全球微生态药物研发现状及发展趋势 *

微生态药物在许多复杂性和慢性疾病中显示出极大的潜力,逐渐成为国际制药行业的新趋势。基于科睿唯安旗下的Cortellis数据库,采用定量分析和专家智慧相结合的方法,从总体研发现状、主要国家/地区、主要适应症、重点企业研发管线、重点在研药物、商业化交易多个维度展现全球微生态药物的研发和商业化全景。分析结果显示:全球共有142个在研微生态药物,其中49个药物处于临床阶段。美国在微生态药物研发和商业化方面遥遥领先,其数量占在研药物总量的70%。在研药物的适应症主要集中于炎症性肠病、艰难梭菌感染、溃疡性结肠炎等肠道感染性疾病。4D pharma公司的在研药物数量最多,微生态药物重点研发企业均建立起核心技术平台。处于临床3期的微生态药物共有7个,全球微生态药物商业化交易共有303起,最大的交易金额是27.8亿美元。未来,微生态药物有望在更难被人类征服的肿瘤和神经系统疾病方面取得突破性进展。     

全球微生态药物研发现状及发展趋势

微生态药物在许多复杂性和慢性疾病中显示出极大的潜力,逐渐成为国际制药行业的新趋势。基于科睿唯安旗下的Cortellis数据库,采用定量分析和专家智慧相结合的方法,从总体研发现状、主要国家/地区、主要适应症、重点企业研发管线、重点在研药物、商业化交易多个维度展现全球微生态药物的研发和商业化全景。分析结果显示:全球共有142个在研微生态药物,其中49个药物处于临床阶段。美国在微生态药物研发和商业化方面遥遥领先,其数量占在研药物总量的70%。在研药物的适应症主要集中于炎症性肠病、艰难梭菌感染、溃疡性结肠炎等肠道感染性疾病。4D pharma公司的在研药物数量最多,微生态药物重点研发企业均建立起核心技术平台。处于临床3期的微生态药物共有7个,全球微生态药物商业化交易共有303起,最大的交易金额是27. 8亿美元。未来,微生态药物有望在更难被人类征服的肿瘤和神经系统疾病方面取得突破性进展。     

医药 CRO 专题报告——蓝海市场，强者恒强

随着全球制药企业研发投资成本加大、研发周期变长、研发成功率降低,作为社会分工专业化的产物,CRO 企业凭借其低成本、高效率、 多服务的特点,快速发展,且服务范畴已涵盖药物研发的整个过程,成为医药研发产业链中不可缺少的环节。报告采用文献调研、数据库检索、 数据统计与分析等定性定量研究方法,从发展概况、发展策略、竞争格局、企业布局等角度对国内外医药 CRO 领域进行多角度、多层次的 分析,旨在为相关企业确定产品研发思路、制定市场策略提供线索和参考。     

溶瘤病毒市场及研发格局分析

溶瘤病毒可以感染和破坏癌组织,是一种治疗癌症的新型生物疗法。溶瘤病毒在癌细胞中选择性复制,进而导致癌细胞裂解,释放肿瘤特异性抗原,诱导抗癌免疫反应,充当原位肿瘤疫苗。对病毒进入、复制、诱导和抑制免疫反应机制的深入了解促进了利用病毒治疗人类疾病技术的发展。过去十年溶瘤病毒领域临床试验的进展证实了其对癌症患者的治疗益处,利用溶瘤病毒作为载体治疗特定类型的癌症是肿瘤免疫治疗市场的新增长点。通过全面分析溶瘤病毒免疫治疗市场的细分领域及其市场动态,从关键技术进展、主要企业竞争格局和产品研发进展角度进行分析,并展望溶瘤病毒的发展前景,旨在为相关企业研发方向选择及地区产业决策提供参考。     

我国转基因植物研发形势及发展战略

当前,发达国家及跨国种业集团在功能基因组学、转基因技术和转基因产品研发方面进展显著,转基因产业发展势头强劲,已成为近年来持续保持高速增长的新兴产业。我国高度重视转基因植物研发及产业化,整体水平领先于发展中国家,但与国际转基因生物产业快速发展和我国衣业发展对转基因产品的需求相比,在转基因技术和产品创新、产业化机制以及支撑条件等方面尚存在较多制约因素。基于系统比较分析,建议我国进一步加强转基因植物研发能力建设,夯实转基因育种基础,突破转基因核心技术,培育转基因植物新品种,加强产学研紧密结合,培育具有自主创新能力和市场竞争力的大型企业,与此同时加强科普宣传,营造良好的社会氛围,推进我国生物育种战略性新兴产业的快速发展。     

抗体治疗的重生

近年来,治疗性单克隆抗体已成为基础和临床医学研究者及企业关注的热点。目前,针对免疫检查点的治疗性抗体用于肿瘤治疗已显示出较好疗效。在微生物耐药性日益增多、全球突发传染病威胁依然存在及持续性微生物感染难以治愈的当下,抗微生物领域中的抗体治疗正在积极研发中。本文综述了抗体治疗在抗微生物感染领域中的进展,并展望了其应用前景。     

转基因玉米双抗12-5转化体特异性PCR方法验证结果分析

抗虫和耐除草剂玉米双抗12-5是我国自主研发的转基因品种,该品种于2020年1月21日获得农业转基因生物安全证书,具有广阔的应用前景。转化体特异性PCR方法是进行转基因生物安全监管的最有效的技术手段之一,可以对转基因产品进行身份鉴定。本研究组织8家实验室对研发单位提供的的双抗12-5转化体特异性定性、定量PCR方法进行了验证,验证结果显示定性与定量PCR检测方法均具有稳定性好、特异性强和灵敏度高的特点,定量PCR方法能精确地定量检测质量分数为5%和0.5%的双抗12-5样品,并且具有良好的重复性和再现性,符合相关标准的要求。本研究有助于后续标准方法的建立和完善,为我国转基因生物安全监管提供技术支撑和决策依据。     

滇黄精资源的开发应用进展及前景分析

滇黄精为重要药食两用资源,誉有"血气双补之王"之称。其在云南蕴藏量大,是黄精品种中产量及市场份额最大的,为重要的"云药"品种。对黄精的药用记载、生长环境、资源状况,以及化学成分、药理作用和产品研发进展进行了综述;并对滇黄精的产品研发前景、产业发展潜力及研发可行性进行了分析。结果显示有必要进一步加大滇黄精的研发力度,充分发挥其药食两用的特点及优势,努力把滇黄精发展成为云药产业、乃至我国中药产业的一大支柱。     

关于特殊医学用途配方食品研发的几点思考

目的：2015年10月1日,《中华人民共和国食品安全法》正式颁布实施,赋予了特殊医学用途配方食品的法律地位,结合注册审评法规及产品特点,对特殊医学用途配方食品的研发提供参考建议。生产企业应当具备相应的研发机构、设备和人员,注重产品配方、生产工艺和稳定性等研发过程。方法：系统整理相关法律法规对特殊医学用途配方食品研发的要求,结合产业发展现状及特点进行讨论分析。结果：生产企业应具备相应的研发机构、设备和人员,注重产品配方、生产工艺和稳定性等研发过程。结论：生产企业应当注重特殊医学用途配方食品的研发管理并建立第一责任人的理念,注册审评部门应当与时俱进、创新工作方式,共同促进特殊医学用途配方食品产业规范、快速发展。     

科学出版社新书

2011工业生物技术发展报告中国科学院生命科学与生物技术局著本书是基于工业生物技术知识环境出版的信息产品,主要报道了工业生物技术领域内的重大规划与政策、技术和产品的研发进展、产业发展等。为了能够全面了解工业生物技术发展的最新进展,本书设置了规划政策篇、基地进展篇、研发进展篇、产业篇、青年人才篇、文献计量篇。在选题上,着重突出了工业生物技术领域的热点和前沿。为了突出各领域的技术     

跨国种企作物育种专利布局及对我国的启示*

当前全球种业基本形成“两超、四强、差异化发展”新格局,种业巨头主导着全球作物育种技术研发和产业发展。通过深入分析和挖掘跨国种企作物育种专利,洞察其技术研发布局,为我国合理部署作物育种技术研发、改善知识产权布局与保护具有借鉴意义。基于Derwent Innovation(DI)专利数据库,以“两超四强”跨国种企2015~2019年申请的作物生物育种专利为研究对象,通过文本聚类法全面分析了“两超四强”跨国种企的生物育种研发布局,通过计量指标结合专家咨询遴选出其重点专利,厘清其技术研发重点。据此提出我国应当瞄准生物育种核心领域加强新兴前沿技术原始创新与集成开发,加强新型抗虫基因挖掘与抗虫新机制研发,强化生物育种核心技术链、产业链知识产权协同保护与布局,提升知识产权保护水平及全球化结合重点布局的知识产权战略意识的建议。     

中国与“一带一路”参与国家抗击新冠肺炎疫情的国际科技合作现状与展望

2019年底暴发并席卷全球的新型冠状病毒肺炎疫情已经成为需要世界各国共同努力克服的全球重大卫生安全挑战。当前,中国已基本控制国内新冠肺炎疫情,并在疫情相关科学研究及公共卫生产品研发方面取得重大进展,同时加强了与“一带一路”参与国家开展国际科技合作。对中国与“一带一路”参与国家抗击新冠肺炎疫情的基础研究合作、国际科技合作项目等方面进行梳理,可以看到:中国与“一带一路”参与国家形成了领域交叉、节点多样的复杂合作网络,并主要与东南亚、中东欧和西亚各国合作密切;中国与“一带一路”参与国家的科研机构已在防控、流行病学和治疗等领域展开了大量实质研究,合作关系更偏向援助型合作。未来应加强与“一带一路”参与国家的生物技术产业合作与技术转移,发挥“一带一路”区域支点国家的示范效应等方面构建与“一带一路”参与国家更丰富、紧密、务实的科技合作关系。     

Antibody Engineering and Therapeutics: December 8-12, 2013, Huntington Beach,CA

The 24^th Antibody Engineering & Therapeutics meeting brought together a broad range of participants who were updated on the latest advances in antibody research and development. Organized by IBC Life Sciences, the gathering is the annual meeting of The Antibody Society, which serves as the scientific sponsor. Preconference workshops on 3D modeling and delineation of clonal lineages were featured, and the conference included sessions on a wide variety of topics relevant to researchers, including systems biology; antibody deep sequencing and repertoires; the effects of antibody gene variation and usage on antibody response; directed evolution; knowledge-based design; antibodies in a complex environment; polyreactive antibodies and polyspecificity; the interface between antibody therapy and cellular immunity in cancer; antibodies in cardiometabolic medicine; antibody pharmacokinetics, distribution and off-target toxicity; optimizing antibody formats for immunotherapy; polyclonals, oligoclonals and bispecifics; antibody discovery platforms; and antibody-drug conjugates.     

Modulation of antibody affinity by a non-contact residue.

Antibody LB4, produced by a spontaneous variant of the murine anti-digoxin monoclonal antibody 26-10, has an affinity for digoxin two orders of magnitude lower than that of the parent antibody due to replacement of serine with phenylalanine at position 52 of the heavy chain variable region (Schildbach, J.F., Panka, D.J., Parks, D.R., et al., 1991, J. Biol. Chem. 266, 4640-4647). To examine the basis for the decreased affinity, a panel of engineered antibodies with substitutions at position 52 was created, and their affinities for digoxin were measured. The antibody affinities decreased concomitantly with increasing size of the substituted side chains, although the shape of the side chains also influenced affinity. The crystal structure of the 26-10 Fab complexed with digoxin (P.D.J., R.K. Strong, L.C. Sieker, C. Chang, R.L. Campbell, G.A. Petsko, E.H., M.N.M., & S.S., submitted for publication) shows that the serine at heavy chain position 52 is not in contact with hapten, but is adjacent to a tyrosine at heavy chain position 33 that is a contact residue. The mutant antibodies were modeled by applying a conformational search procedure to position side chains, using the 26-10 Fab crystal structure as a starting point. The results suggest that each of the substituted side chains may be accommodated within the antibody without substantial structural rearrangement, and that none of these substituted side chains are able to contact hapten. These modeling results are consistent with the substituents at position 52 having only an indirect influence upon antibody affinity.(ABSTRACT TRUNCATED AT 250 WORDS)     

2012 Upcoming Meetings

The Fall/Winter 2012 conference season provides ample opportunities to attend meetings that feature topics relevant to antibody research and development (R&D). Meetings such as these serve critical informational and educational functions and are key networking opportunities. Locations are spread throughout the world, reflecting the global nature of antibody R&D.     

2012 Upcoming Meetings

The Summer/Fall 2012 conference season provides ample opportunities to attend meetings that feature topics relevant to antibody research and development (R&D). Meetings such as these serve critical informational and educational functions and are key networking opportunities. Locations are spread throughout the world, reflecting the global nature of antibody R&D.     

2012 upcoming meetings

The Summer 2012 conference season provides ample opportunities to attend meetings that feature topics relevant to antibody research and development (R&D). Meetings such as these serve critical informational and educational functions and are key networking opportunities. Locations are spread throughout the world, reflecting the global nature of antibody R&D.     

An update analysis of two polymorphisms in encoding ribonuclease L gene and prostate cancer risk: involving 13,372 cases and 11,953 controls

Encoding ribonuclease L (RNASEL) is a ubiquitously expressed latent endoribonuclease involved in the mediation of antiviral and pro-apoptotic activities of the interferon-inducible 2-5A system. Although the relationship between RNASEL gene polymorphisms and prostate cancer (PCa) risk has been widely reported, results were somewhat controversial and underpowered. Now, we performed an update analysis of 14 publications evaluating the association between RNASEL R462Q and D541E polymorphisms and PCa risk. We conducted a literature search of PubMed database to identify all eligible articles that examined the association of RNASEL R462Q and D541E polymorphisms with PCa. Odds ratios (OR) with 95% confidence intervals (CI) were estimated to assess these association. R462Q showed a significantly elevated effect on Africans (QQ vs. RR: OR = 2.50, 95% CI = 1.28–4.87, P_{heterogeneity} = 0.231). In addition, PCa men who contain 462Q genotype had a higher Gleason score ≥ 7 (OR = 1.16, 95% CI = 1.05–1.28, P_{heterogeneity} = 0.906). On the other hand, D541E was associated with increased total PCa. In the stratified analysis by race, there was also significantly increased PCa in Africans and Caucasians, as well as in sporadic PCa studies (OR = 1.09, 95% CI = 1.04–1.15, P_{heterogeneity} = 0.078). Our update analysis showed evidence that RNASEL R462Q and D541E polymorphisms were associated with PCa risk. Still more well-designed studies should be performed to clarify the role of these two polymorphisms in the development of PCa.     

Highly parallel characterization of IgG Fc binding interactions

Because the variable ability of the antibody constant (Fc) domain to recruit innate immune effector cells and complement is a major factor in antibody activity in vivo, convenient means of assessing these binding interactions is of high relevance to the development of enhanced antibody therapeutics, and to understanding the protective or pathogenic antibody response to infection, vaccination, and self. Here, we describe a highly parallel microsphere assay to rapidly assess the ability of antibodies to bind to a suite of antibody receptors. Fc and glycan binding proteins such as FcγR and lectins were conjugated to coded microspheres and the ability of antibodies to interact with these receptors was quantified. We demonstrate qualitative and quantitative assessment of binding preferences and affinities across IgG subclasses, Fc domain point mutants, and antibodies with variant glycosylation. This method can serve as a rapid proxy for biophysical methods that require substantial sample quantities, high-end instrumentation, and serial analysis across multiple binding interactions, thereby offering a useful means to characterize monoclonal antibodies, clinical antibody samples, and antibody mimics, or alternatively, to investigate the binding preferences of candidate Fc receptors.     

Agricultural R&D, technology and productivity

The relationships between basic and applied agricultural R&D, developed and developing country R&D and between R&D, extension, technology and productivity growth are outlined. The declining growth rates of public R&D expenditures are related to output growth and crop yields, where growth rates have also fallen, especially in the developed countries. However, growth in output value per hectare has not declined in the developing countries and labour productivity growth has increased except in the EU. Total factor productivity has generally increased, however it is measured. The public sector share of R&D expenditures has fallen and there has been rapid concentration in the private sector, where six multinationals now dominate. These companies are accumulating intellectual property to an extent that the public and international institutions are disadvantaged. This represents a threat to the global commons in agricultural technology on which the green revolution has depended. Estimates of the increased R&D expenditures needed to feed 9 billion people by 2050 and how these should be targeted, especially by the Consultative Group on International Agricultural Research (CGIAR), show that the amounts are feasible and that targeting sub-Saharan Africa (SSA) and South Asia can best increase output growth and reduce poverty. Lack of income growth in SSA is seen as the most insoluble problem.