2014年全球新药研发报告——第一部分：新药和生物制品（Ⅲ）

2014的新药批准和上市年终报告显示医药行业的活跃性持续保持在高位。截至2014年12月23日,共有55个新药和生物制品 首次上市。此外,29个重要的延伸性新药（新处方、新复方或已上市药物的新适应证）也在2014年上市。在这些新上市的药物中,最多 的是抗感染药物,有11个新药和生物制品。它们大多用于多药耐药菌引发的感染或丙肝的治疗。美国再一次成为这些新上市药物最青睐的 市场,该国是2014年半数以上新上市药物的首选地区。不过,日本在2014年开发上市新药的能力显著增强,多年来首次超越欧盟。另一 重要成果是：2014年上市的新药和生物制品中有15个获得罕见病用药资格,5个获得突破性治疗药物资格,以及3个获得合格传染病产 品（QIDP)资格。另外,2014年还有19个产品首度获批,将于2015年初上市。     

2014年全球新药研发报告—— 第一部分：新药和生物药品（Ⅰ）

2014年的新药批准和上市年终报告显示医药行业的活跃性持续保持在高位。截至2014年12月23日,共有55个新药和生物制 品首次上市。此外,29个重要的延伸性新药（新处方、新复方或已上市药物的新适应证）也在2014年首次上市。在这些新上市的药物中, 最多的是抗感染药物,有11个新药和生物制品。它们大多用于多药耐药菌引发的感染或丙肝的治疗。美国再一次成为这些新上市药物最青 睐的市场,该国是2014年半数以上新上市药物的首选地区。不过,日本在2014年开发上市新药的能力显著增强,多年来首次超越欧盟。 另一重要成果是：2014年上市的新药和生物制品中有15个获得罕见病用药资格,5个获得突破性治疗药物资格,还有3个获得合格传染 病产品（QIDP)资格。另外,2014年还有19个产品首度获批,将于2015年年初上市。     

2014年全球新药研发报告—— 第一部分：新药和生物药品（Ⅱ）

2014的新药批准和上市年终报告显示医药行业的活跃性持续保持在高位。截至2014年12月23日,共有55个新药和生物制品 首次上市。此外,29个重要的延伸性新药（新处方、新复方或已上市药物的新适应证）也在2014年上市。在这些新上市的药物中,最多 的是抗感染药物,有11个新药和生物制品。它们大多用于多药耐药菌引发的感染或丙肝的治疗。美国再一次成为这些新上市药物最青睐的 市场,该国是2014年半数以上新上市药物的首选地区。不过,日本在2014年开发上市新药的能力显著增强,多年来首次超越欧盟。另一 重要成果是：2014年上市的新药和生物制品中有15个获得罕见病用药资格,5个获得突破性治疗药物资格,以及3个获得合格传染病产 品（QIDP)资格。另外,2014年还有19个产品首度获批,将于2015年初上市。     

Development of new biotin/streptavidin reagents for pretargeting

The high affinity of biotin for streptavidin has made this pair of molecules very useful for in vivo applications. To optimize reagents for one potential in vivo application, antibody-based pretargeting of cancer, we have prepared a number of new biotin and streptavidin derivatives. The derivatives developed include new radiolabeled biotin reagents, new protein biotinylation reagents, and new biotin multimers for cross-linking and/or polymerization of streptavidin. We have also modified streptavidin by site-directed mutation and chemical modification to improve its in vivo characteristics, and have developed new reagents for cross-linking antibody fragments with streptavidin. A brief overview of these new reagents is provided.     

新世纪中国菌物新名称发表概况(2000-2020)

2000-2020年间,我国菌物学研究取得了丰硕的成果,在新物种发现、重要类群新分类系统、资源保护与开发利用等多方面取得了重要进展.本文通过对世界菌物名称信息库Index Fungorum、Fungal Names和MycoBank进行数据整理,从中国学者的研究产出和中国的菌物新物种发现的角度展开分析,揭示我国菌物分类...     

Twenty-four new names in Xanthophyllum (Polygalaceae)

Anticipating a complete revision of the genus Xanthophyllum , which will be printed in Blumea within two years, one new subgenus, 17 new species, one new subspecies and two new varieties are described, and for three names a new status is proposed. This is done for nomenclatural reasons, validating the new names in W. C. Dickison's study of the leaf anatomy of Xanthophyllum , published elsewhere in this Journal.     

Hemispheric Asymmetry in New Neurons in Adulthood Is Associated with Vocal Learning and Auditory Memory

Many brain regions exhibit lateral differences in structure and function, and also incorporate new neurons in adulthood, thought to function in learning and in the formation of new memories. However, the contribution of new neurons to hemispheric differences in processing is unknown. The present study combines cellular, behavioral, and physiological methods to address whether 1) new neuron incorporation differs between the brain hemispheres, and 2) the degree to which hemispheric lateralization of new neurons correlates with behavioral and physiological measures of learning and memory. The songbird provides a model system for assessing the contribution of new neurons to hemispheric specialization because songbird brain areas for vocal processing are functionally lateralized and receive a continuous influx of new neurons in adulthood. In adult male zebra finches, we quantified new neurons in the caudomedial nidopallium (NCM), a forebrain area involved in discrimination and memory for the complex vocalizations of individual conspecifics. We assessed song learning and recorded neural responses to song in NCM. We found significantly more new neurons labeled in left than in right NCM; moreover, the degree of asymmetry in new neuron numbers was correlated with the quality of song learning and strength of neuronal memory for recently heard songs. In birds with experimentally impaired song quality, the hemispheric difference in new neurons was diminished. These results suggest that new neurons may contribute to an allocation of function between the hemispheres that underlies the learning and processing of complex signals.     

生物育种新技术作物的安全管理

生物育种新技术（new breeding techniques,NBTs）是指基于分子生物学工具进行作物分子育种的一类新技术,可以短期内使作物产生新的有利性状,促进作物新品种的开发,如基因编辑技术、RNA干扰（RNA interference,RNAi）技术、同源转基因技术等。这些新技术目前正在全球农业育种中广泛应用,并且已有部分作物新品种获准商业化生产。然而,针对生物育种新技术产生的作物新品种的安全性和安全管理政策,全球尚未达成统一共识,对其安全监管的思考也不尽相同,限制了这些作物新品种的研发和商业化应用进程。综述了现阶段全球主要发达国家对于生物育种新技术作物的安全性和监管方面实施的管理政策和法规,以期对我国生物育种新技术作物的安全性管理政策的制定提供一定的借鉴。     

新一代抗结核分枝杆菌疫苗将会建立在现用卡介苗的基础上吗?

本文针对以卡介苗(bacillus Calmette-Guérin,BCG)为基础的结核分枝杆菌新疫苗本身的缺陷问题、临床前药效学评价面临的问题、临床研究可能面临的有效性评价问题及伦理问题等,对"新一代抗结核分枝杆菌疫苗将会建立在现用BCG的基础上"的观点进行评述。认为以BCG为基础的新疫苗保护力可能超过现用BCG,但要显著提高其对成人的保护效果尚有难度;新疫苗用于新生儿的临床研究因存在伦理问题而可能无法开展;针对潜伏结核感染人群的免疫预防是控制结核病的重要手段,以现用BCG为基础的新疫苗可能无法应用于此类人群。因此,新一代主流抗结核分枝杆菌疫苗将不会是建立在现用BCG基础之上的疫苗。     

中国菌绒孢属的研究

菌绒孢是一个小属,已描述过的种约50个,都是植物寄生菌,有的引致植物病害还较 严重.本文报告了我国产的21个种,其中1个是新种,4个是新组合和2个新记录,对18个种均有英文描述和附图,新种还附有拉丁文简介,各个种的地区分布也予以载述.但文中有分布地区而其后未附HMAS标本号码者多系据《中国真菌总汇》(1979)转录.从前人的描述和我们研究中看出,菌绒孢属的属级特征有:(1)产孢细胞合生,合轴式多点全壁芽茁产孢;(2)分生孢子梗壁上和分生孢子顶端和基脐,或仅基脐的孢痕疤明显而厚;(3)分生孢子梗主要从表生甸甸菌丝上作为侧枝或顶生,但有的种也兼有从子座上 簇生的;(4)菌丝多结集成菌丝绳或攀缘于叶毛上;(5)分生孢子链生,少数种也不链生. 这就清楚表明菌绒孢属与尾孢菌属和色链隔孢属(Phaeoramularia)少不同之处在于,尾孢 菌和色链隔孢属二者的分生孢子梗均成簇发生且无表生匍匐菌丝,与极其近似的假尾孢属(Pseudocercospora)不同之处在于,后者的分生孢子梗也着生于表生匍匐状菌丝和簇 生于子座上,但其分生孢子梗和分生孢子的孢痕疤却薄而不明显,因而易于区别开.虽然1974年von Arx在其《纯培养产孢真菌的属》一书中,曾把菌绒孢属作为枝孢 属(Cladosporium)的异名,但这一观点我们未予接受,其理由已在《中国色链隔孢曲(1982)一文中加以说明,这里未予重述.上述这21个种除3个种,即M. costaricensis, M, pawlownicola和M. vaginae我们未获得研究材料,仅据以前作者的报导转录外,其余18个种均系根据标本进行的.这些标本,含M. merremiae sp. nov.的模式标本在内,均贮藏于中国科学院微生物研究所真菌标本室.     

Diploidy, evolution and sex

A new gene for a new purpose may be created by mutation of a pre-existing gene. But if that original gene is still required for its original purpose, and is to be retained side by side with the new, a spare copy is needed initially as raw material for the innovation. Thus in haploids the original gene must be duplicated before it is modified. But in diploids a spare copy of every gene is always available, and a mutant allele serving a new purpose can be easily established and maintained by heterosis in parallel with the old allele. Subsequent gene duplication will lead, via crossing-over, to insertion of the new gene in tandem with the old, as a permanent addition to the genome. Calculations show that diploids can thus enlarge their genomes with new genes for new purposes much more readily than haploids; in particular, they can more easily evolve the complex gene control systems characteristic of differentiated multicellular organisms. Sexual reproduction preserves diploidy, and so can be seen as the basis of these richer possibilities for evolutionary innovation.     

The potential of South African plants in the development of new food and beverage products

A review is presented of the history and recent trends in the exploration and development of food plants in southern Africa. The opportunities for developing new crops and new products for local and international markets are discussed. More than 120 species with potential as new food and beverage products (including functional foods, herbal teas and new flavours) are listed and a subjective rating of the commercial potential is provided for each of them. Some noteworthy examples are discussed and illustrated, including several indigenous fruits and vegetables that are as yet poorly known. There is a growing awareness of the importance of indigenous plants in new product development and numerous new products are already being developed. Basic research in botany (to guide genotype selection), horticulture (to develop new crops), food science (to focus on nutritional analyses) and marketing (to understand and develop new marketing approaches) is mentioned as important priorities.     

基因组学时代的真菌分类学:机遇与挑战

真菌物种的形态特征有限,加之形态滞后和形态可塑性,仅靠外部形态、内部结构及生理生化指标,很难把握真菌的系统亲缘。应用DNA测序、基因组测序、比较基因组学及生物信息学等技术,研究人员可以快速识别真菌演化中出现的数量众多的单系支系,为建立各分类等级的新分类单元提供有力证据,为真菌分类学研究带来了新的希望和活力。自2000年以来,在真菌界至少发表了1新亚界、4新门、7新亚门、19新纲、9新亚纲、40余新目等高级分类单元。近3年来,我国发表了20余个真菌新属,其中绝大多数属的建立都有分子证据支持。可以预见,大量的新种、新属、新科乃至更高级分类单元将会在今后10年内持续发现和建立。这必将大大促进真菌分类学的发展,完善现有的真菌分类系统。我们应该顺势而上,利用我国丰富的真菌资源,为真菌分类学的发展做出应有贡献。与此同时,真菌分类学也面临着十分严峻的挑战。挑战主要来自3个方面,一是研究变得越来越综合,不但需要有相应的研究经费支持,而且要求从事该领域的研究人员技术更全面、知识更广博及知识更新速度更快捷;二是新物种描述进度偏慢,远远不能满足人们对物种认识和利用的日益增长的需要;三是研究人员亟需创新研究模式,以新技术、新思路、新机制来构建新的真菌分类学,加速新物种的发现和描述进度,最终为社会进步和科学发展服务。     

中国南部地区松树上的散斑壳菌Ⅰ.

近年作者对我国南部地区松树上的散斑壳属(Lophodermium Chev.)真菌进行了调查和研究。本文报道8个种,其中椭圆散斑壳(L.ellipticum Y.R.Lin)是新种,喜马拉雅散斑壳(L.himalayense P.F.Cannon & Minter)和库曼散斑壳(L.kumaunicum Minter &M.P.Sharma)为我国新记录种,南方散斑壳(L.australe Dearn.)等5种为国内已记载种。对新种作了拉丁文、汉文描述和图解,对新记录种进行了简要记述。另外,记载了已知种的寄主新记录和地理新分布。     

Identifying subjects who benefit from additional information for better prediction of the outcome variables

Summary .  Suppose that we are interested in using new bio- or clinical markers, in addition to the conventional markers, to improve prediction or diagnosis of the patient's clinical outcome. The incremental value from the new markers is typically assessed by averaging across patients in the entire study population. However, when measuring the new markers is costly or invasive, an overall improvement does not justify measuring the new markers in all patients. A more practical strategy is to utilize the patient's conventional markers to decide whether the new markers are needed for improving prediction of his/her health outcomes. In this article, we propose inference procedures for the incremental values of new markers across various subgroups of patients classified by the conventional markers. The resulting point and interval estimates can be quite useful for medical decision makers seeking to balance the predictive or diagnostic value of new markers against their associated cost and risk. Our proposals are theoretically justified and illustrated empirically with two real examples.     

2020-2021年世界甲螨亚目新分类单元和近15年中国发表新种概况——纪念中国甲螨学开创100周年

甲螨是土壤动物主要的三大类群之一, 数量庞大且种类丰富。截至2020年, 中国已报道的甲螨仅占世界所有已知甲螨种类的7.6%, 这与我国已知甲螨种类真实物种状况仍有较大的差距。值此中国甲螨学开创100周年之际, 本研究以甲螨亚目为研究对象, 分别基于世界2020-2021年度和中国2007-2021年度发表的分类学文献资料, 编制了世界新增分类单元名录和近15年中国发表甲螨新种名录, 分析了新分类单元的地理分布、学者贡献和出版刊物情况。研究结果表明, 2020-2021年, 世界甲螨亚目共描述238个新分类单元, 包括新属及新亚属21个, 新种217个; 新分类单元发表的热点地区在埃塞俄比亚界、东洋界和新热带界; 描述的新分类单元由27位作者所贡献, 其中外国学者贡献占比高; 论文均发表在国外期刊上, Systematic and Applied Acarology是新分类单元发表的主要期刊。2007-2021年, 中国发表甲螨亚目新种183个, 无新科和新属发表; 新种发表的热点地区在华南区和西南区; 描述的新种由24位作者所贡献, 中国学者占主要贡献; 论文多发表在国外期刊上, Systematic and Applied Acarology和Zootaxa是新分类单元发表的主要期刊。基于以上结果, 本文认为目前从事甲螨分类学研究的学者相对较少, 发表的新分类单元在类群分布和区域分布上均表现出极不均衡的现象。传统分类学未来的发展将面临机遇和挑战。     

New remarkable records of microfungi from Sardinia (Italy)

In June 2009 we organized a botanical student excursion to the eastern part of Sardinia, Italy. On this occasion we were able to collect and identify over 80 species of microfungi growing on higher plants. The collecting sites were spread over a large area, among them were La Caletta, Capo Comino, Monte Albo, Cala Gonone, Monte Maccione, San Teodoro, Capo Testa. The collected microfungi were parasitic or saprophytic; Basidiomycotina (Uredinales), Ascomycotina and Deuteromycotina (Hyphomycetes, Coelomycetes) were predominant. Examples are Pezicula corticola (J?rg.) NANNF. (new for Sardinia), on Pyrus communis. Puccinia chamaecyparissi TROTT. (new for Sardinia), on Santolina insularis. Sphaceloma oleae CICC. and GRANITI (new for Sardinia) and Phlyctema vagabunda DESM. (new for Sardinia), on Olea europaea and Arbutus unedo. Puccinia pseudosphaeria MONT. (new for Sardinia), on Sonchus oleraceus. Discula umbrinella (BERK. and BR.) SUTTON (new for Sardinia)(D. quercina WEST. and BARK), on Quercus coccifera. Zaghouania phillyreae PAT. (new for Sardinia), on Phillyrea angustifolia. Phymatotrichum omnivorum (DUGGAR) HENNEBERT, new on Verbascum thapsus for Sardinia. Guignardia punctoidea (COOKE) SCHROTER (new for Sardinia), on Quercus ilex. Many of the collected species are rare or unknown for the area of investigation until now. All specimens are located in the Herbarium ESS, Mycotheca Parva collection G.B. Feige and N. Ale-Agha.     

New species and nomenclature in Prospodium (Uropyxidaceae, Pucciniales) and the new anamorphic genus Canasta in the neotropics

Ten new teleomorphic species, two status novus taxa and two new combinations in the genus Prospodium are established. The following anamorphs, all closely related to the genus Prospodium, also are proposed: the genus Canasta, its two new species and a new combination, three new combinations for the genus Uredo.     

Turning a Drug Target into a Drug Candidate: A New Paradigm for Neurological Drug Discovery?

The conventional paradigm for developing new treatments for disease mainly involves either the discovery of new drug targets, or finding new, improved drugs for old targets. However, an ion channel found only in invertebrates offers the potential of a completely new paradigm in which an established drug target can be re-engineered to serve as a new candidate therapeutic agent. The L-glutamate-gated chloride channels (GluCls) of invertebrates are absent from vertebrate genomes, offering the opportunity to introduce this exogenous, inhibitory, L-glutamate receptor into vertebrate neuronal circuits either as a tool with which to study neural networks, or a candidate therapy. Epileptic seizures can involve L-glutamate-induced hyper-excitation and toxicity. Variant GluCls, with their inhibitory responses to L-glutamate, when engineered into human neurons, might counter the excitotoxic effects of excess L-glutamate. In reviewing recent studies on model organisms, it appears that this approach might offer a new paradigm for the development of candidate therapeutics for epilepsy.