2014 年美国仿制药市场研发动态（I）

本期报告介绍了2014 年第1 季度各国获得简化新药申请（ANDA）批准、《药品管理档案》（DMF）申报、遭遇专利挑战的情况，以及生物仿制药市场、仿制药行业交易和相关仿制药企业的进展。     

2013 年美国仿制药市场发展动态（II）

报告介绍了2013 年第4 季度各国获得简化新药申请（ANDA）批准、《药品管理档案》（DMF）申报、遭遇专利挑战的情况，以及生物仿制药市场、仿制药行业交易和相关仿制药企业的进展。     

仿制药一致性评价品种的美国简略新药申请申报策略

文章从产品的开发以及申报资料的撰写等方面探究仿制药一致性评价品种的美国简略新药申请申报策略,为中国仿制药国际化战 略提供参考。     

化学（2013 年10 月发布）

“化学前沿”从化学学科的角度报告了生物医药研究领域最新的理念和成就。报告中的信息和观点来源于汤森路透IntegritySM 数据库。该数据库结合了生物、化学与药物学等学科的大量信息。本期报告分为有机合成路线展示、研究中的分子骨架、新化合物的作用机制、新研发管线等几个部分,从不同方面描述了对疗效和安全性更好的药物的筛选过程,并介绍了孤儿药的研究现状。     

我国生物仿制药发展现状与策略研究

随着生物药专利失效期到来所带来的成本降低、药物可及性增加及巨大市场空间等因素影响,各大企业对生物仿制药的开发表现出浓厚的兴趣,纷纷涉足这一领域,然而由于生物仿制药的特殊性,开发及产业化困难重重。基于以上背景,首先分析了国内外生物医药行业宏观经济环境、行业政策环境、法律监管环境等外部环境,然后对当前生物仿制药开发存在的关键性技术共性问题进行了阐述。在此基础上对国内外主要生物仿制药企业现状进行分析,提出了我国与国外生物仿制药方面存在的主要差距。在上述分析的基础上,利用SWOT工具进行战略分析,指出我国生物仿制药应该执行的SO战略为主,SW战略为辅的策略。最后提出了一些参考建议。     

特殊制剂一致性评价的开发策略

2016 年 3 月 5 日,国务院办公厅《开展仿制药质量和疗效一致性评价的意见》正式对外公布,提出了全面提高仿制药质量,开 展仿制药质量一致性评价,确保中国仿制药质量不低于美国、欧盟、日本的标准。文章介绍了美国和日本的一致性评价背景,根据中国国情, 结合政策法规,阐述如何科学性、合理性地开展仿制药一致性评价,重点介绍低剂量和微丸压片特殊口服固体制剂一致性评价的开发策略。     

药物经济学在仿制药一致性评价中的运用

药物经济学评价作为新兴学科,在目前如火如荼的仿制药一致性评价中得到广泛关注。文章在简介药物经济学评价基本方法的基础 上,对制药企业在仿制药一致性评价过程中的经济学问题及对策进行了探讨。     

免疫肿瘤学组合疗法

综述了使用相似或者不同技术的化合物对免疫肿瘤学药物进行的组合疗法研究。免疫肿瘤学组合疗法掀起了大型制药公司和规模较 小的生物技术公司的研究热潮,它们已经开始对组合疗法用于癌症治疗进行了专门性测试。综述来源于汤森路透Cortellis?数据库的战略 数据。     

化学前沿(2014年6月发布）

“化学前沿”通过化学家的视角,揭示了生物医药研究领域内新的理念和成就。报告中的见解和信息来自汤森路透Integrity数据库。 该数据库整合了生物学、化学和药理学信息。2014年6月发布的报告包括有机合成路线展示、研究中的分子骨架、新化合物的作用机制、 新研发管线等几个部分,分章别类地阐述了筛选疗效和安全性更好的药物的基本方面,并介绍了帕金森病治疗药物的研究现状。     

2012年全球新药研发报告——第二部分：攻克制药/生物技术行业难关（续Ⅳ）

正如《2012年全球新药研发报告》第一部分所提及的,2012年有大量药物获得批准;而在上市新药中,相当一部分是用于治疗发病率较低的一些疾病的孤儿药。虽然这些药物不会成为“重磅炸弹”产品,但对于小范围的患者来说却是一大福音。这一发展方向顺应了制药业从通用型“重磅炸弹”药物生产转向个体化药物研发的趋势。许多制药公司将其作为解决专利悬崖问题的策略,原因在于2012年有大量专利到期药物都作为仿制药获批。该报告的第二部分总结了新药、生物仿制药及新上市的化学仿制药的新进展,以及制药行业内部如何通过战略性调整巩固其市场地位,如通过兼并并购、子母公司与产权转让等努力获得领先地位。这部分还包含了大量便于快速查阅的数据图表以及制药行业内的战略性调整的大致介绍。更多详细信息,例如作用机制、研究现状、药理学研究、药动学研究、临床研究发现及更新信息等可以查阅Thomson Reuters IntegritySM 和 Thomson Reuters CortellisTM数据库。     

Recent advances in the study of Kaposi's sarcoma-associated herpesvirus replication and pathogenesis

It has now been over twenty years since a novel herpesviral genome was identified in Kaposi's sarcoma biopsies. Since then, the cumulative research effort by molecular biologists, virologists, clinicians, and epidemiologists alike has led to the extensive characterization of this tumor virus, Kaposi's sarcoma-associated herpesvirus(KSHV; also known as human herpesvirus 8(HHV-8)), and its associated diseases. Here we review the current knowledge of KSHV biology and pathogenesis, with a particular emphasis on new and exciting advances in the field of epigenetics. We also discuss the development and practicality of various cell culture and animal model systems to study KSHV replication and pathogenesis.     

The structure, reproduction and taxonomy of Vidalia and Osmundaria (Rhodophyta, Rhodomelaceae)

Comprises species occurring mostly in subtidal habitats in tropical, subtropical and warm-temperate areas of the world. An analysis of the type species, V. spiralis (Sonder) Lamouroux ex J. Agardh, a species from Australia, establishes basic characters for distinguishing species in the genus. These characters are (1) branching patterns of thalli, (2) flat blades that may be spiralled on their axis, (3) width of the blade, (4) primary or secondary derivation of sterile and fertile branchlets and (5) position of sterile and fertile branchlets on the thalli. Application of the latter two characters provides an important basic method for separation of species into three major groups. Osmundaria , a genus known only in southern Australia, was studied in relation to Vidalia , and its separation from the Vidalia assemblage is not accepted. Species of Vidalia therefore are transferred to the older genus name, Osmundaria. Two new species, Osmundaria papenfussii and Osmundaria oliveae are described from Natal. Confusion in the usage of the epithet, Vidalia fimbriala Brown ex Turner has been clarified, and Vidalia gregaria Falkenberg, described as an epiphyte on Osmundaria pro/ifera Lamouroux, is revealed to be young branches of the host, Osmundaria prolifera.     

New or rare chromosome counts in Artemisia L. (Asteraceae, Anthemideae) and related genera from Kazakhstan

Fifteen chromosome counts of six Artemisia taxa and one species of each of the genera Brachanthemum, Hippolytia, Kaschgaria, Lepidolopsis and Turaniphytum are reported from Kazakhstan. Three of them are new reports, two are not consistent with previous counts and the remainder are confirmations of very scarce (one to four) earlier records. All the populations studied have the same basic chromosome number, x = 9, with ploidy levels ranging from 2x to 6x. Some correlations between ploidy level, morphological characters and distribution are noted.     

肝癌中HBV和HCV基因和抗原的分布及意义

采用原位分子杂交方法检测HCV RNA及HBV X基因;采用免疫组织化学方法研究HCV核心抗原,非结构区C33c抗原及HBxAg在肝细胞肝癌中的定位及分布.结果表明(1)HCV RNA、HBV X基因在肝细胞肝癌组织检出率分别为40%(55/136)和82%(112/136).HCV RNA定位于癌细胞的胞浆内,阳性细胞呈散在、灶状及弥漫分布三种形式;HBV X基因在肝癌细胞中的分布呈胞浆型、核型及核浆型,阳性细胞也呈上述三种分布形式;(2)HCV C33c抗原、核心抗原在肝细胞肝癌中的阳性率为81%(133/164)及86%(141/164).C33c抗原定位于癌细胞及肝细胞的胞浆内;核心抗原既定位于癌细胞核中,又可定位于胞浆中.C33c抗原阳性细胞以灶状分布为主;而核心抗原阳性细     

Selection with two alleles and complete dominance

For a plant selection model with frequency-independent viabilities, fertilities and selfing rates, it is shown that apart from global fixation, for certain parameter combinations a protected polymorphism and facultative fixation (either allele may become fixed according to initial frequencies) may both occur. Facultative fixation requires different selling rates for the dominant and recessive type. Protection of the polymorphism requires resource allocation for male and female function. In this connection the problem of purely genetically caused population extinction is discussed.
For general frequency dependence and regular segregation, the chances for establishment of a completely recessive gene are compared to those of a completely dominant gene. It is proven that the process of establishment of the recessive gene, despite a fitness advantage, may be considerably endangered by drift effects if random mating prevails. The recessive gene may reach the same effectivity in establishment as a dominant gene, only if the recessive homozygote mates exclusively with its own type during the period of establishment.