Article(id=1236696517168394310, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1666540800000, acceptedDateStr=2022-10-24, onlineDate=1772781026403, onlineDateStr=2026-03-06, pubDate=1673712000000, pubDateStr=2023-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781026403, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781026403, creator=13701087609, updateTime=1772781026403, updator=13701087609, issue=Issue{id=1236696515473895464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='1', pageStart='1', pageEnd='109', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781025999, creator=13701087609, updateTime=1772782685740, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236703476982542786, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236703476982542787, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=16, endPage=23, ext={EN=ArticleExt(id=1236696517407469647, articleId=1236696517168394310, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Regulatory perspective on non-clinical research and evaluation of monoclonal antibody, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Based on the characteristics of monoclonal antibody, this paper discusses the key points in the pharmacology and toxicology review of monoclonal antibody combined with our review practice and the technical guidelines issued by regulatory agencies. Recommendations are given on the quality of test substance, selection of related animal species, evaluation of immunogenicity and immunotoxicity, and selection of initial dose for the first human clinical trial, so as to provide general principles for designing scientifically acceptable non-clinical research programs for the sponsors and researchers.

, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Yin WANG, Xue-dong DAI, Heng ZHOU, Hua-jing YIN, Shu-jun FU, Mao-shan YIN, Shuang WU, Bing YU, Tao SUN, Qing-li WANG), CN=ArticleExt(id=1236696517646544992, articleId=1236696517168394310, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=单克隆抗体药物非临床研究与评价的监管考虑, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

基于单克隆抗体药物的特点，结合国内外监管机构发布的技术指导原则和工作实践，本文针对单克隆抗体药理毒理专业审评中关注的重点内容进行了探讨，包括受试物质量、相关动物种属选择、免疫原性和免疫毒性评价以及首次人体临床试验起始剂量选择等，以期为申办方和研究者提供参考。

, correspAuthors=null, authorNote=null, correspAuthorsNote=, copyrightStatement=null, copyrightOwner=《中国新药杂志》有限公司, extLink=null, articleAbsUrl=null, sourceXml=XlSqZ+hTPYFd+OL9MPP0rA==, magXml=9Het+nOr8b99DoEqQsNxmg==, pdfUrl=null, pdf=ESdajiqnn39KbagfufaLTQ==, pdfFileSize=1623551, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=viXhompIyVD3Xh/H8TH0VA==, mapNumber=null, authorCompany=null, fund=null, authors=, authorsList=王寅, 戴学栋, 周恒, 尹华静, 付淑军, 尹茂山, 吴爽, 于冰, 孙涛, 王庆利)}, authors=[Author(id=1236703332132253912, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=wangyin@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703332220334303, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703332132253912, language=EN, stringName=Yin WANG, firstName=Yin, middleName=null, lastName=WANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703332320997606, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703332132253912, language=CN, stringName=王寅, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio={"content":"

王寅，女，主管药师，主要从事新药药理毒理专业审评。E-mail: wangyin@cde.org.cn。

"}, bioImg=null, bioContent=

王寅，女，主管药师，主要从事新药药理毒理专业审评。E-mail: wangyin@cde.org.cn。

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703332413272299, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=daixuedong@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703332547490034, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703332413272299, language=EN, stringName=Xue-dong DAI, firstName=Xue-dong, middleName=null, lastName=DAI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703332652347639, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703332413272299, language=CN, stringName=戴学栋, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio={"content":"

戴学栋，男，副主任药师，主要从事新药药理毒理专业审评。E-mail: daixuedong@cde.org.cn。

"}, bioImg=null, bioContent=

戴学栋，男，副主任药师，主要从事新药药理毒理专业审评。E-mail: daixuedong@cde.org.cn。

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703332744622333, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703332866257153, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703332744622333, language=EN, stringName=Heng ZHOU, firstName=Heng, middleName=null, lastName=ZHOU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703333071778057, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703332744622333, language=CN, stringName=周恒, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703333205995791, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703333365379356, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703333205995791, language=EN, stringName=Hua-jing YIN, firstName=Hua-jing, middleName=null, lastName=YIN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703333440876834, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703333205995791, language=CN, stringName=尹华静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703333516374310, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703334925660459, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703333516374310, language=EN, stringName=Shu-jun FU, firstName=Shu-jun, middleName=null, lastName=FU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703335001157933, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703333516374310, language=CN, stringName=付淑军, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703335110209845, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=5, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703335244427576, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335110209845, language=EN, stringName=Mao-shan YIN, firstName=Mao-shan, middleName=null, lastName=YIN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703335324119357, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335110209845, language=CN, stringName=尹茂山, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703335391228227, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=6, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703335517057353, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335391228227, language=EN, stringName=Shuang WU, firstName=Shuang, middleName=null, lastName=WU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703335588360523, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335391228227, language=CN, stringName=吴爽, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703335659663697, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=7, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703335756132690, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335659663697, language=EN, stringName=Bing YU, firstName=Bing, middleName=null, lastName=YU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703335860990297, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335659663697, language=CN, stringName=于冰, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703335944876386, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=8, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=sunt@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703336032956778, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335944876386, language=EN, stringName=Tao SUN, firstName=Tao, middleName=null, lastName=SUN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703336129425776, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703335944876386, language=CN, stringName=孙涛, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])]), Author(id=1236703336221700471, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, orderNo=9, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=wangql@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236703336339140993, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703336221700471, language=EN, stringName=Qing-li WANG, firstName=Qing-li, middleName=null, lastName=WANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236703336410444163, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, authorId=1236703336221700471, language=CN, stringName=王庆利, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])])], keywords=[Keyword(id=1236703336594993549, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=EN, orderNo=1, keyword=monoclonal antibody), Keyword(id=1236703336699851153, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=EN, orderNo=2, keyword=non-clinical research), Keyword(id=1236703336787931541, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=EN, orderNo=3, keyword=animal species selection), Keyword(id=1236703336880206234, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=EN, orderNo=4, keyword=immunotoxicity), Keyword(id=1236703336947315102, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=CN, orderNo=1, keyword=单克隆抗体), Keyword(id=1236703337043784097, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=CN, orderNo=2, keyword=非临床研究), Keyword(id=1236703337123475878, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=CN, orderNo=3, keyword=动物种属选择), Keyword(id=1236703337203167658, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, language=CN, orderNo=4, keyword=免疫毒性)], refs=null, funds=null, companyList=[AuthorCompany(id=1236703332039979218, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, xref=null, ext=[AuthorCompanyExt(id=1236703332048367828, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China), AuthorCompanyExt(id=1236703332052562132, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236696517168394310, companyId=1236703332039979218, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=国家药品监督管理局药品审评中心，北京 100022)])], figs=null, attaches=null, journal=Journal(id=1235980159023624194, delFlag=0, nameCn=中国新药杂志, nameEn=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, issn=1003-3734, eissn=null, cn=11-2850/R, coden=ZXZHA6, periodic=3, language=CN, oaType=null, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=null, officePhone=null, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of New Drugs, journalRemark=null, publicationField=null, createdTime=1772610233314, updatedTime=1772610649152, createdBy=18614031015, updatedBy=13701087609, firstLetterCn=C, firstLetterEn=C, subjectCode=Life Sciences, subjectName=null, subjectCodeEn=Life Sciences, subjectNameEn=null, picCn=ohPEEN//Vz1tDT3ZBNTp4Q==, picEn=f9WK9bvTM4guTmS/iGhOMg==, jcr=null, cjcr=null, exts=[JournalExt(id=1235981903275290962, language=CN, name=中国新药杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1772610649174, updatedTime=1772610649174, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1235981903338205523, language=EN, name=Chinese Journal of New Drugs, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1772610649189, updatedTime=1772610649189, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=http://draft.newdrug.cn/journalx_zgxy/authorLogOn.action, submissionEditorUrl=http://draft.newdrug.cn/journalx_zgxy/editorLogOn.action, submissionReviewUrl=http://draft.newdrug.cn/journalx_zgxy/expertLogOn.action, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1235980733773295621, websiteList=[Website(id=1235982099191222761, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zgxyzz/CN, language=CN, createTime=1772610695884, createBy=18614031015, updateTime=1772610860397, updateBy=18614031015, name=中国新药杂志-中文, tplId=1146099689490845704, title=中国新药杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983918629966444, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=articleTextType, value=kx, createTime=1772611129672, updateTime=1772611129672, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918604800617, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=banner, value=null, createTime=1772611129666, updateTime=1772611129666, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918655132271, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=grayFlag, value=0, createTime=1772611129678, updateTime=1772611129678, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918596412008, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611129664, updateTime=1772611129664, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918667715185, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=minRunFlag, value=0, createTime=1772611129681, updateTime=1772611129681, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918617383531, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/file/pic, createTime=1772611129669, updateTime=1772611129669, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918659326576, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=silenceFlag, value=0, createTime=1772611129679, updateTime=1772611129679, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918613189226, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1772611129668, updateTime=1772611129668, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918634160749, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeColor, value=null, createTime=1772611129673, updateTime=1772611129673, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983918646743662, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099191222761, code=themeStyle, value=null, createTime=1772611129676, updateTime=1772611129676, creator=18614031015, updator=18614031015)]), Website(id=1235982099270914542, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1235980733773295621, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/zgxyzz/EN, language=EN, createTime=1772610695903, createBy=18614031015, updateTime=1772610875891, updateBy=18614031015, name=中国新药杂志-英文, tplId=1146101810881728533, title=Chinese Journal of New Drugs, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1235983955829248630, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=articleTextType, value=kx, createTime=1772611138541, updateTime=1772611138541, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955804082803, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=banner, value=null, createTime=1772611138535, updateTime=1772611138535, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955854414457, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=grayFlag, value=0, createTime=1772611138547, updateTime=1772611138547, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955795694194, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=logo, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic?fileId=W567vm71kFC7UhK9TSU6xw==, createTime=1772611138533, updateTime=1772611138533, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955866997371, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=minRunFlag, value=0, createTime=1772611138550, updateTime=1772611138550, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955820860021, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/file/pic, createTime=1772611138539, updateTime=1772611138539, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955862803066, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=silenceFlag, value=0, createTime=1772611138549, updateTime=1772611138549, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955812471412, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1772611138537, updateTime=1772611138537, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955837637239, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeColor, value=null, createTime=1772611138543, updateTime=1772611138543, creator=18614031015, updator=18614031015), WebsiteProps(id=1235983955846025848, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1235982099270914542, code=themeStyle, value=null, createTime=1772611138545, updateTime=1772611138545, creator=18614031015, updator=18614031015)])], journalTitle=中国新药杂志, weixinUrl=null, journalUrl=http://www.newdrug.cn/, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of New Drugs, journalPhotoCn=ohPEEN//Vz1tDT3ZBNTp4Q==, journalPhotoEn=f9WK9bvTM4guTmS/iGhOMg==, journalFirstLetter=C, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false), detailUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/Y2023/V32/I1/16, detailUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/Y2023/V32/I1/16, pdfUrlCn=https://castjournals.cast.org.cn/joweb/zgxyzz/CN/PDF/Y2023/V32/I1/16, pdfUrlEn=https://castjournals.cast.org.cn/joweb/zgxyzz/EN/PDF/Y2023/V32/I1/16, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, reference=null)