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China, the first country worldwide to approve a gene therapy in 2003, almost lost the advantage for a head start in cell and gene therapy (CGT) development due to a lack of clear and strict regulatory frameworks. The rapid advancements of CGTs' development worldwide as well as their therapeutic potential have triggered the government to conduct a spate of regulatory reforms to promote normative development of CGTs in China. Encouraged by policy support, the remarkable progress for CGTs in China has been observed over the past few years, thereby catapulting China back into the forefront of CGTs worldwide. This article aims to provide an overview of regulatory reforms, the current development landscape of CGTs, as well as key contributors and challenges for CGT development in China. [ABSTRACT FROM AUTHOR]

Background and Objective: China has managed to control the coronavirus disease (COVID-19) with confinement measurements and treatment strategies, while other countries are struggling to contain the spread. This study discusses the guidelines related to COVID-19 in China in order to provide important references for other countries in the fight against COVID-19. Methods: Chinese guidelines relevant to COVID-19 were systematically searched via the China National Knowledge Infrastructure database, YiMaiTong database, and World Health Organization (WHO) COVID-19 database on March 20th, 2020. Guideline information was extracted, including date of publication, source, objectives and the target population. Guidelines specific to the pharmacological treatment of COVID-19 were further investigated to identify the types of antivirus drugs recommended and to report on how treatment recommendations for COVID-19 have evolved overtime. Results: A total of 100 guidelines were identified, of which 74 were national guidelines and 26 were regional guidelines. The scope of included guidelines consisted of: the diagnosis and treatment of COVID-19, the management of hospital departments and specific diseases during the outbreak of COVID-19. Fifty-one of the included guidelines targeted overall COVID-19 patients, while the remaining guidelines concentrated on special patient populations (i.e. geriatric population, pediatric population, and pregnant population) or patients with coexisting diseases. Fifteen guidelines focused on the pharmacological treatments for all COVID-19 patients. Interferon, Lopinavir/Ritonavir, Ribavirin, Chloroquine, and Umifenovir represented the most recommended antivirus drugs. Among them, 7 Chinese guidelines have recommended Chloroquine Phosphate or Hydroxychloroquine for the treatment of COVID-19. Conclusions: China has generated a plethora of guidelines covering almost all aspects of COVID-19. Chloroquine, as one widely affordable treatment, was recommended by Chinese national guidelines and provincial guidelines. Considering the continuous debates around Chloroquine, confirmatory studies with robust methodology are awaited to address the unanswered questions on its potential benefits and risks on COVID-19. [ABSTRACT FROM AUTHOR]

Besides combustion behavior under normal atmosphere, combustion behavior under special environment is also an important aspect for safety operation of China high-speed train. The commercial flame-retardant natural rubber employed in China high-speed train as the main floor cloth material was investigated in this study at low oxygen atmosphere with 18 kW m−2 to 60 kW m−2 external heat fluxes by means of ASTM E2058 fire propagation apparatus to deepen the knowledge of combustion behavior. The ignition time of sample mainly depended on external heat flux not the oxygen concentration (only low and normal oxygen concentration) except 40 kW m−2. During the whole combustion process two main stages appeared, one was thermal decomposition of sample, and the other stage was the forming charry layer combustion. The CO and CO2 yields decreased with external heat flux increasing and the ratio of yCO/yCO2 firstly increased and then decreased. The experimental data in this study can provide guidance for fire safety design and assessment of China high-speed train. [ABSTRACT FROM AUTHOR]

Background: Sichuan University West China Medical School was the first institution in China to develop an undergraduate sonographer education program in 2016. This program was certificated by American Registry for Diagnostic Medical Sonography (ARDMS) and students are qualified for the ARDMS credential verification test. In this 4-year program, the international curriculum of ultrasound physics and hemodynamics was set for students in the third year since 2018. This study is aimed to compare the teaching effect of international remote teaching mode and domestic on-site teaching mode of this international curriculum before and during the COVID-19 pandemic., Methods: All undergraduate sonographer students after completing ultrasound physics and hemodynamics in the academic years 2018-2019 (30 students; before the COVID-19 pandemic) and 2020-2021 (47 students; during the COVID-19 pandemic) were included in the study. The scores of 77 students were analyzed for their curriculum. Independent samples t -test or Mann-Whitney test was employed to compare students' scores before and during the COVID-19 pandemic. The Chi-square test was used to compare students' feedback about this curriculum through an online self-administered questionnaire. A p < 0.05 was considered statistically significant., Results: Total scores were comprised of four parts: in-class tests, homework, mid-term, and final exam scores. The mean in-class test score for domestic on-site teaching mode during the COVID-19 pandemic was significantly higher than that for international remote teaching mode before the COVID-19 pandemic. However, there was no observed a statistically significant difference in homework, mid-term, final exam, and total scores between the two types of teaching modes. For questionnaire feedback, no significant difference was observed between the two groups regarding the satisfaction toward teachers, class atmosphere, teaching mode, curriculum content, exam difficulty, scores, and knowledge students gained. For the overall evaluation of the curriculum, 73.3% (22/30) of students were very satisfied before the COVID-19 pandemic, while 44.7% (21/47) of students felt very satisfied during the COVID-19 pandemic ( p = 0.02)., Conclusion: The general teaching effect of domestic on-site teaching mode during the COVID-19 pandemic was comparable to that of international remote teaching mode before the COVID-19 pandemic, and domestic on-site teaching mode may provide a better in-class teaching effect., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Qiu, Lu, Luo and Ling.)

Background: A small number of regenerative medicines (RMs) have received market authorization (MA) worldwide, relative to the large number of clinical trials currently being conducted. Regulatory issues constitute one major challenge for the MA of RMs., Objective: This study aimed to systematically review the regulation of RMs internationally, to identify the regulatory pathways for approved RMs, and to detail expedited programs to stimulate MA process., Methods: Official websites of regulatory authorities in 9 countries (United States (US), Japan, South Korea, Australia, Canada, New Zealand, Singapore, China, and India) and the European Union (EU) were systematically browsed, and was complemented by a systematic literature review in Medline and Embase database., Results: Specific RM legislation/frameworks were available in the EU, US, Japan, South Korea and Australia. A risk-based approach exempting eligible RMs from MA regulations were adopted in the EU and 6 countries. All investigated regions have established accelerated review or approval programs to facilitate the MA of RMs. 55 RMs have received MA in 9 countries and the EU. Twenty-three RMs received Priority Medicine designation, 32 RMs received Regenerative Medicine Advanced Therapy designation, and 11 RMs received SAKIGAKE (fore-runner initiative) designation., Conclusion: Regulators have adopted proactive strategies to facilitate RM approval. However, addressing the discrepancies in regulatory requirements internationally remains challenging., Competing Interests: Declaration of Competing Interest All authors have no conflicts of interest to report in this work. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Purpose: The objective of this study was to characterize the population pharmacokinetics of voriconazole and to identify factors that significantly affect pharmacokinetic parameters and to further investigate optimal dosage regimens in Chinese adult patients with hematologic malignancies., Methods: A prospective population pharmacokinetic analysis was performed on 186 concentration measurements obtained from 41 adult patients with hematologic malignancies. All enrolled patients were treated with voriconazole for diagnosed or suspected invasive fungal diseases. Oral voriconazole was routinely administered at a maintenance dose of 200 mg q12h. Serial blood samples were collected after steady-state of each patient. Monte Carlo simulation was applied to optimize dosage strategies., Findings: A one-compartment model with first-order absorption and elimination adequately described the data. The typical voriconazole clearance was 4.18 L/h, the volume of distribution was 88.9 L, and the absorption rate constant was 0.729 h -1 . Clearance and steady-state exposure (AUC 0-12 ) were found to be significantly associated with age and CYP2C19 phenotype. The average AUC 0-12 of elderly patients (aged 60-90 years) was 2.1 times higher than that of relative younger patients (aged 18-59 years). The average AUC 0-12 of poor metabolizers (PMs) was approximately 2.5 and 1.8 times higher than that of extensive and intermediate metabolizers (IMs), respectively. Considering both efficacy and tolerability, dosage regimens of 100 and 50 mg orally administered every 12 hours were recommended for elderly IMs and PMs, respectively., Implications: A population pharmacokinetic model for voriconazole in Chinese adult patients with hematologic malignancies was successfully developed and could well capture voriconazole's pharmacokinetic characteristics. Age and CYP2C19 phenotype were found to significantly influence voriconazole clearance and should be taken into consideration clinically for dose optimization. The optimal dosage strategies in specific clinical scenarios were proposed in this study based on model simulation. Because of the high incidence of mutant CYP2C19*2 and *3 alleles, genetic testing seems to be necessary for Asian elderly patients when voriconazole treatment is initiated., (Copyright © 2019. Published by Elsevier Inc.)