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中国专利与商标 2021年第4期 99-104页

作者：无 National medical Products administration China National Intellectual Property administration

On the basis of the Patent Law of the Peopled Republic of China,the National medical Products administration and the China National Intellectual Property administration have organized and formulated the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes(Trial Implementation),which are hereby issued with the consent of the State Council,and shall come into force on the date of promulgation.

关键词： administration Patent Implementation

China National medical Products administration approval summary:anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy

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Cancer Communications 2019年第1期39卷 338-347页

作者： Ming Zhou Xiaoyuan Chen Hong Zhang Lin Xia Xin Tong Limin Zou Ruimin Hao Jianhong Pan Xiao Zhao Dongmei Chen Yuanyuan Song Yueli Qi Ling Tang Zhifang Liu Rong Gao Yuankai Shi Zhimin Yang medical Review Department 1 Center for Drug EvaluationChina National Medical Products AdministrationNo.128 Jianguo RoadChaoyang DistrictBeijing 100022P.R.China Center for Drug Inspection China National Medical Products AdministrationBeijing 100037P.R.China Department of medical Oncology Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsNational Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100021P.R.China

Background:On May 8,2018,the China National medical Products administration(NMPA)approved anlotinib,an orally administered anti-angiogenesis inhibitor,for the treatment of patients with advanced non-small cell lung can-cer(NSCLC)who have progressed after treatment with two or more lines of prior systemic *** body of the abstract:China NMPA reviewed and inspected a regional double-blinded,placebo-controlled,Phase III trial comparing the overall survival(OS)of NSCLC patients between the anlotinib and placebo arms.A total of 437 patients were randomized(2:1)to receive either anlotinib(n=294)or placebo(n=143)once daily on a 2-week on and 1-week off *** with epidermal growth factor receptor(EGFR)or activating anaplastic lymphoma kinase(ALK)genomic tumor aberrations should have disease progression on NMPA-approved *** is the first NMPA-approved drug for patients with advanced NSCLC who have progressed on at least two lines of prior systemic chemotherapies in *** approval was based on a statistically and clinically significant improvement in median OS with anlotinib(9.46 months)compared with placebo[6.37 months;hazard ratio(HR])=0.70,95%confidence interval(CI)=0.55-0.89;two-sided log-rank P=0.002].The confirmed objective response rate(ORR)was 9.2%in the anlotinib arm and 0.7%in the placebo *** median duration of response(DoR)was 4.83 months,with a 95%CI of 3.31-6.97 *** toxicity profile of anlotinib was consistent with that of known anti-angiogenesis *** adverse drug reactions(ADRs)in anlotinib-treated patients included hypertension(67.4%),hand-foot syndrome(43.9%),hemoptysis(14.0%),thyroid stimulating hormone(TSH)elevation(46.6%),and corrected QT interval(QTc)prolongation(26.2%).Short conclusion:Anlotinib demonstrated a clinically significant OS prolongation as a novel therapeutic option for advanced or metastatic NSCLC following at least two lines of chemotherapy.

关键词： Advanced non-small cell lung cancer Anlotinib Anti-angiogenesis Epidermal growth factor receptor Activating anaplastic lymphoma kinase Adverse drug reaction National medical Products administration

Acceptance of overseas clinical trial data of medical devices for pre-market registration: general principles and considerations of the National medical Products administration

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Chinese medical Journal 2021年第18期134卷 2163-2165页

作者： Shan Ju Ying-Hui Liu Yi-Dan Zhang Chuan-Song Wu Li Xiao Lei Sun Department of Clinical and Biostatistics I Center for Medical Device Evaluation National Medical Products AdministritionBeijing 100081China Center for medical Device Evaluation National medical Products Administrition Beijing 100081China

A clinical trial is a systematic investigation or study in or on one or more human subjects,undertaken to assess the safety,clinical performance,and/or effectiveness of a medical device.[1]In this paper,“overseas clinical trial data”refers to data generated from a clinical trial(s)conducted in a foreign country or jurisdiction and proposed to be used as clinical evidence for a pre-market registration application in China.

关键词： clinical market medical

Early identification of stroke through deep learning with multi-modal human speech and movement data

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Neural Regeneration Research 2025年第1期20卷 234-241页

作者： Zijun Ou Haitao Wang Bin Zhang Haobang Liang Bei Hu Longlong Ren Yanjuan Liu Yuhu Zhang Chengbo Dai Hejun Wu Weifeng Li Xin Li School of Computer Science and Engineering Sun Yat-sen UniversityGuangzhouGuangdong ProvinceChina Department of Neurology Guangdong Neuroscience InstituteGuangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences)Southern Medical UniversityGuangzhouGuangdong ProvinceChina Department of Emergency Medicine Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences)Southern Medical UniversityGuangzhouGuangdong ProvinceChina

Early identification and treatment of stroke can greatly improve patient outcomes and quality of *** clinical tests such as the Cincinnati Pre-hospital Stroke Scale(CPSS)and the Face Arm Speech Test(FAST)are commonly used for stroke screening,accurate administration is dependent on specialized *** this study,we proposed a novel multimodal deep learning approach,based on the FAST,for assessing suspected stroke patients exhibiting symptoms such as limb weakness,facial paresis,and speech disorders in acute *** collected a dataset comprising videos and audio recordings of emergency room patients performing designated limb movements,facial expressions,and speech tests based on the *** compared the constructed deep learning model,which was designed to process multi-modal datasets,with six prior models that achieved good action classification performance,including the I3D,SlowFast,X3D,TPN,TimeSformer,and *** found that the findings of our deep learning model had a higher clinical value compared with the other ***,the multi-modal model outperformed its single-module variants,highlighting the benefit of utilizing multiple types of patient data,such as action videos and speech *** results indicate that a multi-modal deep learning model combined with the FAST could greatly improve the accuracy and sensitivity of early stroke identification of stroke,thus providing a practical and powerful tool for assessing stroke patients in an emergency clinical setting.

关键词： artificial intelligence deep learning diagnosis early detection FAST screening stroke

Inhibiting ceramide synthase 5 expression in microglia decreases neuroinflammation after spinal cord injury

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Neural Regeneration Research 2025年第10期20卷 2955-2968页

作者： Wei Zhang Yubao Lu Ruoqi Shen Yingjie Wu Chenrui Liu Xingxing Fang Liangming Zhang Bin Liu Limin Rong Department of Spine Surgery The Third Affiliated HospitalSun Yat-sen UniversityGuangzhouGuangdong ProvinceChina National medical Products administration(NMPA)Key Laboratory for Quality Research and Evaluation of Cell Products GuangzhouGuangdong ProvinceChina Guangdong Provincial Center for Quality Control of Minimally Invasive Spine Surgery GuangzhouGuangdong ProvinceChina Guangdong Provincial Center for Engineering and Technology Research of Minimally Invasive Spine Surgery GuangzhouGuangdong ProvinceChina

Microglia,the resident monocyte of the central nervous system,play a crucial role in the response to spinal cord ***,the precise mechanism remains *** investigate the molecular mechanisms by which microglia regulate the neuroinflammatory response to spinal cord injury,we performed single-cell RNA sequencing dataset analysis,focusing on changes in microglial *** found that the MG1 subpopulation emerged in the acute/subacute phase of spinal cord injury and expressed genes related to cell pyroptosis,sphingomyelin metabolism,and neuroinflammation at high ***,we established a mouse model of contusive injury and performed intrathecal injection of siRNA and molecular inhibitors to validate the role of ceramide synthase 5 in the neuroinflammatory responses and pyroptosis after spinal cord ***,we established a PC12-BV2 cell co-culture system and found that ceramide synthase 5 and pyroptosis-associated proteins were highly expressed to induce the apoptosis of neuron *** ceramide synthase 5 expression in a mouse model of spinal cord injury effectively reduced ***,ceramide synthase 5-induced pyroptosis was dependent on activation of the NLRP3 signaling *** ceramide synthase 5 expression in microglia in vivo reduced neuronal apoptosis and promoted recovery of neurological ***2g7 formed a“bridge”between sphingolipid metabolism and ceramide synthase 5-mediated cell death by inhibiting the NLRP3 signaling ***,these findings suggest that inhibiting ceramide synthase 5 expression in microglia after spinal cord injury effectively suppressed microglial pyroptosis mediated by NLRP3,thereby exerting neuroprotective effects.

关键词： ceramide synthase 5 gasdermin D microglia neuroinflammation NLRP3 nuclear factor kappa B Pla2g7 pyroptosis sphingomyelin metabolism spinal cord injury

Research on diagnosis-related group grouping of inpatient medical expenditure in colorectal cancer patients based on a decision tree model

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World Journal of Clinical Cases 2020年第12期8卷 2484-2493页

作者： Suo-Wei Wu Qi Pan Tong Chen Department of medical administration Beijing HospitalBeijing 100730China

BACKGROUND In 2018,the diagnosis-related groups prospective payment system(DRGs-PPS)was introduced in a trial operation in Beijing according to the requirements of medical and health *** implementation of the system requires that more than 300 disease types pay through the DRGs-PPS for medical *** cancer(CRC),as a common malignant tumor with high prevalence in recent years,was among the 300 disease *** To investigate the composition and factors related to inpatient medical expenditure in CRC patients based on disease DRGs,and to provide a basis for the rational economic control of hospitalization expenses for the diagnosis and treatment of *** The basic material and cost data for 1026 CRC inpatients in a Grade-A tertiary hospital in Beijing during 2014-2018 were collected using the medical record system.A variance analysis of the composition of medical expenditure was carried out,and a multivariate linear regression model was used to select influencing factors with the greatest statistical significance.A decision tree model based on the exhaustiveχ^2 automatic interaction detector(E-CHAID)algorithm for DRG grouping was built by setting chosen factors as separation nodes,and the payment standard of each diagnostic group and upper limit cost were *** correctness and rationality of the data were re-evaluated and verified by clinical *** The average hospital stay of the 1026 CRC patients investigated was 18.5 d,and the average hospitalization cost was 57872.4 RMB *** including age,gender,length of hospital stay,diagnosis and treatment,as well as clinical operations had significant influence on inpatient expenditure(P<0.05).By adopting age,diagnosis,treatment,and surgery as the grouping nodes,a decision tree model based on the E-CHAID algorithm was established,and the CRC patients were divided into 12 DRG cost *** these 12 groups,the number of patients aged≤67 years,and underwent surgery and

关键词： Diagnosis-related groups Health care cost Colorectal cancer Length of stay

Regulatory considerations for animal studies of biomaterial products

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Bioactive Materials 2022年第5期7卷 52-56页

作者： Maobo Cheng Wenbo Liu Jiazhen Zhang Song Zhang Zhaojun Guo Lu Liu Jiaxin Tian Xiangmei Zhang Jin Cheng Yinghui Liu Gang Deng Guobiao Gao Lei Sun Center for medical Device Evaluation National Medical Products AdministrationBeijing100081China National medical Products administration Beijing100037China

Animal studies play a vital role in validating the concept,feasibility,safety,performance and efficacy of biomaterials products during their bench-to-clinic *** article aims to share regulatory considerations for animal studies of biomaterial *** briefly emphasizing the importance of animal studies,issues of animal studies during biomaterial products’translation are *** studies with unclear purposes,flawed design and poor reporting quality could significantly reduce the translation efficiency and create regulatory *** perspectives on the purpose,principle,quality and regulatory science of animal studies are also *** studies should have clear purposes,follow principles of 3R+DQ(replacement,reduction,refinement,design and quality)and execute under an efficiently operating quality management *** the advancement of regulatory science,National medical Products administration of China has been developing a series of standards and guidance documents on animal studies of medical *** studies of making decisions on whether to conduct animal studies are provided in the end with drug-eluting stents as *** summary,animal studies of biomaterial products should pay close attention to the rationale,design and quality in order to achieve their purposes.

关键词： Animal studies Biomaterials 3R(Replacement,Reduction and refinement) Design and quality

New era of drug innovation in China

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Acta Pharmaceutica Sinica B 2019年第5期9卷 1084-1085页

作者： Xuan Ye Qingli Wang Haixue Wang Office of Pharmacology and Toxicology Center for Drug Evaluation National Medical Products Administration

In 2018, the China National medical Products administration(NMPA) approved new drug applications (NDAs) of 48 new drugs, which was the highest annual approval rate by the Chinese regulatory agency in the past 20 years. Nine of the 48 new drugs,including fruquintinib, anlotinib, toripalimab and sintilimab, are global new molecular entities (NME) that were developed by Chinese pharmaceutical companies.

关键词： New era drug innovation China

Western North Pacific Tropical Cyclone Database Created by the China Meteorological administration

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Advances in Atmospheric Sciences 2021年第4期38卷 690-699页

作者： Xiaoqin LU Hui YU Ming YING Bingke ZHAO Shuai ZHANG Limin LIN Lina BAI Rijin WAN Shanghai Typhoon Institute China Meteorological AdministrationShanghai 200030China Key Laboratory of Numerical Modeling for Tropical Cyclone/China Meteorological administration Shanghai 200030China

This paper describes the access to, and the content, characteristics, and potential applications of the tropical cyclone(TC) database that is maintained and actively developed by the China Meteorological administration, with the aim of facilitating its use in scientific research and operational services. This database records data relating to all TCs that have passed through the western North Pacific(WNP) and South China Sea(SCS) since 1949. TC data collection has expanded over recent decades via continuous TC monitoring using remote sensing and specialized field detection techniques,allowing collation of a multi-source TC database for the WNP and SCS that covers a long period, with wide coverage and many observational elements. This database now comprises a wide variety of information related to TCs, such as historical or real-time locations(i.e., best track and landfall), intensity, dynamic and thermal structures, wind strengths, precipitation amounts, and frequency. This database will support ongoing research into the processes and patterns associated with TC climatic activity and TC forecasting.

关键词： tropical cyclone multi-source database western North Pacific

Human neural stem cell-derived extracellular vesicles protect against ischemic stroke by activating the PI3K/AKT/mTOR pathway

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Neural Regeneration Research 2025年第11期20卷 3245-3258页

作者： Jiayi Wang Mengke Zhao Dong Fu Meina Wang Chao Han Zhongyue Lv Liang Wang Jing Liu Stem Cell Clinical Research Center The First Affiliated Hospital of Dalian Medical UniversityDalianLiaoning ProvinceChina Dalian Innovation Institute of Stem Cell and Precision Medicine DalianLiaoning ProvinceChina Institute(College)of Integrative Medicine Dalian Medical UniversityDalianLiaoning ProvinceChina

Human neural stem cell-derived extracellular vesicles exhibit analogous functions to their parental cells,and can thus be used as substitutes for stem cells in stem cell therapy,thereby mitigating the risks of stem cell therapy and advancing the frontiers of stem cell-derived *** lays a foundation for the development of potentially potent new treatment modalities for ischemic ***,the precise mechanisms underlying the efficacy and safety of human neural stem cell-derived extracellular vesicles remain unclear,presenting challenges for clinical *** promote the translation of therapy based on human neural stem cell-derived extracellular vesicles from the bench to the bedside,we conducted a comprehensive preclinical study to evaluate the efficacy and safety of human neural stem cell-derived extracellular vesicles in the treatment of ischemic *** found that administration of human neural stem cell-derived extracellular vesicles to an ischemic stroke rat model reduced the volume of cerebral infarction and promoted functional recovery by alleviating neuronal *** human neural stem cell-derived extracellular vesicles reduced neuronal apoptosis by enhancing phosphorylation of phosphoinositide 3-kinase,mammalian target of rapamycin,and protein kinase B,and these effects were reversed by treatment with a phosphoinositide 3-kinase *** findings suggest that human neural stem cell-derived extracellular vesicles play a neuroprotective role in ischemic stroke through activation of phosphoinositide 3-kinase/protein kinase B/mammalian target of rapamycin signaling ***,we showed that human neural stem cell-derived extracellular vesicles have a good in vivo safety ***,human neural stem cell-derived extracellular vesicles are a promising potential agent for the treatment of ischemic stroke.

关键词： behavior exosome extracellular vesicles ischemic stroke mammalian target of rapamycin(mTOR) middle cerebral artery occlusion neural stem cells neuronal apoptosis phosphoinositide 3-kinase(PI3K) protein kinase B(AKT)