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| 1 | Viral vector platforms within the gene therapy landscape显示文摘Throughout its 40-year history,the field of gene therapy has been marked by many transitions.It has seen great strides in combating human disease,has given hope to patients and families with limited treatment options,but has also been subject to many setbacks.Treatment of patients with this class of investigational drugs has resulted in severe adverse effects and,even in rare cases,death.At the heart of this dichotomous field are the viral-based vectors,the delivery vehicles that have allowed researchers and clinicians to develop powerful drug platforms,and have radically changed the face of medicine.Within the past 5 years,the gene therapy field has seen a wave of drugs based on viral vectors that have gained regulatory approval that come in a variety of designs and purposes,these modalities range from vector-based cancer therapies,to treating monogenic diseases with life-altering outcomes.At present,the three key vector strategies are based on adenoviruses,adeno-associated viruses,and lentiviruses.They have led the way in preclinical and clinical successes in the past two decades.However,despite these successes,many challenges still limit these approaches from attaining their full potential.To review the viral vector-based gene therapy landscape,we focus on these three highly regarded vector platforms and describe mechanisms of action and their roles in treating human disease. | Jote T.Bulcha Yi Wang Hong Ma Phillip W.L.Tai Guangping Gao | 2021 | Signal Transduction and Targeted Therapy2021，6，3： | 5 |
| 2 | Therapeutic siRNA:state of the art显示文摘RNA interference(RNAi)is an ancient biological mechanism used to defend against external invasion.It theoretically can silence any disease-related genes in a sequence-specific manner,making small interfering RNA(siRNA)a promising therapeutic modality.After a two-decade journey from its discovery,two approvals of siRNA therapeutics,ONPATTRO®(patisiran)and GIVLAARI™(givosiran),have been achieved by Alnylam Pharmaceuticals.Reviewing the long-term pharmaceutical history of human beings,siRNA therapy currently has set up an extraordinary milestone,as it has already changed and will continue to change the treatment and management of human diseases.It can be administered quarterly,even twice-yearly,to achieve therapeutic effects,which is not the case for small molecules and antibodies.The drug development process was extremely hard,aiming to surmount complex obstacles,such as how to efficiently and safely deliver siRNAs to desired tissues and cells and how to enhance the performance of siRNAs with respect to their activity,stability,specificity and potential off-target effects.In this review,the evolution of siRNA chemical modifications and their biomedical performance are comprehensively reviewed.All clinically explored and commercialized siRNA delivery platforms,including the GalNAc(N-acetylgalactosamine)–siRNA conjugate,and their fundamental design principles are thoroughly discussed.The latest progress in siRNA therapeutic development is also summarized.This review provides a comprehensive view and roadmap for general readers working in the field. | Bo Hu Liping Zhong Yuhua Weng Ling Peng Yuanyu Huang Yongxiang Zhao Xing-Jie Liang | 2020 | Signal Transduction and Targeted Therapy2020，5，1： | 4 |
| 3 | Technical Vaccination Recommendations for COVID-19 Vaccines in China(First Edition)显示文摘To date,five coronavirus disease 2019(COVID-19)vaccines have been conditionally approved for market authorization or granted emergency use authorization in China by the National Medical Products Administration(NMPA).Three inactivated COVID-19 vaccines and one adenovirus-vectored vaccine were granted conditional approval,as phaseⅢclinical trial data for these four conditionally-approved vaccines have demonstrated protective efficacy levels that meet requirements of NMPA’s Guidelines for Clinical Evaluation of COVID-19 vaccine(interim version)and also meet requirements recommended by the World Health Organization(WHO)in their COVID-19 Vaccines Target Product Profile. | COVID-19 Vaccine Technical Working Group | 2021 | China CDC weekly2021，3，21： | 4 |
| 4 | 价值判断与刑法解释的功能:从陆勇案的刑法困境说起(英文)显示文摘Lu Yong’s Case,which once attracted much public attention,finally had achieved an ideal result thanks to the efforts of all sides.According to the Written Decision Not to Prosecute rendered by Yuan Jiang People’s Procuratorate of Hunan Province,Lu Yong’s acts of buying the imported drug and of helping others to buy the drug without approval are considered non-selling acts,which do not constitute the crime of selling counterfeit drugs as prescribed in article 141 of the Criminal Law;moreover,Lu Yong’s act of purchasing three debit cards issued to other people and of using one of them is deemed to be obviously minor circumstance and the harm done | 劳东燕 Li Xing | 2016 | China Legal Science2016，4，2： | 3 |
| 5 | Active Vaccine Safety Surveillance: Global Trends and Challenges in China显示文摘Importance.The great success in vaccine-preventable diseases has been accompanied by vaccine safety concerns.This has caused vaccine hesitancy to be the top 10 in threats to global health.The comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval surveillance.It has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical trials.Highlights.In the present study,the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety concerns.Then,the global progress of active surveillance systems was reviewed,mainly focusing on population-based or hospital-based active surveillance.With these successful paradigms,the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases,methodology challenges,policy supports,and ethical considerations.Conclusion.In the inevitable trend of the global vaccine safety ecosystem,the establishment of an active surveillance system for vaccine safety in China is urgent and feasible.This process can be accelerated with the consensus and cooperation of regulatory departments,research institutions,and data owners. | Zhike Liu Ruogu Meng Yu Yang Keli Li Zundong Yin Jingtian Ren Chuanyong Shen Zijian Feng Siyan Zhan | 2021 | Health Data Science2021，，1： | 2 |
| 6 | Neoantigens:promising targets for cancer therapy显示文摘Recent advances in neoantigen research have accelerated the development and regulatory approval of tumor immunotherapies,including cancer vaccines,adoptive cell therapy and antibody-based therapies,especially for solid tumors.Neoantigens are newly formed antigens generated by tumor cells as a result of various tumor-specific alterations,such as genomic mutation,dysregulated RNA splicing,disordered post-translational modification,and integrated viral open reading frames.Neoantigens are recognized as non-self and trigger an immune response that is not subject to central and peripheral tolerance.The quick identification and prediction of tumor-specific neoantigens have been made possible by the advanced development of next-generation sequencing and bioinformatic technologies.Compared to tumor-associated antigens,the highly immunogenic and tumor-specific neoantigens provide emerging targets for personalized cancer immunotherapies,and serve as prospective predictors for tumor survival prognosis and immune checkpoint blockade responses.The development of cancer therapies will be aided by understanding the mechanism underlying neoantigen-induced anti-tumor immune response and by streamlining the process of neoantigen-based immunotherapies.This review provides an overview on the identification and characterization of neoantigens and outlines the clinical applications of prospective immunotherapeutic strategies based on neoantigens.We also explore their current status,inherent challenges,and clinical translation potential. | Na Xie Guobo Shen Wei Gao Zhao Huang Canhua Huang Li Fu | 2023 | Signal Transduction and Targeted Therapy2023，8，2： | 2 |
| 7 | New light on the horizon of Alzheimer’s disease显示文摘The beginning of the year 2020 is marked by a groundbreaking event in drug development in China.A first-in-class drug for Alzheimer’s disease(AD),GV-971,received conditional approval by the China Food and Drug Administration for the Chinese market.China now has at least 10 million patients with diagnosed AD;afflicting almost one-third of the population aged 90-94 years.There is increasing demand for new AD drugs,as the societal burden caused by this devastating disease is becoming a major healthcare issue in all aging societies.This urgency is reflected by the conditional approval of the drug,a widely used method by drug regulatory agencies in advanced countries to expedite promising new medicines to the market and facilitate early patient access,before long-term assessment of the treatment is available. | Mu-ming Poo | 2020 | National Science Review2020，7，5： | 2 |
| 8 | National Cancer Data Linkage Platform of China:Design,Methods,and Application显示文摘Background:The National Cancer Center(NCC)and China CDC cooperatively designed a National Cancer Data Linkage(NCDL)Platform to fulfill the task of sharing cancer outcome data through an automatic web-based system.Methods:NCC and China CDC established a web-based NCDL Platform to link death information from China CDC with the cancer database from NCC.Overall,76,708 cancer patients’data were analyzed to assess the feasibility and match rate of the NCDL Platform for 7 major cancers.Results:The function of the platform includes a data application and approval system,data linkage module,and results visualization system.Through the platform,38.9%cases were identified as deaths cases from the NCDL Platform in the first 3 years after cancer diagnosis.The linkage rate was highest in liver cancer and lowest in breast cancer.Conclusions:The NCDL Platform provides a powerful and efficient way to link national vital statistics with national cancer programs’data.Expanding cancer outcome data linkage may not only improve data collection efficiency,but also improve data use. | Hongmei Zeng Yunning Liu Lijun Wang Peng Yin Baohua Wang Ruiying Fu Xianhui Ran Rongshou Zheng Siwei Zhang Jiangmei Liu Jinling You Kexin Sun Shaoming Wang Li Li Ru Chen Wenqiang Wei Maigeng Zhou Jing Wu Jie He | 2022 | China CDC weekly2022，4，13： | 1 |
| 9 | Functional food products in Japan:A review显示文摘Japan has a long history of using foods with health benefits and Japanese people are well-known for their longevity.In 1991,the Ministry of Health,Labor and Welfare introduced a functional food regulation called“foods for specified health uses”(FOSHU)in Japan.After the introduction of the functional food system,many clinically proven FOSHU products with health benefits have been developed and launched in the market.As a result,the net sales of FOSHU products reached 6.2 billion dollars in 2007.Most of the health claims relate to improving gastro-intestinal health using probiotics.Triglycerides,high blood pressure,high LDL-cholesterol,and high blood glucose are mainly associated with the related health claims.After 2007,the market for FOSHU products was almost saturated.However,a novel functional regulatory system\called“Foods with Function Claims”was established in 2015 based on the Dietary Supplement Health and Education Act system established in the USA.Major health claims in the new regulation system are associated with fatigue,eyes,memory,stress,sleep,joints,blood flow,body temperature,muscles,and Body Mass Index.After the introduction of the new system,the total sales for functional foods including FOSHU products reached 8 billion dollars in 2018.The new functional regulatory system is more flexible in terms of health claims,the protocol for clinical studies,and the required results.Therefore,the market for new regulatory products is still growing.In the present paper,the potential of both regulatory systems and some related issues will be discussed. | Shun Iwatani Naoyuki Yamamoto | 2019 | Food Science and Human Wellness2019，8，2： | 1 |
| 10 | 生物类似药评价显示文摘[编者按]生物类似药是继原研生物制品之后进入市场,在安全性、纯度和效价上与原研生物制品具有高度相似性的新药物。由于生物药在治疗某些严重威胁人类健康疾病时具有明显的临床优势,以原研生物药质量、安全性和有效性为基础的生物类似药的研发,不仅可以降低生物药研发失败的风险和经费,也有助于提高生物药的可获得性,满足病人用药需求,故而受到广泛的青睐,成为当前的一个国际热点。 | | 2015 | 药物分析杂志2015，35，5： | 1 |
| 11 | Golden Trails:A Roadmap Leading to China’s Internet Industry显示文摘On February 19,2012,WalMart Stores,Inc.disclosed its additional investment in Yihaodian,a fast-growing electronic commerce website in China,making Walmart’s total ownership stake in Yihaodian to reach approximately 51%.It was Wal-Mart’s second investment for the purpose | Liang Tao from an international law firm | 2012 | China's Foreign Trade2012，，4： | 1 |
| 12 | Bibliometrics Is Valuable Science.Why Do Some Journals Seem to Oppose It?显示文摘Of all forms of research that can be accepted as valuable investigations,bibliometrics is often thought to be one of the most accessible to the widest number of researchers.Qualitative methods like interviewing and ethnography require extensive training,time,and often need ethical approval.Even basic quantitative methods like using questionnaires require significant drafting,mastery of language,and ethical review.Bibliometrics,being based on the analysis of publicly-available bibliographic data,does not have these requirements.Unlike with these other research approaches,where the top software(e.g.,SPSS,NVIVO)are expensive for researchers to afford. | Brady Lund | 2022 | Journal of Data and Information Science2022，7，3： | 1 |
| 13 | Immunological surrogate endpoints of COVID-2019 vaccines:the evidence we have versus the evidence we need显示文摘lIn response to the severe acute respiratory syndrome coronavirus-2(SARS-CoV-2)pandemic,over 200 vaccine candidates againstcoronavirus disease 2019(COVID-2019)are under development and currently moving forward at an unparalleled speed.Theavailability of surrogate endpoints would help to avoid large-scale filed efficacy trials and facilitate the approval of vaccine candidates,which is crucial to control COVID-19 pandemic.Several phase 3 efficacy trials of COVID-19 vaccine candidates are underway,which provide opportunities for the determination of COVID-19 correlates of protection.In this paper,we review currentknowledge for existence of COVD-19 correlates of protection,methods for assessment of immune correlates of protection andissues related to COVID-19 correlates of protection. | Pengfei Jin Jingxin Li Hongxing Pan Yanfei Wu Fengcai Zhu | 2021 | Signal Transduction and Targeted Therapy2021，6，3： | 1 |
| 14 | COVID-19 vaccines: progress and understanding on quality control and evaluation显示文摘The outbreak of COVID-19 has posed a huge threat to global health and economy.Countermeasures have revolutionized norms for working,socializing,learning,and travel.Importantly,vaccines have been considered as most effective tools to combat with COVID-19.As of the beginning of 2021,>200 COVID-19 vaccine candidates,covering nearly all existing technologies and platforms,are being research and development(R&D)by multiple manufacturers worldwide.This has posed a huge obstacle to the quality control and evaluation of those candidate vaccines,especially in China,where five vaccine platforms are deployed in parallel.To accelerate the R&D progress of COVID-19 vaccines,the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations worldwide.The Center for Drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D,which greatly supported the progression of vaccines R&D,and accelerated the approval for emergency use and conditional marketing of currently vaccine candidates.In this paper,the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized,which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide. | Qunying Mao Miao Xu Qian He Changgui Li Shufang Meng Yiping Wang Bopei Cui Zhenglun Liang Junzhi Wang | 2021 | Signal Transduction and Targeted Therapy2021，6，6： | 1 |
| 15 | 美国FDA 1个月内连续批准3种新药治疗多发性骨髓瘤显示文摘多发性骨髓瘤(multiple myeloma)是一种血癌,属于罕见疾病,多发生于骨髓内的原生质细胞(一种白细胞),患者体内癌细胞不断增殖,会产生一种异常的蛋白并损害骨髓内的正常血细胞,并破坏机体免疫系统。据美国国立癌症研究院(NCI)估计,2015年全美国约有26 850人被诊断出罹患多发性骨髓瘤,约有11 240人死于该疾病。美国FDA最近在1个月之内连续批准了3种治疗多发性骨髓瘤的新药。 | 夏训明 | 2015 | 广东药学院学报2015，31，6： | 1 |
| 16 | Response to 'Myocardial dysfunction in SARS-CoV-2 infection in infants under 1 year of age'显示文摘First of all,we want to thank the author for the approval of our article,focusing on SARS-CoV-2 infection in infants.Our article was aimed to describe the characteristics of infants under 1 year of age(excluding newborns)with COVID-19.Clinical features,chest imaging findings,laboratory tests results,treatments and clinical outcomes were analyzed.Our replies to the questions mentioned in author's letter are as follows. | Dan Sun Zhi-Sheng Liu | 2020 | World Journal of Pediatrics2020，16，5： | 1 |
| 17 | Evolving cognition of the JAK-STAT signaling pathway:autoimmune disorders and cancer显示文摘The Janus kinase(JAK)signal transducer and activator of transcription(JAK-STAT)pathway is an evolutionarily conserved mechanism of transmembrane signal transduction that enables cells to communicate with the exterior environment.Various cytokines,interferons,growth factors,and other specific molecules activate JAK-STAT signaling to drive a series of physiological and pathological processes,including proliferation,metabolism,immune response,inflammation,and malignancy.Dysregulated JAK-STAT signaling and related genetic mutations are strongly associated with immune activation and cancer progression.Insights into the structures and functions of the JAK-STAT pathway have led to the development and approval of diverse drugs for the clinical treatment of diseases.Currently,drugs have been developed to mainly target the JAK-STAT pathway and are commonly divided into three subtypes:cytokine or receptor antibodies,JAK inhibitors,and STAT inhibitors.And novel agents also continue to be developed and tested in preclinical and clinical studies.The effectiveness and safety of each kind of drug also warrant further scientific trials before put into being clinical applications.Here,we review the current understanding of the fundamental composition and function of the JAK-STAT signaling pathway.We also discuss advancements in the understanding of JAK-STAT–related pathogenic mechanisms;targeted JAK-STAT therapies for various diseases,especially immune disorders,and cancers;newly developed JAK inhibitors;and current challenges and directions in the field. | Chen Xue Qinfan Yao Xinyu Gu Qingmiao Shi Xin Yuan Qingfei Chu Zhengyi Bao Juan Lu Lanjuan Li | 2023 | Signal Transduction and Targeted Therapy2023，8，6： | 1 |
| 18 | A viral RNA-dependent RNA polymerase inhibitor VV116 broadly inhibits human coronaviruses and has synergistic potency with 3CLpro inhibitor nirmatrelvir显示文摘During the ongoing pandemic,providing treatment consisting of effective,low-cost oral antiviral drugs at an early stage of SARSCoV-2 infection has been a priority for controling COVID-19.Although Paxlovid and molnupiravir have received emergency approval from the FDA,some side effect concerns have emerged,and the possible oral agents are stillimited,resulting in optimized drug development becoming an urgent requirement. | Yumin Zhang Yuan Sun Yuanchao Xie Wejuan Shang Zhen Wang Hualiang Jiang Jingshan Shen Gengfu Xiao Leike Zhang | 2023 | Signal Transduction and Targeted Therapy2023，8，10： | 1 |
| 19 | Considerations on Planning and Development Strategies of Beijing in New Era显示文摘1. New situation after the approval of the new Master Plan of Beijing Completed in 2004, the new Master Plan of Beijing articulates the four major urban functions of Beijing and the | WU Liangyong Professor, School of Architecture, Tsinghua University Director, Institute of Architectural & Urban Studies, Tsinghua University Member, Chinese Academy of Science Member, Chinese Academy of Engineering, Beijing, P. R. China. LI Caige | 2007 | China City Planning Review2007，16，3： | 1 |
| 20 | Pandemic Woes:Antigen Tests to the Rescue?显示文摘On 26 August 2020,following unexpectedly strong,post-initiallockdown resurgences of coronavirus disease 2019(COVID-19)in the late spring and summer,the medical-manufacturer giant Abbott and the US federal government announced approval,for emergency use in public health efforts to control the pandemic,of a new diagnostic testing device the size of a credit card and costing only 5 USD apiece[1].Moreover,the federal government would spend 760 million USD to purchase 150 million of the tests and begin shipping them to nursing homes and schools roughly a month later[2]. | Peter Weiss | 2021 | Engineering2021，7，1： | 1 |
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