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An Update on the Clinical Pipelines of New Antibacterial Drugs Developed in China

Engineering 2024年第7期38卷 52-68页

作者： Xinyi Yang Congran Li Xiukun Wang Zhonghui Zheng Peiyi Sun Chunjie Xu Luni Chen Jiandong Jiang Staffan Normark Birgitta Henriques-Normark Xuefu You Beijing Key Laboratory of Antimicrobial Agents/Laboratory of pharmacology Institute of Medicinal BiotechnologyChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China Division for Medicinal Microorganism-Related Strains CAMS Collection Center of Pathogenic MicroorganismsChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China State Key Laboratory of Bioactive Substances and Functions of Natural Medicines Institute of Medicinal BiotechnologyChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China Shandong Xinhua Pharmaceutical Co. Ltd.Zibo 255005China Department of Microbiology Tumor and Cell BiologyKarolinska InstitutetStockholm SE-17177Sweden State Key Laboratory of Bioactive Substances and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China Institute of Medicinal Biotechnology Chinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China Clinical Microbiology Karolinska University HospitalBioclinicumStockholm SE-17176Sweden

Antibacterial resistance is a global health threat that requires further concrete action on the part of all *** this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and *** 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 *** this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since *** 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 *** of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and *** 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 *** of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial ***,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 ***,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.

关键词： Antimicrobial resistance New antibiotics Clinical pipelines WHO priority pathogens National Mega-Project for Innovative Drugs

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The meta-analyses on effectiveness and safety of colorectal cancer screening

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Chinese medical Journal 2024年第12期137卷 1471-1473页

作者： Pei Li Xueyang Zeng Zuoxiang Liu Jichun Yang Yueying Li Le Gao Hongmei Zeng Lin Zhang Feng Sun Department of Epidemiology and Biostatistics School of Public HealthPeking UniversityBeijing 100191China peking union medical college Beijing 100005China Centre for Safe Medication Practice and Research Department of Pharmacology and PharmacyLi Ka Shing Faculty of MedicineThe University of Hong KongHong KongChina Department of Cancer Registry National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China School of Population Medicine and Public Health Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100730China

To the Editor:The colorectal cancer(CRC)is the fourthmost common cause of cancer deaths in China that was treated as a public health threat,accounting for approximately 10%of all the cancer-caused mortalities each year.[1]It usually takes decades to develop from a polyp to full CRC,[2]which allows a time window for detecting precancerous lesions and taking early steps for preventions and treatments.

关键词： colorectal prevention cancer

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Phomaketals A and B,pentacyclic meroterpenoids from a eupC overexpressed mutant strain of Phoma sp.

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Chinese Chemical Letters 2024年第7期35卷 350-354页

作者： Chuan Li Yangyang Han Yanan Zhai Ke Li Xingzhong Liu Zhuan Zhang Cai Jia Yongsheng Che NHC Key Laboratory of Biotechnology of Antibiotics Institute of Medicinal BiotechnologyChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China State Key Laboratory of Toxicology&medical Countermeasures Beijing Institute of Pharmacology&ToxicologyBeijing 100850China Department of Microbiology College of Life SciencesNankai UniversityTianjin 300071China

Phomaketals A(1)and B(2),two tropolonic meroterpenoids with the unprecedented pentacyclic skeletons,were isolated from the solid-substrate fermentation cultures of a eupC overexpressed mutant strain of the fungus Phoma sp.,together with a biogenetically related secondary metabolite pughiinin B(3),and the known one noreupenifeldin B(4).The structures of 1–3 were elucidated primarily by nuclear magnetic resonance(NMR)*** absolute configurations of 1 and 2 were assigned by electronic circular dichroism calculations and the calculated NMR with DP4+analysis,while that of 3 was established by single-crystal X-ray diffraction analysis using Cu Kα***,phomaketals A(1)and B(2)could be derived from the hypothetical tropolonic sesquiterpene intermediates neosetophomone B(6)and 9-R-neosetophomone B(6),respectively,via different reactions *** 1 showed antiproliferative effect only against the SUPB15 cells,with an 50%inhibitory concentration(IC50)value of 4.85μmol/L,while the co-isolated known meroterpenoid 4 displayed potent effects against three tumor cell lines,SUPB15,EL4,and H9,showing IC50values of 0.36–27.08μmol/L.

关键词： Phoma sp. Tropolonic sesquiterpenes Biosynthetic pathways Hetero-Diels–Alder Cytotoxicity

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Chemokine-like factor 1 (CKLF1) is expressed in myocardial ischemia injury in vivo and in vitro

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BIOCELL 2024年第6期48卷 981-990页

作者： JULING FENG HAODONG CHEN YANGBO LIU QIDI AI YANTAO YANG LEI ZHAO SHIFENG CHU NAIHONG CHEN School of Pharmacy Department of PharmacyHunan Engineering Technology Center of Standardization and Function of Chinese Herbal Decoction PiecesHunan University of Chinese MedicineChangsha410208China Department of pharmacology State Key Laboratory of Bioactive Substances and Functions of Natural MedicinesInstitute of Materia Medica&Neuroscience CenterChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing100050China Department of Diagnostics Research Lab of Translational Medicine Hengyang Medical CollegeUniversity of South ChinaHengyang421001China Department of Gastrointestinal Surgery The First Affiliated HospitalHengyang Medical CollegeUniversity of South ChinaHengyang421001China

Introduction:Chemokine-like factor 1(CKLF1)is a chemokine that is overexpressed in several *** previousﬁndings revealed a signiﬁcant increase in CKLF1 expression in the ischemic brain,suggesting its potential as a therapeutic target for ischemic ***:In this study,we examined the expression dynamics of CKLF1 in both in vivo and in vitro models of ischemic cardiac *** infarction(MI)was induced in vivo by ligation of the left anterior descending artery(LAD)of the rat *** levels of CKLF1,Creatine Kinase MB Isoenzyme(CK-MB),and Lactate dehydrogenase(LDH)in the serum were detected using Enzyme-linked immunosorbent assay(ELISA).The expression of CKLF1 in the infarcted area was detected by immunohistochemistry,immunoﬂuorescence,quantitative PCR(qPCR),and Western blotting(WB).H9C2 and AC16 cardiomyocytes cultured in vitro were subjected to oxygen and glucose deprivation(OGD).LDH was used to detect cell damage,and CKLF1 expression was detected by qPCR and ***:CKLF1 mRNA and protein expression were signiﬁcantly increased in h9c2 cells at 1.5 h and in AC16 cells at 4 h after *** serum CK-MB in rats increased signiﬁcantly on theﬁrst day after infarction,while the LDH concentration increased signiﬁcantly on the third day after ***1 blood levels signiﬁcantly increased on theﬁrst day following MI in ***1 expression notably increased in the infarct area on days 1,3,and 7 *** MI tissue,CKLF1 colocalizes with cardiomyocytes,macrophages,and ***:CKLF1 was substantially expressed during myocardial ischemia injury both in vivo and in vitro and was colocalized with macrophages and neutrophils,indicating that CKLF1 is expected to be a biomarker and a drug target for the treatment of myocardial infarction.

关键词： Chemokine-like factor 1 Overexpression Myocardial infarction

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Estimating the Scarlet Fever Epidemics Using a Seasonal Autoregressive Fractionally Integrated Moving Average Model

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Biomedical and Environmental Sciences 2024年第3期37卷 336-340页

作者： WANG Yong Bin XUE Chen Lu ZHOU Pei Ping ZHANG Bing Jie XU Chun Jie Department of Epidemiology and Health Statistics School of Public HealthThe First Affiliated Hospital of Xinxiang Medical UniversityXinxiang 453003HenanChina Beijing Key Laboratory of Antimicrobial Agents/Laboratory of pharmacology Institute of Medicinal BiotechnologyChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China

Scarlet fever(SF)is a common infectious disease caused by group A streptococcus(GAS)[1].During the 18th and 19th centuries,SF was a significant cause of mortality in children aged 5-15 years worldwide[2].The incidence and fatality rates of SF have decreased remarkably due to the widespread use of effective antibiotics and improvements in diet and sanitation[3].However,the recent resurgence of SF has sparked significant interest in infectious diseases[1,3].Given the insufficient understanding of the triggers that cause SF outbreaks and the absence of available vaccines to prevent GAS infection to date[1],effective prevention and control programs are needed to manage the ongoing spread of SF.

关键词： prevention mortality let

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我国自主开发的抗菌新药临床管线最新进展（英文）

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Engineering 2024年第7期 52-68页

作者：杨信怡李聪然王秀坤郑忠辉孙培译许春杰陈鲁妮蒋建东 Staffan Normark Birgitta Henriques-Normark 游雪甫 Beijing Key Laboratory of Antimicrobial Agents/Laboratory of pharmacology Institute of Medicinal Biotechnology Chinese Academy of Medical Sciences & Peking Union Medical College Division for Medicinal Microorganism-Related Strains CAMS Collection Center of Pathogenic Microorganisms Chinese Academy of Medical Sciences & Peking Union Medical College State Key Laboratory of Bioactive Substances and Functions of Natural Medicines Institute of Medicinal Biotechnology Chinese Academy of Medical Sciences & Peking Union Medical College Shandong Xinhua Pharmaceutical Co. Ltd. Department of Microbiology Tumor and Cell Biology Karolinska Institutet State Key Laboratory of Bioactive Substances and Function of Natural Medicines Institute of Materia Medica Chinese Academy of Medical Sciences & Peking Union Medical College Institute of Medicinal Biotechnology Chinese Academy of Medical Sciences & Peking Union Medical College Clinical Microbiology Karolinska University Hospital

Antibacterial resistance is a global health threat that requires further concrete action on the part of all *** this context,one of the biggest concerns is whether enough new antibacterial drugs are being discovered and *** 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 *** this review,we summarize the latest progress of novel antibacterial drugs approved for marketing and under clinical evaluation in China since *** 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 *** of June 30,2023,a total of 20 antibacterial projects from 17 Chinese pharmaceutical companies or developers were identified and *** 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 18antibacterial agents are in clinical development,with one under regulatory evaluation,five in phase-3,six in phase-2,and six in *** of the clinical candidates are new analogs or monocomponents of traditional antibacterial pharmacophore types,including two dual-acting hybrid antibiotics and a recombinant antibacterial ***,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 ***,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 drug

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Let-7i-5p maintains the stemness via R-spondin2/Wnt pathway in hepatocellular carcinoma

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Genes & Diseases 2024年第4期11卷 20-23页

作者： Qinghua Wei Xueshan Dai Jiahui Wei Wenwei Sun Xiaoqian Yang Yuxin Zhang Xin Guo Yi Chen college of Pharmaceutical Sciences&Chinese Medicine Southwest UniversityChongqing 400716China Center for Basic medical Research TEDA International Cardiovascular HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeTianjin 300457China Chongqing Key Laboratory of New Drug Screening from Traditional Chinese Medicine Chongqing 400716China pharmacology of Chinese Materia Medica-the Key Discipline Constructed by the State Administration of Traditional Chinese Medicine Chongqing 400716China Division of Cell Developmental and Integrative BiologySchool of MedicineSouth China University of TechnologyGuangzhouGuangdong 510006China National Demonstration Center for Experimental Pharmacy Education(Southwest University) Chongqing 400716China Engineering Research Center of Coptis Development and Utilization(Ministry of Education) College of Pharmaceutical Sciences and Chinese MedicineSouthwest UniversityChongqing 400716China

Cancer stem cells(CSCs)are related to tumorigenesis,recurrence,metastasis,and drug resistance in hepatocellular carcinoma(HCC).1 Let-7i is a noncoding small RNA,belonging to the famous miRNA let-7 ***,let-7i has been ... 详细信息

关键词： hepatocellular Cancer metastasis

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Bioactive materials from berberine-treated human bone marrow mesenchymal stem cells promote alveolar bone regeneration by regulating macrophage polarization

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Science China(Life Sciences) 2024年第5期67卷 1010-1026页

作者： Ziyue Qin Yanxing Han Yifei Du Yixuan Zhang Yifeng Bian Ruyu Wang Haoran Wang Fanyi Guo Hua Yuan Yongchu Pan Jianliang Jin Qigang Zhou Yuli Wang Feng Han Yan Xu Jiandong Jiang Department of Oral and Maxillofacial Surgery The Affiliated Stomatological Hospital of Nanjing Medical UniversityNanjing 210029China Jiangsu Province Key Laboratory of Oral Diseases Nanjing Medical UniversityNanjing 210029China Jiangsu Province Engineering Research Center of Stomatological Translational Medicine Nanjing 210029China State Key Laboratoryof BioactiveSubstances andFunction of Natural Medicine Instituteof Materia MedicaChinese Academyof MedicalSciencesandPeking Union MedicalCollegeBeijing100050China Gusu school Nanjing medical universitySuzhou 215002China Key Laboratory of Cardiovascular&Cerebrovascular Medicine Drug Target and Drug Discovery CenterSchool of PharmacyNanjing Medical UniversityNanjing 211166 China Department of Orthodontics The Affiliated Stomatological Hospital of Nanjing Medical UniversityNanjing 210029China Department of Human Anatomy Research Centre for Bone and Stem CellsKey Laboratory for Aging&DiseaseThe State Key Laboratory of Reproductive MedicineNanjing Medical UniversityNanjing 211166China Department of Clinical pharmacology School of PharmacyNanjing Medical UniversityNanjing Jiangsu211166China Department of Periodontology The Affiliated Stomatological Hospital of Nanjing Medical UniversityNanjing 210029China Department of Virology Institute of Medicinal BiotechnologyChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China

Alveolar bone regeneration has been strongly linked to macrophage polarization.M1 macrophages aggravate alveolar bone loss,whereas M2 macrophages reverse this ***(BBR),a natural alkaloid isolated and refined from Chinese medicinal plants,has shown therapeutic effects in treating metabolic *** this study,we first discovered that culture supernatant(CS)collected from BBR-treated human bone marrow mesenchymal stem cells(HBMSCs)ameliorated periodontal alveolar bone *** from the BBR-treated HBMSCs contained bioactive materials that suppressed the M1 polarization and induced the M2 polarization of macrophages in vivo and in *** clarify the underlying mechanism,the bioactive materials were applied to different animal *** discovered macrophage colony-stimulating factor(M-CSF),which regulates macrophage polarization and promotes bone formation,a key macromolecule in the *** of pure M-CSF attenuated experimental periodontal alveolar bone loss in ***-stimulating factor 1 receptor(CSF1R)inhibitor or anti-human M-CSF(M-CSF neutralizing antibody,Nab)abolished the therapeutic effects of the CS of BBR-treated ***,AKT phosphorylation in macrophages was activated by the CS,and the AKT activator reversed the negative effect of the CSF1R inhibitor or *** results suggest that the CS of BBR-treated HBMSCs modulates macrophage polarization via the M-CSF/AKT *** studies also showed that CS of BBR-treated HBMSCs accelerated bone formation and M2 polarization in rat teeth extraction ***,our findings established an essential role of BBR-treated HBMSCs CS and this might be the first report to show that the products of BBR-treated HBMSCs have active effects on alveolar bone regeneration.

关键词： berberine human bone marrow mesenchymal stem cells alveolar bone regeneration macrophage colony-stimulating factor AKT phosphorylation

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Author correction to“Identification of the dietary supplement capsaicin as an inhibitor of Lassa virus entry”[Acta Pharmaceutica Sinica B 10(2020)789-798]

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Acta Pharmaceutica Sinica B 2024年第7期14卷 3294-3294页

作者： Ke Tang Xiaoyu Zhang Ying Guo State Key Laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China Department of pharmacology Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China

The authors regret that there is an error in Fig.2B(Page 793),in which the fluorescence image of the“DMSO(Before&during low pH treatment)”group was mistakenly pasted in the process of assembling *** correction does not significantly impact the findings and conclusions of the *** authors would like to assure readers that the corrected image does not alter the validity of the *** original data of these figures have been provided to the Editorial Office,and the corresponding authors or the Editorial Office can be contacted for original data access.

关键词： correction figures image

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Artificial Bear Bile:A Novel Approach to Balancing medical Requirements and Animal Welfare

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Engineering 2024年第7期38卷 100-112页

作者： Yong Li Yuhong Huang Nan Feng Heping Zhang Jing Qu Shuanggang Ma Yunbao Liu Jiang Li Shaofeng Xu Ling Wang Mi Zhang Jie Cai Weiping Wang Ru Feng Hang Yu Bo Yu Dailiang Liang Heping Qin Suxiang Luo Yanfen Li Meifeng Li Ruihua Wang Chen Ma Yan Wang Xiaobo Cen Xiaoxian Xu Boli Zhang Xiaoliang Wang Shishan Yu State Key Laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300250China Zhongshan Belling Biotechnology Co. Ltd.Zhongshan 528437China Zhongshan Anshi Biopharmaceutical Co. Ltd.Zhongshan 528437China e WestChina-Frontier Pharma Tech Co.Ltd.Chengdu 610041China Tianjin University of Traditional Chinese Medicine Tianjin 301617China

Bear bile has been a valuable and effective medicinal material in traditional Chinese medicine(TCM)for over 13 ***,the current practice of obtaining it through bear farming is under scrutiny for its adverse impact on bear ***,we present a new approach for creating artificial bear bile(ABB)as a high-quality and sustainable alternative to natural bear *** study addresses the scientific challenges of creating bear bile alternatives through interdisciplinary collaborations across various fields,including resources,chemistry,biology,medicine,pharmacology,and TCM.A comprehensive efficacy assessment system that bridges the gap between TCM and modern medical terminology has been established,allowing for the systematic screening of therapeutic *** the utilization of chemical synthesis and enzyme engineering technologies,our research has achieved the environmentally friendly,large-scale production of bear bile therapeutic compounds,as well as the optimization and recomposition of ABB *** resulting ABB not only closely resembles natural bear bile in its composition but also offers advantages such as consistent product quality,availability of raw materials,and independence from threatened or wild *** preclinical efficacy evaluations have demonstrated the equivalence of the therapeutic effects from ABB and those from commercially available drained bear bile(DBB).Furthermore,preclinical toxicological assessment and phase I clinical trials show that the safety of ABB is on par with that of the currently used *** innovative strategy can serve as a new research paradigm for developing alternatives for other endangered TCMs,thereby strengthening the integrity and sustainability of TCM.

关键词： Artificial bear bile Chemical profile Formula optimization Pharmacodynamic consistency Preclinical toxicological assessment

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