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| 1 | China National Medical Products Administration approval summary:anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy显示文摘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 chemotherapy.Main 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 schedule.Patients with epidermal growth factor receptor(EGFR)or activating anaplastic lymphoma kinase(ALK)genomic tumor aberrations should have disease progression on NMPA-approved therapy.Anlotinib is the first NMPA-approved drug for patients with advanced NSCLC who have progressed on at least two lines of prior systemic chemotherapies in China.The 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 arm.The median duration of response(DoR)was 4.83 months,with a 95%CI of 3.31-6.97 months.The toxicity profile of anlotinib was consistent with that of known anti-angiogenesis inhibitors.Common 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. | 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 | 2019 | Cancer Communications2019，39，1： | 35 |
| 2 | 中国国家药品监督管理局批准安罗替尼用于经两种系统化疗后疾病进展的晚期非小细胞肺癌的治疗显示文摘背景2018年5月8日,中国国家药品监督管理局(National Medical Products Administration,NMPA)批准了小分子多靶点抗血管抑制剂盐酸安罗替尼,用于既往经过至少两种系统化疗后疾病进展的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的治疗。概要中国NMPA审查了一项随机双盲、安慰剂对照的III期临床试验,该临床试验的主要终点为总生存期(overall survival,OS)。试验共纳入437例患者随机分组(2∶1)接受安罗替尼(n=294)或安慰剂(n=143)治疗,每日1次,连服2周,停药1周。表皮生长因子受体(epidermal growth factor receptor,EGFR)基因敏感突变或间变性淋巴瘤激酶(activating anaplasticlymphomakinase,ALK)阳性的患者须经过NMPA已批准的药物治疗后出现疾病进展。安罗替尼为中国NMPA批准的用于治疗既往经过两种及以上系统化疗后疾病进展的晚期NSCLC患者的首个药物。安罗替尼组的中位OS(9.46个月)较安慰剂组[6.37个月;风险比(hazard ratio,HR)=0.70,95%置信区间(confidence Interval,CI):0.55–0.89;双侧log-rank P=0.002]显著延长。安罗替尼组的客观缓解率(objective responserate,ORR)为9.2%,安慰剂组为0.7%。安罗替尼组的中位缓解持续时间(durationofresponse,DoR)为4.83个月,95%CI为3.31–6.97个月。安罗替尼的常见不良反应(adverse drug reactions,ADRs)包括高血压(67.4%)、手足综合征(43.9%)、咳血(14.0%)、促甲状腺激素(thyroid stimulating hormone,TSH)升高(46.6%)、心电图QT间期(corrected QT Interval,QTc)延长(26.2%)。结论安罗替尼显著延长了患者的OS,可作为经二线及以上化疗后晚期或转移性非小细胞肺癌的一种新的治疗方案。 | 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 | 2019 | 癌症2019，38，12： | 7 |
| 3 | Precipitation data and their uncertainty as input for rainfallinduced shallow landslide models显示文摘Physical models used toforecast the temporal occurrence of rainfall-induced shallow landslides are based on deterministic laws.Owing to the existing measuring technology and our knowledge of the physical laws controlling landslide initiation,model uncertainties are due to an inability to accurately quantify the model input parameters and rainfall forcing data.An uncertainty analysis of slope instability prediction provides a rationale for refining the geotechnical models.The Transient Rainfall Infiltration and Grid-based Regional Slope Stability-Probabilistic(TRIGRS-P)model adopts a probabilistic approach to compute the changes in the Factor of Safety(FS)due to rainfall infiltration.Slope Infiltration Distributed Equilibrium(SLIDE)is a simplified physical model for landslide prediction.The new code(SLIDE-P)is also modified by adopting the same probabilistic approach to allow values of the SLIDE model input parameters to be sampled randomly.This study examines the relative importance of rainfall variability and the uncertainty in the other variables that determine slope stability.The precipitation data from weather stations,China Meteorological Administration Land Assimilation System 2.0(CLDAS2.0),China Meteorological Forcing Data set precipitation(CMFD),and China geological hazard bulletin are used to drive TRIGRS,SLIDE,TRIGRS-P and SLIDE-P models.The TRIGRS-P and SLIDE-P models are used to generate the input samples and to calculate the values of FS.The outputs of several model runs with varied input parameters and rainfall forcings are analyzed statistically.A comparison suggests that there are significant differences in the simulations of the TRIGRS-P and SLIDE-P models.Although different precipitation data sets are used,the simulation results of TRIGRS-P are more concentrated.This study can inform the potential use of numerical models toforecast the spatial and temporal occurrence of regional rainfall-induced shallow landslides. | Yueli CHEN Linna ZHAO Ying WANG Qingu JIANG Dan QI | 2019 | Frontiers of Earth Science2019，13，4： | 2 |
| 4 | Status and Suggestions of the Pesticide Use in the Protected Vegetable Fields in Shandong Province显示文摘This paper briefly introduced the issues of food safety and environmental pollution caused by pesticide residues in protected vegetables, discussed the status and problems of pesticide use in the protected vegetables in Shandong Province, and analyzed the main factors leading to the pesticide residues, including the low education of most farmers, lack of correct identification of diseases and insect pests, use of pesticides based on personal experience, pesticide preparation by bare hands, large dose of pesticide, frequent application, pesticide spraying without protection, uneven spraying, leakage of pesticide from the sprayers, etc.. Finally, based on the vegetable planting features and advantages in Shandong Province, some suggestions were proposed for references, such as, to enhance the monitoring of pesticide residue, to improve the educational level of farmers and to scentifically use the pesticide. | Bo ZHANG Yan LI Xinhao GAO Changsong LI Junshan QI Yueli ZHANG Wei ZHAO | 2013 | Asian Agricultural Research2013，5，4： | 2 |
| 5 | Clinical review considerations of class I PI3K inhibitors in hematolymphatic malignancies by Center for Drug Evaluation显示文摘Several phosphoinositide 3-kinase(PI3 K) inhibitors are currently approved to treat hematolymphatic malignant diseases worldwide, and many drugs that have the same target are in the clinical research stage. In March 2022,duvelisib became the first PI3 K inhibitor approved in China indicated for the treatment of hematolymphatic malignant diseases. Meanwhile, linperlisib and copanlisib have almost completed the technical review of the clinical specialty. The Center for Drug Evaluation(CDE) of the China National Medical Products Administration(NMPA) found that class I PI3 K inhibitors can cause various degrees of immune-related adverse events, which are associated with action mechanisms, affecting the benefit-risk assessment of the drugs. On April 21, 2021, the United States Food and Drug Administration(FDA) convened the Oncologic Drugs Advisory Committee(ODAC)meeting to discuss the safety of PI3 K inhibitors indicated for hematolymphatic malignancies and their related risk of death. The hematological tumor group of CDE of the China NMPA summarized and combined the data on PI3 K inhibitors listed or under technical review for marketing authorization applications and found that such products may have unique efficacy and safety characteristics in Chinese patients with malignant lymphoma. | Limin Zou Yueli Qi Ling Tang Yu Du Meiyi Xiang Xiaoming Chen Jun Ma Zhimin Yang | 2022 | Chinese Journal of Cancer Research2022，34，4： | 0 |
| 6 | Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China:from the perspective of clinical reviewers显示文摘1 BACKGROUND Before the State Council of the People’s Republic of China issued the“Opinions on the Reform of the Examination and Approval System of Pharmaceutical and Medical Devices”[1],several problems existed in China’s drug evaluation and approval system.The long approval time and low efficiency of new drug marketing seriously affected the enthusiasm for drug innovation.To this end,the current“Drug Registration Regulation”(DRR)[2]was initiated by the National Medical Products Administration of China and officially implemented on July 1,2020.To encourage clinical value-oriented drug innovation,four expedited drug programs were first proposed,including breakthrough therapy drugs,conditional approval,priority review,and special approval procedures.For drugs listed in the expedited programs,the drug regulatory authorities and professional technical institutions should provide policy and technical support,prioritize the allocation of communication and review resources,and thereafter shorten the review time as much as possible. | Limin Zou Yueli Qi Yongling Jiang Ling Tang Yu Du Boyuan Zhao Yanzhe Sun Meiyi Xiang Jun Ma Zhimin Yang | 2023 | Cancer Communications2023，43，2： | 0 |
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