1Overview of accelerated assessment and approval policies for cell and gene therapy products in the United States and Europe and its implications for ChinaWANG Jing, LU Shuang2441-24462A brief analysis of the focus of production capacity research of autologous CAR-T therapeutic productsWANG Xue, MA Yan-song, WEI Wei, HE Wu2447-24513Considerations on pharmaceutical quality assessment and control of lipid nanoparticles of prophylactic mRNA vaccinesYANG Dan, ZHAO Xin, LI Xiao-jing, LI Min2452-24564Several special considerations on the registration of post-approval changes for vaccines based on lifecycle managementJIN Su, GUO Sheng-nan, QIU Xiao, GUO Shu-yang, YIN Xiao, XIANG Jin-zhong, LI Min2457-24625Considerations of pharmaceutical review of therapeutic recombinant protein drugs for subcutaneous injectionSAI Wen-bo, XU Long-chang2463-24666Quality control and evaluation concerns of recombinant glycoprotein hormones:"macro"and"micro"heterogeneity of glycosylation modificationsLI Yi-jun, HU Ying-ying, WEI Wei2467-24767Discussion on similarity assessment of denosumab biosimilarsKAN Hong-jin, WEI Wei2477-24828Research progress and regulatory perspectives in neoantigen immunotherapyLI Qian, DAI Yi-fei, WEI Wei2483-24889Risk management and technical considerations on donor screening for cellular therapy productsLIU Dan, JIA Dong-chen, CUI Jing, WEI Wei2489-249410Research progress in SARS-CoV-2 neutralizing antibody products and pharmaceutical assessmentJIA Dong-chen, WU Zhou-yi, YU Peng-li2495-250011Considerations on CMC research and evaluation of anti-viral antibodiesWANG Wen-bo, WEI Wei2501-250612CMC research and evaluation considerations of fatty acid chain-modified glucagon-like peptide 1 drugsZHAO Jing, WEI Wei, WEI Kai-kun2507-251213Technical requirements for allergen products registration regulated as drug managementJIA Yan-hua, ZHANG Ying, LI Min2513-251614Supplementing experimental data,a double-edged sword in pharmaceutical patent protectionXU Lei, YIN Xin, YANG Yue2517-252515A review of the application of asfotase alfa in the rare disease hypophosphatasiaLIU Qing-yang, HOU Zi-jing, GE Yu, WANG Shao-hong, LIU Xin, ZHANG Bo, TANG Yan2526-253016The latest research progress of daridorexant,a dual orexin receptor antagonist for insomniaLI Xin-ru, SHENG Dan-dan, LIU Jing, LIU Wei-ping2531-253417A comparison of the effects of methylphenidate extended-release tablets and atomoxetine on sleep parameters in patients with attention deficit hyperactivity disorderWU Wei-ge, WANG Wen-qiang, LI Zong-lei, LI Yun, WEI Xuan, ZHENG Shu-chuan2535-253918Discussion on the management and implementation of clinical research on foreign subjects in ChinaLIU Xiao-hui, LI Ke-xin, BAI Wen-jing, WANG Juan, CONG Duan-duan, XU Xiao-yu, LIU Yue, QI Wen-yuan, XUE Wei2540-2543 