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 2...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.展开更多
To realize low harmonic distortion of the vibration waveform output from electromagnetic vibrators,we propose a vibration harmonic suppression technology based on an improved sensorless feedback control method.Without...To realize low harmonic distortion of the vibration waveform output from electromagnetic vibrators,we propose a vibration harmonic suppression technology based on an improved sensorless feedback control method.Without changing the original driving circuit,the alternating current(AC)equivalent resistance of the driving coil is used to obtain high-precision vibration velocity information,and then a simple and reliable velocity feedback control system is established.Through the study of the effect of different values of key parameters on the system,we have achieved an effective expansion of the velocity characteristic frequency band of low-frequency vibration,resulting in an enhanced harmonic suppression capability of velocity feedback control.We present extensive experiments to prove the effectiveness of the proposed method and make comparisons with conventional control methods.In the frequency range of 0.01-1.00 Hz,without using any sensors,the method proposed in this study can reduce the harmonic distortion of the vibration waveform by about 40%compared to open-loop control and by about 20%compared to a conventional sensorless feedback control method.展开更多
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...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.展开更多
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 ca...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.展开更多
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.
基金Project supported by the Natural Science Foundation of Heilongjiang Province,China(No.LH2021E060)the National Natural Science Foundation of China(No.52075133)the CGN-HIT Advanced Nuclear and New Energy Research Institute,China(No.CGN-HIT202215)。
文摘To realize low harmonic distortion of the vibration waveform output from electromagnetic vibrators,we propose a vibration harmonic suppression technology based on an improved sensorless feedback control method.Without changing the original driving circuit,the alternating current(AC)equivalent resistance of the driving coil is used to obtain high-precision vibration velocity information,and then a simple and reliable velocity feedback control system is established.Through the study of the effect of different values of key parameters on the system,we have achieved an effective expansion of the velocity characteristic frequency band of low-frequency vibration,resulting in an enhanced harmonic suppression capability of velocity feedback control.We present extensive experiments to prove the effectiveness of the proposed method and make comparisons with conventional control methods.In the frequency range of 0.01-1.00 Hz,without using any sensors,the method proposed in this study can reduce the harmonic distortion of the vibration waveform by about 40%compared to open-loop control and by about 20%compared to a conventional sensorless feedback control method.
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.
基金This work was supported by the Grant from Chinese National Major Project for New Drug Innovation(Grant No.2017ZX09304015)
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.
