resource investment was ahead.It is recommended that the adjustment should be made to reduce the input of resources,and increase the efficient key personnel to take the place of some less efficient staff. 展开更多
关键词 new drug research and development earned value management cost analysis
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The CAS System of New Drug Research and Its Key Results
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作者 Yuan Ping & Ma Cheng(CAS Bureau of Life Science & Bio-technology) 《Bulletin of the Chinese Academy of Sciences》 2000年第4期213-219,共7页
The Chinese Academy of Science (CAS), the top national research hub for natural sciences, has always been committed itself to the national target of research and development (R&D) of new medicines. During the past... The Chinese Academy of Science (CAS), the top national research hub for natural sciences, has always been committed itself to the national target of research and development (R&D) of new medicines. During the past several decades, a great number of R&D achievements have been attained. During the period from 1986 to 1999, for example, 135 pharmacutical projects won prizes of the CAS awards for natural sciences, inventions and S&T progress (roughly ac- 展开更多
关键词 In The CAS System of new drug Research and Its Key Results CAS
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Direction of new drug research: soft regulation of inflammatory immune responses
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作者 Wei WEI 《中国药理学与毒理学杂志》 CAS CSCD 北大核心 2017年第10期942-943,共2页
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改良型左甲状腺素钠相关药疹2例
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作者 高妍 陶蕾 +1 位作者 张群群 钱芳 《中国医药导刊》 2024年第4期417-420,共4页
优甲乐是一种人工合成外源性左甲状腺素,成分类似于甲状腺自然分泌的四碘甲状腺原氨酸,且可在外周器官中转化为游离三碘甲状腺原氨酸,并进一步结合受体,调节甲状腺功能。我院2例患者均为年轻女性,既往无药物及食物过敏史,也无家族遗传... 优甲乐是一种人工合成外源性左甲状腺素,成分类似于甲状腺自然分泌的四碘甲状腺原氨酸,且可在外周器官中转化为游离三碘甲状腺原氨酸,并进一步结合受体,调节甲状腺功能。我院2例患者均为年轻女性,既往无药物及食物过敏史,也无家族遗传史。入院后行甲状腺切除术,术后常规给予优甲乐预防甲状腺肿复发,且服用同一批次、同一厂家优甲乐。2例患者前后出现不同程度的药物性皮疹,经抗过敏治疗后好转。2例患者的不良反应均与优甲乐的服用具有时间相关性,考虑为优甲乐的新辅料甘露醇引起。甘露醇静滴时,常见的不良反应包括过敏性皮疹和荨麻疹。本研究基于我院2例优甲乐疑似引起药物性皮疹病例,综合分析患者相关指标变化,并结合国内外相近案例回顾分析,探讨药物性皮疹特点及可能机制,以期提高临床医师对这一现象的关注,并为该疾病的深入研究、促进优甲乐安全合理用药提供一定参考。 展开更多
关键词 改良型新药 左甲状腺素钠片 药疹 药品不良反应 病理机制
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新药研究与开发课程思政教学探索
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作者 葛金芳 温家根 +4 位作者 虞晓凡 吴繁荣 吕雄文 陈飞虎 李俊 《药学教育》 2024年第4期20-23,共4页
在新药研究与开发课程教学中融入课程思政理念,将其与学科教学内容融合,发挥思政课程与课程思政的协同效应,是以专业技能知识为载体开展育人工作的必由之路。这一教学改革可有效推进以创新为核心的学生综合能力培养,是成功实现“健康中... 在新药研究与开发课程教学中融入课程思政理念,将其与学科教学内容融合,发挥思政课程与课程思政的协同效应,是以专业技能知识为载体开展育人工作的必由之路。这一教学改革可有效推进以创新为核心的学生综合能力培养,是成功实现“健康中国”战略下复合型药学人才培养的有效途径。 展开更多
关键词 健康中国 课程思政 新药研究与开发 教育改革
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医疗机构基于“三结合”中药新药研发及管理体系的构建
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作者 路遥 申琳 +3 位作者 鲁雨荍 刘殿娜 王乐 陈旭 《中国药事》 CAS 2024年第2期147-151,共5页
目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药... 目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药研发的相关要求,从机构层面加强人用经验研究相关配套建设,从管理层面搭建中药研发、成果转化服务平台,从临床层面规范开展人用经验研究,构建医疗机构中药新药研发及管理体系。结果:医疗机构中药新药研发及管理体系的构建,有助于将临床诊疗数据转变为支持中药新药注册的人用经验证据,通过提高中药研发水平促进中药新药转化。结论:在医疗机构构建基于“三结合”的中药新药研发及管理体系,是“三结合”审评证据体系落地、政策引导研发实践的路径之一。 展开更多
关键词 “三结合”审评证据体系 人用经验 医疗机构 中药新药研发 中药新药转化 医疗机构中药制剂
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不同新型降糖药在2型糖尿病患者中的心血管改善作用进展
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作者 王茹 姚朱华 《现代诊断与治疗》 CAS 2024年第11期1619-1622,共4页
2型糖尿病是导致心血管疾病死亡的重要原因之一,合理控制血糖,可降低心血管疾病的发生风险,改善心血管疾病患者的预后结局。传统降糖药仅能降低血糖,对大血管合并症影响较小,而新型降糖药在2型糖尿病患者降糖预后方面有着诸多优势,也取... 2型糖尿病是导致心血管疾病死亡的重要原因之一,合理控制血糖,可降低心血管疾病的发生风险,改善心血管疾病患者的预后结局。传统降糖药仅能降低血糖,对大血管合并症影响较小,而新型降糖药在2型糖尿病患者降糖预后方面有着诸多优势,也取得了较好的临床效果。新型降糖药包括肠促胰素类药物、二肽基肽酶-4抑制剂、钠-葡萄糖协同转运蛋白2抑制剂、葡萄糖激酶激动剂、胰岛淀粉样物多肽类似物等。本文总结2型糖尿病合并心血管疾病的发病现状,探讨不同新型降糖药对2型糖尿病患者心血管保护作用,展望不同新型降糖药物未来应用方向。 展开更多
关键词 心血管保护作用 心血管疾病 新型降糖药物 肠促胰素类药物 二肽基肽酶-4抑制剂
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