翁啟惠..”台灣有八十四項新藥在人體試驗階段!” 包含外商上市前試驗??

SIC掛牌籌錢 尋生技千里馬 2011-11-02 中國時報在行政院「生技起飛、鑽石行動」方案被賦予「伯樂」任務的台灣生技整合育成中心（ＳＩＣ），終於在昨日成立，由旅美華裔生技專家蘇懷仁擔任首席顧問，負責籌募種子基金，並領導國內外顧問群發掘具有商業化潛力的研發計畫，投資開發新藥或生醫器材，以台灣品牌進軍全球生技市場。　生技整合育成中心（ＳＩＣ）成立後，行政院「生技起飛、鑽石行動」方案四大支柱已全數到位，預定在六個月內協助籌募十億種子基金及製藥型國家級創投基金。　行政院政務委員兼科技顧問組副召集人朱敬一昨日表示，建全推動轉譯研究的生技中心、成立食品藥物管理局、催生國家級生技創投和生技整合育成中心等四大支柱到位，只是第一步。但任何一個產業，不是新設了那個機構，成功就會從天上掉下來；政府必須每天不斷地回應產業需求，想辦法解決各項難題。　中央研究院長翁啟惠表示，台灣已有八十四項新藥研發在作人體試驗，進入第三期臨床試驗的十四項計畫，有七件是依照美國食品藥物管理局規範進行臨床試驗。無論是這些計畫或者是未來的研發計畫，有一件成功開發成新藥上市，台灣生技產業馬上就晉升兆元產業。ＳＩＣ成立茶會生技界產官學研重量級人物幾乎到齊，立法院長王金平也到場致賀。

兩岸基因相似度高 製藥分工共同開發5新藥???

朱敬一：兩岸合作開發新藥【2011/11/03 經濟日報】行政院政務委員朱敬一昨（2）日表示，中國大陸有14億人口，兩岸生醫產業可以合作，大陸「十二五」規劃中，目標25種新藥，兩岸可以合作開發五種新藥，這是國內生醫產業可以考慮的方向。 朱敬一昨天在第九屆華人企業領袖高峰會，以「台灣生醫產業的機會與挑戰」為題發表演說。朱敬一表示，台灣生技起飛鑽石行動方案目前已請來兩位國際級「大和尚」，一位是主導台灣生技創投（TMF）的張有德，專長醫療器材；一位是主導超級育成中心的蘇懷仁，尚缺對新藥育成有經驗的國際級「大和尚」，他將催生第二個國際級生技創投。 發展台灣生技產業，朱敬一提出四大因應作為，一、探討切入哪裡；二、跑第二棒，即實驗室至臨床二期，因需要的經費較少，加值明顯；三、成立超級育成中心；四、兩岸生醫產業合作。朱敬一指出，生技製藥的價值鏈非常長，中國大陸有14億人口，國際藥廠都想賣藥至中國大陸，在這中間台灣可以扮演角色。 朱敬一說，兩岸經濟協議（ECFA）生效，且兩岸皆華人，基因相似度（gene similarity）是全球唯一，兩岸生技製藥分工，最好是建立在gene similarity上，由於台灣病人樣本不夠，可由台灣做臨床實驗第一階段，中國大陸病人樣本多，可做臨床實驗二、三階段，這是最理想的分工。 朱敬一說，台灣已累積多年華人特有疾病研究，如肝癌、肺癌，這是很好利基，大陸「十二五」規劃中，目標25種新藥，兩岸可合作開發五種。兩岸已簽定醫藥衛生合作協議，同意加強合作，積極推動雙方技術標準及規範的協調性，以提升醫藥品的安全、有效性。朱敬一指出，在此基礎上，可進行醫藥品查驗、檢驗登記（審批）及生產管理規範檢查合作，探討逐步採用對方執行的結果。

Taiwan looks to recruit high-tech talent in U.S.

Central News Agency   2011-11-01 Taipei, Nov. 1 (CNA) Vice Minister of Economic Affairs Francis Liang is set to lead a business delegation on an eight-day visit to the Silicon Valley and Boston on Thursday. With over a thousand opportunities on offer, Liang said the trip was part of the Cabinet's 2009 goal to develop six emerging industries (biotechnology, green energy, tourism, long-term medical care, high-end agriculture, and cultural and creative industries), four smart industries, and other areas in the service industry. The four key smart industries are electric vehicles, cloud computing, green architecture, and the intellectual property industry. The Department of Investment Services (DIS) of the Ministry of Economic Affairs said a total of 30 corporations and research institutes will participate in the upcoming recruitment drive. They will be looking for senior executives, engineers, and research and development experts, the DIS said. Key research institutes involved in the trip include the Industrial Technology Research Institute, the Institute for Information Industry, Metal Industries Research and Development Centre, Taiwan Textile Research Institute, and the Development Center for Biotechnology. Meanwhile, technology companies to participate include Taiwan Semiconductor Manufacturing Company --the world's No. 1 contract chip maker, Chimei Innolux Corp., one of Taiwan's leading flat-panel makers, Macronix International Co., and United Microelectronics Corp., the world's second-largest contract chip maker. The government has been involved in foreign recruitment drives since 2003. Since that time, a total of 3,672 foreign-based talent with high-tech backgrounds have been attracted to work in Taiwan. (By Huang Chiao-wen and Ann Chen)

輔大校園內將蓋醫院!!

輔大將蓋醫院 推升周邊房價 2011年 11月03日 【馮牧群╱台北報導】內政部都市計劃委員會已通過將輔仁大學校區內5415坪土地由住宅區及宗教專區變更為醫療專區，4年後將有新醫院大樓啟用，加上明年3月捷運輔大站即將通車，醫療與交通雙重利多加持下，業者估捷運輔大站周邊房價可望漲2成。捷運加持雙利多 新北市政府城鄉發展局主任祕書邱敬斌指出，輔大醫院鄰近捷運機場線與捷運新莊線輔大站，方便就醫，輔大醫院預計2013年動工，2015年完工，隨著新莊副都心開發，人口成長，可滿足新莊、泰山民眾的醫療需求。永慶房屋幸福店店長鄭仁凱說，輔大醫院啟用及新莊線通車後，房價估漲2成。

Taiwan-China Pact to Sharpen Local Pharma Ind. Global Edge

 2011/11/02  Taipei, Nov. 2, 2011 (CENS)--The signing of a cooperation agreement between China and Taiwan regarding medical and healthcare issues will raise international competitiveness of Taiwan-made pharmaceuticals, especially in emerging markets, according to the Council for Economic Planning and Development (CEPD) of Taiwan's Cabinet. Quoting the latest report by IMS, CEPD says the global pharmaceutical market totaled US$856 billion in 2010, and the value is expected to jump to US$1.1 trillion by 2015. Over the next few years, the council says, the U.S. market share will decline to 31% by 2015 from 41% in 2005; while that of the five major European nations (Germany, France, Italy, Spain and the U.K.) will fall to 13% by 2015 from 20% in 2005. During the same period, total market share of the 17 emerging economies, including China, Brazil, India etc., is expected to climb to 28% by 2015 from only 12% in 2005. CEPD also says the emerging markets are the major drivers of global pharmaceutical consumption, due to surging economic growth and institutional changes in the nations. So the emerging markets are expected to create annual demand for US$150 billion of drugs by 2015, in which only 20% is for active pharmaceutical ingredients (API) while the rest for generic drugs. CEPD says Taiwan enacted special statues for the focal-point development of the pharmaceutical industry in Taiwan in 2007, and signed an agreement with China in 2010 for bilateral promotion of the pharmaceutical industry, with the joint efforts to enable Taiwan's pharmaceutical industry to win higher market share in the booming global market.

沒有醫師的醫院???

業者：兩岸都渴望遠端醫療2011-11-02 旺報  摩根士丹利中國投資銀行業務創始人、信中利資本集團董事長汪潮涌表示，大陸已經快速進入老齡化社會，醫療產業將會有大量的創業機會。　昨日的華人企業領袖高峰會論壇中，許多人都談到大陸「三網融合」政策會帶來的影響和商機，天成醫療體系董事長張育美表示，他在活動中與IBM聊到，是否會出現「沒有醫師的醫院」，現在的雲端科技就能達成，遠距照護正是兩岸都在熱烈談論的話題。汪潮涌表示，大陸有一胎化政策後，老人醫療、養護都是很重要的問題，目前的科技創新、三網融合等正可以解決這個老齡化需求，包括遠端醫療、電子病歷等，是很重要的機會。　台灣工研院生醫所所長邵耀華則建議，遠端醫療在設備上最好採取「傻瓜機」的方式，讓一般使用者能安心、正確操作，才是重要的突破。汪潮涌表示，大陸近年來醫藥行業成長比GDP還多2倍，產值超過1.1兆元人民幣，正規醫院超過2萬家，然而還有很多改進空間，包括體質、觀念、藥物和醫療器具的創新。　汪潮涌表示，大陸醫療體系80%是公營機構，需要引進更多民營資本，而長期資源不足，使醫生與護士從業人員觀念不對，不會把關懷放在第一位，也缺乏精神上的溝通。

三高用藥 年花健保逾300億

【2011/11/02 聯合晚報】國衛院教授蘇益仁日前投書媒體，擔憂肥胖帶來的慢性病，成為拖垮健保的負擔，根據健保局統計，光是跟肥胖息息相關的高血壓、高血脂、高血糖等三高用藥，近三年每年都花掉健保逾300億元，占健保藥費的四分之一。

營養午餐有氯黴素!!

如惡意添加 衛署不排除重罰2011-11-02 中國時報　營養午餐竟檢出人、動物都不能使用的禁藥「氯黴素」，林口長庚臨床毒物科主任林杰樑感到不可思議，因氯黴素恐引起骨髓再生不良性貧血、白血病。衛生署食品藥物管理局科長鄭維智表示，將追查來源依《食品衛生管理法》，處以六萬元以上、六百萬元以下罰鍰。營養午餐原意要讓孩童吃得營養、健康，現在卻檢出多項農藥、動物用藥殘留不合格。鄭維智表示，不合格的食品業者，將依六月底新修正的《食品衛生管理法》開罰，若情節重大、惡意添加，不排除祭出最高六百萬重罰，至於最上游的農戶、養殖業者則由農政單位做處分。　鄭維智強調，食品藥物管理局每年會定期抽驗市售肉品的動物用藥殘留及農產品的農藥殘留量，今年度抽驗目標肉品為三百件、農產品二千件，違規者皆追查來源開罰。

Breast cancer screening not a surgeon's privilege: gynecologists

2011/11/02 Taipei, Nov. 2 (CNA) General gynecologists are every bit as knowledgeable as surgeons about breast cancer screening, a gynecologist association said Wednesday. Countering a statement issued earlier by a breast cancer patient group that it is "wrong" to visit a gynecologist when one has a suspect lump in the breast, Taiwan Association of Obstetrics and Gynecology Secretary-General Huang Min-chao said that in fact, spending time looking for a surgeon who can give a diagnosis could in fact lead to a delay in timely treatment. In an event held Oct. 30 to mark breast cancer awareness month, the Taiwan Breast Cancer Alliance told the public that breast cancer is treated by surgeons rather than gynecologists. This misconception needs to be revised, Huang told CNA in a telephone interview. In Taiwan, breast cancer screening and diagnosis is jointly implemented by four different medical departments -- surgery, medical imaging, family medicine, and obstetrics and gynecology, he said. "One can go to see a doctor in any of those departments for help to get the most timely assistance," he noted. Huang pointed out that it can be difficult to secure an appointment with a surgeon specialized in breast surgery if every woman who suspects she might have the disease calls in for a screening session. "Gynecology clinics nowadays are mostly equipped with breast ultrasound devices and their doctors are familiar with breast exam techniques. It is not necessary to go to big hospitals for preliminary checks," he added. "Everyone is responsible for breast cancer screening, including the patient," he went on, urging women with a family history of cancer to conduct regular self-examinations and to see a doctor to ensure early detection.

Taiwan opens integration and incubation center

Publication Date：11/02/2011•Source： Taiwan Today  The Supra Integration and Incubation Center (Si2C), the first government-sponsored agency in Taiwan dedicated to promoting the nation's biotechnology industry, was formally inaugurated Nov. 1, according to Si2C organizer the Science and Technology Advisory Group of the Executive Yuan. "The primary purpose of our center is to allocate resources to the nation's biotech industry and pharmaceutical companies, so that they can develop new and innovative biotech products," said Soo Whai-jen, managing director of the Si2C. In addition, Soo added, the Si2C will provide Taiwan's biotech companies with legal counsel, help them with patent applications, and offer them technical assistance. STAG Vice Convener and Minister without Portfolio Cyrus C. Y. Chu said that with the establishment of the Si2C, the government set up all "four pillars" needed to develop a complete value chain for the nation's biotech industry. The other three pillars, Chu said, are creating the Taiwan Food and Drug Administration, a task accomplished in 2009; setting up the NT$60 billion (US$2.03 billion) Biotech Venture Capital; and underwriting research investments in genetic translation and rapid prototyping production of medical devices. These efforts are part of the government's 2009 plan to double the biotech industry's output value in four years, according to the STAG. "Erecting these four pillars is only the first step," Chu said. "The government still needs to respond to the needs of industry and help firms overcome many difficulties." Soo, a former researcher and executive for Hoffmann-La Roche Ltd. and Shire PLC, both in the United States, assumed his present position after he was strenuously recruited by STAG. STAG said it is also working to have Shaw T. Chen, deputy director of U.S. Food and Drug Administration's Office of Drug Evaluation, join the Si2C team as soon as possible. (HZW)

中華電信雲市集佈局動物醫院及寵物美容

中華電雲市集 扮領頭羊2011-11-02 工商時報  資策會MIC預估指出，3年後台灣雲端市場規模將達新台幣410億元，中華電信將以雲市集、打造全台最大雲端聚落 ，並扶植本土廠商儘速與雲端商機接軌，扮演國內雲端產業發展的領頭羊。　目前國內外知名廠商包括微軟、IBM、嘉惠集團、叡揚資訊、精誠資訊、網擎資訊、萊碼創意科技等20家軟體供應商陸續進駐，超過100件產品上架。中華電信表示，中華雲市集預計2012年會有超過百家軟體供應商提供SaaS應用產品上架，並服務1萬家企業客戶。預期至2016年將會與超過500家來自全球的軟體供應商合作，讓全球15萬家企業客戶可享受便利服務，為需端應用服務100億元商機。中華電信強調，雲市集除了已經針對個人及企業用戶推出健康照護雲之外，未來將陸續針對製造、動物醫院及寵物美容、零售等行業分別推出針對各行各業提供客製化雲端解決方案。　針對健康管理，中華電計畫將行動電話SIM卡內建於血糖機內，未來用戶自行在家透過泰博血糖機量測血糖及血壓指數時，相關資料都可以透過血糖機裡的SIM卡，以過行動網路上傳資料到泰博的遠端醫療雲端平台；而當病友赴醫院就診時，醫生便可以直接透過中華電信的醫療健康雲網站，閱覽用戶在家量測的相關資料，或者用戶也可以自行到醫材通路列印出儲存在SIM卡的相關資料，提供醫生診斷及調整配藥。中華電信投入雲端研發多年，最近推出的中華雲市集，主要以提供企業雲端應用服務為主，具有軟體需求一站購足、彈性付費改買為租、不需繁複安裝程序、無痛升級更新版本、隨時隨地隨選即用、產品全面品質把關、安全穩定雲端環境等7大特色。市場人士分析表示，過去軟體供應商(ISV)苦於研發產品沒有好的行銷管道，中小企業對於必須花大錢購買軟、硬體，才能佈建雲端，而紛打退堂鼓，中華電信總經理張曉東表示，該公司努力建設寬頻網路的活水沃土，致力節能減碳的綠能永續，全面發展創新的數位服務及多元整合服務平台，打造多元共生的數位雨林環境，因此，推出台灣雲端最大聚落中華雲市集。雲市集具備快速取得豐富應用資訊，降低採購決策風險、使用量計費方式取代高額授權金或硬體的模式，協助軟體供應商找到精準的客戶群，降低行銷成本，透過中華雲市集，中小企業可以租代買軟、硬體設備，降低維運成本，不因硬體限制，隨時隨地使用服務。

Taiwan launches government-sponsored biotech incubator

 Published: 02/11/2011 Taiwan has tapped executives from pharma company Roche and US regulator the Food and Drug Administration (FDA) to help set up a national biotech incubator. The newly-launched Supra Incubator Center (SIC) will focus on promoting and fostering the development of the country's biotechnology sector. "The primary purpose of our centre is to allocate resources to the nation's biotech industry and pharmaceutical companies, so that they can develop new and innovative biotech products," SIC managing director Soo Whai-jen told Taiwan Today. Soo, who has held senior R&D roles at Roche, Shire and Biogen, said the SIC would also provide Taiwan's biotech companies with legal counsel, help them with patent applications, and offer them technical assistance. Soo will shortly be joined at SIC by Shaw Chen, who is currently deputy director of the US FDA's Office of Drug Evaluation. The SIC's creation is part of Taiwan's "four pillars" strategy for developing its biotech industry. The other elements of this saw the 2009 creation of the Taiwan Food and Drug, the launch of a $2bn biotech venture capital fund, and moves to provide financial support for research in genetic translation and the rapid prototyping production of medical devices.

輔大醫院變更案通過 102年開發

 自由時報2011-11-02 內政部都市計畫委員會昨天審議通過輔大醫院變更案，新北市政府城鄉局說，預計明年都市計畫發布實施後，輔仁大學將在一○二年辦理醫院開發作業，順利的話，一○四年即能完成，提供新莊、泰山優質的醫療環境。城鄉局解釋，輔仁大學為落實深耕台灣醫學教育、培養優秀醫護人才、符合國際醫療品質標準，擬興建輔仁大學附設醫院，將位於輔大運動場西側一．七九公頃土地，由住宅區及宗教專用區變更為醫療專用區，這項都市計畫變更案昨天經內政部都委會審議通過。

未來免費接駁 城鄉局主任秘書邱敬斌說，這項都市計畫變更案位在輔仁大學西北側，屬於泰山都市計畫塭仔圳地區，計畫區東鄰新莊市，南至貴子路，西接貴子路六十七巷，北界三十米計畫道路，計畫範圍總計一．七九公頃；基地交通條件相當良好，未來將鄰近捷運機場線與新莊線輔大站，加上輔大允諾未來醫院營運後，將提供免費接駁公車，方便民眾就醫。輔仁大學校長黎建球提到，依據衛生署新制醫療資源劃分，輔大附設醫院位於台北醫療區西北次區域（含泰山、三重、蘆洲、林口、八里與五股），目前在急性、一般病床上短缺三千多床，加上新北市人口持續增加，輔大附設醫院的設立，可兼負起當地急重症醫療，提升對病患的照顧。

Par Pharmaceuticals builds up generics business

Par Pharmaceuticals (NYSE: PRX) revved up its generic drugs category with two substantial acquisitions in the third quarter as several companies seek to benefit from the imminent expiration of exclusive patents.In August, the Woodcliff Lakes, New Jersey drug company agreed to acquire Anchen Pharmaceuticals, a privately-held company focused on developing and commercializing extended release and niche generic products, for $410 million in cash. It expects the deal to be completed by the end of the year.

Advertisement In a conference call earlier this year, Paul Campanelli, president of the company's generics division, said the deal "will expand our portfolio of high-value market products, including sustainable products with longer life cycles." Last month Par acquired rights to three products from Teva Pharmaceuticals (NASDAQ: TEVA) in connection with Teva's $6.8 billion acquisition of Cephalon in Frazer, Pennsylvania: fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, the generic version of Amrix, and modafinil tablets, the generic version of Provigil. In October, Par began shipping all strengths of olanzapine orally disintegrating tablets, the generic version of Eli Lilly's (NYSE: LLY) Zyprexa Zydisto. The company had $77.6 million loss for the third quarter partly due to acquisition and restructuring costs on revenues of $672.5 million. Watson Pharmaceuticals (NYSE: WPI) is poised to launch a generic version of Lipitor once Pfizer's (NYSE PFE) patent on the blockbuster drug expires this month. Teva is expecting to release a generic form of Lilley's schizophrenia drug Zyprexa in the fourth quarter in a move it believes will boost sales.

台灣最大魚鱗膠原蛋白年產13.5公噸: 台肥

搶食700億商機 台肥保健食品將上架【2011/11/03 經濟日報】台肥（1722）跨足生技業歷經三年多，首度推出五款保健系列產品正式在藥屈臣氏上架銷售。台肥表示，因生技部門規模效益逐步顯現，明年初將成立子公司，資本額預計約1億元，專注衝刺保健產品業務。 台肥說，公司行銷策略也將大轉變，從BtoB（企業對企業）改為BtoC（企業對消費者），目前先從藥妝通路做起，未來也要擴展至百貨及大賣場，並走平價化策略搶食國內700億元的市場商機。台肥昨（2）日下跌1.3元，收77.7元。 台肥表示，此次首推五種全新保健食品隨身包系列包含了保持年輕活化的「深海魚油軟膠囊」、保持水嫩彈肌的「胜（月太）美姬膠原」、維持完美曲線的「胜（月太）日夜窈窕」調理包、調整體質增加免疫力的「ATP益菌」隨身包以及維持身體靈活度的「胜（月太）膠原葡萄糖胺」隨身包，將於本周正式在屈臣氏開賣。 台肥說，此次開賣代表公司將從BtoB行銷領域跨足至BtoC領域，目前首度合作對象為屈臣氏，未來各種藥妝店也都會積極去洽談上架事宜。而接下來則會考慮上架至大賣場如家樂福，至於百貨公司則會以專櫃方式銷售。 大陸銷售方面，因其銷售程序申請方面須考量到當地政府，所以目前已開始研究當地市場商機以及辦理申請保健食品過關程序。台肥於2008年完成設立魚鱗膠原胜（月太）工廠並正式投入量產，年產量可達13.5公噸，是目前台灣魚鱗膠原胜（月太）產能最大工廠。台肥魚鱗膠原胜（月太）工廠已獲ISO22000及HACCP認證，生產的「台肥魚鱗膠原胜（月太）」原料並在2010至2011連續二年榮獲「國家品質標章」。生產原料來源為台灣養殖的台灣鯛魚及虱目魚，現正進行生產履歷安全製程實施計劃及美國FDA註冊及列名中。

CEL-SCI (CVM) Updates on Multikine Phase III Progression

CEL-SCI Corporation (AMEX: CVM) provided an update today of the progress of its Phase III clinical trial of Multikine (Leukocyte Interleukin, Injection)*, which is currently being investigated in an open-label, randomized, controlled, multi-center study. Notable highlights include: Arrangements have been completed with leading clinical investigators and institutions from 8 countries on 3 continents to conduct the study. So far thirty five (35) clinical centers have met all legal, regulatory, and protocol requirements to screen and enroll patients. Ten of these centers in the study are controlled by CEL-SCI's partners Teva Pharmaceuticals Industries Ltd. (Israel) and Orient Europharma (Taiwan). Both companies manage their parts of this Phase III trial under procedures provided by CEL-SCI's global Clinical Research Organization (CRO). CEL-SCI is currently arranging to bring on line an additional 10 centers to ensure rapid enrollment of the study. MD Anderson Radiological Physics Center, the contractor that CEL-SCI hired to assess that each clinical center is adequately equipped to accurately and precisely deliver the radiotherapy dosage regimen prescribed by CEL-SCI's protocol to the study subjects as part of their standard care and assess that each center has an established a satisfactory Radiotherapy Quality Assurance (RTQA) program so as to assure that the radiotherapy delivered to the subjects which meets the requirements of our Phase III protocol and is consistent and comparable between patients and centers worldwide, has concluded its assessment of all 35 clinical centers. Each center has demonstrated these capabilities to the satisfaction of MD Anderson Radiological Physics Center. CEL-SCI has produced multiple lots of its investigational therapy Multikine (Leukocyte Interleukin, Injection) for the Phase III trial in its manufacturing facility and has supplied the product to the clinical sites in the U.S. and Canada, and six other countries around the world. CEL-SCI has sufficient manufacturing capacity in its manufacturing facility to produce the entire drug supply that will be needed for all the subjects in the trial who will receive Multikine. The cold chain distribution and storage methods used during shipping and storing Multikine at the clinical centers have been established and validated, and also tested in numerous shipments of Multikine around the world. Multiple subjects have been enrolled in the Phase III trial and have received either Multikine followed by standard therapy (surgery followed by radiation or surgery followed by radiation plus chemotherapy), or only standard therapy, the control group for the Phase III trial. The Company also extended the existing licensing agreements with Teva Pharmaceuticals to include the countries of Croatia and Serbia. CEL-SCI also entered into a licensing agreement with IDC-GP Pharm for Argentina and Venezuela.

基亞在23日上櫃掛牌價約23元??

基亞生技將於11月23日登入櫃買中心【2011/11/03 經濟日報】全球肝癌新藥公司基亞生技（3176）昨（2）日表示，預計於11月23日正式掛牌上櫃。此外，研發中的肝癌新藥PI-88，目前進入第三期臨床試驗，預計最快於2013年完成期中分析，如達標準，即可申請新藥上市，為未來成長動能。 基亞昨日興櫃參考價為28元，上漲0.03元；由於該公司今年在研發費用方面支出持續增加，前三季稅後虧損約1億元，每股稅後虧損為1.04元。法人表示，基亞在23日上櫃後，推估掛牌價約23元。基亞董事長張世忠表示，公司目前以肝癌新藥開發，及高階核酸檢驗試劑為核心業務，並將成為未來營收及獲利成長的雙動能。此外，基亞研發中的肝癌新藥PI-88，已於今年正式在台灣及韓國共18所醫學中心，開始收納肝癌病患進行第三期臨床試驗，預計香港及中國近期可獲核准再加入PI-88臨床研究。 張世忠說，基亞計畫在未來的18個月中，於全球收納500名病患，驗證PI-88減少肝癌術後復發的作用，該臨床試驗預計最快於2013年完成期中分析，期中分析如達標準，即可申請新藥上市。 基亞表示，根據工研院生醫所的報告指出，2015年全球市場於肝癌術後藥品銷售值每年約新台幣520至738億元；如果PI-88能盡快上市，將有機會成為全球第一個核准做為肝癌術後預防復發的藥物，也將成為台灣開發出世界級新藥的成功案例。 除了肝癌新藥以外，基亞表示，公司也銷售合酸檢驗產品與服務；而基亞也是亞洲唯一產銷基因分型試劑（HLA）的公司。

基亞PI-88中國衛生部快速審查案件/ EMA孤兒藥認定!!

基亞11/23上櫃 PI-88新藥3年內上市 搶食700億元商機  鉅亨網　2011-11-02 新藥生技類股再添生力軍！全球肝癌新藥領導廠商基亞生技(3176-TW)，將於11月23日掛牌上櫃，掛牌價暫訂25元。董事長張世忠表示，基亞搭載肝癌新藥開發及高階核酸檢驗試劑雙成長引擎，其中肝癌新藥PI-88正進行第三期臨床，將於2013年完成6成臨床試驗，2014年正式藥品上市銷售，搶食全球738億元肝癌市場。張世忠進一步指出，公司肝癌新藥開發及高階核酸檢驗試劑為核心業務，研發中的肝癌新藥PI-88，已於今年正式在台灣及韓國共18所醫學中心，開始收納肝癌病患進行第三期臨床試驗，預計香港及中國近期可獲核准再加入PI-88臨床研究。基亞生技計畫在未來的18個月中，於全球收納500名病患，驗證PI-88減少肝癌術後復發的作用，該臨床試驗預計最快於2013年完成期中分析，期中分析如達標準，即可申請新藥上市。 張世忠認為，肝癌治療是全球關注的重要課題，目前生技醫藥界尚無通過臨床試驗的肝癌術後藥物。根據工研院生醫所的報告指出，樂觀估計2015年全球市場於肝癌術後藥品銷售值每年達738億元，悲觀估計市場值也可以達到520億元，如果PI-88上市，將有機會成為全球第一個核准做為肝癌術後預防復發的藥物，成為台灣優先於歐、美藥證的第一個世界級新藥的成功案例。 基亞開發肝癌新藥PI-88第三期試驗是亞洲公司少見的大規模跨國臨床試驗，同時為台灣衛生署醫藥品查驗中心 (CDE) 的指標案件，及中國大陸衛生部的快速審查案件。此外，PI-88於今年取得歐盟藥物管理局 (EMA)給予「孤兒藥」 的資格認定，未來藥品上市後，將有十年的歐洲市場專賣獨占權，有助於PI-88於歐美市場的授權以及未來市場拓展。此外，基亞生技另一成長引擎核酸檢驗(Nucleic Acid Test)，已開發出具世界級競爭力的檢驗試劑，目前用以檢驗基因分型的HLA試劑，已通過台灣衛生署、美國FDA 與歐盟CE 認證，行銷全球多個國家。 另外，為爭取中國大陸醫改及十二五計畫中血液檢驗的龐大商機，基亞大陸子公司上海浩源生技的新一代B型肝炎、C型肝炎及愛滋病毒三合一檢驗試劑及全自動化檢驗設備，取得三合一核酸檢驗試劑藥證，搶下多家客戶採購案或標案，包括遼寧、河北、唐山、襄陽四家血液中心及中國衛生部北京醫院與中國醫學科學院輸血研究所，年底前及明年隨著更多的血液中心公開招標，逐漸打入400家「試點血站」，因此全年營收將倍數成長，明年大陸血液檢驗市場將達25%市占率，可望拿下超過12億元訂單。 張世忠強調，大陸為提高用血安全，已逐步於大型血站使用核酸檢驗試劑進行血液篩檢，未來十二五規劃結案前，將進一步增加至400家血站，保守估計血液檢驗試劑市場規模將達人民幣10億元。目前上海浩源的主要產品，包括用於測試B、C型肝炎，及愛滋病毒的試劑，目前獲得大陸藥品監管局（SFDA）核准的核酸檢驗試劑，全球僅羅氏藥廠擁有同類產品，但羅氏該項產品在大陸尚處於臨床階段。 張世忠樂觀表示，大陸目前對於血液檢驗的要求日趨嚴格，包括各個血站、血液試劑廠都要求必須使用核酸檢驗試劑，未來大陸各級醫院也將提高測試標準，公司同時開發配套全自動化檢驗設備，並於今年8月獲SFDA核准，已於大陸血站及國家臨床中心使用，未來基亞的產品滲透率將逐年提高，挹注新成長動能。