A Multi-center, Randomized, Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) as Booster in Participants Aged 18 Years and Older Who Completed Primary/1 Booster Dose(s) of SARS-CoV-2 Vaccination

This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.

开始日期2023-03-25

申办/合作机构

艾美疫苗股份有限公司

[+2]

NCT05599802 / Not yet recruiting临床1期

An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) in Healthy Participants Aged 18 Years and Older

An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)

开始日期2023-02-01

申办/合作机构

艾美疫苗股份有限公司

[+2]

NCT05682638 / Recruiting临床3期

A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older

A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older

开始日期2023-01-30

申办/合作机构

艾美疫苗股份有限公司

[+2]

100 项与珠海丽凡达生物技术有限公司相关的临床结果

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0 项与珠海丽凡达生物技术有限公司相关的专利（医药）

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项与珠海丽凡达生物技术有限公司相关的文献（医药）

2023-11-01·Vaccine

Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults

Article

作者: Chen, Gui-Ling ; Zhu, Jing-Rui ; Guo, Tong ; He, Jian-Xing ; Lou, Dan-Feng ; Pei, Rong-Juan ; Gao, Hai-Nv ; Cao, Fang ; Li, Lan-Juan ; Shao, Xi ; Peng, Yu-Cai ; Shen, Zhen-Wei ; Luo, Li-Ping ; Jiang, Qi ; Dai, Xia-Hong ; Liu, Qi ; Li, Yu-Hua ; Zhang, Fan ; Li, Nan ; Deng, Fei ; Zhong-Chen ; Yu, Xu-Ya ; Jin, Ting-Han ; Huang, Yu-Mei ; Wu, Kai-Qi ; Wu, Xiao-Hong ; Jiang, Guo-Ping ; Peng, Cong-Gao

BACKGROUND:

COVID-19 caused by SARS-CoV-2 is a great threat to public health. We present the safety and immunogenicity data from a phase I trial in China of an mRNA vaccine (LVRNA009).

METHODS:

In the single-centre, double-blind, placebo-controlled and dose-escalation study, 72 healthy unvaccinated adults aged 18-59 years were randomized (3:1) to receive LVRNA009 with one of three vaccine dosage (25, 50 and 100 μg) or placebo, to evaluate for the safety, tolerability and immunogenicity of LVRNA009.

RESULTS:

All these participants received two injections 28 days apart. No adverse events higher than grade 2 were reported during the study. A total of 30 participants (42 %) reported solicited adverse reactions during the first 14 days after vaccinations. Of the events reported, fever (n = 11, 15 %) was the most common systemic adverse reaction, and pain at the injection site (n = 17, 24 %) was the most frequent solicited local adverse reaction. Anti-S-protein IgG and neutralising antibodies were observed to have been induced 14 days after the first dose, significantly increased 7 days after the second dose, and remained at a high level 28 days after the second dose. Specific T-cell responses peaked 7 days and persisted 28 days after second vaccination.

CONCLUSION:

LVRNA009 has demonstrated promising results in safety and tolerability at all three dose levels among Chinese adults. LVRNA009 at three dose levels could rapidly induce strong humoral and cellular immune responses, including binding and neutralising antibody production and IFN- γ secretion, which showed good immunogenicity.

CLINICAL TRIAL REGISTRATION NUMBER:

Clinicaltrials.gov NCT05364047; Chictr.org.cn ChiCTR2100049349.

Biology

Evaluating the Metabolic Basis of α-Gal A mRNA Therapy for Fabry Disease

Article

作者: Li, Shuang ; Liu, Qi ; Peng, Yucai ; Zhang, Zhendong ; Deng, Zhiwen ; Hong, Mei ; Liu, Jun

mRNA injection-based protein supplementation has emerged as a feasible treatment for Fabry disease. However, whether the introduction of LNP-encapsulated mRNA results in the alteration of metabolomics in an in vivo system remains largely unknown. In the present study, α-galactosidase A (α-Gal A) mRNA was generated and injected into the Fabry disease mouse model. The α-Gal A protein was successfully expressed. The level of globotriaosylsphingosine (Lyso-Gb3), a biomarker for Fabry disease, as well as pro-inflammatory cytokines such as nuclear factor kappa-B (NF-κB), interleukin 6 (IL-6), and tumor necrosis factor-α (TNF-α), were greatly decreased compared to the untreated control, indicating the therapeutic outcome of the mRNA drug. Metabolomics analysis found that the level of 20 metabolites was significantly altered in the plasma of mRNA-injected mice. These compounds are primarily enriched in the arachidonic acid metabolism, alanine, aspartate and glutamate metabolism, and glycolysis/gluconeogenesis pathways. Arachidonic acid and 5-hydroxyeicosatetraenoic acid (5-HETE), both of which are important components in the eicosanoid pathway and related to inflammation response, were significantly increased in the injected mice, possibly due to the presence of lipid nanoparticles. Moreover, mRNA can effectively alter the level of metabolites in the amino acid and energy metabolic pathways that are commonly found to be suppressed in Fabry disease. Taken together, the present study demonstrated that in addition to supplementing the deficient α-Gal A protein, the mRNA-based therapeutic agent can also affect levels of metabolites that may help in the recovery of metabolic homeostasis in the full body system.

Coatings

Screening of Essential Oils and Effect of a Chitosan-Based Edible Coating Containing Cinnamon Oil on the Quality and Microbial Safety of Fresh-Cut Potatoes

作者: Yang, Chunmiao ; Hu, Wenzhong ; Wang, Liying ; Feng, Ke ; Sarengaowa ; Liu, Yumeng

Fresh-cut potatoes (Solanum tuberosum L.) are a popular food owing to their freshness, convenience, and health benefits. However, they might present a potentially high health risk to consumers during transportation, processing, and marketing. In the current study, 18 essential oils (EOs) were screened to test their antimicrobial activity against Listeria monocytogenes (LM), Salmonella typhimurium (ST), Staphylococcus aureus (SA), and Escherichia coli O157:H7 (EC O157:H7). The antibacterial effectiveness of a chitosan edible coating (EC) containing cinnamon oil was evaluated against microorganisms on fresh-cut potatoes. Fresh-cut potatoes were treated with chitosan EC and chitosan EC containing different concentrations (0, 0.2, 0.4, and 0.6%, v/v) of cinnamon oil, and uncoated samples served as the control. The viability of naturally occurring microorganisms and artificially inoculated LM on fresh-cut potatoes was evaluated, as were the colour, weight loss, and firmness of potatoes, every 4 days for a total of 16 days at 4 °C. The results demonstrate that the inhibition zones of cinnamon, oregano, and pomelo oils were 16.33–30.47 mm, 22.01–31.31 mm, and 21.75–35.18 mm, respectively. The cinnamon oil exhibits the lowest MIC (0.313 μL/mL) for four foodborne pathogens compared with oregano and pomelo oils. The chitosan EC containing 0.2% cinnamon oil effectively maintains the quality of fresh-cut potatoes including inhibiting the browning, preventing the weight loss, and maintaining the firmness. The decline of total plate counts, yeast and mould counts, total coliform counts, lactic acid bacteria count, and Listeria monocytogenes in EC containing 0.2% cinnamon oil were 2.14, 1.92, 0.98, 0.73, and 1.94 log cfu/g, respectively. Therefore, the use of chitosan EC containing cinnamon oil might be a promising approach for the preservation of fresh-cut potatoes.

项与珠海丽凡达生物技术有限公司相关的新闻（医药）

2024-10-30

·艾美疫苗

mRNA 呼吸道合胞病毒（RSV）疫苗获得临床试验许可

本集团控股子公司珠海丽凡达生物技术有限公司研发的mRNA 呼吸道合胞病毒（RSV）疫苗已于近日获得国家药品监督管理局出具的《药物临床试验批准通知书》，标志着该疫苗的研发进入了新的阶段。 RSV是常见的呼吸道感染病原体，具有高度传染性，在全球范围内广泛流行，RSV感染是导致一周岁以内婴儿死亡的重要原因，也是造成老年人呼吸道感染死亡的重要因素。同时感染过RSV的人群仍存在再次感染RSV的可能性。目前，全球尚无获批的针对RSV可用于临床的抗病毒特效药，对RSV的预防成为抵御其健康威胁的重要策略，接种疫苗进行主动免疫预防是避免RSV重症感染的有效手段，中国尚无RSV疫苗获批上市，全球现有葛兰素史克和辉瑞两家公司的RSV疫苗上市销售。2023年度，RSV疫苗的全球销售额为24.6亿美元。根据行业顾问灼识咨询预测，预计到2030年，RSV疫苗在全球的市场规模将达到约167亿美元，市场空间极其广阔。本集团是中国最早开发mRNA疫苗产品的企业之一，也是国内第一批取得mRNA技术自主专利的疫苗企业，具有成熟的mRNA疫苗研发体系，已开发了数款mRNA候选疫苗（包括但不限于mRNA狂犬疫苗、mRNA RSV疫苗、mRNA带状疱疹疫苗等），并已建立了完善的mRNA疫苗质量管理体系和符合GMP标准的商业化规模生产车间，在mRNA技术平台上生产的疫苗也已经过临床试验验证。本集团现已打通mRNA疫苗研发、生产等全生命周期的流程，在完成临床试验后可以迅速实现mRNA疫苗产品的产业化，加快疫苗产品的商业化进程。本集团将加速推进mRNA 呼吸道合胞病毒（RSV）疫苗的临床试验。作为全球疫苗市场新的重磅大单品，该款产品上市后有望成为本集团新的业绩增长点。内容来源于网络，如有侵权，请联系删除。

疫苗信使RNA上市批准临床研究

2024-10-27

·信狐药迅

罗欣药业替戈拉生第3个适应症根除幽门螺杆菌 | 新获批（10.21-10.27）

每周药品注册获批数据，分门别类呈现，一目了然。(10.21-10.27）新药上市申请药品名称企业注册分类受理号替戈拉生片山东罗欣药业集团股份有限公司2.4CXHS2300114替雷利珠单抗注射液勃林格殷格翰生物药业(中国)有限公司2.2CXSS2400013 新药临床申请药品名称企业注册分类受理号TQB3616胶囊正大天晴药业集团股份有限公司1CXHL2400823TQB3616胶囊正大天晴药业集团股份有限公司1CXHL2400822TQB3912片正大天晴药业集团股份有限公司1CXHL2400820注射用SM-V-61上海糖霁生物科技有限公司1CXHL2400766RBD1016注射液苏州瑞博生物技术股份有限公司1CXHL2400235BIOS2210杭州百诚医药科技股份有限公司2.2CXHL2400815BIOS2210杭州百诚医药科技股份有限公司2.2CXHL2400814贝派度酸片甘李药业山东有限公司3CYHL2400161冻干带状疱疹mRNA疫苗武汉瑞佶生物科技有限公司1.2CXSL2400514LVRNA007珠海丽凡达生物技术有限公司1.2CXSL2400512SCTV02注射液神州细胞工程有限公司1.2CXSL2400481四价流感病毒裂解疫苗(ZFA02佐剂)安徽智飞龙科马生物制药有限公司1.3CXSL2400485流感病毒亚单位疫苗(佐剂)江苏中慧元通生物科技股份有限公司1.4CXSL2400493三价流感病毒裂解疫苗(MDCK细胞)成都欧林生物科技股份有限公司2.2CXSL2400430注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400543XKH001注射液浙江鑫康合生物医药科技有限公司1CXSL2400541注射用DB-1305映恩生物制药(苏州)有限公司1CXSL2400537PM8002注射液普米斯生物技术(珠海)有限公司1CXSL2400536注射用BGB-B3227广州百济神州生物制药有限公司1CXSL2400535HD004细胞华道(上海)生物医药有限公司1CXSL2400524SYS6020注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400511MSCohi-O镜片广东普罗凯融生物医药科技有限公司1CXSL2400496MSCohi-O镜片广东普罗凯融生物医药科技有限公司1CXSL2400495MSCohi-O镜片广东普罗凯融生物医药科技有限公司1CXSL2400494NK510细胞注射液上海贝斯昂科生物科技有限公司1CXSL2400492POV-601-1A1溶瘤病毒注射液苏州般若生物科技有限公司1CXSL2400482阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400538 仿制药申请药品名称企业注册分类受理号注射用盐酸瑞芬太尼江苏恩华药业股份有限公司3CYHS2303613注射用盐酸瑞芬太尼江苏恩华药业股份有限公司3CYHS2303612盐酸丙美卡因滴眼液沈阳兴齐眼药股份有限公司3CYHS2303373氯硝西泮注射液江苏恩华药业股份有限公司3CYHS2301736盐酸美金刚口服溶液温岭市创新生物医药科技股份有限公司3CYHS2301351环丝氨酸胶囊石家庄四药有限公司3CYHS2301331己酮可可碱注射液华夏生生药业(北京)有限公司3CYHS2301197己酮可可碱注射液安徽美来药业股份有限公司3CYHS2301115注射用尼可地尔天大药业(云南)有限公司3CYHS2301036注射用尼可地尔天大药业(云南)有限公司3CYHS2301035己酮可可碱注射液南京卡文迪许生物工程技术有限公司3CYHS2300961磷酸奥司他韦干混悬剂华润三九医药股份有限公司3CYHS2300906琥珀酸美托洛尔缓释胶囊福建省宝诺医药研发有限公司3CYHS2300677生理氯化钠溶液辽宁民康制药有限公司3CYHS2300655生理氯化钠溶液辽宁民康制药有限公司3CYHS2300654注射用吲哚菁绿南京正大天晴制药有限公司3CYHS2300225克林霉素磷酸酯注射液国药集团国瑞药业有限公司3CYHS2300140克林霉素磷酸酯注射液国药集团国瑞药业有限公司3CYHS2300139乙酰半胱氨酸注射液四川汇宇制药股份有限公司3CYHS2201814国;CYHS2201814复方醋酸钠林格注射液仁合益康集团有限公司3CYHS2201740国;CYHS2201740复方醋酸钠林格注射液仁合益康集团有限公司3CYHS2201739国;CYHS2201739卡络磺钠注射液湖北欣泽霏药业有限公司3CYHS2200513国;CYHS2200513注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400225注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400224注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400223普拉洛芬滴眼液合肥利民制药有限公司4CYHS2302244间苯三酚注射液康普药业股份有限公司4CYHS2302141地诺孕素片湖南醇健制药科技有限公司4CYHS2301993艾曲泊帕乙醇胺片宏越科技(湖州)有限公司4CYHS2301969注射用氯诺昔康陕西丽彩药业有限公司4CYHS2301951复方聚乙二醇电解质散(III)成都利尔药业有限公司4CYHS2301884利培酮口腔崩解片兰西哈三联制药有限公司4CYHS2301879注射用头孢唑肟钠成都天之翼尚品医药科技有限公司4CYHS2301859注射用头孢唑肟钠成都天之翼尚品医药科技有限公司4CYHS2301858他达拉非片安徽贝克生物制药有限公司4CYHS2301709他达拉非片安徽贝克生物制药有限公司4CYHS2301708注射用阿糖胞苷四川上善六经医药科技有限公司4CYHS2301707注射用阿糖胞苷四川上善六经医药科技有限公司4CYHS2301706恩格列净片湖南汉森制药股份有限公司4CYHS2301626玻璃酸钠滴眼液吉林敖东药业集团延吉股份有限公司4CYHS2301526盐酸艾司洛尔氯化钠注射液北京百美特生物制药有限公司4CYHS2301401枸橼酸氢钾钠颗粒湖北午时医药研究院有限公司4CYHS2301399来曲唑片北京轩升制药有限公司4CYHS2301264克立硼罗软膏齐鲁制药有限公司4CYHS2301244克立硼罗软膏齐鲁制药有限公司4CYHS2301243精氨酸布洛芬颗粒南京卡文迪许生物工程技术有限公司4CYHS2301222精氨酸布洛芬颗粒南京卡文迪许生物工程技术有限公司4CYHS2301221精氨酸布洛芬颗粒南京卡文迪许生物工程技术有限公司4CYHS2301220盐酸羟考酮缓释片西南药业股份有限公司4CYHS2301181注射用氯诺昔康石家庄四药有限公司4CYHS2301147舒更葡糖钠注射液福建省宝诺医药研发有限公司4CYHS2301132吸入用复方异丙托溴铵溶液成都普什制药有限公司4CYHS2301122间苯三酚注射液四川诺非特生物药业科技有限公司4CYHS2300949注射用厄他培南重庆圣华曦药业股份有限公司4CYHS2300831盐酸乌拉地尔注射液江苏正大丰海制药有限公司4CYHS2300676玻璃酸钠滴眼液浙江尔婴药品有限公司4CYHS2300659玻璃酸钠滴眼液浙江尔婴药品有限公司4CYHS2300658依托咪酯中/长链脂肪乳注射液四川国瑞药业有限责任公司4CYHS2300636盐酸莫西沙星氯化钠注射液江苏睿实生物科技有限公司4CYHS2300575盐酸奥洛他定滴眼液湖北远大天天明制药有限公司4CYHS2300542盐酸奥洛他定滴眼液呋欧医药科技(湖州)有限公司4CYHS2300125卡贝缩宫素注射液成都通德药业有限公司4CYHS2300106普瑞巴林胶囊安徽九洲方圆制药有限公司4CYHS2202083国;CYHS2202083阿加曲班注射液浙江华海药业股份有限公司4CYHS2201603国;CYHS2201603b型流感嗜血杆菌结合疫苗罗益(无锡)生物制药有限公司3.3CXSS2400014托珠单抗注射液金宇博沃润泽生物技术有限公司3.3CXSS2300001 进口申请药品名称企业注册分类受理号尼拉帕利醋酸阿比特龙片Janssen-Cilag International NV2.3JXHS2300035尼拉帕利醋酸阿比特龙片Janssen-Cilag International NV2.3JXHS2300034多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200008国;JXHS2200008多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200010国;JXHS2200010多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200009国;JXHS2200009多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200011国;JXHS2200011阿卡波糖片STANDARD CHEM.& PHARM.CO.,LTD.5.2JYHS2200002国;JYHS2200002盐酸奎扎替尼片Daiichi Sankyo, Inc.2.4JXHL2400200盐酸奎扎替尼片Daiichi Sankyo, Inc.2.4JXHL2400199CID-103注射液CASI Pharmaceuticals, Inc.1JXSL2400148 中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

疫苗临床申请临床1期CSCO会议申请上市

2024-10-25

·珠海丽凡达生物技术有限公司

丽凡达RSV mRNA疫苗获批临床试验

2024年10月25日，据国家药品监督管理局药品审评中心（CDE）官网公示，艾美疫苗旗下珠海丽凡达生物技术有限公司（以下简称“丽凡达生物”）研发的RSV mRNA疫苗LVRNA007获临床试验默示许可。临床前研究显示，LVRNA007在小鼠体内能刺激免疫系统产生较强的体液免疫和细胞免疫，中和抗体滴度高。在小鼠和棉鼠攻毒试验中，LVRNA007相较于灭活疫苗，能显著降低肺部病毒滴度，改善肺部病理，并有效预防RSV感染和感染相关炎症反应。 RSV是常见的呼吸道感染病原体，具有高度传染性，在全球范围内广泛流行，RSV感染是导致一周岁以内婴儿死亡的重要原因，也是造成老年人呼吸道感染死亡的重要因素。同时感染过RSV的人群仍存在再次感染RSV的可能性。目前，全球尚无获批的针对RSV可用于临床的抗病毒特效药，对RSV的预防成为抵御其健康威胁的重要策略，接种疫苗进行主动免疫预防是避免RSV重症感染的有效手段。中国尚无RSV疫苗获批上市，全球现有葛兰素史克和辉瑞两家公司的RSV重组蛋白疫苗和Moderna的mRNA疫苗上市销售。感谢项目负责人李江龙博士设计和验证了LVRNA007疫苗的序列及其有效性，此次临床批件的获得，更离不开公司各个部门的配合及全体员工的辛勤努力，恭喜丽凡达创此佳绩！也祝愿丽凡达越战越强，勇闯辉煌！

疫苗信使RNA临床研究

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