我国生化制药工业的现状与对策

<正>我国生化制药工业是一支正在发展壮大的新兴工业,被国家列为高科技领域。自1978年国务院确定该行业由商业部统一归口管理以来,各级政府和主管部门对发展我国生化制药工业十分重视,投资改造老企业、培养技术人才、建立科研机构、引进先进生产技术和装备,建立了一批基本符合GMP标准的新企业。目前拥有生产经营企业192个,职工18000人.其中科技人员2000余人。1992年工业总产值达13.57亿元,1993年达17.10亿元,1994年达 21.87亿元,比 1993年增长27. 9％。生产手段从传统的生物提取逐步向高新技术──生物技术发展。现在能生产各种剂型300多种,其中人工牛黄、胰岛素、肝素钠、胸腺素（肽）、细胞色素丙、催产素,胰酶等主要部管产品已形成了一定规模,不仅满足了国内市场需要,而且大量出口创汇,其出口创汇额每年过1亿元。     

我国创业板制药企业药物研发现状与成果分析

目的分析我国创业板制药企业的药物研发现状与成果。方法选择创业板制药企业中年度营业收入达10亿元的20家企业,从研发投入、专利产出、1类新药产出和仿制药一致性评价现状4个角度分析其药物研发现状与成果。结果在纳入分析的20家企业中,40%研发投入金额不足1亿元,45%研发强度不到5%;19家企业获得了专利授权,但仅8家企业有专利获得了不少于3个国家的授权;仅半数企业有1类新药产出,大多处于临床研究阶段,过去10年内仅有1个1类新药获批上市;7家企业共计21个仿制药处于一致性评价审评中,仅1个产品通过了一致性评价;26项获得不少于3个国家授权的专利和23个在研或上市的1类新药中,分别有15项(57.69%)和9个(39.13%)来自贝达药业。结论我国创业板制药企业大多创新投入少,近半数企业研发强度较低,具有高潜在市场价值的专利储备较少,技术含量高的1类新药较缺乏,一致性评价成果也不足,总体研发实力较弱。虽整体创新实力不足,但也有个别企业创新成果丰硕。     

制药巨头在许愿

在大众面前透露自己的心迹并不容易，作为大众媒体和专业媒体关注的焦点，世界排名前列的制药公司的一举一动，自然是闪光灯下的捕猎对象，2002年制药行业虽然还有10%的增长率，但只要稍有些微的风吹草动，这个双位娄的增长率就难保了。制药公司很不容易又熬过了年关，然而，新一年的门槛也并不好跨越。     

浅析跨国制药巨头与国内制药企业之间的专利纠纷

目的:为国内制药企业应对或减少专利纠纷提供参考。方法:从跨国制药巨头与国内制药企业之间的专利纠纷案入手,深入分析案件背后的原因,进而提出对策。结果与结论:跨国制药巨头与国内制药企业之间存在专利纠纷的原因主要包括国内制药企业自身存在的不足、跨国制药巨头的专利战略日益升级以及专利本身的复杂性。国内制药企业应针对纠纷原因,从提高创新药物研发能力、增强专利意识以及主动利用专利本身的复杂性等方面入手,沉着应对与跨国制药巨头之间的专利纠纷,进而有效地回击跨国制药巨头发动的专利战。     

国内制药企业新产品研发的现状与对策

科学技术是第一生产力，企业要发展得先重视科技，依靠科技力量发展企业经济。恒瑞制药董事长孙飘扬说过，衡量一个企业生命力的强弱，关键就看产品占领市场如何。开拓市场的前提是要有更新更好的产品，新药销售是制药企业获得长期稳定利润的重要条件。在已经国际化的市场竞争中，我国制药企业想要生存，就必须把科技创新和开发科技含量高的新产品视为生命。可见，新产品研发是制药企业可持续发展的重要因索，制药企业要生存、发展，就必须重视、加强科技创新及新产品的研发。     

华北制药研发翁沥通胶囊进军中药新领域

前列腺增生是老年男性常见病、多发病,严重影响着老年人的生活质量。前列腺增生的病因至今尚无定论,多数学者支持该病是由内分泌平衡失调等综合因素引起的观点。对前列腺增生,现代医学除手术治疗外,至今还没有特效药物治疗。以本病的临床表现看,病程发展缓慢,一旦出现症状就属于慢性疾病。而对于慢性疾病的治疗,我国中医中药有其独到之处。 前列腺增生属中医“癃闭”范畴,祖国医学在癃闭的治疗方面     

药物研究与开发中的高通量结晶技术

1　前言药物固体剂型 (片剂、颗粒剂,胶囊等 )使用方便,贮存稳定,是市场上主要剂型。一种活性药物组分 (activepharmaceuticalingredients, APIs)可能存在多种固体形式,包括多晶型、溶剂化物、水合物、共晶、无定形固体和盐 (可能形成水合物、溶剂化物、多晶型、共晶和无定形固     

基因修饰体细胞国内外临床研究和相关产业现状及未来发展趋势

基因编辑技术可针对性增强体细胞的靶向性,一定程度上解决了传统过继性免疫疗法在肿瘤等多种疾病治疗中显露出的靶向性差等问题.最具代表性的是嵌合抗原受体T细胞(CAR-T)免疫疗法,其在血液系统肿瘤治疗中已取得良好疗效,此外,T细胞受体基因工程化的T细胞(TCR-T)、基因修饰的树突状细胞以及基因修饰的干细胞在多种疾病治疗的...     

Nonprofit organizations and pharmaceutical research and development

Not‐for‐profit or nonprofit organizations (NPOs) are playing an increasingly important role in providing solutions to the significant challenges faced by both large pharmaceutical and smaller biotechnology companies in today's world. NPOs chartered for the public benefit are common in the United States and in selected other parts of the world. The largest NPOs in the U.S. with bioscience programs include Battelle, the Midwest Research Institute, the Research Triangle Institute, Southern Research, and SRI International. To provide a perspective on NPO business models, 10 SRI case studies spanning a broad range of technical and business initiatives are summarized herein, including basic and contract research, discovery of new drugs and biologics, pharmaceutical and biotech R&D services, technology pivots, company spin‐ins and spin‐outs, and the creation of new NPOs. The article concludes with lessons learned and food for thought for both pharmaceutical companies and outsourcing participants. Drug Dev Res 70: 461–471, 2009. © 2009 Wiley‐Liss, Inc.     

The role of marketing in pharmaceutical research and development

Pharmaceutical marketing, which is primarily targeted at physicians, has been criticised because it may distort physician prescribing and thus potentially raise costs and/or worsen health. An alternative view, presented in this paper, is that successful marketing of pharmaceuticals can improve consumer welfare by increasing incentives for research and development (R&D) investment and by providing guidance to R&D to make it more consistent with consumer preferences. There are a number of arguments that support this view, despite impediments to pharmaceutical marketing such as the prohibited dissemination of off-label information in the US, difficulties in estimating potential pharmaceutical demand, and the long time lag between demand assessment and the introduction of new drugs. For example, physicians are often slow to modify their prescribing practices, even when new evidence-based practice guidelines are issued by prestigious organisations. Pharmaceutical promotion is likely to be particularly valuable because information plays a key role, is highly technical, and can change rapidly. Even consumer advertising can potentially improve health, for example, by improving patient compliance with drug therapy. In addition to disseminating information about the benefits of new therapies, an essential (and perhaps unique) role for pharmaceutical promotion is to encourage physicians and payers to pay closer attention to consumer needs (i.e. willingness to pay) for new medical technology. Moreover, successful marketing of pharmaceuticals increases the returns from R&D, thus increasing incentives to explore consumer demand and to contribute to basic research on the role of drug therapy. Consumer benefits from this process may be very large.     

Purity as an issue in pharmaceutical research and development

In the third EUFEPS Nuremberg Conference, three important aspects in the purity area were extensively covered. The first one dealt with the setting up of practical strategies to establish specifications during the complete R&D process. An industrial strategy on how this goal could be reached was presented. A safety evaluation aspect reflecting the discussion between ten pharmaceutical companies was given and the regulatory point of view was presented. The second one focused on the physical aspect of the purity issue (polymorphism, crystallinity...). The scientific background of this problem was presented and the necessity to cover this problem during the early phases of an industrial R&D project was outlined. Regulatory aspects were covered and the necessity to perform in certain cases bioequivalence studies was pointed out. The last session raised the particularity of biotechnological products. The contributors stressed that the impurity limits should be based on safety evaluation as well as the necessity to review carefully the production methods. Finally, a review was done on the current progress of the ICH guidelines establishment.     

Advances in knowledge management for pharmaceutical research and development

There are two assumptions that are taken for granted in the pharmaceutical industry today. Firstly, that we can generate an unprecedented amount of drug-related information along the research and development (R&D) pipeline, and secondly, that researchers are more connected to each other than they have ever been, owing to the internet revolution of the past 15 years or so. Both of these aspects of the modern pharmaceutical company have brought many benefits to the business. However, the pharmaceutical industry is currently under fire due to allegations of decreased productivity despite significant investments in R&D, which if left to continue at the present pace, will reach almost US 60 billion dollars by 2006. This article explores the role of knowledge in the industry and reviews recent developments and emerging opportunities in the field of knowledge management (KM) as it applies to pharmaceutical R&D. It is argued that systematic KM will be increasingly necessary to optimize the value of preceding advances in high-throughput approaches to R&D, and to fully realize the anticipated increase in productivity. The application of KM principles and practices to the business can highlight opportunities for balancing the current reliance on blockbuster drugs with a more patient-centric focus on human health, which is now becoming possible.     

原料药产业现状和发展趋势

2006年10月2日至6日,一年一度的欧洲世界原料药展览会(CPHI)在法国巴黎召开。这是迄今为止布展规模最大、参展人数最多的一次展会,具有以下3个方面的鲜明特点:1)展览会设有6个展馆,有实力的公司,尤其是所有著名跨国制药公司均布置独立展厅,内含多个大小不同的洽谈室;上药集团所