凝血因子药物市场分析

凝血因子是一类特殊的药物,是血友病等血液疾病的治疗药物,目前已经成为血液制品的重要组成部分。国外已经有二十多种重组凝血因子药物上市,2015年全球重组凝血因子药物的市场规模已经达到78.54亿美元,未来还将持续增长,Baxalta公司的重组凝血因子产品销售额位居全球首位,达到28.40亿美元。国外有多种重组凝血因子处于研发阶段,其中长效重组凝血因子将成为新的市场增长点。国内各类凝血因子药物的批签发状况良好,且随着国家发展和改革委员会取消血液制品最高零售价,各类产品价格均有不同幅度增长,其中人纤原蛋白原增长幅度最高,达到189%。国产凝血因子市场空间巨大,但存在产品供给和研发力度不足等问题,发展受到限制,必须改革行业管理制度、提高血浆分离技术、加强重组产品研发。     

第二代新型冠状病毒疫苗研究进展

自2019年12月以来,新型冠状病毒（SARS-CoV-2）在全球范围内迅速传播,逐步发展成全球大流行疾病（COVID-19）,为全球社会带来了重大损失。疫苗接种是预防传染性疾病的重要措施之一,自COVID-19流行以来,研制安全、有效的疫苗成为了当下最紧急的任务。据报道,目前全球范围内多条技术路线研究的疫苗多达172种处于临床阶段。世界卫生组织紧急批准了超过10种新冠疫苗用于紧急预防。然而,目前已获批的疫苗几乎都是针对原始毒株进行研发的。面对目前不断突变的病毒,开发更加广谱、高效的第二代新冠疫苗就显得尤为重要了。本文汇总了目前研究进展较快的第二代新冠疫苗,同时对第二代新冠疫苗的临床研究所应关注的问题及所面临的挑战进行了论述。     

创新科技 推动疫苗安全生产 GE医疗助力辽宁成大生物股份公司疫苗生产与国际接轨

据卫生部《中国狂犬病防治状况》指出,2008年中国狂犬病发病例达2466例,近几年来一直维持在年均2400人以上,仅次于印度,位居全球第二。狂犬疫苗属于二类疫苗,是自费接种疫苗。近年来中国犬、猫的饲养量快速增加,虽然我国目前的宠物犬数量已达1.5亿只,而动物狂犬病平均免疫率与国际公认的75%的免疫覆盖率差距甚大.可见,我国目前对狂犬疫苗有着巨大的市场需求,同时随着     

产业动向

IMSHealth展望全球医药市场据IMSHealth近期公布的数据显示,2005年处方药的销售量增长了7%,销售额为6020亿美元。美国仍然独占鳌头,年销售量为2520亿美元。但是美国及另外九个大市场的销售量只增长了5.7%,而中国、俄罗斯、韩国、墨西哥等新兴市场的销售量增长了81%。其中,中国医药市场增长了约20%,达到93亿美元的市场规模;墨西哥市场增长12%,达到75亿美元的规模。拉美地区2005年医药市场增长18.5%,达到240亿美元;而不包括日本在内的亚太及非洲地区的药品销售额也达到464亿美元,增长率为11%。全球10种最畅销药物的销售额达到569亿美元,其…     

产业动向

全球酶市场2015年将达80亿美元美国弗里多尼亚集团的最新研究报告指出,未来4年全球酶市场需求将以年均6.8%的速度快速增长,2015年将达到80亿美元。从市场区域来看,中美、南美和非洲/中东等地区的酶市场增速最快,中国和印度也将快速增长,而北美和西欧市场受生物燃     

国内外单抗药物市场概述

单抗药物具有特异性强、不良反应小等优势,近年来在肿瘤和自身免疫性疾病治疗等领域取得了快速发展。目前全球上市抗体药物共55个,2015年销售总额达到916.3亿美元。中国当前正处在抗体药物快速发展阶段,国家食品药品监督管理局(CFDA)共批准生产抗体药物22种,其中国产产品10个,进口产品12个。2014年国内单抗药物市场规模为50.34亿元,随着生物技术的不断发展,国内单抗药物的市场前景将会越来越广泛。     

亚洲各国艾滋病疫苗简介

获得性免疫缺陷综合征(acquired immunodeficiencysy ndrome,AIDS),即"艾滋病",是一种致死率极高的全球传染性疾病,尚无有效的治愈方法。目前,亚洲已成为世界第二大艾滋病高发区。对经济并不发达的亚洲地区来说,研发艾滋病疫苗,对于预防人类免疫缺陷病毒(human immunodeficiency virus,HIV),即"艾滋病病毒"的传播具有重要的战略意义。本文对中国、泰国、印度、日本和澳大利亚的艾滋病疫苗研发和临床试验进行了分析和总结,并分析了亚洲开发艾滋病疫苗的前景及应对策略。     

我国病毒疫苗研发现状与进展

200多年来,疫苗研究取得了巨大发展.至今,仪用于人类疾病预防控制的疫苗就有30多种.中国是疫苗生产大国,多数人用疫苗均能自主生产.疫苗的广泛应用在预防和控制严重危害人类健康疾病方面发挥了重要作用.然而,至今仍有许多重要疫苗未能研制成功,特别是一些严重危害人类健康的病毒的疫苗需要加大研发力度;     

医药生物技术前沿及其产业前景——我国病毒疫苗研发现状与进展

200多年来,疫苗研究取得了巨大发展。至今,仅用于人类疾病预防控制的疫苗就有30多种。中国是疫苗生产大国,多数人用疫苗均能自主生产。疫苗的广泛应用在预防和控制严重危害人类健康疾病方面发挥了重要作用。然而,至今仍有许多重要疫苗未能研制成功,特别是一些严重危害人类健康的病毒的疫苗需要加大研发力度;     

肺炎链球菌疫苗研制进展

肺炎链球菌导致的疾病已成为全球一个重要的公共卫生问题。疫苗开发及使用成为重要的预防策略,目前肺炎球菌疫苗主要有多糖疫苗和多糖蛋白结合疫苗二类。对肺炎链球菌病原学、流行病学、所致疾病、疫苗研发进展及疫苗使用情况进行了综述。     

Vaccine design: future possibilities and potentials

Recent developments in the understanding of the structure and replications of a wide range of pathogens, including viruses, bacteria and parasites have opened up ways of designing novel vaccines which should both improve the quality and extend the range and value of vaccines as major prophylactic and therapeutic tools of the future. Two main strategies have emerged, one involving the development of synthetic vaccines which are essentially composed of selected epitopes of the pathogenic agent that will elicit neutralising antibodies. The other strategy attempts to make use of chimeric agents that will allow live virus or bacteria to be used as vectors for carrying appropriate epitopes of the target pathogen. Current knowledge about the immunology and improvements in the presentation of antigen to the immune system will also play an important role in the rational design of vaccines. This review summarises present methods of producing vaccines and considers the development of more rational methods of vaccine design that will greatly influence the production of vaccines in the future.     

Prevalence of Met-203 type spaA variant in Erysipelothrix rhusiopathiae isolates and the efficacy of swine erysipelas vaccines in Japan

Since 2009, erysipelas infection among pigs in Japan has been increasing. This study investigated the prevalence, and characteristics of Erysipelothrix rhusiopathiae isolates in Japan from 2008 to 2010 and assessed the efficacy of current commercial erysipelas vaccines. Based on polymorphisms in a 432-bp hypervariable region in the surface protective antigen A (spaA) gene, 34 isolates were classified into three groups: (i) Group 1 with methionine at position 203 (Met-203) and isoleucine at position 257 (Ile-257) (18 isolates of serotype 1a and one untypable isolate). (ii) Group 2 with Ile-257 (12 isolates of serotypes 1a, 1b, 2, 10 and 11), and (iii) Group 3 with alanine at position 195 (Ala-195) and Ile-257 (three isolates of serotype 1a). Isolates with Met-203 were highly pathogenic in mice and pigs, causing death in the pig and LD₅₀ values of 0.45–1.45 CFU per mouse. One live and three inactivated commercial E. rhusiopathiae vaccines were evaluated for efficacy against a Met-203 isolate. Almost all mice and pigs that received vaccine survived, while non-vaccinated controls all died within 5 days of the challenge. This indicates that swine erysipelas vaccines might be still effective in protecting animals against the recently prevalent Met-203 isolates in Japan.     

Efficiency of estimating vaccine efficacy for susceptibility and infectiousness: randomization by individual versus household

In designing vaccine efficacy studies based on the secondary attack rate (SAR) or transmission probability in which both vaccine efficacy for susceptibility, VE(S), and vaccine efficacy for infectiousness, VE(I), are estimated, the allocation of vaccine and placebo within transmission units has an important influence on the efficiency of the study. We compared the following randomization schemes that result in different allocations of vaccine and placebo within two-member households: (1) randomization by individual for a mixed allocation, (2) randomization by transmission unit for concordant allocation, and (3) randomization of only one individual in each transmission unit to either vaccine or placebo. There is a complex interaction among the VE(S), VE(I), and the SAR that determines which allocation of vaccine and placebo within households provides the most information. In general, individual randomization with a mixed allocation of vaccine and placebo is better for estimating both VE(S) and VE(I) than is randomizing by household. However, for estimation of VE(I), at very low SARs and low VE(S), randomization by household is slightly more efficient than randomization by individual.     

The new vaccine strains (or variants) of Francisella tularensis

Abstract A colony (N83) of the vaccine strain of Francisella tularensis (15/10) and a strain (N268) isolated from a water sample in nature were revealed for susceptibility to cultivation at 42°C. Both strains had low virulence for white mice and were avirulent for guinea pigs but possessed high immunogenicity in these animals. The spontaneous mutant of vaccine strain 15/10 showed resistance to doxicycline and rifmanpicine (15/10 Dox ^r40 Rif ^r40). The obtained mutant had biological characteristics similar to the parent vaccine strain. It provided immunity in experimental animals when vaccination and antimicrobial agents were used in combination.     

rHB-DTaP联合疫苗中抗-HBs抗体应答

在乙肝、白喉、破伤风、无细胞百日咳（ｒＨＢ－ＤＴａＰ）四联疫苗的研制过程中,我们采用基因工程乙肝疫苗（ＣＨＯ）,精制白喉、破伤风类毒素和无细胞百日咳菌苗原液,按不同的稀释液,不同的加入顺序以及不同的含量等制备四联疫苗,并以单价基因工程乙肝疫苗（ｒＨＢ）做对照,进行小鼠试验,接种４周后采血检测抗－ＨＢｓ水平。结果表明,不同配方的四联疫苗中ｒＨＢ与ＤＴａＰ均无干扰,相容性好;抗－ＨＢｓ免疫应答水平与单价苗（ｒＨＢ）无显著性差异（Ｐ＞０．０５）,使用生理盐水制备的ｒＨＢ－ＤＴａＰ其抗－ＨＢｓ免疫应答水平较醋酸盐缓冲液者高（Ｐ＜０．０５）,ｒＨＢ－ＤＴａＰ中的抗－ＨＢｓ免疫应答水平与ｒＨＢ原液的加入顺序无关（Ｐ＞０．０５）;ｒＨＢ含量以２０μｇ／ｍｌ为宜。     

Tularemia vaccine: past,present and future

Francisella tularensis is a Gram negative intracellular pathogen that causes the highly debilitating or fatal disease tularemia. F. tularensis can infect a wide range of animals and can be transmitted to humans in a variety of ways, the most common being by the bite of an infected insect or arthropod vector. The attenuated F. tularensis live vaccine strain (LVS) has been used previously under investigational new drug status to vaccinate at-risk individuals. However the history of the strain and lack of knowledge regarding the basis of attenuation has so far prevented its licensing. Therefore the focus of current research is on producing a new vaccine against tularemia that would be suitable for licensing.     

结核疫苗研究进展

结核病是由结核分枝杆菌感染引起的传染病,是危害人类健康的主要传染病之一。目前被广泛应用的卡介苗对于新生儿和儿童的严重播散性疾病有很好的保护效果,但对于成人活动性结核病的有效性,却存在很大的争议。近年来,人们一直努力研发新疫苗并且已经取得了一些成果。这些新型结核疫苗在临床测试中的结果是非常令人兴奋和鼓舞人心的。但是,我们仍需继续探索新型结核疫苗。     

汉坦病毒疫苗研制进展

本文从脑组织灭活疫苗、培养细胞单双价灭活疫苗、基因重组疫苗、DNA疫苗、减毒活疫苗、佐剂、灭活方法、免疫策略等方面概述了汉坦病毒疫苗研制近况。     

冻干风疹活疫苗生产工艺研究

文报告了冻干风疹减毒活疫苗生产工艺及疫苗研制结果。在对日本化学血清疗法研究所疫苗生产株—松叶株全面检定的基础上,通过对原代兔肾细胞培养条件及病毒培养条件的试验优化,建立了疫苗生产工艺并制备出了冻干风疹活疫苗制剂,稳定性试验表明其安全有效、质量稳定可靠,而且其生产工艺切实可行、投入产出率高。     

When measles came to class: a look back at the 1989 Kent State University measles epidemic

BackgroundMeasles was eliminated from the United States in 2000, following a change from a single dose of measles vaccine to two doses after an epidemic 1989–1991. Several college campuses experienced outbreaks, including Kent State University (KSU) in Ohio.MethodsLocal news media from 1988 to 1989 were searched in August 2019. Interventions taken by the university were recorded, and an epidemic curve constructed.ResultsThe first measles cases were reported in October 1988. The outbreak diminished over winter break. New cases were confirmed in February 1989. Infected students were instructed to vacate the dorms. Vaccines were mandated for student groups. The epidemic grew rapidly in March but slowed after spring break. By April, 380 cases had been reported and 7000 students vaccinated.ConclusionsKSU was one of the hardest-hit universities during the 1989 measles epidemic. A combination of vaccination, isolation, quarantine, and elimination of public events helped to curtail the epidemic.