中國超生罰款 每年估近千億元!!

（中央社台北15日電）20120515中國大陸推行一胎化計劃生育政策，陸媒曾推估報導，每年「超生罰款」可能逾人民幣200億元（約台幣934億元），不過，大陸官方從未公布或證實相關數字。人民網旗下的「中國經濟週刊」做以上報導。大陸「超生罰款」是對違反計劃生育政策民眾徵收款項。1980年代初期稱超生罰款、1994年改為「計劃外生育費」、2001年「人口與計劃生育法」明定為「社會撫養費」。根據大陸國務院「社會撫養費徵收管理辦法」規定，社會撫養費徵收由縣級計生部門作出書面徵收決定，縣級計生部門可以委託鄉（鎮）政府或者街道辦事處作出書面徵收決定。即各地有「自由裁量權」。多年來，大陸每年處罰超生人數有多少？徵收社會撫養費金額有多少？大陸官方並未公布，但一直備受關注。報導引述大陸國家人口和計劃生育委員會（國家計生委）表示，社會撫養費按城鎮居民平均每人可支配收入人民幣2萬6738元的9倍，即為24萬600元（約新台幣112萬5000元）徵收。目前大陸超生罰款分為4類標準，第1，按固定倍數徵收，例如江西3.5倍，上海、河南、湖北為3倍；第2，設置一定倍數區間，如北京3至10倍、新疆1至8倍。第3，固定金額區間，黑龍江城鎮居民3至6萬元、農村居民1至3萬元；第4，設置倍數或金額下限，如河北不低於2.5倍、山西不低於7000元等。這篇調查報導也發現，越窮、越富的族群，越難徵收超生罰款。報導說，大陸全國無戶籍人口約1300萬人，大部分是因超生未報戶口的人。依此推算，即使按保守水準每人平均所得人民幣1萬元計算，應當依法徵收社會撫養費總數就高達1300億元。不過，實際徵收率遠遠低於應徵收總數。一項統計顯示，2002年到2007年底，雲南全省應徵社會撫養費人數33.56萬人，但實際徵收26.66萬人，占79%；應徵社會撫養費5.62億元，實際徵收僅1.68億元，僅占30%。因此，北京市也提出加強對名人、富人超生的處罰力道，但卻有執行上的困難，因為很難定義名人或富人，而且計生部門並非可以對資產或收入進行調查的機關。另外，赴境外生子，例如體育選手田亮夫婦在香港生第2胎，是否需繳納社會撫養費也受到關注。不過，國家計生委2010年曾發函表示，夫妻雙方均為大陸居民，在國外、境外生育的子女回大陸居住，辦理入戶手續或兩年內累計居留滿18個月的，在適用各地人口和計劃生育政策規定時，應當計算該子女數。

基亞 被納入MSCI全球小型指數!!

新MSCI小型指數成分股，基亞收高2012-05-16【時報】MSCI調降台股權重，台股今日臉黑大跌超過2%，基亞生技(3176)在納入MSCI全球小型指數成分股的利多激勵下，盤中逆勢上漲，一度重回60元之上，終場小漲0.2元，以59元作收。基亞為生技新藥公司，PI-88肝癌新藥用於早期肝癌術後輔助治療，日前取得美國FDA(食品藥物管理局)「孤兒藥」資格認定(Orphan Drug Designation)，未來上市將有七年的美國市場專賣獨占權，此有助提升PI-88於美國市場之價值，有利與國外大廠的授權談判及未來市場的拓展，法人認為，最快上半年會有結果，授權金上看4億美元。　進度最快的PI-88去年在台灣及韓國共18所醫學中心進入三期臨床試驗，香港、中國大陸今年將陸續進入三期臨床，預計2013年完成期中分析，2014年申請新藥上市。中期藥物OBP-301與日本Oncolys結盟，已獲美國FDA台灣TFDA核准進行二期/三期肝癌臨床試驗。末期治療藥物LS-01目前在動物試驗，與國際大藥廠協商中。新藥研發還在臨床試驗階段，投入的資金龐大，今年首季維持虧損，稅後虧3789萬元，每股虧損0.34元。目前主要營收來源為核酸檢驗，台灣母公司營收主要來自HLA基因分型試劑，用在骨髓、器官移植及臍帶血移植等檢驗，業績持續向上。持股7成的上海浩源，持續拿下大陸的血液中心標案，今年業績展望也佳。

快速战略调整 台湾园定位….!!

东莞台湾高科技园调整战略定位：合作共赢2012-05-16来源：《南方日报》　　日前，松山湖工委书记、管委会常务副主任刘宁在接受本报记者专访时表示，省党代会报告中提到东莞台湾高科技园（简称"台湾园"）很振奋人心，台湾园是松山湖的"重中之重"，松山湖今后将继续加强对台湾园发展所需人力和财力的双重保障。　刘宁说，"我们已经调整了对台湾园定位的战略思路，从原来的招商引资转为如今的合作共赢"。他透露，松山湖有望在年内成立专门的国有全资企业，密切与台湾集团企业的合作，由此加快台湾园内"地标"研发总部的建设；同时，还将与台湾的财团合作成立两亿美元的投资基金，以资金为杠杆撬动台湾园发展生物医药产业。　　

关键词：定位转变　　从工业发展转向高科技研发　　之前在规划台湾园的布局时，留了很多工业用地，主要是为了招商引资，承接台湾高端电子信息产业的转移。然而，现在园区的定位已经从单纯的招商引资转为了合作共赢，也就是共同发展和创新，园区场地的布局上发生了变化。　为什么说台湾园是松山湖发展的重中之重？刘宁解释，台湾园占地6.8平方公里，可出让土地超过3平方公里，非常具有开发潜力。为了在组织架构和人力资源上给予充分的支持，东莞市和松山湖管委会去年9月份还专门成立了东莞松山湖高新区台湾高科技园管理局（简称"台湾园管理局"）。同时还对台湾园划拨充足的预算，在财力上予以保障。此外，松山湖管委会推出一系列相应的人才政策、产业政策，并专门为台湾园制定了发展相关产业的优惠政策。　　刘宁说："去年9月份台湾园就开始了国际招标，为的是打造国际一流的科技园区，我们先把环境做好，以此推动招商工作"。台湾园从单纯的招商引资转为合作共赢，表明了政府不希望园区仅仅起到产业转移的作用，更希望通过合作共同谋求发展。也因此园区场地的布局上发生了变化：原来台湾园的布局留了很多工业用地，目前台湾园莞深高速以南土地留作工业发展，大约为三分之一，其余的作为研发用地以及园区配套建设。　　

关键词：产业发展　　主攻生物医药和IC设计　　台湾园开园以来，已成功引进十多家亚洲一流的IC设计企业，到年底进驻台湾园的IC设计企业有望达到20余家。此外，今年预计至少有8个生物科技项目将落户台湾园。东莞市政府顾问宋涛说，台湾园的建设起点要高，不能走回劳动密集型发展的老路，庞大的生产型项目引进一个就足够了，其余的都要引进有自主研发的高科技中小企业，发展智力密集型产业，这样才能实现台湾园所肩负的重大合作平台的使命，才能发挥推动东莞转型升级的引擎作用。因此，台湾园正集中精力发展生物医药和IC设计产业。前者市场前景广阔，属于战略新兴产业；后者将帮助东莞大量电子企业摆脱因没有核心设计而受制于人的局面。台湾高科技园管理局副局长潘路明说，台湾园开园以来，已成功引进十多家亚洲一流的IC设计企业，到年底进驻台湾园的IC设计企业有望达到20余家。而对于生物科技的发展，潘路明介绍，这也是战略性新兴产业，未来的市场前景很好。台湾生物科技的产业优势明显，国际渠道广泛，但台湾的生物科技企业要想持续发展，最好的方式就是与大陆合作，该领域也是台湾园深化莞台合作的切入点。潘路明说，今年预计有8―10个生物科技项目将落户台湾园。　　

关键词：投资建设　　两岸企业共建研发总部　　松山湖管委会打算成立国有全资企业与台湾一到两家财团合作，共同建设台湾园"地标"研发总部。为什么要找台湾财团合作？刘宁解释，"与台湾企业家合作，对方除了投资，还可以协助管委会招商，一举两得。这个想法正在做方案，要等市里审批，进展快的话年内就能成立"。刘宁说，从今年年初开始，管委会全面推进台湾园基础设施和生活配套建设，正在加紧做绿化、场地平整等工作。台湾园已拿出1400亩土地发展生物科技。同时，还将与台湾投资者共同设立总计2亿美元的创投基金和跟投基金，并取名为生命1号和生命2号。宋涛说，台湾园能写入本次党代会报告，其实并不意外，基于东莞现有的产业基础和未来的产业发展前景的判断，台湾园将在推动东莞产业全面转型升级中起到不可估量的作用，"我每个月都要往台湾跑至少两次去谈合作，台湾的企业家也经常来松山湖，可以说双方的关系已经非常密切，接下来就是要加强合作出成果，我是将它当作一生的事业来经营的"。　　宋涛说："东莞台湾高科技园要想加快发展，需要在财税返还、投融资平台搭建、产业配套、公共服务等多方面争取到市、省乃至国家相关主管部门的大力支持，台湾园未来就是要发展成为以高科技产业为主导的投资乐土和宜居小城"。

聯合報健康事業部與生達合作!!

生達製藥與聯合報 異業結盟 【2012/05/17 聯合報】   生達化學製藥股份有限公司深耕新營有成，已連續3年榮獲國家生技暨醫療保健品質金質獎，近年來更積極布局大陸及全球市場，展開多角化的經營策略。生達化學製藥昨天與聯合報簽訂異業結盟合作案，雙方期能共創更多合作空間，並有助促進國民健康。  生達製藥公司總經理陳威仁及聯合報事業處業務部總經理周正賢，昨天在新營總公司簽約，兩人握手互換合約，對外宣布生達與聯合報攜手合作的時代來臨了。   陳威仁說，國內製藥產業及報業的異業結盟，堪稱是國內首例。生達在西藥製劑、保健食品、原料藥、動物用藥、檢驗試劑等領域占有一席之地，他強調，尤其在醫院、診所及藥局行銷通路上，將有助於聯合報拓展閱報市場。   周正賢表示，聯合報成立健康事業部，發展養生、健康、熟齡族群的媒體傳播工作，包括健康、養生商品訊息傳播，與生達多元化結合，進行異業結盟，並協助辦理健康講座等，未來雙方合作，可以有很大的發展，聯合報促進推廣醫學新知，也有助國民健康。   陳威仁認為，經由合作案，以生達在通路上的優勢，以及醫師、藥師、營養師的人脈，搭配聯合報專業人員，將有更多的合作空間。他表示，現在製藥界很競爭，生達也試圖拓展大陸市場，與聯合報合作，希望能在實體及虛擬市場，創造更多商機。   周正賢強調，雙方異業結盟的新面向，將有助共創媒體與產業界雙贏。

衛生署解釋 為何美國牛肉需要用萊克多巴胺???

衛署：澳洲牛不用瘦肉精 豬可用 【2012/05/16 聯合報】  針對民眾質疑「為何美國牛肉需要用萊克多巴胺」，衛生署食品藥物管局今天表示，美國牛隻以玉米飼養，肉質肥油較多，因此在最後飼養階段，會在飼料中添加瘦肉精萊克多巴胺，可以將油脂轉換成瘦肉；紐澳地區則以牧草飼養牛隻，無須在飼料中添加萊克多巴胺。衛生署食藥局長康照洲表示，食品會因生產、製造、原料配方及加工方式的需求使用農藥、動物用藥、添加物，因此會有殘留物質。以澳洲為例，該國牛隻飼養雖未核准使用萊克多巴胺，卻允許豬隻飼養時使用，且訂有殘留標準。他說，衛生署在開放美牛瘦肉精的政策，最後會依科學證據訂定最高殘留量標準之安全容許量，以保障消費者之權益。民眾也可根據牛肉產品的原產地標示，選擇沒有使用萊克多巴胺的國產牛肉。

惠合再生醫學 於南科生產膠原蛋白/透明質酸!!

惠合「多孔狀膠原蛋白基質技術」不怕競爭者眾  科技生活記者：葉玉琴報導(2009/7/6)惠合再生醫學生技投資金額新台幣1.7億元，申請在南部科學工業園區投資設立，擬研發、設計、生產及銷售：膠原蛋白/透明質酸系列與其衍生物相關之產品，如：止血棉；再生醫學與組織工程相關之醫療器材或器具產品，如：牙醫敷料、傷口敷料，中長期將發展人工皮膚等產品。由於人體組織之主要結構性蛋白質為膠原蛋白（collagen），其於臨床應用已有長久歷史，因此最適於作為組織工程與再生醫學的基材，尤其是應用於促進組織再生的基質鷹架（scaffold）。人體另一重要細胞外基質成份為透明質酸（hyaluronan; HA），有促進細胞移行、細胞增生、傷口癒合、血管新生、組織潤滑等功能，也常被用為整形外科與眼科手術之醫療器材產品。目前膠原蛋白相關產品競爭者眾多，但本案公司所掌握的多孔狀膠原蛋白基質技術，具有基質結構張力強、傷口癒合快及生物相容性佳之優勢。短期內將著重於止血棉、再生薄膜與傷口敷料產品之開發，中長期則著重於開發屬第三級醫療器材的人工皮膚產品。本案公司產品具有技術與成本優勢，尤其人工皮膚國內過去多向國外購買，但成本較高，若能在地化生產，並培養國內相關技術人才，對於生技產業聚落的完整與發展將有極大效益。

過度運動 未老先衰!!

過度節食+重度運動瑜珈老師未老先衰  欣傳媒2012-05-16天天教學生練瑜珈更健康的37歲的劉姓女瑜珈老師近來突然經常感到疲勞，而且還冒出滿臉痘花，皮膚又粗糙又老化，而且脾氣暴躁，她以為自己得了怪病趕快到婦產科檢查，抽血才發現她體內的去氫氧皮質酮（DHEA）濃度低得離譜，形同7、80歲的老太太。幫劉小姐治療的康寧醫院婦產科主任楊再興今（16）日表示，他詢問劉小姐的日常生活，發現劉小姐除了和朋友聚會時會吃大餐以後，平常為了減肥及健康都吃素，長期營養不良，加上當瑜珈老師運動量大，深層脂肪燃燒過度，無法讓體內雄性荷爾蒙順利轉化成女性荷爾蒙，以致雄性荷爾蒙堆積。而她出現月經失調、皮膚冒痘及粗糙等現象，就是因為雄性荷爾蒙無法轉化為女性荷爾蒙造成的男性化及早衰症狀，甚至比停經後更嚴重。因此建議補充DHEA 4個月，劉小姐除了情緒變穩定、臉上痘痘消失，皮膚也變回光滑的觸感。楊再興提醒，現代年輕女性常為了保持身材而拼命節食，結果減到體內脂肪不夠，脂肪組織無法讓男性荷爾蒙轉變成女性荷爾蒙，就會出現冒青春痘、皮膚粗糙、毛髮濃密及聲音低沉等男性化特徵，不僅外觀會變老變醜，而且情緒起伏大，而他臨床就看過至少5位同樣也是瑜珈老師的患者，他提醒，素食或適當節食保持體態雖有益健康，但過度限制飲食太瘦反而有害。不過，可不要為了讓自己更年輕，而隨意補充含有荷爾蒙作用的食物或未經醫師診斷而攝取DHEA，楊再興提醒，曾接獲一位60歲婦女，因為停經怕變老而大量吃蜂王乳，後來發生陰部出血到門診治療，檢查發現罹患初期子宮內膜癌，研判是蜂王乳的類雌激素作用不斷刺激子宮內膜而引起。楊再興認為，近年來台灣女性子宮內膜癌患者發生率激增，而且有年輕化趨勢，主因除了營養過度外，恐和女性愛吃包含大豆異黃酮、胎盤素、蜂王乳、當歸、山藥、花粉等有雌激素作用的補充品有關，造成子宮內膜異常增厚。因此他提醒，政府目前尚無完整法規來規範保健食品的使用，不少民眾透過網路或親友介紹就使用號稱可以留住青春又「健康無害」的保健食品，但只要有類荷爾蒙作用，長期不當使用就可能危害健康，嚴重者可能還要洗腎。建議民眾在購買保健食品時，應特別注意產品品質、成份標示及來源使用等標示，如果吃起來還是不安心，最好尋求有專業背景的醫療人員諮詢，才能吃得安全又健康。

DHEA (Dehydroepiandrosterone)  is a hormone that is naturally made by the human body. It can be made in the laboratory from chemicals found in wild yam and soy. However, the human body cannot make DHEA from these chemicals, so simply eating wild yam or soy will not increase DHEA levels. Don't be misled by wild yam and soy products labeled as "natural DHEA."DHEA is used for slowing or reversing aging, improving thinking skills in older people, and slowing the progress of Alzheimer's disease. Athletes and other people use DHEA to increase muscle mass, strength, and energy. But DHEA use is banned by the National Collegiate Athletic Association (NCAA).DHEA is also used by men for erectile dysfunction (ED), and by healthy women and women who have low levels of certain hormones to improve well-being and sexuality. Some people try DHEA to treat systemic lupus erythematosus (SLE), weak bones (osteoporosis), multiple sclerosis (MS), low levels of steroid hormones (Addison's disease), depression, schizophrenia, chronic fatigue syndrome (CFS), and to slow the progression of Parkinson's disease. It is also used for preventing heart disease, breast cancer, diabetes, and metabolic syndrome. DHEA is used for weight loss, for decreasing the symptoms of menopause, and for boosting the immune system. People with HIV sometimes use DHEA to ease depression and fatigue. Women who have passed menopause sometimes use DHEA inside the vagina for strengthening the walls of the vagina and for increasing bone mineral density. Like many dietary supplements, DHEA has some quality control problems. Some products labeled to contain DHEA have been found to contain no DHEA at all, while others contained more than the labeled amount. DHEA is being investigated and may eventually be approved by the Food and Drug Administration (FDA) as a prescription drug for treating systemic lupus erythematosus (SLE) and improving bone mineral density in women with lupus who are taking steroid drugs for treatment. The FDA is still studying the pharmaceutical company's application for approval.

Source: MedlinePlus

林衛理引進 港資晨興生技創投!!

中天生技攜港商搶300億商機 【經濟日報2012.05.16】中天生技（4128）昨（15）日子公司泉盛生技董事長林衛理宣布，公司與香港晨興集團旗下龍瑞藥業簽訂合約，共同開發Xolair生物相似藥物。法人估，未來雙方可望共同搶攻全球10億美元（約新台幣300億元）市場。中天昨日股價以34.7元作收，下跌0.25元；該公司今年首季稅後純益9,600萬元，每股稅後純益達0.35元。據了解，泉生於今年第1季就和香港晨興集團屬下的深圳龍瑞藥業簽訂合作意向書，共同在大陸開發「治療過敏抗體新藥」Xolair的生物相似藥。泉盛說，歷經4個月的協商，雙方終於正式簽訂合作契約，未來可望攜手進軍大陸市場。泉盛說，香港晨興集團為亞洲最大生技創投集團之一，在大陸已垂直整合建構「單株抗體藥物」的研發、生產、臨床前試驗，並對藥物臨床試驗審查申請（IND)具有一定經驗。其中，龍瑞藥業對申請藥物臨床試驗批件具實務經驗，並曾經成功取得大陸食品、藥品監督管理局（SFDA）數項臨床試驗申請許可。

保險公司爭搶台灣自由行市場10元錢搞定旅行保險

 鉅亨網2012-05-16繼北京、上海和廈門后，今年4月份，杭州正式入選為台灣自由行的第二批城市。"放行"消息一出，不少杭城市民躍躍欲試，打算來個暢快的環島自由行，開始受理赴臺個人游申請當天，杭州就有150多位市民遞交了相關申請。不過，業內人士提醒，鑒於目前相關的保險規定與頻發的旅遊意外事件，建議內地游客在赴臺自由行之前最好投保一份保額較高的保險產品，以應對在旅遊期間出現意外后需要支付的高額醫療費用。去年6月份，上海、北京和廈門三個城市成為第一批赴臺自由行開放的城市。據了解，當時台灣個人旅遊的放開，在保險上是參照申根簽證的規定，要求個人旅遊者必須投保保額在200萬元新臺幣（約合45萬元人民幣）以上、保險期限與旅遊天數相符的旅遊險，這也是個人獲得旅遊簽證的前提條件之一。上月末，國家旅遊局頒布的文件正式確定天津、重慶、南京、杭州、廣州、成都為"大陸居民台灣自由行第二批城市"。平安保險浙江分公司境外旅遊險的相關負責人王小姐表示，此次杭州作為第二批開放台灣自由行的城市，在保險方面的規定與首批城市基本一致，單位游客投保旅遊險的累積保額必須達到至少45萬元人民幣。

保險公司爭搶市場  針對國內游客對寶島游的熱捧，各大保險公司自是不會放過這個千載難逢的好機會。美亞保險就針對赴臺游客專門設計了一款名為"寶島游蹤"旅行保障計劃的保險項目，其"鉆石計劃"境外意外傷害保險金達50萬元，符合台灣自由行簽證保險辦理要求；同時還提供高保額醫藥補償保障，住院津貼每天100元。在保費方面，以成人投保7天為例，"鉆石計劃"所需的保費為150元。而美亞保險相關工作人員表示，雖然目前美亞在杭州并沒有設立分公司，杭州的市民可以通過專門的網銷渠道意時網在線投保。太平洋境外旅行綜合保險尊貴計劃（不含門診費用）（計劃D）的保障也頗為全面，其中包括境外意外傷害保險金50萬元和境外住院醫療保險金50萬元。此外，根據相關保險電子商務網站的推薦，平安"暢行天下"境外旅行保險（全球行全面計劃）、華泰"安達天下"國際旅遊保障計劃（至尊款）等多家保險公司的相關產品也適用於赴臺自由行游客。

10元錢也能搞定赴臺行保險  由於保險涵蓋保障范圍較廣，保額也相對較高，上文介紹的幾款保險產品的保費都相對較高。不過，相比保費動輒上百的保險計劃，也有保險公司專門推出了平價港澳臺綜合旅行保險，最低只要10元的保費，也同樣能夠達到赴臺自由行保額在45萬元人民幣以上的保險要求。平安保險就於近期在中國平安天貓官方旗艦店內，上線了一款名為"平安港澳臺旅遊意外保險"的產品，根據產品介紹，3天和7天的保費分別為10元和15元，不過該款產品目前僅有這兩個保險期可供選擇，而且其保額相對較低，包含意外身故、傷殘、燒燙傷、醫療（含急性病）等7項責任在內的總保額為66.15萬元。"這款產品主要還是針對80後、90后等對價格較為敏感的消費者，價格優勢比較明顯，但是這款產品屬於純保障產品，并不配備緊急救援，客戶還是要根據自己的實際情況進行選擇。"平安保險浙江分公司境外旅遊險的相關負責人王小姐表示，如果經濟能力可以承受，還是建議消費者盡量選擇責任保障更加全面的計劃。

中天生技指定每日閱讀經濟日報!!

財經檢定／中天生技：培養人才增加競爭力【經濟日報2012.05.16】經濟日報推出「全民財經檢定」，中天生技率先發起員工參與，中天生技董事長路孔明認為，辦理這項財經檢定，不僅對國家社會有裨益，對企業界也是一大助益。他認為，企業當前培養人才重視「才」與「識」，才即能力，識是願景。他說，「才」除了本職學能外，也應該具備特定「工具性」的知識。其中，財經知識是員工在參與企業營運時不可或缺的鎖鑰，從基礎的業務規劃到高階的決策判斷，都將起關鍵性作用。此外，路孔明表示，中天生技極為重視人才培養，之所以率先參與經濟日報所舉辦的「全民財經檢定」，也是為了讓中天的員工更具有競爭力，未來將針對需要加強的同仁，除了指定每日閱讀經濟日報外，並將繼續鼓勵在職進修。

外资进入中国疫苗市场…Ⅱ类疫苗市场往Ⅰ类布局!!

关注医改推进下的医药产业　　我国《疫苗供应体系建设规划》提出，到2015年初步建成满足经济社会发展需要的疫苗供应体系，并安排近百亿元资金扶持。上市疫苗企业也在不断推进自主研发疫苗产品研发，沃森生物15日表示，公司23价肺炎球菌多糖疫苗获得SFDA批准，使疫苗产业的投资机会再引关注。　　不过我国疫苗产业面临较大成长压力，多位业内专家在接受中国证券报记者采访时表示，传统的体制机制因素制约疫苗产业壮大。特别是国内疫苗研发环节与投融资环节的脱节，致使跨国疫苗巨头利用资金优势加大产业竞争，甚至大量收购国内有潜力的"苗子"项目。

疫苗：高毛利率诱人　　美中生物医药协会会长陈志宏表示，作为传统性强和高度普及的生物制品，疫苗行业正不断焕发新活力。他介绍，目前国内疫苗开发以传统疫苗为主，欧美疫苗研发则以治疗用疫苗为主，治疗用疫苗等新型疫苗的发展成为市场趋势。　　我国疫苗分为Ⅰ类疫苗和Ⅱ类疫苗，Ⅰ类疫苗由财政拨款集中采购，下游需求稳定；Ⅱ类疫苗实行市场定价，公民自费且自愿接种，对国外制药公司开放，价格远比Ⅰ类疫苗高，利润空间大。　　统计的生物制品行业上市公司2011年财务数据显示，多数疫苗产品呈现高毛利率特征。沃森生物Hib（西林瓶）疫苗毛利率达93.92%，流脑A+C疫苗销售毛利率达88.27%；华兰生物疫苗产品毛利率达75.23%；智飞生物ACYW135群脑膜炎球菌多糖疫苗毛利率达92.28%。　　中国证券报记者了解到，国内疫苗市场增长迅速，2007年时的市场规模约40亿元人民币，2008年超过50亿元，预计2012年国内疫苗市场规模将达120亿元。全球疫苗市场规模从2006年时的100亿美元增长至当前超过200亿美元。2008年开始，我国Ⅰ类疫苗从6种增加到15种，促进了疫苗产业的壮大。　　目前Ⅰ类和Ⅱ类疫苗市场分别保持15%和20%左右的增速，相比Ⅰ类疫苗，Ⅱ类疫苗有着更好的盈利，同时市场竞争也更激烈。Ⅱ类疫苗仅占疫苗总批签发数量的20%，但收入占整个市场的比例达70%。以流感疫苗、肺炎球菌疫苗和轮状病毒疫苗等为代表的Ⅱ类疫苗是国内外疫苗企业研发和竞争的重要对象。

研发：外资联合控股　　中国食品药品检定研究院相关人士表示，未来10年，我国疫苗行业增长速度将超过传统医药产业，创新疫苗的增长率有望超过50%。在高盈利前景刺激下，Ⅱ类疫苗和以治疗用疫苗为代表的创新性疫苗是研发重点。　　陈志宏表示，与传统药物相比，针对乙型肝炎、癌症等的治疗用疫苗通过激活人体免疫力治疗，具有更好的效用，不过治疗用疫苗的研发还需要时间来考验。　　创新疫苗产品刚露头角，研发领域的激烈角逐却已上演。银河证券医药行业研究员黄国珍的研究显示，目前疫苗行业全球份额掌握在赛诺菲-安万特、默沙东、葛兰素史克、辉瑞、诺华五大国际制药公司手中，控制全球市场85%份额，在中国主要抢占二类疫苗市场。国内目前有30多家疫苗厂商，主要产品品种达49个，可预防26种传染病，在Ⅰ类疫苗市场占有垄断地位。但葛兰素史克和诺华等五大跨国药企均以联合控股形式进入国内疫苗市场，分别控制多家生物制品企业。　　据了解，跨国药企在中国直接收购疫苗项目或并购相关公司是常用手段。赛诺菲-安万特有关人士对中国证券报记者表示，这种方式可以减少文化因素和管理过程中的麻烦。　　另外，在新药研发产出效率不断走低的背景下，联合开发成为主流。赛诺菲巴斯德外部研发部亚太区负责人Raman RAO日前在上海表示，2005年时国际前10大疫苗公司中仅有3个公司与外部联合开发产品，现在则非常普遍，研发过程中会有很多大学和小型疫苗公司参与，并将基因组工具和蛋白组工具相联系，但中国目前联合开发力度仍不够。　　Raman RAO介绍，当前全球疫苗市场价值达178亿欧元，2015年将达218亿欧元，市场发展迅速，但现有疾病疫苗数量仍不够。已有的约70个感染病的疫苗研发目标，只有25个有疫苗产品。Raman RAO表示，容易开发的疫苗都已经完成了，余下的将是非常大的挑战。据介绍，除疾病外，在法规方面也面临问题，如轮状病毒疫苗的效力，FDA设定的法规非常复杂，需要针对6万-7万个婴儿做试验，对产品的研发而言非常困难。　　事实上，国内疫苗企业研发也不断加快联合，2010年华兰生物与中科院上海巴斯德所共建疫苗研发联合实验室，沃森生物此前与葛兰素史克联合开发麻腮风疫苗，均引起业内关注。　　但业内人士对中国证券报记者称，国内疫苗产业环境相对封闭，体制机制难以适应竞争日益激烈的疫苗产业，以传统疫苗为主要研发领域的现状也亟须改变，以推动创新疫苗产品的研发。融资：体制仍不成熟　　医药生物研发是产业发展的生命线。中国科学院上海药物研究所副所长沈竞康表示，世界前500强企业中研发年投入最多的前三名企业全是医药公司，均在90亿美元以上。由此可见医药生物研发的高投入特点。　　但国内医药生物投融资环境不佳，即使是疫苗研发居前的民营企业，也时常被迫为新的疫苗项目向外部融资。这给在投资领域非常成熟的外资疫苗企业提供了很好的切入点。　　创时杰生物医药科技有限公司是国内疫苗研发新锐企业，其融资现状具有代表性。创时杰总经理孟夏介绍，公司的癌症疫苗产品先期已收到外资合作伙伴的1000万美元的预付款，如果研发出现实质性进展，将再收到7000万欧元付款；公司的非小细胞肺癌疫苗已针对200多个病人进行了实验，外部合作伙伴将在第三期临床试验后接管，并展开800多个病人的试验和在全球各个研究中心的研究；此外，其丙肝疫苗和肺结核疫苗项目，也希望找到更多融资。　　业内专家对此称，疫苗产品以预防性为主，因此安全性要求更高，使得国内研发体制相对保守，政府投资也主要流向了国资背景的生物制品研究所。许多小型疫苗企业因研发资金不足而寻求外部支援，被外资药企趁机收购。　　德诚资本一位投资合伙人向中国证券报记者介绍，欧美国家疫苗研发投融资已经比较成熟，好的概念便可以吸引风投前来投资开发，当研发遇到困难时，可以作价卖掉。而国内在这一方面仍处弱势。　　据美国默沙东公司高级科学家Laura HONG介绍，在疫苗研发领域，大型制药公司最擅长的领域是产品研发、注册、药品上市和全球营销；小型生物技术公司和学术机构的优势在于创新型研究、动物模型的概念验证和人体中的验证，甚至是进入临床Ⅰ期和Ⅱ期试验，这些都可以提升项目的估值。　　由于国内疫苗产业投融资体制不成熟，目前外资药企对疫苗项目的收购又被称为"找苗子"，看到好的"苗子"，通常会直接买下或控股，国内许多较好的疫苗早期研发项目被跨国药企收入囊中。

生物医药的融资尴尬　　"送上门的资金不敢要，想要的资金拉不来，我们的可植入医疗器械研发项目融资正成为难题。"江苏江阴一家医药孵化企业总经理宋先生对中国证券报记者表示。　　说这话时，宋先生正奔波于三江资本举办的一场投融资峰会上，他的融资项目是一种可降解的血管支架。正当他踌躇满志欲大干一场时，项目在研发的关键阶段面对的融资烦恼却越来越突出。　　"江浙一带的房地产老板找上门来，问需要多少资金、多少年产生收益？这个问题实在很棘手，因为医药研发本身的长周期和高风险难以揣摩。"宋先生说，他无法给出如同房地产行业一样精确的盈利时间表。　　许多医药孵化企业期待专业投资机构的资金，但懂得医药行业的投资机构未必对这类项目轻易支持。宋先生介绍，遍布各地的生物医药孵化企业良莠不齐，宣称研发抗癌药物的企业俯拾皆是。真正握有投融资话语权的是大型创投、龙头药企和跨国公司，可在当前国内医药投融资环境下，乐于投资早期研发阶段的机构凤毛麟角。　　浙江一家疫苗孵化企业高管孙女士表示，这种早期研发如同一个黑箱，医药生物专业投资机构能估计其分量，却无法预料最后结果，因而不愿投资。孙女士原在美国一家医药研究机构工作，把项目带回国后创办了公司，但融资难的问题无法解决。一番坎坷之后，她感觉到国内医药孵化企业的项目开发与其说是拼实力，不如说是拼人脉。她说，即使政府主建的生物医药产业园能够给予她300万元人民币的资金支持，相对长周期的疫苗研发而言仍是杯水车薪。　　而在医药生物产业成熟的欧美地区，孵化企业的类似融资难题不是如此突出。研究团队提出具备说服力的研发设计，便可以引来投资，在不同的试验阶段，可以将成果进行估值转让，实现医药项目研究的滚动向前和价值提升，各路风险资本在医药生物研发过程中起到极大的推动作用。　　"像重庆啤酒和岳阳兴长两家上市公司投资研究治疗用乙型肝炎疫苗和"幽门螺杆菌"胃病疫苗，已是敢吃螃蟹者，却吃力不讨好。"一上市药企高管对中国证券报记者表示。在他看来，研发是医药企业的核心竞争力，非专业机构投资医药研发有利于行业发展，但大量孵化企业的资金缺位却同时表明医药研发出现病态。　　一些业内人士认为，国内不缺少天使基金，而是缺少愿意投资医药行业的基金。近年来医药生物产业的战略性新兴产业地位衍生大量投资机会，资金层面却仍是雷声大雨点小，专业医药行业基金和创投屈指可数。与此形成鲜明对比的是，重庆啤酒在过去13年来向疫苗研发投入不到1亿元人民币，众多机构却在一年内增加持仓几十亿元，让业内人士望洋兴叹。　　宋先生称，如果获得1000万元人民币，完全可以凭借研发的推进来使这笔投资升值。他介绍，目前的金属血管支架在治疗循环系统疾病后会留在体内，长期对身体不利，而可降解材料制成的支架在完成使命后会逐步降解成为人体需要的金属元素，一旦上市对现有的同类医疗器械冲击巨大。　　在三江资本生物医疗投融资峰会上，看着数量有限的医药企业上台路演，以及红杉资本副总裁陆勤超等在台下细致记录和询问的场景，宋先生称，真想上台毛遂自荐一下自己的研发项目，但无奈僧多粥少，"融资在心口难开。"

华邦制药募6.85亿开发6个中间体

行业景气度提升带动农药中间体及原料药的需求  发布时间：2012/5/16  来源：药品资讯网信息中心  农药行业景气和大量专利药到期带动下游需求保持旺盛。2011年全球农药市场销售额达到512.1亿美元，增速达到了15.9%。其中六大农化公司的增长率是12.53%，中国十八家上市公司农药销售增长率为23.69%。推动全球农药市场增长的主要因素是全球粮价的持续上涨带来种植面积的提升以及原油上涨和农药审核的趋严带来农药价格的上涨。在全球油价和粮价继续维持高位的情况下，全球农药市场仍将实现较快增长，带动农药中间体及原料药的需求。　　近年来是全球农药及医药专利药到期的高峰期，专利药的大量到期为仿制药及中间体的增长带来了发展机遇。华邦制药主要从事农药、医药中间体的生产经营，其农药中间体业务占工业业务的73.75%(2011年数据)，毛利率高达39.87%，与去年同期相比增长44.43%。2012年1季度，华邦制药营业总收入同比增长44.43%，净利润增长25.74%。　　2011年华邦制药通过增发募集了6.85亿元资金，投向6个中间体项目的建设。其中年产300吨唑草酮、500吨联苯菌胺和300吨甲虫胺项目预计2012年6月30日投产，年产300吨淳尼胺、300吨氟唑菌酸和200吨环丙嘧啶酸项目预计投产时间是2013年4月30日。唑草酮为FMC定制生产的新型除草剂原料药，其销售具有很好的保障；淳尼胺则为替米沙坦的高级中间体，在替米沙坦即将到期，大量非专利药企即将参与生产的情况下，未来市场需求十分广阔。这些项目投产后，预计将贡献10.18亿元和2.18亿元的利润，保障公司未来三年内的业绩增长。

楊志良：憂健保撐不過15年

2012-05-16中央社　中央社台北16日報導指出，台灣醫療改革基金會召開「總統先生，這才叫做歷史定位」記者會，建議總統馬英九應關心全民生命健康與社會安全的醫改問題，並解決健保保費收取不公、醫療資源分配不義、醫院經營管理不仁的三大問題。　楊志良表示，自1995年實施全民健保以來，在馬總統任內啟動唯一一次修法，而這個修法有進步，仍差最後一哩，但能把二代健保法通過是很不容易的，所以給馬總統65到70分。　他建議，應廢除6類14目與未來二代健保實施後的6類15目規定，讓全民站在同一基準；要讓財務更公平，應回歸到家戶總所得制；追求醫療品質與永續發展，但醫療體系面臨四大皆空問題，因為有很多無效醫療且又有血汗醫事人員的困境。　他認為，未來挑戰會更大，如果害怕得罪人，就不能改革。　人口高齡化，楊志良表示，台灣健保撐不到15年，到2025年進入超高齡社會時，健保支付將會更多，隨著科技日新月益，大家可以多活幾年，然而卻面臨到醫護人力也高齡化、青壯年就業人口少，則交付的健保費用也將減少。　除健保保費收費不公外，還有醫療資源分配不義，前健保局總經理朱澤民表示，不義之處有「以藥養醫」，健保過於著重藥物、檢查、檢驗給付，產生多開藥、多排檢驗讓藥價差彌補虧損。　醫院投資採購高精密儀器，形成另類「軍備競賽」，朱澤民提出疑惑，「需要如此多的高設備儀器嗎？」他認為，這也是構成血汗醫院成因之一，這些儀器也多數被濫用，對健保耗損大，同時也對醫事人力造成影響。

泰宗 雅節關節內注射劑 營收最強!!

Ｃ肝授權金入帳，泰宗今年獲利勝去年2012-05-15【時報】興櫃新兵泰宗生技(4169)瞄準華人超過4千萬C肝病患商機，董事長徐煥清今(15)日表示，完成美國FDA、台灣TFDA的二期臨床的TCM-700C(C型肝炎合併治療劑)，已與中國廠商簽訂技術授權意向書，今年將開始有授權金入帳。保健食品也進軍中國市場，下半年開始貢獻業績，加上關節內注射劑等產品銷售持續成長，今年獲利表現可望優於去年。透過醫藥銷售的營收支撐新藥研發支出，泰宗為少數現金流穩定的新藥研發生技公司，近三年營收成長都超過3成，去年更轉虧為盈，全年營收2.42億元、年增68%，稅後純益1080萬元，每股盈餘為0.31元。1-4月營收8823萬元。　泰宗目前銷售的產品包括西藥、醫材及有機食品，保健護肝的健康食品為自行研發，西藥、醫材、有機食品為代理銷售，通路以醫療院所、藥房、中藥通路及有機食品通路。　徐煥清表示，過去三年營收高成長主要來自西藥，今年的成長動能則以治療退化性關節炎的關節內注射劑最強。目前市面上的治療方法主要有葡萄糖胺、復健及止痛藥，不是沒效就是治標不治本，未來會藉由衛教來導正觀念，將市場的餅做大。　保健食品部分，除台灣市場，也看好中國市場的商機。徐煥清表示，甘喜康、紅遍天今年在中國大陸進行產品登記及市場規劃，下半年會開始貢獻營收，紅遍天已出了第一批貨，甘喜康預計年底會上市銷售。台灣市場銷售則以藥房及醫生通路為主。

Children With Rare, Incurable Brain Disease Improve After Gene Therapy

 By Staff Editor May 16, 2012      (HealthNewsDigest.com) - "Subject 1" was bedridden with a rare inherited disease before participating in a gene therapy clinical trial in Taiwan. Pictured here two years later in a photo supplied by lead researcher Dr. Paul Wuh-Liang Hwu of National Taiwan University Hospital, she smiles and displays greater mobility. The University of Florida supplied gene therapy expertise and the "vector" used to deliver corrective genes to the four clinical trial patients.  Using gene transfer techniques pioneered by University of Florida faculty, Taiwanese doctors have restored some movement in four children bedridden with a rare, life-threatening neurological disease.  The first-in-humans achievement may also be helpful for more common diseases such as Parkinson's that involve nerve cell damage caused by lack of a crucial molecule in brain tissue. The results are reported today (May 16) in the journal Science Translational Medicine.  The children in the study, who ranged in age from 4 to 6, inherited a rare disease known as aromatic L-amino acid decarboxylase deficiency, or AADC. Patients with AADC are born without an enzyme that enables the brain to produce the neurotransmitter dopamine. They generally die in early childhood. In a phase 1 clinical trial led by Wuh-Liang Hwu, M.D., of the National Taiwan University Hospital, surgeons used a delivery vehicle called an adeno-associated virus type 2 vector to transport the AADC gene into localized areas of the brains of three girls and a boy.  Before therapy, the children showed practically no spontaneous movement and their upper eyelids continually drooped. After receiving the corrective gene, the children gradually gained some head movement. Sixteen months afterward, the children's weight had increased, one patient was able to stand and the other three were able to sit up without support. The study shows gene therapy that targets AADC deficiency is well-tolerated and leads to improved motor development and function, according to co-authors Barry Byrne, M.D., Ph.D., director of UF's Powell Gene Therapy Center, and Richard O. Snyder, Ph.D., director of UF's Center of Excellence for Regenerative Health Biotechnology. Both are members of the UF Genetics Institute. "The children in this study have the most severe form of inherited movement disorder known, and the only treatments so far have been supportive ones," said Byrne, a pediatric cardiologist and associate chairman of the department of pediatrics in the College of Medicine. "It is gratifying to see it is possible to do something to help them, other than providing feeding tubes and keeping them safe. This absolutely opens the door to the possibility of even earlier treatment of neurological diseases by direct gene transfer, and has implications for Parkinson's disease, ALS and even cognitive diseases such as dementia when caused by gene defects."  "Subject 1" was bedridden with a rare inherited disease before participating in a gene therapy clinical trial in Taiwan. Pictured here two years later in a photo supplied by lead researcher Dr. Paul Wuh-Liang Hwu of National Taiwan University Hospital, she smiles and displays greater mobility. The University of Florida supplied gene therapy expertise and the "vector" used to deliver corrective genes to the four clinical trial patients. The Powell Gene Therapy Center provided expertise to the Taiwanese physicians on treating the patients and engineering the corrective gene that spurs production of the absent AADC enzyme. UF's Center of Excellence for Regenerative Health Biotechnology manufactured the vector, packaging genetic material it received from Taiwan into virus particles that were purified, characterized and tested for sterility and stability before being shipped to the clinic for use in patients. "We are ecstatic that we manufactured a product that provided therapeutic benefit to these patients," said Snyder, an associate professor in UF's department of molecular genetics and microbiology. "What really makes it special is there are just a handful of examples of gene therapy in children in the world, and these patients all improved." Doctors injected the AADC vector into a brain area called the putamen, a site known for AADC activity and part of a "loop" of brain connections related to movement. Postoperative CT and MRI scans of the patients showed no evidence of bleeding and all four patients were discharged within a week. Three to six months after gene transfer, all the children had gained weight, including one patient who doubled her weight within a year. Before gene therapy, all patients showed low raw scores in cognition and motor development on a scale called the Comprehensive Developmental Inventory for Infants and Toddlers. Afterward, scores in both areas increased. Parents reported the children also slept better and had improved eye coordination, emotional stability and body temperature stability. Eight additional children — four in Taiwan and four in the United States — are expected to receive the experimental treatment, Byrne said.

Dip Chip biosensor uses microbes to detect almost any toxic substance, right away

 By Ben Coxworth  May 16, 2012    The Dip Chip biosensor, with a key for scale   Once upon a time, tasters were employed by the well-to-do, in order to check that their food or drink wasn't poisonous. Today, there are electronic biosensors that can do more or less the same thing. Unfortunately, as was no doubt sometimes the case with the tasters, the biosensors can't always give us immediate results. Additionally, they're usually only able to test for specific substances, and not simply for "anything that's toxic." An experimental new device known as the Dip Chip, however, is said to address both of those problems.  The biosensor was created by Professors Yosi Shacham-Diamand and Shimshon Belkin, of Tel Aviv University and the Hebrew University of Jerusalem, respectively.  It contains microbes, which have been genetically modified to produce a biochemical reaction whenever they're exposed to a toxic material, not unlike the reactions that occur in humans and other animals. A dip stick-like tube holds the microbes immobilized, next to the device's sensing electrodes. When that tube is introduced to a substance, the microbes will react accordingly, with any chemical signals released by them being converted into an electrical signal. The device analyzes the output of the electrodes, and delivers a "toxic" or "not toxic" diagnosis.  The Dip Chip reportedly gives very few false readings, either positive or negative. Because it simply senses toxicity in general, it could reportedly be used to detect any kind of poisonous substance – even ones that haven't been heard of yet. It also provides results in real time, so could be invaluable for field use by people such as soldiers or campers.  Shacham-Diamand hopes that the Dip Chip can be miniaturized to the point that it could be used with a smartphone or other mobile device. A larger version of it has already been produced, however, designed for the continuous online monitoring of municipal water supplies.  The technology could conceivably also be used in place of lab animals, for testing the toxicity of newly-developed materials. 

Source: Tel Aviv University     

Research and License Agreements between National Cheng Kung University and Novo Nordisk A/S

  TAINAN, Taiwan--(BUSINESS WIRE)--May 15, 2012 - A southern Taiwan-based National Cheng Kung University (NCKU) research team led by Ming-Shi Chang, NCKU professor of the Department of Biochemistry and Molecular Biology, has discovered an anti-interleukin-20 (anti-IL-20) antibody, a potential new anti-osteoporosis and anti-rheumatoid arthritis drug, and agrees to license selected intellectual property and transfer certain technology to Novo Nordisk A/S, a Danish-based pharmaceutical company for a total payment of US$ 13.3 million in case of a successful completion of the project.   In addition, Professor Ming-Shi Chang and Novo Nordisk A/S have established a 2-year research collaboration to further strengthen and possible expand the usages of an IL-20 antibody.   NCKU President Hwung-Hweng Hwung hailed the groundbreaking discovery of anti-interleukin-20 antibody: "The findings not only mark a milestone in global healthcare, but also raise the visibility of Taiwan's academic research."   This medical discovery was published in the Journal of Experimental Medicine (JEM) and has drawn huge attention in the academic world and the biotechnology industry as well.   IL-20 has a key role in osteoclast differentiation, and blockading this cytokine could represent a novel therapeutic approach for osteoporosis, according to data from the NCKU medical team.   The chief editor of Nature Reviews wrote a research highlight in the September issue of Nature Reviews Rheumatology commenting on this finding, while Science-Business eXchange (SciBX) published a cover story reporting on the discovery in the same month.   The study not only signifies groundbreaking findings in the pathogenesis of osteoporosis, but could lead to the innovation of new drugs to treat osteoporosis and rheumatoid arthritis.   Professor Chang pointed out that the medical expense of anti-osteoporosis drugs for patients around the world is estimated to be as much as US$8 billion per year, and that the amount spent on them by 2015 will be about US$8.8 billion.   Chang's team has discovered that IL-20 is an important factor in bone cell differentiation and that high serum IL-20 levels in osteoporosis patients cause bone destruction.

A new window of opportunity

Virander S Chauhan and Rajat Goyal May 15, 2012  The mandate for healthcare — a key BRICS (a group comprising Brazil, Russia, India, China and South Africa) collaborative area — stands at a crossroads. There is a greater emphasis on funneling new investments into efforts to improve health in the poorest countries, thanks to the rise of domestic biotechnology and pharmaceutical industries. The health biotech sector in India, particularly vaccines, is a case in point. While figures point to an innovation-fuelled boom (India produces about 60% of the world's vaccines and accounts for 60-80% of annual UN vaccine purchases), a cautionary note needs to be sounded here.  The emphasis on the South-South collaboration appears to be in the non-innovative sector, says a study ('South-South Entrepreneurial Collaboration in Health Biotech', Nature Biotechnology Volume 8, Number 5, May 2010). Of the firms surveyed in the study, the 13% citing research and development as one of the collaboration sectors contrast sadly with the 72% citing distribution and 34% citing marketing. Compared with the extent of R&D collaboration in the North-North space, in a similar study (20% in the mid-to-late 1990s, up from 6% in the 70s) this is a rather dismal figure.  On a positive note, however, southern firms are becoming epicentres of new knowledge products, particularly with the emergence of institutes like the Beijing Genomic Institute. Global collaboration in the Indian health biotech sector has seen a perceptible shift towards the South in the past decade with the graduation of start-up firms from concept development to drug development. Clinical Research Organisations (CROs) are now developing their own drugs.   While India is well ahead in the volume game (the last decade saw about 240 CROs emerging in India), there are gaps in knowledge-sharing. South-South collaboration is underpinned by parity in socio-economic development and in some instances, culture.  The 'Big 3' killer diseases — tuberculosis, malaria and Aids — currently lack vaccines and require a strong focus on collaborative research. Efforts like the ongoing South Africa-India Bilateral Collaboration for HIV antigens, in particular, have tremendous benefit for India and South Africa as well as for research in HIV.  It's becoming evident that there are multiple collateral benefits to be derived from such collaborative efforts. It would be useful to note that both the means and ends for some of these collaborative efforts converge at some point during the process path.  Innovation: India's focus on innovation has helped it strengthen South-South regional collaboration and allowed an effective engagement with the global North. The emphasis on upgrading traditional skills and developing advanced capabilities in frontier areas of science appears to be an approach that is well placed, demonstrating how modern science and technology is helping lower the burden of disease and spur economic growth. India's success in containing polio is a good example of how science and innovation is delivering broader socio-economic benefits.  Collateral benefits: A key incentive for collaboration, especially in HIV vaccine R&D, where India has built robust programmes in applied research as well as those resulting in the completion of three Phase 1 clinical trials of HIV vaccine candidates. The conduct of these trials has helped in creating benchmarks for good clinical practices, good clinical laboratory practices and good participatory practices. These standards ensure ethical and effective trials of HIV vaccine candidates and establish capacity for clinical research to address other health challenges facing the country.  National ownership: Crucial for any collaborative effort of this nature, Indian industry must sustain the shift in investment towards research, to the development of medicines that prevent, treat or cure and tackle unmet medical needs over the next decade or so.   A close examination of geopolitical trends suggests that the BRICS configuration has some way to go before it can become a more effective platform for regional collaboration. The good news is that India is beginning to show that it has much more to offer to the world as its in-country R&D expertise grows significantly in both public and private sectors.  Though there are several factors that contribute to South-South collaboration in global health biotech, the overarching aim remains constant — one that can deliver good science with humanism for the greater public good.  Virander S Chauhan is director International Centre for Genetic Engineering and Biotechnology, Delhi; Rajat Goyal is country director, International AIDS Vaccine Initiative, Delhi  

MSCI cuts Taiwan weighting in two indices

 2012/05/16  Taipei, May 16 (CNA) MSCI, a global index provider, on Wednesday cut Taiwan's weighting in two of its indices after its semi-annual review.   Taiwan's weighting fell 0.04 percentage points in the MSCI Emerging Markets Index to 11.17 percent, while in the MSCI Asia-Pacific Index (excluding Japan) Taiwan dropped to 18.52 percent from 18.56 percent.   Market analysts said the cuts in Taiwan's weighting reflected recent losses in the local bourse amid concerns over a possible capital gains tax and lingering worries over the debt problems in the eurozone.   MSCI has removed home appliance supplier Tatung Co. from its global standard indices and has added automation equipment maker Airtac International Group and engineering and construction company CTCI Corp.   Meanwhile, MSCI added eight Taiwan stocks to its Global Small Cap Indices. They include Medigen Biotechnology Corp., Tatung Co., food maker TTET Union Corp., and LCD backlit module supplier Ubright Optronics Corp.   The index provider has removed 25 other Taiwan stocks from its global small cap indices. Among them are software developer Astro Corp., optoelectronics firm Cando Corp., Central Reinsurance Corp., CTCI Corp., Mayer Steel Pipe Corp., semiconductor firm Mosel Vitelic Inc., Hung Ching Development & Construction Co., and Ta Chong Securities Co.   China's weighting in the Emerging Markets Index rose by 0.24 percentage points and in the Asia-Pacific Index (excluding Japan) by 0.45 percentage points.   The weighting of Thailand and the Philippines also increased in those two indices.   Meanwhile, India's weighting in the Emerging Markets Index was cut by 0.2 percentage points and in the Asia-Pacific Index (excluding Japan) by 0.32 percentage points.   MSCI has also lowered South Korea's weighting in those two indices, by 0.08 percent and 0.09 percent, respectively.   MSCI said the index adjustments are scheduled to take effect after the close of the Taiwan market May 31.  

Taiwanese Study Identifies Top Three Drugs for Type 2 Glycemic Control

 May 16, 2012   Researchers in Taipei, Taiwan, report that they have identified the top three drugs for reducing A1C levels in type 2 diabetes: biphasic insulin, GLP-1 analogs, and basal insulin. They hedged a little on their endorsement of GLP-1 analogs, however, by saying that although they are not decisively better at controlling A1Cs than other oral diabetes drugs, they have the advantage of helping to reduce weight without adding to the danger of hypoglycemia.   Biphasic insulin is a combination of intermediate- and fast-acting insulin. Basal insulin is the standard dose a person with diabetes takes daily, often supplemented by shorter-term bolus insulin to cover blood sugar spikes at meals. GLP-1 (glucagon-like peptide 1) analogs, which include exenatide and liraglutide, are derived from a gut hormone that helps increase insulin production and sensitivity and reduce glucagon production in the pancreas. A beneficial side effect is weight reduction. The scientists at the Mackay Memorial Hospital, Division of Endocrinology and Metabolism, Department of Internal Medicine, Taipei, Taiwan, reached their conclusion after conducting a meta-analysis of drugs used to treat type 2 diabetes that was inadequately controlled by metformin. The analysis eventually studied 819 articles on diabetes drugs, including coverage of 39 controlled trials that involved almost 18,000 patients.   Overall, GLP-1 analogs were found to lead to a greater decrease in A1C levels than sulfonylureas, glinides, thiazolidinediones, alpha-glucosidase inhibitors, and DPP-4 inhibitors, producing results similar to those of basal and biphasic insulin.   According to the Taiwanese researchers, the meta-analysis also showed that compared with placebo, sulfonylureas, glinides, basal insulin, and biphasic insulin carried an increased risk of hypoglycemia.   While the study conclusions are interesting, the researchers cautioned that of the studies they reviewed, the longest was only 52 weeks-not long enough to establish a definitive long-term trend.

Baxter Announces ADVATE Approval in China for the Treatment of Hemophilia A

ADVATE Now Approved in More than 50 Countries         DEERFIELD, Ill., May 16, 2012 (BUSINESS WIRE) -- Baxter International Inc. /quotes/zigman/219387/quotes/nls/bax BAX -0.40% today announced the approval of ADVATE[Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration (SFDA). It is estimated that more than 50,000 people in China are living with hemophilia A.   ''The introduction of recombinant FVIII therapies in China offers new treatment options for hemophilia patients. The launch of ADVATE is another step in advancing hemophilia care in China,'' said Professor Yang Renchi, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, the leading professional hematological institution providing basic medical research with clinical services in China.   ''Great strides have been made in managing hemophilia, allowing people with this serious condition to live longer, more active and fulfilling lives than ever before,'' said Guan Tao, Secretary General of Hemophilia Home, the hemophilia patient organization in China. ''The availability of ADVATE will be an important milestone for people with hemophilia in China.''   ADVATE is infused directly into the bloodstream and works by temporarily raising the level of factor VIII in the bloodstream, allowing the body's blood clotting process to properly function. Extensive global use and multiple clinical trials demonstrate clinical evidence for ADVATE. With SFDA's action, ADVATE is now approved in 54 countries worldwide.   ''The approval of ADVATE in China marks an important milestone for Baxter and supports our ongoing commitment to treating individuals living with hemophilia,'' said Ludwig Hantson, Ph.D., president of Baxter's BioScience business.   Baxter continues to work closely with the Chinese hemophilia community, including both patients and treaters, to provide access to care for this life-saving, life-sustaining therapy. In 2010, Baxter cooperated with the Ministry of Health to set up a ''Hemophilia Disease Management System,'' China's first nationwide hemophilia patient registration and management system integrating diagnosis and treatment information. In recent years, Baxter has donated more than five million IUs of hemophilia products to Chinese patients and has provided a number of resources to raise awareness of the disease.   

About ADVATE   ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] was initially approved by the FDA in July 2003 for control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII therapies.   ADVATE is approved in the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Hong Kong, Iceland, Iraq, Japan, Macau, Malaysia, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Uruguay and Venezuela.   In the United States, ADVATE [Antihemophilic Factor (Recombinant) Plasma/AlbuminFree Method] is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is the only antihemophilic factor approved in the United States for prophylactic use in both adults and children. ADVATE is not indicated for the treatment of von Willebrand disease.   

About Hemophilia A   Hemophilia is a rare genetic blood clotting disorder that primarily affects males.(1)People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood.(1)Two of the most common forms of hemophilia are A and B.(2) In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent.(2) Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.(2) According to the World Federation of Hemophilia, more than 400,000 people in the world have haemophilia.(1) All races and economic groups are affected equally.(1)

Pluristem Therapeutics: PLX (PLacental eXpanded) cells !!

Cardiac Function in Pre-Clinical Diabetic Diastolic Heart Failure Subjects Improved by Pluristem's PLX Cells,  May 15, 2012   HAIFA, Israel, May 15, 2012 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics, Inc. /quotes/zigman/108591/quotes/nls/psti PSTI -3.39% (tase:PLTR) today announced that cardiac function in a diabetic-induced diastolic dysfunction in animals improved following PLacental eXpanded (PLX cells) administration. The study was conducted as part of the European Commission's Seventh Framework Program (FP7) in collaboration with Professor Doctor Carsten Tschöpe and his staff at the Charite Universitaetsmedizin Berlin, Berlin-Bradenburg Center for Regenerative Therapies (BCRT), Berlin, Germany. Dr. Tschöpe is also a member of the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology.   "Currently, there are limited treatment options for diastolic dysfunction and even fewer options for diabetic induced diastolic dysfunction," said Dr. Tschöpe. "This study holds promise that PLX cells might be able to inhibit diabetic induced diastolic dysfunction progression as well as possibly repair the existing damage, hypotheses that will be further explored in future studies."   Diabetes was induced in thirty-six C57b/6 mice, which resulted in the development of diastolic heart failure. After seven days, the animals received either PLX cells from two separate batches or placebo (12 subjects in each of the three groups). Ten mice were not treated (controls).   After twenty-one days, several cardiac parameters were assessed and found to be significantly improved following the treatment with PLX cells. Important measurements included the cardiac ejection fraction and the left ventricular (LV) relaxation time constant, believed to be the best index of LV diastolic function and a determination of the stiffness of the ventricle. Cardiac ejection fraction improved 19%, the left ventricular (LV) relaxation time constant decreased 16% and the stiffness of the ventricle decreased 19%.   Additionally, the administration of either batch of PLX cells resulted in a significant anti-inflammatory effect, documented by findings including a significant down regulation of the left ventricular vascular cell adhesion inflammatory mediator-1 (LV VCAM-1) and a significant up regulation of the left ventricular interleukin-10 anti-inflammatory mediator (LV IL-10).   "As we demonstrated last week with the announcement that our cells successfully treated the seven years old patient suffering from aplastic bone marrow disease, our strategy is to develop a minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases," said Zami Aberman, Chairman and CEO of Pluristem. "Our initial testing of a treatment for diastolic heart disease opens a new potential indication where our cells can be used and potentially positions Pluristem as a "first-line of defense" for diastolic dysfunction. Based on these studies as well as the previously announced acute myocardial infarction data, and with the support of the European Commission's Seventh Framework Program, we were able to determine that our PLX cells can become an important treatment for various cardiac indications and we look forward to quickly moving from these initial studies towards human trials."   

About Cardiac Diastolic Dysfunction   Diastolic heart failure or diastolic dysfunction refers to a decline in performance of one or both ventricles of the heart during the time phase when the heart is filling with blood. The National Heart, Lung, and Blood Institute reports that approximately 4.8 million Americans suffer from heart failure with approximately 400 thousand new cases appearing annually. Additionally, it has been reported that 50% of these heart failure patients are afflicted with diastolic heart failure (J Am Coll Cardiol. 1999;33:1948--55).   About Pluristem Therapeutics   Pluristem Therapeutics Inc. /quotes/zigman/108591/quotes/nls/psti PSTI -3.39% (tase:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.   Data from two phase I/II studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-BMP for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.   Pluristem has a strong patent portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com , the content of which is not part of this press release.

FDA 核可OTC 販售愛滋病快篩!!

FDA approves 20 minute take-home HIV test   By Jonathan Fincher  May 16, 2012    One of the biggest problems in fighting the spread of AIDS has always been convincing people to have themselves tested regularly. Unfortunately, getting someone to take a trip to a clinic isn't always easy, particularly in areas where there aren't many options for discrete testing. In a development that could leap right over this privacy hurdle, the U.S. Food and Drug Administration has just unanimously approved an over-the-counter HIV test that enables people to test themselves in their own home and receive results in just 20 minutes.  The company behind the test, Orasure, has been distributing its OraQuick HIV test to doctors and medical facilities since 2004. With the stamp of approval from the FDA though, the same test could be as easy for consumers to obtain and use as a pregnancy test. There have been take-home HIV tests before, but those have involved mailing a blood sample off to a lab and then waiting several days for results.  By approving the test - which uses an easier and faster testing method - the FDA hopes to appeal to a much broader range of potential customers and help people determine whether they are HIV-positive much sooner. With government officials estimating that as much as 240,000 people in the U.S. alone do not realize they are infected, a test like this could be a huge step towards slowing the spread of the disease.  When used by medical professionals, the test has shown to be accurate 99% of the time, but a trial conducted by Orasure found that this accuracy dropped to 93% when used by average consumers. After deliberating with a panel of experts, the FDA decided the benefits of the test far outweighed this drawback. Panelists who spoke with the FDA also stressed the importance of clearly stating on the test's packaging that a negative result does not necessarily mean a person is HIV-free.  Orasure has not revealed how much the OraQuick HIV test will cost once it appears in stores, but the professional version is currently priced at US$17.50. 

Source: Orasure via New York Times  

Samsung Bioepis Selects QUMAS on Microsoft SharePoint 2010 to Manage Regulatory Documents

 May 15, 2012, CORK, IRELAND, May 15, 2012 (MARKETWIRE via COMTEX) -- QUMAS today announced that Samsung Bioepis has selected QUMAS ComplianceSP on Microsoft SharePoint 2010 to manage all of its regulatory documents following an extensive vendor evaluation process. Samsung Bioepis is a joint venture between Samsung Biologics and Biogen Idec to develop, manufacture, and market biosimilars. Both Samsung Biologics and Biogen Idec are existing QUMAS customers, and are displaying their commitment to and satisfaction with QUMAS in their selection of ComplianceSP for their new joint venture.   Samsung Bioepis is building a state-of-the-art research and development center in Song-do Incheon, Korea. It is expected that the center will be completed by the end of the year.   Initially, QUMAS ComplianceSP will be deployed in the Research and Development group and will provide users with a secure, structured, and controlled environment for creation, approval, and management of documents from all areas of the organization that have an impact on regulatory submissions, including electronic common technical documents (eCTDs).   QUMAS ComplianceSP is an innovative compliance management solution that combines the power of Microsoft SharePoint 2010 with the proven regulatory domain expertise that QUMAS has gained since 1994 in providing solutions to regulated industries. Combined with a best practice approach for managing documents, processes, people and tasks, ComplianceSP on SharePoint 2010 delivers a unique solution that can manage a wide range of compliance activities on the latest technologies.   "Samsung Bioepis chose QUMAS for a number of reasons," said Steve Dawson, Head of the QUMAS Asia office. "It was clear that our product has the built-in regulatory compliance features they Samsung Bioepis required, such as support for electronic signatures, full lifecycle state management and an extended audit trail. The feedback that Samsung Bioepis received from our reference customers was also extremely positive."   "We are delighted to be involved in this joint venture between our longtime client Biogen Idec and one of our newer clients Samsung Biologics," said Kevin O'Leary, CEO for QUMAS. "Samsung is shooting for the sign-off by international regulatory authorities by the end of the year, and QUMAS will support them throughout the process of achieving this goal."   

About QUMAS   QUMAS is the leader in Compliance and Quality Management Solutions for the Life Sciences industry, with more than 260 global customer deployments and domain expertise in regulatory compliance since 1994.   QUMAS Quality Management solutions provide Electronic Document Management (SOPs, QA documents), Electronic Process Management (CAPA, Deviation, Change Control, Audit), and GMP Compliance Management. QUMAS Regulatory Affairs solutions provide content and Submission Management including eCTD authoring templates, collaborative review, full integration with leading publishing solutions, scanning, and automated import of paper documents.  

GPhA underscores commitment to providing consumers timely access to safe and effective biosimilars

 May 16, 2012    The Generic Pharmaceutical Association (GPhA) last week reiterated its commitment to safeguarding the intent of the Biologics Price Competition and Innovation Act (BPCIA) and ensuring that patients have timely access to safe, effective and affordable biosimilar medications.   "GPhA's priority is to support safe, pure and potent biologics being made available to all patients who need them with no compromise in quality," said Ahaviah Glaser, GPhA Vice President for Policy and Strategic Alliances, in comments to the FDA public meeting. "Moving forward, we will work to ensure that no barriers, like unique non-proprietary names or unnecessary clinical trials, are put in place that could raise safety concerns or interfere with the competitive market BPCIA was designed to create."   GPhA has long maintained that, as proven with chemical prescription drugs, competition from generics will be the most important factor in holding down the cost of biologic medicines. In comments submitted in response to the FDA's draft guidance on biosimilars, the Association stressed several key issues, including:  

■What matters most to patients is that all biologics licensed by the FDA — reference product or biosimilar — are approved to the same standards. If these uniform standards are applied, providers and patients alike can trust FDA's approval of biosimilars as safe, pure and potent.  

■A determination of interchangeability is essential to creating a robust, competitive market for biosimilars. This should be science-based for biosimilars, just as for reference products, and available as part of the initial approval process.  

■All biosimilars should be tracked uniquely, but this does not require, and in fact would be inhibited by, a unique International Nonproprietary Name (INN).   "As we all know, biologic drugs have revolutionized modern medicine, providing vital treatments for patients with a wide range of conditions," Glaser said. "With the application of the best-in-class scientific standards and most appropriate methodologies — while avoiding the creation of artificial barriers to market entry — the FDA will make the BPCIA a success."

Source: GPhA press release         

(5月17日) TFDA輔導生技製藥產業說明會!!

為促進國內製藥產業發展，食品藥物管理局特於5月17日舉辦「藥品專案諮詢輔導要點」輔導機制之產官說明會 (TFDA發布日期2012-05-16) 針對國內準備上市或研發中之新藥(含生物藥品)，並符合「創新程度」、「貢獻程度」、「早收程度」與「滿足法規程度」等四項評估指標之藥品，由食品藥物管理局與醫藥品查驗中心共同推動藥品專案諮詢輔導機制，該局特別於今(101)年5月17日假張榮發基金會國際會議中心舉辦「藥品專案諮詢輔導要點輔導機制之產官說明會」，藉由本次說明會，希望讓國內製藥廠商能了解運作機制，並利用藥品專案諮詢輔導機制，及時掌握藥品臨床試驗及上市法規之要求，期在保障民眾用藥安全前提下，縮短國內自行開發新藥上市時程，同時亦拓展國際市場。此次說明會除了介紹制訂藥品專案諮詢輔導機制之政策考量，更佐以相關推動實例，讓廠商更瞭解政府在建構藥品諮詢輔導機制之用心與成效，未來更以實際行動協助廠商在開發藥品過程中及早納入法規考量，有助對新藥研發方向與規劃有更明確之了解，及時掌握符合法規的前瞻性研發策略。為有效整合食品藥物管理局與醫藥品查驗中心諮詢輔導能量，自99年8月起，食品藥物管理局與醫藥品查驗中心著手推動藥品專案諮詢輔導，100年8月2日正式公告「行政院衛生署食品藥物管理局藥品專案諮詢輔導要點」，針對國內準備上市或研發中之新藥(含生物藥品)，「創新程度」、「貢獻程度」、「早收程度」與「滿足法規程度」等四項評估指標之藥品進行專案諮詢輔導。回顧99年8月藥品專案諮詢輔導開辦至今，食品藥物管理局已輔導10件專案達到研發新里程碑，其中2件已上市，5件進入第三期臨床試驗，1件進入第二期臨床試驗，2件進入第一期臨床試驗。另外，食品藥物管理局也召開至少6件專案之廠商諮詢輔導會議，以了解廠商研發經過與開發現況，並協助解決研發所遇到之法規相關問題。輔導國內生技製藥產業之發展是政府一向的施政重點，衛生署食品藥物管理局自民國99年成立以來，執行行政院生技起飛鑽石行動方案，積極推動藥政改革，強化醫藥產業輔導，以促進我國製藥產業發展，提升國際競爭力，以收產值倍增之成效。
一、日期：101年 5月 17日 星期四  10:00~12:00
二、地點：張榮發基金會國際會議中心 10樓 1002會議室                
三、主席：醫藥品查驗中心高執行長純琇
四、出席人員（稱謂略）：TFDA：敬邀局內長官蒞臨致詞，並與會提供法規機制介紹之講演 / CDE：專案諮詢輔導業務負責之相關同仁/ 邀請廠商：開放所有國內研發業者參與
 

五、議程：

時間	內容	致詞者/ 主講者
10:00~10:05	主席致詞	醫藥品查驗中心 高執行長純琇
10:05~10:10	長官致詞	敬邀 食品藥物管理局藥品組鄒玫君組長致詞
10:10~10:40	TFDA「藥品專案諮詢輔導要點」機制介紹	食品藥物管理局藥品組第四科連恆榮科長
10:40~11:20	CDE指標案件輔導業務介紹	醫藥品查驗中心基礎醫學組 葉組長嘉新
11:20~12:00	綜合討論	所有與會長官與講者