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Tuesday, September 11, 2012

Gleevek(Glivec) ramifications in India !!!


Indian Case Could Impact Availability of Generic Drugs   Anjana Pasricha September 10, 2012NEW DELHI — India's generic drug industry began to flourish in the 1970s when India disallowed the patenting of medicines, enabling domestic companies, which did not have to invest in research, to make copies of branded drugs at a far lower cost. In 2005, India allowed patenting, but set the bar higher for patents than other countries. Novartis went to court in 2006 after India turned down a patent for Gleevek - a medicine used to treat leukemia. Indian authorities argue it is not a new medicine, but a modification of an earlier one, and therefore not eligible for a patent under Indian law. The head of the Swiss pharmaceutical company in India, Ranjit Shahani, says the legal challenge is about protecting intellectual property rights."Novartis is seeking clarity to see how innovation will be valued and protected in India," said Shahani. "Now Gleevek has received patent protection in 40 countries across the world including China, Taiwan and Russia. And truly you know, protecting intellectual property advances the practice of medicines and brings hope to patients." The case is being watched closely, because its ramifications will go far beyond a single drug. Groups such as Doctors Without Borders argue that a ruling in favor of Novartis could severely limit the availability of low-priced versions of medicines used to treat life-threatening diseases such as HIV and tuberculosis. In the past 10 years generic drugs have slashed the annual cost of HIV treatment from $10,000 to $150.Leena Menghaney, a lawyer with Doctors Without Borders, or MSF, in New Delhi, says these affordable drugs brought life-saving medicines within the reach of tens of thousands of people living with HIV across the developing world. That could be impacted by applying more stringent patent standards."We have got more than 180,000 people living with HIV on Indian made generics. Now if we are unsure about whether we can in the future continue to procure the medicine, then it basically means that AIDS treatment itself for MSF could get heavily affected. It also means that AIDS treatment run by governments in developing countries could be very seriously affected," said Menghaney. "Currently about eight million people are on treatment and you can safely say that a large number of them could get affected. Scaling up AIDS treatment will just be a dream then."The hearing of the landmark case is expected to last several weeks.Critics of India's patent law say it does not meet standards set by the World Trade Organization. Defenders say it leans in favor of public health concerns over private patent rights.

サプリメントで自閉症の一部症状、改善の可能性 米研究

 AFP=時事 911()1424分配信 AFP=時事】自閉症の症状のうちアミノ酸不足との関係が判明しているまれな症状が、ごく一般的なサプリメント(栄養補助食品)によって改善される可能性が、6日の米サイエンス(Science)誌に掲載された研究論文で明らかになった。
米国で自閉症の子どもが急増、米疾病対策センタ 研究チームは、一部の自閉症患者にみられる、特定のアミノ酸の代謝を促進する遺伝子変異を突き止めた。こうした必須アミノ酸(分岐鎖アミノ酸、BCAA)はヒトの体内で作り出すことができないため、食品から摂取する必要がある。今回特定された遺伝子変異のある患者では、代謝が促進されるために通常よりも早く体内のアミノ酸が消費されてしまい、このことが自閉症の神経行動学的症状と関係した(アミノ酸の)不均衡を生んでいるのではないかと研究者らは指摘している。研究を行った米カリフォルニア大学サンディエゴ校(University of California, San Diego)、ジョセフ・グリーソン(Joseph Gleeson)氏らのチームは、てんかん性発作がみられる自閉症の子どもたち数人の遺伝子情報を調べた後にこの遺伝子変異を特定した。次に、てんかん性発作など自閉症的な症状を示すように遺伝子を操作したマウスに、健康食品店で入手できるサプリメントを与えたところ、マウスの症状に改善がみられたという。グリーソン氏の研究所のメンバーで、論文の第1著者であるガイア・ノバリーノ(Gaia Novarino)氏は「マウスで症状改善が確認されたので、次は我々の患者の治療に効果があるかどうかが問題だ」と語った。同チームによれば、人間の患者でもこのサプリメントを使用してアミノ酸の不均衡を修正することはできたが、こうした処置が自閉症の症状を改善する治療法につながるかどうかを決定付ける十分なデータは得られていない。自閉症でてんかん性発作がみられるのは患者全体の約4分の1だが、グリーソン氏はそうした患者は「極めてまれ」だとの認識を示した。このサプリメントが効く仕組みは不明だが、今回の遺伝子変異の特定は、自閉症やてんかんの検査基準の設定に役立つとの期待も呼んでいる。【翻訳編集】 AFPBB News

凯雷Carlyle Group 布局健检产业 (美年大健康) !!


凯雷旗下人民币基金入股美年大健康产业集团 20120816 08:15 金融时报 本报北京815 全球另类资产管理公司凯雷投资集团今天宣布,旗下的人民币基金——北京凯雷投资中心(有限合伙)已经入股中国预防性健康体检行业最大的私立服务提供商美年大健康产业(集团)有限公司,获13.5%股权。该人民币基金是在北京市政府的支持下,由凯雷亚洲基金所设立。此次投资的其他财务事项未公开。凯雷投资集团董事总经理冯军元女士说:"凯雷除了提供全球平台、分享深入的行业知识和最佳实践外,将利用其医药健康行业的专长,有力地支持美年大健康产业(集团)的业务开拓和网络扩展,提升各种服务,使公司在快速发展的健康产业里的领导地位获得进一步加强。"凯雷投资集团是最早进入中国的国际私募股权企业之一,也是最早在中国设立人民币基金的全球性私募股权企业之一。其人民币基金得到了本土有限合伙人的大力支持,并对本土高增长的企业进行投资。迄今,凯雷的并购基金、增长基金、房地产基金和人民币基金已经在中国投资了60多个项目,总投资额约40亿美元。凯雷在世界各地投资了众多的医药健康企业,包括中国最大的无创伤医疗服务网络——泰和诚医疗服务有限公司。

JV: AZ & WuXi for MEDI5117 (Anti-IL-6 Monoclonal Antibody) in China


MedImmune and WuXi AppTec Announce Joint Venture to Develop Novel Biologic for Chinese Market By WuXi PharmaTech (Cayman) Inc. Published: Monday, Sep. 10, 2012 - 10:29 am GAITHERSBURG, Md., and SHANGHAI, Sept. 10, 2012 -- /PRNewswire/ -- MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, a leading research and development outsourcing company, today announced that they have formed a joint venture to develop and commercialize MEDI5117, a novel biologic for autoimmune and inflammatory diseases, in China. MedImmune will provide technical and development expertise, while WuXi AppTec will provide local regulatory, manufacturing, pre-clinical and clinical trial support. When undertaking clinical trial development in China, the government requires local manufacture of medicines that have not been approved in other markets."We are pleased to partner with WuXi AppTec, a company with strong leadership in the Chinese pharmaceutical R&D sector, to help us address the healthcare needs of Chinese patients through the co-development of MEDI5117," said Bahija Jallal, Executive Vice President, Research & Development, MedImmune. "This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AstraZeneca's investment in this important emerging market."The joint venture will control the development of MEDI5117 for autoimmune and inflammatory diseases in China, and the two companies will have equal ownership in the joint venture. AstraZeneca / MedImmune will have the option to acquire the full rights to commercialize MEDI5117; otherwise, the joint venture will have the right to commercialize the product. WuXi AppTec will earn revenue based on services provided to the joint venture. MedImmune will receive various milestone payments as the program progresses."WuXi is delighted to work with MedImmune, an innovative biologics company, to develop and manufacture a novel product for first use in China," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "WuXi is working to build long-term drug development partnerships with leading biopharmaceutical companies like MedImmune to help accelerate the development of novel medicines for the large and rapidly growing Chinese pharmaceutical market."Today's announcement supports AstraZeneca's ongoing commitment to collaborating across Asia in ways that maximize the scientific and local knowledge of its partners and tap into the region's strong history of innovation.The Chinese government's focus on healthcare reform, along with its investment in improving healthcare infrastructure and expanding medical insurance coverage, are expected to continue to drive growth and demand for quality medicines over the long term. China also continues to increase its biomedical R&D investment, fuelled by sustained GDP growth. The Chinese pharmaceutical market grew from $10 billion in 2004 to $41 billion in 2010 and, according to IMS Health, is projected to grow to over $100 billion by 2014.
About MEDI5117 MEDI5117 is currently being studied in autoimmune and inflammatory diseases such as rheumatoid arthritis. MEDI5117, a novel investigational biologic, is a fully human monoclonal antibody that depletes IL-6 and bears MedImmune's proprietary half-life extending mutation (known as the "YTE" technology) designed to give a long duration of action. IL-6 is known to be an important mediator in the production of inflammation and pain in a variety of disease states. MEDI5117 is currently in phase I in the US and Europe. In China, a local investigational new drug (IND) application will be filed for MEDI5117. Following that process, phase I trials will be initiated.

MEDI5117: A Human High Affinity Anti-IL-6 Monoclonal Antibody With Enhanced Serum Half-Life In Development For The Treatment Of Inflammation And Rheumatological Diseases This modification does not alter the biological potency and specificity of MEDI5117 in comparison with its parent mAb. MEDI5117 binds to recombinant human IL-6 with high affinity in ELISA, consistent with the results from KinExa assays for affinity constant determination (KD < 1 pM). MEDI5117 exhibits potent neutralizing activity against recombinant human IL-6-induced TF-1 cell proliferation (IC50 = 5.2 pM) in vitro via inhibition of productive engagement of IL-6 with membrane-bound IL-6Ra (classical signaling mechanism). In addition, MEDI5117 also displays high neutralizing activities (IC50 = 1.2 nM) against native human IL-6-induced VEGF production by fibroblast-like synoviocytes from rheumatoid arthritis patients in the presence of exogenous recombinant soluble IL-6Ra (trans-signaling mechanism). In both assays, MEDI5117 shows similar or slightly better anti-IL-6 neutralizing actvities as compared to a benchmark anti-IL-6 monoclonal antibody (CNTO-136). Mutagenesis studies of human IL-6 show that MEDI5117 binds to an epitope on IL-6 known to be responsible for IL-6Ra interaction. In a pharmacokinetic and pharmacodynamic study in cynomolgus monkeys, MEDI5117 shows approximately 3 fold longer plasma half-life than the parent mAb when given by iv (28 vs 8.5 days) and sc (27 vs 9.1 days) administrations.
Arthritis Rheum 2009;60 Suppl 10 :401 DOI: 10.1002/art.25484

私募淡马锡RRJ Capital 布局 检测试剂Triplex Biosciences


Rx for China Biotech: Private Equity   September 6, 2012, 7:19 PM HKT Originally posted on Deal Journal: Private-equity fund RRJ Capital, best known for its investments in U.S. natural gas sector, has invested $50 million in a Chinese biotech company, an industry Beijing is pushing hard to develop. RRJ on Friday agreed to invest $50 million in Triplex Biosciences Co., according to a person close to the deal. Triplex, a closely held company based in the city of Xiamen, makes products used to detect and diagnose hepatitis B and C and certain cancers from blood and tissue samples. Another person familiar with the deal said the fund took between an 11% and 19% stake in the company but declined to give an exact figure. A Triplex spokesman declined to comment. With China's population both aging and growing more affluent, the government is looking for cost-effective ways to manage growing health-care demands. China's leaders are cheering on the growth of biotechnology, offering special loans and creating grants to open hundreds of publicly funded laboratories, as part of an effort to shift the country's economy from low-level manufacturing to high-tech, skilled industries. Private equity investment into Chinese health care doubled to $489 million in the first half of the year compared with the same period a year earlier, according to the Centre for Asia Private Equity Research Ltd. In August, Washington, D.C.-based Carlyle Group CG +0.45% bought a 13.5% stake in Chinese health-care check-up services provider Meinian Onehealth Healthcare (Group) Co. In April Kohlberg Kravis Roberts & Co. L.P. said it would invest $65 million in China Cord Blood Corp CO -0.37%., which provides services pertaining to umbilical cord blood, which is rich in stem cells. RRJ is best known for its energy deals, in which it has repeatedly teamed up with some of the biggest state-backed investors in Asia.RRJ and Singapore state-owned investment firm Temasek Holdings Pte. Ltd. together invested $468 million in Cheniere Energy Inc LNG +3.63%. in May to process and export liquefied natural gas from the U.S. Gulf Coast. In April RRJ invested $341 million in a Hong Kong-listed crude-oil and natural-gas company Kunlun Energy Co 0135.HK -0.29%. as part of a share placement, said a person familiar with the deal.In April last year the fund, again with Temasek, led a consortium that also included Korea Investment Corp 019660.KQ +3.34%. that invested about $3.5 billion in Frac Tech Holdings. RRJ Capital contributed $400 million.Still, the fund also focuses on investing in the health care and consumer sectors as well as financial institutions. In June 2011 it invested in AAB International Group Holdings, a private Chinese diaper maker.RRJ, which raised $2.3 billion for its first fund in March last year, is currently raising $5 billion for its second Asia-focused fund. The new fund's first close is expected in September. 

Shionogi: dolutegravir...better-than-expected !!!

Jefferies Maintains a 'Hold' on Gilead Sciences (GILD); Mixed ICAACJefferies maintains a 'Hold' on Gilead Sciences (NASDAQ: GILD) price target of $55.00.Analyst, Thomas Wei, said, "Phase 3 SINGLE data for Glaxo (NYSE: GSK) / Shionogi's dolutegravir, a competitor to GILD's elvitegravir/Stribild, was presented at ICAAC. These data were better-than-expected including the lack of resistance mutations in patients failing dolutegravir, a strong increase in CD4 cells, the lack of side effects, and an improvement in liver adverse events. We continue to believe dolutegravir will be competitive and pressure GILD's HIV franchise."

骨の治療薬重い副作用で死亡2例厚労省が注意呼びかけ

 産経新聞 911()1934分配信 厚生労働省は11日、多発性骨髄腫や骨に転移したがんの進行で骨がもろくなることなどを抑える治療薬「ランマーク」について、副作用の「低カルシウム血症」によるとみられる死亡例が2例報告されたとして、製造販売を行う第一三共(東京)に対し、「使用上の注意」を改訂し、関係者に速やかに注意を呼びかけるよう指示した。厚労省によると、ランマークは骨からカルシウムが溶け出すことを抑制する作用があるため、血中のカルシウム濃度が低下する低カルシウム血症を引き起こす恐れがあるとされている。今年4月に販売を開始し、約7300人が使用。このうち8月末までに重篤な低カルシウム血症の副作用が32例報告され、うち死亡との関連が否定できない症例が2例あったという。

亦药亦日化: 中国药企 “大健康”转型 from OTC to CHC (Consumer Health Care) 药妆


云南白药、片仔癀、马应龙等涉足药妆,争抢日化蛋糕2012091109:29来源:南方日报 随着药品利润逐渐摊薄,横跨药品和化妆品两大领域的药妆,正被越来越多的药企当作新的利润增长点。相关资料显示,近几年来,同仁堂、云南白药、马应龙、片仔癀、滇虹药业等纷纷向"大健康"转型,药妆成为其中关键业务,而目前涉及化妆品业务的药企数量已有近300家。药妆,顾名思义,就是药品与化妆品之间的结合体。与保养护理型化妆品相比,药妆在产品上更突出其功效性与专业性。有药企人士认为,未来化妆品市场将迎来"亦药亦日化"的时代,从产业链延伸趋势看,与日化企业相比,药企从医药向药妆过渡在专业性上更有优势。而随着越来越多的本土药企进军日化行业,由薇姿、雅漾、理肤泉等外资药妆品牌一统天下的局面将逐渐被打破。
药企纷纷涉足药妆 近日,在"2012全国药品零售业信息发布会"上,滇虹药业高调推出了两大药妆新品牌——芙芮芬丝和倍润。被滇虹视为明星产品的"康王发用洗剂",也推出了200ml家庭装、28ml方便装2种新规格。 滇虹药业的做法,只是国内药企的一个缩影。在主营业务不理想的情况下,众多药企纷纷向"大健康"业务转型。同仁堂是其中的先行者,其较早进军日化并在北京建立了首家美容旗舰店;康恩贝药业推出了孕产妇肌肤修复系列产品;昆明圣火和广州敬修堂均进军药妆。云南白药无疑是转型成功的典型。2011年,云南白药牙膏销售额超过10亿元,成为云南白药药妆业务的核心产品。目前,云南白药药妆业务包括三类产品:云南白药牙膏系列、养元青洗发水系列、沐浴露和面膜等身体护理产品。云南白药健康事业部今年上半年收入达7.5亿元,其中牙膏系列销售额7亿元,洗发水5000万元。 片仔癀也是较早介入药妆业务的老牌药企。在片仔癀201110亿元的销售收入中,化妆品、护肤品销售收入7658万元,在公司销售额中占比7.5%。根据公司目标,未来5年片仔癀药妆和牙膏将是公司的主要营收增长点,预期2015年销售达到5亿元。而以痔疮膏闻名的马应龙,其推出的八宝眼霜同样受到市场欢迎。数据显示,马应龙八宝眼霜2010年的销售额就已突破了1000万元。2011年底,马应龙成立了湖北马应龙八宝生物科技有限公司,专门推广眼妆、面部护理等产品。
药妆未来前景看好 药企为何放着主营业务不干,争相涉足化妆品领域? "由OTCCHCConsumer Health Care,消费者健康护理)全面转型,这是医药行业的共识与市场趋势。"在滇虹药业集团董事长郭振宇看来,相对于传统医药产业,大健康产业以保持健康、预防疾病为主,其面向普通大众而并非患者,同时可以将医药产业的内涵扩大为OTC药品、保健品、健康消费品及服务业。医药行业向大健康转型的大背景是,药品的利润空间越来越小。据中国医药企业管理协会会长于明德透露,2012年上半年,我国药品销售总额增长了19%,利润总额增长了17%,出口增长了5.1%,但同比去年,增幅均出现了下降。而与此相对应的是,药妆市场的份额正在迅速扩大。据统计,2004-2012年中国药妆市场销售额年增长率达10%-20%2010年,中国化妆品市场销售总额达1200亿元,其中药妆市场份额由20%增长到40%。中国药妆市场销售额增长率是欧美市场的两倍,在20-50岁的女性市场调查中,10人中平均就有4-5人使用药妆。尽管药妆市场增速很快,但是与国外60%的市场相比,中国药妆市场占有份额明显小很多。据知我药妆CEO苏海峥介绍,日本、韩国、台湾等国家和地区的女性已经从"大牌崇拜"转变成为使用针对自身肌肤问题的理性消费者,中国大陆地区要比日本、台湾市场落后五六年的发展,所以药妆必然成为一种流行趋势。
渠道难题有待破解 面对药妆市场这一块大蛋糕,当前摆在药企面前的最大一道难题是:如何迈过销售渠道这道坎。据了解,自2010年下半年开始,原来专注于药店渠道的外资药妆品牌雅漾、薇姿、理肤泉已大举进军百货。而由于品牌知名度不高,本土药企仍主要是通过药店这一渠道进行销售。 "国内的化妆品销售渠道分布,商场占比达七成,其次是连锁超市,再次是屈臣氏、万宁等个人护理店,之后是电商。"广东金康大药房连锁有限公司董事长郑浩涛表示,药店的消费群体和药妆的消费群体不太具有重合性,而这势必成为药企发展药妆业务的制约因素。中康资讯总经理吴翰则认为,药企的主营业务毕竟是药品,药品与快消品的营销模式完全不同,短期内要找到两种业务营销模式的差异、组建快消品营销团队并实现盈利比较难。不过,本土药企正在努力做着尝试。目前云南白药的药妆已经走出药店,佰草集、相宜本草等国内药妆品牌成功进驻商超渠道,同仁堂、京卫本草等也已进驻了知我药妆、聚美优品和乐蜂网等化妆品电商平台。而为了适应药企向大健康转型的发展趋势,药店也掀起了转型"药妆店"的热潮。老百姓大药房将其2000平方米的长沙东塘店变身为药妆店;海王星辰也再度试水药妆概念,在深圳宝安开出新店;第一医药开出了10家健康加芬药妆店,其中一半为对原有的药店进行模式嫁接。 南方日报记者 周照

Stem Cell: ES细胞改善帕金森病症状

 发布时间:2012-9-11 来源:药品资讯网信息中心 日本京都大学再生医科学研究所高桥淳副教授的研究小组成功地利用胚胎干细胞(ES细胞)培养出神经细胞,并将其移植到患有帕金森病的猿猴脑中,使得原先几乎瘫痪的猿猴能够来回走动,极大改善了症状。此项技术在灵长类动物身上成功应用尚属世界首次,是临床医学的一大进步。相关研究成果发表于美国科学期刊《STEMCELLS》(电子版)。帕金森病(Parkinson's disease)的症状主要表现为患者动作缓慢,手脚或身体其它部分的震颤,身体失去柔软性,变得麻痹僵硬,晚期患者大多伴有痴呆或抑郁症状。此病症是因缺少脑神经传达物质多巴胺所引起,预防困难,是一种慢性神经疑难疾病。ES细胞是从早期胚胎(原肠胚期之前)或原始性腺中分离出来的一类细胞,具有体外培养无限增殖、自我更新和多向分化的特性。此次高桥淳副教授的研究小组从受精后1周的受精卵内侧取出一部分细胞进行培养,制作成ES细胞。接着,使ES细胞经过42天的生长,使其变为发育成神经的细胞,制作成含有35%的能够分泌多巴胺的细胞团块。再将细胞团块分别移植到4只患有帕金森病的猿猴脑内。结果,在6个月之后猿猴的手足震颤均消失,从原先抱着笼子不能活动的瘫痪状态变为能够在笼子中来回走动。通过检查发现,猿猴的脑中长成了新的神经细胞。此前,高桥淳副教授的研究小组曾利用与ES细胞具有相同机能的诱导性多能干细胞(iPS细胞)制成多巴胺神经细胞并移植到1只猿猴的脑中,成功地改善了其帕金森的症状。此次在4只猿猴身上均得到了再次验证。此项研究成果被认为是攻克帕金森病治疗难关的重要突破,具有深远的意义。

抗肿瘤近40在研项目 恒瑞独家I类新药阿帕替尼

发布时间:2012-9-11 来源:药品资讯网信息中心 抗肿瘤项目进展调查:恒瑞独家I类新药阿帕替尼,江苏吴中抗癌药临床三期,丰原宣告中弹。从立项到上市,医药公司要经历至少11大关,每一关出了差错都将导致项目进展终止或延后。癌症,恶性肿瘤,这一人类医学上仍然没有攻克的难题。任何关于它的治疗药物动向都能引起一阵兴奋和骚动。

敏感的资本同样不例外。A股市场近200只医药股中,能够成为"牛股"的股票总免不了和"抗肿瘤"、"抗癌"等概念联系起来。理财周报在进行了地毯式的在研项目扫描之后,我们将目光聚焦到抗肿瘤新药上来。我们能够统计到的设计抗肿瘤的项目共有38个项目。这之中有仿制药,仿创药,创新药。有已经上市了的,也有完全没有上市的。我们以药物上市销售为脉络,理出一张抗肿瘤新药里程碑刻度。恒瑞医药:抗肿瘤大鳄又添翼在以仿制为主的中国医药公司中,恒瑞医药无论是在研发投入和专利药物以及国际市场的攻占方面,都是毫无疑问的佼佼者。"该药物为国家一类新药,是一种分子靶向抗肿瘤药物目前三期临床结束后,还有四期临床研究,将会在药物上市之后进行。"据参与恒瑞医药创新药物阿帕替尼临床研究的中山大学肿瘤防治中心教授张力表示。从A11的配图中可以看到,阿帕替尼目前已完成III期临床试验。而公司表示,阿帕替尼胃癌适应症技术审评排位第16位,预计一月内进行技术审评,技术审评完走程序大概需要三到四个月时间,预计年内有望获批。而除了阿帕替尼已经完成肺癌III期临床之外,公司8月底发布公告称,注射用奥沙利铂获准在欧盟上市销售。

这是个什么概念呢? 奥沙利铂是已经在直肠癌治疗中常用的通用药。原研厂家——赛诺菲公司目前在中国的份额为18%,而恒瑞医药的份额为36%,其2011年销售收入达5-6亿。此次获批在欧盟上市销售,是恒瑞医药继伊立替康注射液在美国上市销售后,又成为国内第一家注射液获准在欧盟上市销售的制药企业。对公司在欧盟市场的拓展,东方证券李淑花分析认为公司可能采取和当地知名仿制药企(如诺华Sandoz公司,全球非专利药领域的领导者)共同合作的模式,利用对方成熟的销售网络帮助公司在欧盟建立合适的商业模式和营销方案,快速切入欧盟市场。仿制药临床期间的等待:莱美药业从临床前到申请批件都有戏除了恒瑞医药的阿帕替尼,目前统计中的在研项目,全部为仿制药。其中比恒瑞医药的阿帕替尼快一步的是誉衡制药的注射用盐酸拓扑替康,这是一种已经在市场上销售的针对小细胞肺癌的细胞毒抗癌药。莱美药业的两个原料药和制剂也都申请到了生产批件。分别是盐酸吉西他滨原料及注射剂,临床上主要用于治疗局限晚期或已转移的非小细胞肺癌,局限晚期或已转移的胰腺癌。另一个是替莫唑胺原料及胶囊,用于治疗成人顽固性多形性成胶质细胞瘤。这两种药物均为在美国上市的抗肿瘤药物,莱美药业进行仿药研发。替莫唑胺的国内仿制药早在2004年就被天士力研发成功,并命名为蒂清,成功上市。莱美药业此时的研发成功也只能就现有市场分一杯羹。红日药业的抗癌新药PTS(对甲苯磺酰胺注射液)也进入了力争取得生产注册批件的程序。目前公司的产业化工作正在有序实施中,公司称"力争到2014年取得生产注册批件并投放市场"。对甲苯磺酰胺注射液是红日药业参股子公司健达康拥有化合物专利的研发项目。红日药业当初以投资250万元投资入股,占健达康公司12.5%的股权。而莱美药业除了之前的两个项目跑得比较快之外,地西他滨原料及冻干粉针已经报生产,拟近期获得药品注册批件。地西他滨目前在国内已有西安杨森公司可以生产,品牌为达珂。多聚半乳糖醛酸及冻干粉针则刚刚完成了临床研究,来那度胺原料及胶囊则刚进入临床研究阶段,来那度胺是由美国celgene公司研发,2005年开始在美国上市,并在印度有大量生产。或许除了海欣股份之外,另一只抗癌牛股——江苏吴中,还被投资者津津念到。江苏吴中的抗癌概念药:重组人血管内皮抑素注射液皮抑素注射液目前取得了三期临床批件。但公司相关负责人表示"目前三期临床还没有展开,要先进行评估,给各个临床医院做培训等等,顺利的话也要到明年年底才能上市。""临床展开前,我们已经征集到80名临床患者了。"公司表示。西南合成的康普瑞汀磷酸二纳及注射剂研发项目研发共3期,一期研发已经结束,全部资金由研究院承担。 二期临床批件还在申请阶段,目前还没有和研究院签订合同,预计今年可以获得临床批件审批。西南合成对研发项目没有具体时间预期,得看研究院的研究进度。临床前项目的挣扎:

沃森进军单抗挑战复星医药 相对较早进单克隆抗体研发的复星医药表示有5只单抗药物进入了小试阶段。并且已有3个单克隆抗体产品完成高表达生产细胞株的构建和筛选,其中1个单克隆抗体产品已向国家食品药品监督管理局提交临床申请;有1项创新候选化合物正在系统地开展临床前动物试验,并在试验中显示了很好的安全性和有效性,当然由临床前实验到临床,再到上市,10年时间都不算短。单抗药物市场的争夺战已经拉响,沃森生物以收购上海丰茂公司为入口,也开始进军单抗市场,并携带了5个单抗品种,其中的利妥昔、贝伐珠和阿达木都是与复星医药一样的。据沃森生物的介绍,上海丰茂是专注做单抗药品的研发和销售的,但这五只单抗药物的上尚未有明确的时间表。对于处在临床前的在研项目,基本未来5年都鲜有上市的可能。安科生物人源化抗肿瘤抗体新药,预计2012年下半年进入临床。公司表示"2012年完成动物的药理及安全性评价(包括毒代)研究;完成申报资料的撰写并进行注册申报工作","进行人体临床试验阶段,人体临床试验阶段需要I期、II期、III期临床试验,如果临床试验都顺利进行,则预计7-8年后获得生产批件,到获得生产批件预计需要8000-1亿的资金投入。"千红制药的肿瘤靶向性细胞凋亡诱导剂TRAIL变体的药物研发也处于临床前研究阶段。舒泰神的治疗脑胶质细胞癌的基因药物研发项目还处于临床前药学研究的第一个阶段:完成其基础性药学研究工作之后,预期35年完成临床研发,目前公司还没有具体投资计划。精华制药的卡培他滨(Capecitabine )研发项目在小规模生产,且公司在建新厂区,化学原料新品开发处于中试阶段,且大规模生产的时间预期未定,研发成果对于公司的影响得观测市场竞争而定。

丰原药业进军抗肿瘤领域折戟, 研发进度不敌预期 研发有风险,投资需谨慎。相比长春高新各种疫苗概念十几年未兑现,丰原药业与安徽中人科技合作开发的抗肿瘤药物似乎可靠性更高。20129月份上市是公司两年前成立合资公司时定下的目标。丰原药业以4550万元资金和30 亩土地使用权作为出资,占合资公司注册资本的60%;中人科技以顺铂、甲氨蝶呤抗癌植入剂的相关专利技术、临床批件及全部生产技术作价3333万元作为出资,继续研发上市两个植入剂,直至上市。这是丰原药业首次进入抗肿瘤领域,预计"植入用缓释顺铂"2012年下半年能上市销售,"植入用缓释甲氨蝶呤"2013年下半年能上市销售。新药不仅能够降低抗癌药物的全身毒性反应,同时还能选择性地提高肿瘤局部的药物浓度,增强抗癌药物的治疗效果,有望成为新的利润增长点。按照双方约定,顺铂植入剂抗癌新药应该在20129月底前上市。但是由于客观原因,该新药上市的时间将推迟。"植入用缓释顺铂"和"植入用缓释甲氨蝶呤"于1999年就获得SFDA批准进入临床,因在临床研究中遇到了一些困难而没有完成。中人科技于2009年底获批重新进行临床试验。丰原药业表示,为降低投入风险,合资公司在顺铂植入剂抗癌新药临床研究主适应症选择上,采取了很慎重的态度,对顺铂植入剂批准进入临床试验十多年来,在全国多家医院进行的多种临床适应症前期试验的病例资料进行整理,在前期肝癌等癌种疗效提示的基础上,由原临床研究负责单位重新开始进行规范的临床研究,客观上增加了临床研究内容和延长了临床研究的时间。而为了确保新药上市及产销步伐,丰原药业2010年已经与中人科技签订了对赌协议,中人科技保证,顺铂植入剂抗癌新药在20129月底前上市,如每推迟一个季度上市,中人科技在合资公司中所占股权比例下降2%,该下降部分股权无偿转让给丰原药业。如今这份对赌协议被兑现。新药继续研发,中人科技火烧眉毛!理财周报记者采访国元证券分析师刘斌,他表示公司比较敏感,信息不透露,这两年不再写其研报。由图中可以看到,目前上市公司的抗肿瘤在研项目所处的进展位置。这把从立项到上市的尺子,丈量的是上市公司还要经历的关卡,也丈量着投资这项项目带来的风险和回报。

PHarmacells 香港临床试验: stem cells from blood to cure wrinkles


用自身血液提纯的干细胞治疗皱纹 发布时间:2012-9-11 来源:药品资讯网信息中心 据《每日电讯》910(北京时间)报道,位于英国格拉斯哥的PHarmacells公司正在开发一种治疗方法,将患者自身血液中提纯的干细胞注射入其皮下,以长出新的皮肤细胞恢复弹性,有效"对抗"皱纹。第一期临床试验将在短期内开始进行。对于有些人来说,皱纹被视作是个人特征的一种标志,而对于大多数人来说,它们的出现是不受欢迎的老化提醒。减少脸部皱纹的建议办法,可能落脚点都是日常的护理和使用保湿剂,以尽量维持陷入困境的脸部线条。该公司董事长阿瑟尔·哈斯说:"皮肤具有自然弹性的属性是来自于被称为纤维母细胞的细胞。随着年龄的增长,身体产生这种弹性细胞的能力会逐渐减缓,因为这些纤维母细胞的数量在减少。"他说:"通过引入大量的干细胞到皮下合适的位置,即可增加身体生产这种细胞的能力。当然,这种疗法仍然处于早期阶段,但我们希望在未来12个月内开始一期临床试验。"一直以来,任何一个人都希望摆脱自身的皱纹,并依赖美容治疗注射合成胶原蛋白于皮肤下,作为填充物以"祛除"细纹。如今,肉毒杆菌毒素已经成为流行的美容疗法,但这种疗法具有副作用,甚至还可能会导致新的皱纹。纤维母细胞会产生胶原蛋白,有助于保持皮肤的结构完整性。PHarmacells公司将与香港一家诊所进行第一期临床试验,使用一种技术来净化非专业类型细胞,一种被称为类似囊胚的干细胞,其在体内可以长成许多不同类型的组织。这将是首次用这种类型的细胞进行治疗,该公司还希望基于此开发新的技术来治疗疾病,如心脏疾病和骨关节炎。英国美容整形外科协会当选负责人、整形外科医生拉吉夫·格罗弗说:"有一些证据表明,干细胞在注射时能改善皮肤的质量,但是,对于看到其长期的效果和安全性的研究,尚不能确定。在干细胞用于皱纹的广泛治疗之前,可能还需要510年的时间。这是一个令人兴奋的前景,干细胞会显著影响未来的整形外科及美容医学。"总编辑圈点:干细胞美容被形容为"世界在试验,中国已疯狂"的技术,曾被评为"十大科技骗局"之一。这种全世界至今没有进入临床运用、也没有获得我国任何部门批准的非法手段,却已经在国内大行其道多年,广告漫天飞舞,各种上当受害的案例屡见报端。我们选择这篇新闻的目的不是为干细胞美容鼓吹,而是让读者了解到其在国外研究的状况:刚刚起步且有效性、安全性都有待检验,不要被蒙蔽而成为"试验品"。

Geron乳腺癌药物遭遇二期受挫

发布时间:2012-9-11 来源:药品资讯网信息中心 Geron公司首席执行官John Scarlett决定放弃公司持续十年对干细胞药物的研发而转为对癌症进行攻克仅仅十个月后,这间生物公司就收到了一份来自在研药物的挫折。在一项针对乳腺癌患者的二期试验中,其抗癌新药未能延长患者的生存期。Geron的股份因此暴跌50%Geron抗癌药物imetelstat针对166例转移性HER2阴性乳腺癌患者的临床实验中,药效不及对照药物紫杉醇。而在另一个针对非小细胞肺癌的药物临床实验中中,Geron也表示数据并不乐观,很可能不再进行三期实验。Geron希望imetelstat能够对血液系统中的恶性肿瘤进行瘟啤2metelstat对原发性血小板增多症和多发性骨髓瘤生物标志物的影响进行观察,预计今年年底获得结果。然而,不少投资商表示不愿意继续信任Geron。这间公司被认作目前最古老的"有投入,无产出"的公司,在20年的经营时间里,Geron曾一度被认作干细胞研究领域的领军人物。直到前Proteolix首席执行官Scarlett接管Geron后,公司转型癌症领域却挫折重重。

礼来抗癌药AlimtaIII期肺癌临床试验失败

 发布时间:2012-9-11 来源:药品资讯网信息中心 礼来(Eli Lilly)宣布,有关抗癌药Alimta的一项III期肺癌研究,未能达到改善非鳞状非小细胞肺癌(nonsquamous non-small cell lung cancer)患者整体存活率(overall survival)的主要目标。在这项名为POINTBREAKIII期临床试验中,一组患者接受礼来的Alimta+贝伐单抗(bevacizumab,品牌名为阿瓦斯汀,Avastin)及卡铂(carboplatin)、随后接着Alimta+贝伐单抗治疗。另一组患者接受紫杉醇+贝伐单抗及卡铂、随后接着贝伐单抗治疗。不过,该项研究达到了其改善Alimta患者组无进展生存期的次要目标。"II期临床试验的结果表明,这一组合是非常有前途的,我们也一直希望该项III期试验能够证明该组合对非鳞状非小细胞肺癌患者生存率的改善,然而,试验的结果令我们失望,"礼来肿瘤学医学主任Allen Melemed博士在一份声明中说道。"POINTBREAK确实显示出了改善的无进展生存期,然而,并没有转化成改善患者整体存活率的优势。"有关该项研究的全部数据,将提交至97在芝加哥举行的胸部肿瘤多学科研讨会上。

全自動電擊器 日本配置是台灣16倍!!!


消基會:電擊器每1千人才配置0.17 2012-09-11 17:08 新聞速報 【中廣新聞/閻大富】 消基會近日調查國內公共場所配置「全自動電擊器(AED)」的現況,發現台灣每一千人只有配置零點一七台,日本卻是台灣的十六倍,而且日本孩童至少會接受三次AED訓練。消基會呼籲政府,除了應修法廣設AED外,也應加強國內急救教育。行政院日前通過「緊急救護法修正案」,規定在機場、火車站、遊樂園等公共場所,應設置必要的緊急救護設備,民眾施與急救也可免責,但消基會近日調查發現,除了台北市、桃園縣市有一百零七台AED,其他縣市配置數量明顯不足,例如苗栗縣只有十台、台東縣十一台、金門縣兩台,澎湖縣更低只有一台。消基會醫療糾紛處理委員趙凱醫師表示,目前全台設置院外AED數量只有四千多台,按人口比例約為千分之零點一七,遠遠落後日本的千分之二點七,呼籲政府應增設。根據國外資料顯示,如果能在突發心跳停止的一分鐘內,立即給予電擊,心跳回復正常的成功率可達九成,每延遲一分鐘就下降百分之七到十,而台灣整體救護車平均到達時間為十一分鐘,已錯過黃金時間,可見廣設自動電擊器的重要性。

To be the world pharmacy: India !


Will India keep Novartis at bay? Wants to patent cancer drug, Glivec, in India Sushmi Dey / New Delhi Sep 06, 2012, 00:48 IST Much of the world — from patients to pharmaceutical companies to health activists and even governments — is watching an intense battle currently being fought by Swiss pharma giant Novartis in India's Supreme Court. The company wants to patent and sell its anti-cancer drug, imatinib mesylate, known as Glivec, in India but, so far, its efforts have failed. This is a high-stake contest, with serious implications for many of the above constituents.At the heart of the dispute is the Indian government's contention that Glivec, which treats myeloid leukaemia and some gastrointestinal cancers, is simply a retooled avatar of a pre-existing version patented in the US in 1993, and, therefore, doesn't deserve one here. The core issue, then, is over the degree of innovation required to obtain a patent in India. Section 3(d) of the Indian Patent Law prevents what the industry calls 'evergreening' — a process of churning out a version of the medicine with incremental modification and no innovation, simply in order to prolong the life of the patent. The case has an acrimonious history. Novartis had filed for a patent in 2006, which was denied. Then, in 2007, the Madras High Court rejected Novartis' plea. The company also lost the case at the Intellectual Property Appellate Board, which rejected the company's appeal in 2009. Novartis, then, decided to take the case to the highest court in the country.

Is Novartis 'evergreening'?  Novartis describes the case as a crucible for the future of pharma investment. "Novartis is seeking clarity on the patent law in India," says Novartis India Vice-Chairman & Managing Director Ranjit Shahani. "Knowing we can rely on patents in India benefits the government, industry and patients, because research-based organisations will know if investing in the development of better medicines for India is a viable long-term option."Besides, Novartis cannot be accused of evergreening, says Shahani. According to the company, imatinib mesylate is the salt form of an older medicine, imatinib, and the new version represents a 30 per cent increase in the bioavailability of the medicine. "Scientists at Novartis developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to make it suitable for patients to take in a pill form, which would deliver consistent, safe and effective levels of medicine. This process resulted in a viable drug which revolutionised cancer treatment," says Shahani.However, health activists argue that granting a patent on such incremental innovations would be violating the basic principles of inventive science. "The selection of a salt of the active ingredient with the purpose of improving bioavailability is well known in pharmaceutical art, and is an often-used form of what is known as 'evergreening'," says Leena Menghaney of Medecins Sans Frontieres, which campaigns for access to essential medicines.The drug has been granted a patent in 40 countries, including China, Russia, Mexico and Taiwan. The Supreme Court will hear final arguments in the case on September 11.

Pharmacy to the world  India provides half the world with AIDS medication, most of it in the generic form. Various developing countries, and now even developed ones, depend on India for low-cost, quality drugs, hence the country's nickname, 'pharmacy to the world.' If Novartis wins its case, this spigot of cheap drugs to those who cannot afford them could be turned off.One reason India has become such a big drugstore: Until 2005, India did not grant patents on medicines, which allowed drug makers to manufacture and sell generic versions at a much lower price. Eventually, India's stance on patents changed after it joined the World Trade Organization (WTO) and signed the trade-related aspects of intellectual property rights (TRIPs) agreement. From then on, patents would be applied in India as well. However, the Doha round gave a large degree of flexibility to governments to decide what kind of innovation was patentable, what should be the criteria included in 'novelty', what constituted an 'inventive step', and so on. There was another important clause from the Doha Declaration: "Each member has the right to grant compulsory licence and the freedom to determine the grounds upon which such licences are granted."The government was, thus, able to legitimately award Natco Pharma a compulsory licensing deal that made it possible for the company to sell Bayer's anti-cancer drug, Nexavar, used in the treatment of liver and kidney cancer, for Rs 8,880, versus Rs 2.8 lakh under Bayer. 

Taiwan, Canada extend technology cooperation

ROC Representative to Canada Liu Chih-kung (left), John R. McDougall, president of the NRCC (center), and NSC Minister Cyrus C.Y. Chu beam as they show off the memorandum extending bilateral science and technology cooperation. (CNA) Publication Date09/07/2012 Source Taiwan Today Liu Chih-kung, ROC representative to Canada, and the Canadian Trade Office in Taipei inked a memorandum of understanding Sept. 7 to extend cooperation on science and technology for five years. The signing came on the 15th anniversary of the beginning of such collaboration, and was witnessed by ROC National Science Council Minister Cyrus C.Y. Chu and John R. McDougall, president of the National Research Council of Canada. Liu said that over the past decade and a half, the two sides have worked jointly through academic and research organizations in many fields, including bio-optics, nanotechnology and biological products. On the same occasion, Chu, McDougall and Sean S.H. Wang, head of ITRI International Inc., a subsidiary of Taiwan's Industrial Technology Research Institute, announced that the two countries have launched a joint project on vaccines and biopharmaceuticals to combat hospital-acquired infections.The goal of the project is to complete development of a preventive vaccine within three years and begin preliminary clinical trials within five years, they said. (SB-THN)

US risks losing out to Asia in medical research

August 23, 2012 in Health Medical research saves lives, suffering and dollars – while also creating jobs and economic activity. The United States has long led the world, with hundreds of thousands of jobs and marketable discoveries generated by government research funding every year. Top students from around the world come here for training—and often stay to help fuel medical innovation. Now, warns a team of researchers in the New England Journal of Medicine, the U.S. risks losing out to Asia as the hub of medical discovery. The result, they caution, could be a "brain drain" of top young researchers, and the loss of untold discoveries and economic activity. The authors are two physician researchers from the University of Michigan Medical School and VA Ann Arbor Healthcare System, and an American researcher who left the U.S. for better job prospects in Singapore. They compiled data on five Asian countries – China, India, Singapore, South Korea and Taiwan – that are all boosting their government support for medical research right now. All five have a long-term plan for increased support for such research, as part of efforts to boost their national economies and world standing. By contrast, American medical scientists and physician researchers face almost certain cuts to federal research funding. At best, the authors say, funding for the National Institutes of Health – which supports most U.S. medical research – will fail to keep pace with inflation next year. At worst, if the federal budget falls off the 'fiscal cliff' of automatic cuts, American medical research spending will fall by 8 percent, with thousands of researchers cut off from funding. One estimate says this could cost the U.S. $4.5 billion in economic activity. There are also proposals to cut entire health research agencies. By contrast, China has increased spending on medical research by 67 percent, South Korea by 24 percent, India by 15 percent, Singapore by 12.5 percent and Taiwan by 4 percent in the most recent year for which data was available. Ads by Google Clinical Research Course - Want a Career in Clinical Research? CRA Education & Training Program - www.CRA-Training.com Clinical Research CEUs - Join ACRP and and earn credits while learning through The Monitor - www.acrpnet.org/join "In recent years, NIH funding has not kept pace with growth in biomedical innovation, making it harder for scientists to win grants," says first author Gordon Sun. M.D., an otolaryngologist and health researcher who is currently a 2011-2013 Robert Wood Johnson Foundation Clinical Scholar at U-M, supported by the U.S. Department of Veterans Affairs. "Meanwhile, these five Asian countries have pledged long-term increases in funding." He notes that the number of clinical trials of new medical ideas in the U.S. has fallen, while the number in countries like China has grown. Sun and his co-authors warn that this trend could lead to long-term economic damage for the United States and the loss of its stature as a global leader in the field. "Powerful incentives that can retain an elite biomedical research workforce are necessary to strengthen the U.S. health care system and economy," they write. The stakes of this Asian rise and American decline are highest for current and future postdoctoral fellows – young researchers who have finished their M.D. or Ph.D. training and have decided to go into research as a career. Post-doctoral training in a laboratory or health research specialty usually primes them for their first full-time research position – and their first grant applications as independent researchers. Winning grants year after year is vital to a research career – making sustained federal research support important. But with grant dollars becoming harder to find in the U.S., and easier to obtain in Asia, young researchers may choose to take their very portable talents overseas. In fact, China has started programs to attract young Chinese scientists back to China after training in the U.S. And with English being the common language for researchers in India and Singapore, those nations may attract increasing numbers of American-born researchers – such as Jeffrey Steinberg, Ph.D., Sun's co-author and personal friend. He now works at the Singapore Bioimaging Consortium, supported by the nation's Agency for Science, Technology, and Research. "In researching this article, we were surprised at how well-developed other countries' plans are for including medical research and scientific research as part of long-term goals," says Sun. "All of them have a fairly well-defined plan, which is part of their overall efforts to become economic powers. Whereas in the U.S., NIH funding is considered as just another part of the annual budget, and can be cut at any time." The American approach to budgeting for medical research appears to ignore the long-term economic payoff of sustained research, says Sun. "Simply cutting research spending off will end a lot of projects immediately. Then, all these well-trained people – what are they going to do? Many will go somewhere where their work may be more appreciated." Journal reference: New England Journal of Medicine 

Infectious disease experts monitor outbreaks of enterovirus 71 in Asia

September 11, 2012More than 100 deaths of children aged three and under have been caused by enterovirus 71 in Asia. Canadian infectious disease experts are monitoring a strain of enterovirus 71, which causes hand, foot and mouth disease with neurological and cardiovascular complications that is killing children in Asia.Taiwan, Malaysia, Cambodia, Vietnam, Japan, South Korea, Singapore, Thailand and China have all seen large outbreaks of the acute viral illness, which is usually transmitted by the fecal-oral route. In July, the World Health Organization reported that 54 children, most aged three and under, had died in Cambodia after contracting what was originally described as a "mystery illness." Earlier this year, enterovirus 71 killed 56 people in China, where there have been 1.5 million cases reported to date, up from 964 000 in all of 2011. Another 33 deaths were reported in Vietnam."It's a bit of a mystery as to why it [enterovirus 71] continues to circulate, especially in Borneo, in [the state of] Sarawak, where it has caused problems for the last 10 years with cycles occurring every three years," says Dr. Donald Low, microbiologist-in-chief and infectious diseases consultant at the University Health Network/Mount Sinai Hospital in Toronto, Ontario. "It's an interesting disease — it's sort of the replacement for polio."Isolated cases of enterovirus 71 have occurred in Canada, says Low. No large outbreaks have taken place here, however, and symptoms are typically milder than those experienced by people in Asia. In Ontario, for example, there have been just nine cases of enterovirus 71 reported since 2005, says Jonathan Gubbay, a medical microbiologist at the Public Health Ontario Laboratory. Although hand, foot and mouth is not a reportable disease, the public lab did conduct molecular typing of enteroviruses during 2009–2010, Gubbay says, because there was some increase in meningitis due to a different strain of enterovirus.But given the extent and pace of global travel and the possibility that Canadians or visitors to Canada could come in contact with enterovirus 71 overseas, the infectious disease community is watching to make sure that the "very adaptable" virus, as Low describes it, does not mutate and become more deadly in North America."With the amount of travel that we see to different countries, if there is a particularly virulent strain that is readily transmitted — why wouldn't we see it here?" Low asks. "We saw SARS (Severe Acute Respiratory Syndrome) here, we saw (pandemic) influenza here … nobody really understands that."Hand, foot and mouth disease is usually a mild disease in Canada, caused by the coxsackievirus A16 and resulting in fever, sores in the mouth and a rash with blisters on the hands, feet and sometimes the buttocks. Most people recover in 7 to 10 days without any medical treatment. However, enterovirus 71 can be associated with meningitis and encephalitis, as well as neurological, cardiovascular and respiratory problems. Because different types of viruses cause hand, foot and mouth disease, getting infected with one form does not confer immunity to all types of the disease.Better public sanitation systems and personal hygiene practices in Canada are likely one reason that the isolated cases of enterovirus 71 haven't spread here, and aren't likely to do so to the same degree as in countries such as Cambodia, says Dr. Anna Banerji, assistant professor of pediatrics at the University of Toronto's Dalla Lana School of Public Health."It's possible if the virus does mutate it could be more transmissible, but right now we don't have any reason to think that we're going to have an epidemic here," she says. "But that's always a possibility, just like SARS."But if an outbreak did occur in Canada, "the impact here is not going to be the same as there, because we have public sanitation systems and in general are a healthier population," Banerji says.Both Low and Banerji speculate that host factors, such as coinfections in people in Asia who contract enterovirus 71, as well as the virulence of the strain and access to clean water, may all be factors in the severity of the outbreaks and complications in Asia."The mortality rate is actually pretty low" given the thousands of people who are infected there, Low says, adding that if large numbers of people were to get infected with the same strain in Canada, a similar incidence rate of complications and deaths could occur. "I would imagine it would be the very same."There is no cure for enterovirus 71, although intravenous immune globulin has been tried to modify the immune response, he adds. Several research groups are attempting to develop a vaccine, including Taiwanese researchers who announced in August that they are ready to begin human clinical trials on a vaccine.Low encourages parents who suspect their children might have hand, foot and mouth disease to go to their family doctor, and suggests that physicians do order diagnostic tests. "There's no intervention but this is something that we are interested in monitoring," he says.

Taiwanese oncologist develops cheap, high-precision cancer therapy system

Staff writer, with CNAA New York-based Taiwanese radiation oncologist said on Tuesday he has developed a high-precision robotic image-guided therapy system called Arc-Knife, which offers the most cost-effective cancer treatment. Clifford Chao (趙坤山), chairman of the Combined Program in Radiation Oncology at New York's Presbyterian Hospital, said the therapy system can map the exact location of a tumor and accurately direct radiation toward malignant cells without damaging surrounding healthy tissue. After five years of painstaking development, Arc-Knife's breakthrough technology is now mature enough for mass production, Chao said. The technology has already drawn interest from foreign investors, but Chao said he wishes to bring the system to Taiwan to contribute to the country's biotechnology sector. Traditional radiation therapy uses X-ray beams that go through the cancerous tissue, destroying both healthy and cancerous areas along the path of the beam, he said. In order to block the radioactive beams, thick walls are built around the therapy equipment, which takes up a huge chunk of space in a hospital, Chao added. As for the more advanced proton therapy, it enables targeted radiation beams that kill the cancerous tissues while avoiding hurting healthy tissues, he said. However, this therapy costs at least US$30 million just to introduce one proton device to a hospital in New York, which most general hospitals cannot afford, he added. In contrast, Arc-Knife enables both targeted radiation beams and costs 1.6 percent and 2.5 percent of the cost of traditional radiation therapy and proton therapy devices, respectively, Chao said. It is cheaper because "beam stoppers" are inserted in Arc-Knife equipment, which drastically reduce the thickness of the concrete shield walls, from 150cm in other devices to 25cm, he said. That means the equipment no longer needs to be placed in a bunker-like room, making the technology easily adoptable in most hospitals without having to remodel their existing facilities, which drives down costs dramatically, Chao said. In addition, Arc-Knife is more compact in size. It is about 2.5m high, compared with traditional radiation therapy equipment that is up to 5m high, he said. 

AstraZeneca fast-tracks biotech drug with China JV

By Ben Hirschler LONDON | Mon Sep 10, 2012 2:31pm IST (Reuters) - AstraZeneca (AZN.L) raised its bet on the Chinese drugs market on Monday by clinching a joint venture deal with local firm WuXi AppTec (WX.N) to develop a novel biotech medicine in the country, speeding its path to market.The experimental treatment for rheumatoid arthritis and other inflammatory diseases, known as MEDI-5117, is already in initial Phase I clinical development in the United States and Europe.The partnership with WuXi will allow similar clinical tests in China, where the government requires local manufacture of medicines that have not been approved in other markets.Bahija Jallal, head of research at AstraZeneca's biotech division MedImmune, said the move could see the drug launched four to six years earlier in China compared to the conventional route of getting an import licence after approval in the West.The joint venture is the first of its kind for AstraZeneca and one of the first by an international company for a biotech drug in China."If it is successful, we hope this could be a good pathway for further molecules," Jallal told Reuters.She added that MEDI-5117 had been chosen for the project since there was still a high unmet medical need for effective rheumatoid arthritis treatments in China and AstraZeneca believed its product had potential advantages over rivals.China is a market of growing importance to all international drug companies - but AstraZeneca punches above it weight in the country, ranking number two in China among multinational pharmaceutical companies after Pfizer Inc (PFE.N).AstraZeneca's sales in China grew 12 percent in the last quarter and the British-based company, which established its operation in China in 1993, sees the country as a critical part of its future growth.WuXi will provide local regulatory, manufacturing, pre-clinical and clinical trial support for MEDI-5117, and the joint venture between the two firms will control the development of the experimental drug.AstraZeneca will have the option to acquire the full rights to commercialise MEDI-5117, assuming it is successful in clinical development. Otherwise, the joint venture will have the right to market the product.(Reporting by Ben Hirschler; Editing by Elaine Hardcastle) 

臺南生技展 緊追 臺北生技展 !


台南生技展 聚焦六大主題 2012-09-12 01:38 工商時報 【記者陳惠珍/台南報導】大廠雲集臺南市政府經濟發展局長方進呈與本報經理羅榮釧,共同主持「2012臺南生技產業博覽會」展前記者會。本屆參展廠商激增,連台鹽、台糖也來共襄盛舉。 圖文/陳惠珍「2012臺南生技產業博覽會」定本周五(14日),在仁德南紡世貿展覽中心展出。臺南市府經濟發展局長方進呈表示,全國唯有臺北與臺南有生技專業展,今年第2屆臺南生技展的參展廠商數,已由去年首展41家,激增至今年156家,成長近3倍,總參展攤位數突破300大關,達到351個攤位規模,除知名的保健食品及設備廠外,更吸引臺鹽、景岳生技、康那香等十幾家上市櫃公司共襄盛舉。由臺南市政府與本報共同主辦的「2012臺南生技產業博覽會」將登場。方進呈指出,延續去年南市政府首屆舉辦綠能、生技展,今年生技產業博覽會規模倍增,主要呈現以健康為取向的生技相關產品,以及如面膜等特化相關產品、中西藥品與醫療器材等,期望能創造B2B(公司對公司)更多的商機,以及讓更多人了解生技產品與生活健康的密切關係。方進呈表示,今年首度以生技產業為主軸辦展覽,展覽規劃六大主題區,有生技保健產品區、生技美容保養區、醫療器材專區、儀器設備暨耗材應用區等;另有政府形象區、臺南市政府主題館,將介紹臺南市發展策略成果,如推動觀光工廠、區域特色等成功案例及實品展示。此外,花蓮縣政府也共襄盛舉,並邀集十多家業者,含括醫療、美容、觀光等組成花蓮主題館。參展的更不乏多家生技業者,如臺鹽、台糖、中油、綠川;益生菌大廠有景岳、東宇、益力康;中草藥大廠有德英、港香蘭、華昌製藥、勝昌製藥;醫材類有康那香、南六、愛民衛材;通路商有杏輝藥品、佳醫健康等。製程設備及後段加工業者有凌廣工業、天成包裝;原料商有維克氏、欣茂實業等,參展廠商不勝枚舉,除六大主題區,有學、研單位及公協會團體,如臺灣生技產業聯盟主題館,計15家單位以群聚方式呈現生技研發成果,皆為轄區內具前瞻性廠商,另有工業技術研究院、南台科技大學、中華醫事科技大學、嘉南藥理科技大學等。

保德信江宜虔…中國學名藥廠成長將趨緩 !


三大強勁需求 打造醫療生化業的投資魅力 2012/09/11 15:21 (保德信投信 提供) 保德信全球醫療生化基金經理人江宜虔表示,「人口高齡化」、「新興市場」、「醫療創新創造新需求」是醫療生化產業三大強勁成長的需求。首先隨著人類平均壽命不斷延長,2050年全球65歲以上的人口將超過19億以上,是目前三倍之多(資料來源:聯合國,世界人口白皮書,2006年出版),同時,新興市場的人口與所得持續增長,生活品質提升對醫療需求快速成長,都將成為全球醫療產業重要的成長動能。此外,過去十年罕見疾病、多發性硬化症或高血壓等疾病的新藥上市,造就龐大市場需求,未來如阿茲海默症及增加高密度脂蛋白(好的膽固醇)等藥品,將是下一波醫療創新創造的新藍海。就個別產業而言,今年以生技產業表現最突出,那斯達克生技指數年初至今漲幅已超過30%(資料來源:Bloomberg2011/12/31~2012/9/10)江宜虔指出,生物科技與醫療器材產業較具有研發與創新的題材,尤其今年是生物科技產業豐收年,多項藥品將商品化或將發表臨床實驗進度,法令環境也將有利生物科技藥品發展,隨著科技進度,預料生物科技將成為未來醫療產業的主流。著眼中長期需求趨勢,以具有研發創新能力的公司為較佳布局選擇。 此外,江宜虔認為,當全球經濟成長仍存在不確定性,大型製藥廠因具有健全財務及高股利收益等優勢,較易受投資人青睞,股價也較有機會超越整體股市的表現。學名藥廠由於大型藥廠專利藥過期件數增加,將釋出龐大的市場給學名藥廠,加上新興市場對價格較低廉的學名藥需求成長快速,因此長期產業趨勢看好,然而短期以中國為首的新興市場因經濟成長減緩的疑慮,學名藥廠營運受到挑戰,因此建議宜優先選擇具有領先地位的企業。

Research Study Links Nutrients, Genes and Cancer Spread

Published August 28, 2012 Related Searches: Research • Nutrition • Research • Amino Acids •Gary Meadows, WSU professor and associate dean for graduate education and scholarship in the College of Pharmacy, says he is encouraged by his findings because the spread of cancer is most often what makes the disease fatal. Moreover, said Dr. Meadows, diet, nutrients and plant-based chemicals appear to be opening many avenues of attack."We're always looking for a magic bullet," he said. "Well, there are lots of magic bullets out there in what we eat and associated with our lifestyle. We just need to take advantage of those. And they can work together." Dr. Meadows started the study, recently published online in the journal Cancer and Metastasis Reviews, with some simple logic: Most research focuses on the prevention of cancer or the treatment of the original cancer tumor, but it's usually the cancer's spread to nearby organs that kills you. So rather than attack the tumor, said Dr. Meadows, let's control its spread, or metastasis.He focused in particular on genes that suppress metastasis. As search engine terms go, it took him down many a wormhole in the PubMed research database, as the concept of nutrients and metastasis suppressor genes is rarely identified by journals. It's even an afterthought of some of the researchers who find the genes. "People for the most part did not set out in their research goals to study metastasis suppressor genes," said Dr. Meadows. "It was just a gene that was among many other genes that they had looked at in their study." But Dr. Meadows took the studies and looked to see when metastasis suppressor genes were on or off, even if original authors didn't make the connection. In the end, he documented dozens of substances affecting the metastasis suppressor genes of numerous cancers.He saw substances like amino acids, vitamin D, ethanol, ginseng extract, the tomato carotenoid lycopene, the turmeric component curcumin, pomegranate juice, fish oil and others affecting gene expression in breast, colorectal, prostate, skin, lung and other cancers. Typically, the substances acted epigenetically, which is to say they turned metastasis suppressor genes on or off. "So these epigenetic mechanisms are influenced by what you eat," he said. "That may also be related to how the metastasis suppressor genes are being regulated. That's a very new area of research that has largely not been very well explored in terms of diet and nutrition." Dr. Meadows said his study reinforces two concepts. First, he has a greater appreciation of the role of natural compounds in helping our bodies slow or stop the spread of cancer. The number of studies connecting nutrients and metastasis suppressor genes by accident suggests a need for more deliberate research into the genes."And many of these effects have not been followed up on," he said. "There's likely to be more compounds out there, more constituents, that people haven't even evaluated yet."Dr. Meadows also sees these studies playing an important role in the shift from preventing cancer to living with it and keeping it from spreading."We've kind of focused on the cancer for a long time," he said. "More recently we've started to focus on the cancer in its environment. And the environment, your whole body as an environment, is really important in whether or not that cancer will spread." 

水刀抽脂手術!


一次擁有勻稱完美體態 自體脂肪移植2012/09/10   高雄市河堤美先皮膚科診所院長 朱冠州醫師。 ■朱冠州院長/口述、林曼平/整理■ 現在人對於自身的美麗越來越苛求,不少人羨慕窈窕的名模明星:為什麼她們可以這麼苗條卻同時擁有傲人的曲線和上圍?大家都急於把肚子上或是大腿上的肥肉弄掉,殊不知道自身的脂肪其實可以經過水刀抽脂手術抽出後回收再利用進行移植,讓自己變得更加性感美麗。高雄河堤美先皮膚科診所朱冠州院長表示,自體脂肪移植手術最常移植到臉頰及雙峰,由於填充物是自身的脂肪,因此術後幾乎無任何排斥性,自體脂肪效果比人工填充物更加柔軟自然。可進行的脂肪移植的部位只要是身體較凹陷部位經專業醫師評估後皆可施作,目前常見部位有:豐胸、豐臀、豐頰、豐額、豐太陽穴、豐蘋果肌、豐下巴等。將水刀雕脂手術結合脂肪移植因為既可達到雕塑線條的目的,又可增加身體曲線,所以相當受到歡迎青睞。脂肪經過移植後,不會全部都存活下來,一般而言,依照個人體質以及移植部位而論,存活率一般大約為68成,臉部填充的存活率會比身體高一些。補充後的脂肪約1個月是脂肪的穩定期,3個月後就會固定存活下來。剛移植的脂肪最需要靠新生血管提供養分,會輔以PRP生長因子及間質幹細胞來幫助存活,術後不建議患者持續進行按摩或冰熱敷,因為可能會影響到脂肪的存活率。朱院長表示不鼓勵一次移植過量的脂肪,過量脂肪移植容易有鈣化情形甚至降低存活率,因此比較建議採用適量、多次移植。自體脂肪豐胸手術後的初期會有輕微腫脹感,大約需要710日的恢復期須選擇穿著無鋼圈或無壓迫型的內衣穿著36個月,朱院長提醒填補的胸部1個月內禁止按摩、3個月內需避免到高溫的場所及過度壓迫(如有鋼圈的內衣)當移植脂肪進入穩定存活期後,就可重新穿戴合適的內衣。

 

Patients Beyond Borders(R) Announces Taiwan Simplified Chinese Edition

 PR Web Chapel Hill, NC (PRWEB) August 22, 2012 The Taiwan Task Force for Medical Travel (TTFMT) and Patients Beyond Borders jointly announce the launch of Patients Beyond Borders: Taiwan Edition, Simplified Chinese Translation for international distribution in January 2013. Supported by the Taiwan government, hospitals, and related private organizations, the guidebook, originally published in 2009, will be fully updated and translated into Simplified Chinese, and will offer an in-depth overview of Taiwan's leading international hospitals, medical specialties and procedures, selected health travel agents, nearby recovery and guest accommodations, and area travel information. Healthcare consumers, particularly those from neighboring China in search of quality and value, will find Taiwan's prices for medical procedures to be on par with other leading international healthcare destinations such as Thailand, South Korea, and Singapore. Taiwan currently boasts 14 facilities with clinical accreditation from the Joint Commission International (JCI), which provides additional comfort to the international medical traveler seeking the highest level of care. "Taiwan offers some of the best healthcare in Asia," says Patients Beyond Borders CEO Josef Woodman. "With a long and respected history of quality healthcare, exceptional facilities, and affordable prices, Taiwan continues to be a premiere choice among Chinese patients seeking top-quality healthcare and wellness services in the region." Recent initiatives by the Taiwanese government to simplify and expedite the medical visa process for Chinese patients, coupled with an increase in direct flights from China to Taiwan, have attracted significant numbers of visitors from China. Further fueling the 20%+ growth, a new government policy implemented earlier this year allows hospitals to apply for visas for groups of up to 30 mainland Chinese citizens seeking medical treatment, health screenings, and cosmetic procedures. "The release of Patients Beyond Borders: Taiwan Edition, Simplified Chinese Translation, will now allow Chinese-speaking patients everywhere even greater access to one of the world's most comprehensive healthcare systems," says Dr. Mingyen Wu, CEO of TTFMT and Secretary-General, Taiwan Nongovernmental Hospitals and Clinics Association. "We are pleased to be working with Patients Beyond Borders on this project." Patients Beyond Borders: Taiwan Edition, Simplified Chinese Translation will be available through a variety of sources including Alibaba, Amazon China, Baidu (Chinese-language search engine), Dangdang (digital book distributor), Renren, and libraries (Digital Library of China) as well as the Patients Beyond Borders and TTMFT websites. About the Taiwan Task Force for Medical Travel Launched in October of 2007, the Taiwan Task Force for Medical Travel (TTFMT) was created as a platform to promote Taiwan-inbound medical travel, integrate resources and streamline cooperation across leading governmental organizations, the Department of Health (DOH), and related industries and medical institutions. TTFMT is administered by the Taiwan Nongovernmental Hospitals and Clinics Association and supported by the DOH, Council for Economic Planning and Development, the Tourism Bureau, Government Information Office, Taiwan External Trade Development Council, and the Chung-Hua Institution for Economic Research. Its vision is to position Taiwan as a global leader of five-star medical travel destinations. For more information, visit http://medicaltravel.org.tw. For media queries, please contact: Yu-Jen Serena Lin 行政院衛生署國際醫療管理工作小組 Taiwan Task Force for Medical Travel, sponsored by DOH 專員 Administrator Tel: 886.2.2885.1528 ext 20 Web: http://medicaltravel.org.tw Email: nhca06 (at) gmail (dot) com About Patients Beyond Borders Patients Beyond Borders, based in Chapel Hill, NC, publishes books, eBooks, online and mobile applications for healthcare consumers seeking the best global options in medical care. Its flagship international title, Patients Beyond Borders, soon to be published in its Third Edition, is the world's leading consumer reference guide for medical tourism. Country Editions, City Editions, and Facility Editions help healthcare consumers make informed choices in searching, vetting, and obtaining safe, high-quality, affordable healthcare around the world. For more information or media queries, please contact: Judy Orchard, communications manager Tel: +1 919.924.0636 Email: jorchard (at) patientsbeyondborders (dot) com Web: patientsbeyondborders.com Note: Qualified members of the media are invited to request a review copy of Patients Beyond Borders: Taiwan Edition, Simplified Chinese Translation or any other title from our library. Please contact jorchard@patientsbeyondborders.com.

海峽兩岸 針對醫療器材安全管理 進行對話 !

2012/09/11【台北訊】行政院衛生署食品藥物管理局今年特委託財團法人自強工業科學基金會,日前於台北舉辦『海峽兩岸醫療器材安全管理研討會』,會中邀請中國大陸食品藥品監督管理局、上海市食品藥品監督管理局以及廈門市食品藥品監督管理局派員代表出席,分享海峽兩岸的醫療器材法規實施現況,以及醫療器材產品安全管理相關法規介紹。活動反映熱烈,約計160人共襄盛舉。 行政院衛生署食品藥物館理局劉麗玲組長表示,此次研討會目的,主要是希望兩岸可以避免兩岸重覆檢測,兩岸合作能擁有快速的綠色通道,另一方面高階產品方面的人體臨床實驗合作,能互相承認臨床實驗報告,節省不必要的醫療資源浪費。另外也希望透過兩岸法規的比對,了解彼此的差異性,在遵守國際規範與安全性的原則下,保障民眾的權益。醫療器材產業為台灣繼續成長及生技起飛鑽石行動方案發展的重要產業,亦是台灣繼3C 電子產業發展頂點後下一波多專業(生化、光學、機電、軟體、材料、臨床前試驗、臨床試驗、品牌行銷OBLODMOEM 供應鏈)整合應用並具有相當發展潛力之產業,此產業能繼續成長的主因源於衛生署十幾年來對醫療器材產業GMP品質管理系統的持續推動,以及國內醫療器材廠商多年努力取得GMP登錄許、/ISO 13485 國際驗證、和先進國家如歐盟醫療器材CE 證書,及美國FDA 上市許可證,積極開拓國內市場及龐大的國際醫療器材外銷市場有關。而20111221兩岸第六次的江陳會談,簽署「海峽兩岸醫藥衛生合作協議」,希望建置兩岸制度化的合作機制,進而有效控管兩岸交流深化所可能衍生的醫藥衛生風險,亦有助於台灣與大陸地區醫療市場的互動更加頻繁。(李憶伶)