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Wednesday, September 12, 2012

血糖儀廠 華廣 佈局 藥品及處方零售市場 !


華廣生技 切入大陸零售通路市場 2012-09-11 01:27 旺報 【記者戴瑞芬/專題報導】大陸鼓勵醫藥流通業併購,並開放外資參與下,看好將是台灣供應鏈切入的最佳契機,華廣生技9月底將結盟大陸大型生醫通路,今年底將正式布建大陸藥品及處方的零售市場。華廣生技專利生產的血糖儀,今年已成為台灣醫療器材輸出的最大項,近幾年的年複合成長率皆超過40%,而且逐年升高。華廣生技董事長黃椿木認為,血糖儀的產品生命周期很長且毛利很高,千億產值的效益可以期待,它將大於IT產業5千億以上的產值。尤其「台灣廠商更有優勢能利用聚落效應及製程管理來建立完整的供應鏈」。 因此華廣生技繼去年切入大陸三等甲級醫院,9月底更將結盟大陸大型生醫通路,預備今年底以自有品牌(BIONIME)行銷大陸藥房零售通路。 華廣代理發言人賴美芳說,深耕大陸醫院體系,包括區域型和3醫院都有布局,但今年最大改變,是開發大陸零售市場。 賴美芳說,大陸醫療器材商機絕對有很大的潛力跟市場,尤其是保健醫療還不廣泛,水準正在慢慢提升,加上十二五計劃,在預防保健商機非常遠大。只是醫療器材要在大陸打開行銷通路,的確需要時間耕耘,「生技不像電子產品,看到就能買,生技醫藥尤其是醫院市場,需要長期布局耕耘。」 他認為,大陸十二五計劃下的新醫改政策,將大舉提升農村醫療品質下,掌握通路的生技業最具利基。而華廣布建全大陸醫療通路,會依據不同產品屬性、品牌價值、採中高階產品定位,雙管齊下布局專業市場跟一般生技保健通路,提升市占率。

中關村博奧生物: 北京20萬兒童免費耳聾基因篩查 !!


博奧生物小晶片大科技:讓專利從牆上走下來 鉅亨網新聞中心 (來源:北美新浪) 2012-09-1308:57 10年過去了,"中關村"的概念早已超越了"電子一條街"。10年前,提及"中關村",映入腦海的恐怕便是那海龍門前熙熙攘攘、川流不息的人群。作為中國第一個國家級自主創新示範區,中關村經過20多年的發展建設,規劃面積達232平方公里,已發展為"一區十園"。聚集高新技術企業近2萬家,形成了以電子信息、生物醫藥、能源環保等為代表,以研發和服務為主要形態的高新技術業集群,成為首都跨行政區的高端業功能區。在不久的將來,中關村的"版圖"還會繼續"擴張"。來自中關村管委會的最新消息顯示,中關村有望擴大到"一區十六園",面積將達488平方公里。地點:北京市海淀區生命科學園博奧生物 時間:9912日不久前,毛毛媽媽拿到北京一家兒童醫院給毛毛出具的報告,很急。這份名為"新生兒遺傳性耳聾基因篩查"的報告顯示,出生兩個多月的毛毛被發現帶有母親傳給他的"基因12SrRNA A1555G突變型",提示受檢者可能與遺傳性耳聾或藥物中毒耳聾有關。媽媽馬上帶毛毛進行復查。結果很快出來了,毛毛是藥物性耳聾易感基因攜帶者,但聽力正常,只要注意用藥,避開鏈黴素、慶大霉素等十多種藥物,寶寶就能擁有健康的人生。毛毛是幸運的。他將獲得一張終生"用藥指南卡",看病出示此卡,就能避開這些藥物。和毛毛一樣,今年北京約20萬新生寶寶能享受到這種便捷快速的耳聾基因篩查。他們中的數百人有望避開耳聾的風險。這是怎麼做到的?答案是生物晶片。位於北京西北角的中關村生命科學園裡,博奧生物有限公司的近200位科學家,在一片樹葉狀的環形建築裡開發了數百種生物晶片。耳聾基因檢測晶片只是其中的一種。如果說,CPU的硅晶片是構建中關村互聯網業的"基石",那麼生物晶片則是中關村生物業中的一顆"明珠"。
小小玻璃片匯聚大科技99,還沒踏進博奧生物大廈,樓外的風景便吸引了我。別緻新穎的樹葉狀大廈,綠色的玻璃外墻,DNA雙螺旋結構的花園小徑……進入大廈,映入眼帘的前台被設計成一顆受精卵狀的"恐龍蛋",大廈頂部是形狀各異的"細胞燈",公司展台的支架由象徵染色體的"X"和"Y"組成。博奧生物醫學市場部的培訓師袁莉說,這座大廈的主題是"生命",凝結了企業文化和公司對生命奧妙不斷探索的夢想。博奧生物還有一個名字,叫生物晶片北京國家工程研究中心。取來一滴血液,放到晶片上檢測,不久一份個人遺傳信息的報告就呈現在醫生面前,醫生憑藉這份報告診斷健康和罹患相關疾病的風險。這就是生物晶片技術。生物晶片是指在一塊指甲大小的玻璃片上,通過技術手段固定細胞或細胞內相關基因或蛋白的生物信息。在博奧生物的展台,我見到了生物晶片,一塊約1厘米寬、5厘米長的玻璃片上,分佈指甲大小的4塊細密的"點陣"。博奧生物的工作人員說,別小看這個不起眼的"玻璃片",它能通過技術手段固定細胞內DNA的生物信息。臨床時,通過收集人體血液、尿液、痰液等待測樣品,與晶片上已有的DNA信息發生"鹼基互補"反應,生相應信號,再用計算機分析數據,就能獲得待測樣品的基因信息,用於基因檢測,治病,預防等領域。比如可以通過收集新生兒的微量血液,檢測他們是否有致聾基因;通過收集咳嗽病人的痰液,確診他們是否患有結核和是否有耐藥性。毛毛的篩查報告,就是通過收集他的微量血液,檢測出是否有致聾基因。像這樣的生物晶片,博奧生物的近200位科學家,經過十余年的研究,已經開發出數百種。
致聾基因篩查列入實事在博奧生物公司大廳,掛許多獎牌和證書的"專利墻"格外引人注目。不過,在博奧生物副總裁張志堅看來,比榮譽更重要的,是如何讓"掛在牆上"的專利"走下來"。"千手觀音那21個女孩,有18個是因為小時候吃藥造成的耳聾。"張志堅說,中國最多的殘疾人是耳聾患者,有2780萬。很多孩子本來聽力正常,但因為生病時注射了鏈黴素等藥物,導致"一針致聾"。張志堅說,許多正常人體內可能遺傳有一種藥物易感基因,比如耳聾基因,服用鏈黴素等藥物時,帶有這種基因的人就會耳聾。而鏈黴素等藥物廉價有效,也不可能停。過去,這種基因常規檢測方法必須進行基因組測序,檢測難度非常大,全國只有兩三家實驗室能進行檢測,通常要兩周才能拿到結果,還需要專家詳細解讀。2009年,博奧生物率先研發出生物晶片,歷時四年。張志堅介紹,有了晶片,檢測費用和難度大大降低。醫院只需要購買基因晶片和配套的檢測儀,就可以方便快捷地開展檢測。普通醫生就能在電腦上直接讀取檢測結果。市場價格僅數百元。醫院只要購買一台檢測儀和幾塊晶片,就能檢測,普通醫生在電腦上就能直接讀取檢測結果。據張志堅介紹,晶片研製成功後,經過中關村管委會的協調和支持,博奧生物的耳聾基因檢測晶片在今年獲得了北京市政府為民辦實事的4800萬項目採購。從今年3月起,北京將為新生兒提供免費耳聾基因篩查服務,凡是在本市130多家助技術服務機構出生的北京市常住人口新生兒均可獲得該項服務。據北京市衛生局副局長雷海潮介紹,在2012年北京市政府為民辦實事的35個項目中,為北京市常住人口新生兒提供自願免費耳聾基因篩查服務是其中之一,預計每年將有約20萬兒童因此受益。
小團隊10年成"參天大樹" 博奧生物是200310月搬進位於昌平區的中關村生命科學園的。在擁有這座24000平方米研發大樓之前,它的起源地是清華大學一間20多平方米的實驗室。1999年,在美國納米基因公司晶片實驗室項目擔任研發首席科學家的程京回國創業,成為清華"百名人才引進計劃"第一人,任清華大學生物晶片研究與開發中心主任。創業之初,程京帶領4名老師、3個研究生"打天下"。盡管條件艱苦,但程京是幸運的。20002月,程京受邀在中南海"國務院辦公廳第十次科技講座"上,作了題為《生物晶片--下個世紀革命性的技術》的主題報告。程京在報告中建議:中國應加大在生物晶片研發方面的投資力度,迅速研究開發出一批具有自主智慧財產權的專門技術,積極參與到國際競爭的行列中去。這份建議引起了國家對生物晶片技術的高度重視。2000930,博奧生物成立,程京出任工程中心主任、公司技術總監……如今,博奧生物已成為中關村互聯網、電子信息之外的另一張名片。其實,在中關村生命科學園,像博奧生物這樣從"小樹苗"長成"參天大樹"的公司還有很多。而今,這裏匯聚了近百家生物醫藥出口企業。2011年,中關村生物醫藥業實現總收入793.2億元,同比增長25.9%。示範區生物醫藥出口企業92家,實現出口總額4.8億美元,同比增長44.8%。程京 中國工程院院士、生物晶片北京國家工程研究中心主任,博奧生物有限公司總裁兼技術總監。2002年,39歲的程京帶領的博奧生物還是一個名不見經傳的小公司。十年後,博奧生物成為中關村繼互聯網、電子信息後的又一張"名片"。博奧生物也從一個20多平方米的實驗室、4個老師、3個研究生成長為擁有24000平方米研發大樓,擁有500多人隊伍的國際生物晶片研發和生巨頭。200912月,程京當選中國工程院醫藥衛生學部院士。作為科學家的程京院士,十年來,在科研之外,更加顯露出一個關注民生、關注制度建設和完善的知識分子情。除了在他自己所在的生物晶片領域,程京也曾為改革國內相關醫療衛生制度弊端大聲疾呼。程京曾在《健康報》發表文章《新技術進臨床瓶頸在哪》。他認為,雖然用於臨床檢測的創新品,為醫療進步提供了很大助力。由於當前的法規政策所限,這些品在通過國家食品藥品監督管理局批准、獲得醫療器械許可證後,仍然不能直接進入醫院得到應用。為此,他疾呼對那些能讓老百姓真正受益、價格合理的創新成果品,應該制定相應的鼓勵政策,通過"綠色通道"使其盡快納入醫保。而針對物價在各個省市重覆報批的問題,國家發改委應攜手衛生部等相關部委進行解決。
讀這十年"新興業支撐大國崛起"王德祿 長城企業戰略研究所所長、參與制定"中關村規劃綱要"專家之一。王德祿是參與制定《中關村國家自主創新示範區發展規劃綱要(2011-2020)》的專家之一。他曾在多個場合表示,新興業是大國崛起的必然支撐,中關村應先行一步,重發展原創性新興業。而生物工程,就是他認為的原創性新興業之一。來自中關村管委會的數據顯示,2011年,中關村生物醫藥業實現總收入793.2億元,同比增長25.9%。示範區生物醫藥出口企業92家,實現出口總額4.8億美元,同比增長44.8%。中關村生物醫藥業規模逐步壯大,總收入占示範區比重逐年提高,生物醫藥業成為示範區出口增長亮點。 王德祿表示,國家對中關村的批復是"戰略新興業策源地",是要成為"全球創新中心之一",當前中關村已經出現了物聯網、生物CRO、移動互聯網等原創性新興業的雛形。中關村這些新興業領域與世界發達地區站在同一起跑線上,並湧現出一些擁有改變世界夢想的創業者和天使投資人。生物醫藥業的發展,將給中關村注入新的活力。王德祿表示,北京應將生物醫藥研發外包(CRO)作為生物業的突破口給予重點支持。

有感政策: 70億有感雲


張善政:政府投70 建置10朵雲 2012-09-13 01:26 工商時報 【記者呂雪彗/台北報導】行政院政務會談昨(12)日聽取雲端運算應用與產業發展方案,政務委員張善政表示,政府將投入70億元建10朵雲,機房和伺服器基礎建設以共用為原則,9月底將啟動雲端開發測試平台,媒合政府雲的商機給國內外軟硬體業者、電信業及資料中心業者。 行政院長陳冲昨天在政務會談聽取張善政報告「雲端運算應用與產業發展方案」,規劃以新台幣70億元總經費推動政府重點推動警政雲、食品雲、健康雲、環資雲、農業雲、交通雲、圖資雲、防救災雲、教育雲和文化雲10個「有感雲」的開發。張善政在這項發展方案中,採先軟後硬策略,媒合政府雲商機給國內外軟硬體業、電信業及資料中心的業者,9月底將啟動「雲端開發測試平台」,這是一個虛擬平台,搭建本土和外商公平競爭平台,並可作為本土雲端解決方案的練兵場,軟硬體業者或法人可將雲端測試的解決方案放置在平台上,供政府雲應用服務機關選定採購商,未來此一平台若民間企業有需要,可能考慮要收取費用。 在總統馬英九提出要推動「有感」政策後,張善政說,政府雲端應用採五大策略包括推動民眾有感應用、建構創新應用開發能量、奠定系統軟體基礎、落實雲端基礎建設和發揮綠色節能效率。其中電子病歷交換的健康雲、有關美牛管理食品雲,與民眾生活息息相關,就是「有感雲」。 張善政表示,「食品雲」藉食品履歷與追溯,強化食品安全控管,提供民眾容易接觸了解的整合式食品安心資訊。 在健康雲方面,第一步是應用電子病歷交換機制,民眾在不同醫院就診時,在經當事人授權下,可透過雲端調閱電子化病歷。
張善政:半年內 盼推電子病歷帶著走 記者黃文奇台北8日電 September 08, 2012 06:00 AM |行政院科技政委張善政昨日出席「UDN TALKS聯合大講堂」時表示,任內聚焦打造10朵「生活運用有感雲」,首波年底前希望完成初階醫療雲建構,推動「電子病歷」、「個人醫療資訊」帶著走。 「聯合大講堂」昨日邀請張善政以「TOP10 雲端服務:影響未來生活的雲端應用」為題引言外,包括工研院知識經濟與競爭力研究中心主任杜紫宸、iPhone4.TW網站站長.基米事業公司行銷總監吉米丘,以及蓬萊島科技公司執行長蔡彥欣都應邀在講堂上發表演說。何謂「民眾有感運用」,張善政舉例,熱門演唱會門票、過年的火車票,這些票務處理通常都透過網路,但時常在開放訂購的一剎那間,由於網路湧進成千上萬使用者而當機,這個問題要先解決,民眾在使用時感到方便,才叫做「有感」。又如建構醫療雲,而病歷如何分享,張善政說,衛生署10年前及開始訂定病歷「電子簽章」,讓病歷逐步電子化並做到資訊交換,但隱私如何保護,又是一個問題。光是病歷能在各大醫院間分享還不夠,半年內希望能夠做到,讓個人健檢紀錄完成雲端應用可以「帶著走」。張善政表示,「電子食品履歷」還有「電子發票雲」等,也都將陸續完成,聚焦打造10朵生活有感雲。

ES細胞移植で聴覚回復

 英の大学、ネズミで成功  聴覚を失わせたネズミに移植した人のES細胞。黄色が聴神経に成長した細胞(英シェフィールド大提供) さまざまな細胞に成長する胚性幹細胞(ES細胞)からつくった細胞で、耳を聞こえなくしたネズミに聴覚を回復させる実験に成功したと、英シェフィールド大などのチームが12日、英科学誌ネイチャー電子版に発表した。 聴覚は聴神経が一度失われると元に戻らないとされるが、幹細胞からつくった細胞を移植して回復させる再生医療につながると期待される。 チームは、人のES細胞から、耳の奥(内耳)にあって音の振動を感知する有毛細胞に似た細胞と、その刺激を伝える聴神経に似た細胞をそれぞれ作製。聴覚を失わせたネズミの耳に移植。10週後、ネズミの聴覚が回復したことが分かった。2012/09/13 02:00 

因華INNOPHARMAX 上興櫃!!!

2012/09/12【台北訊】由上市公司健喬信元 (4114)的轉投資公司因華生技製藥(417213日將正式登錄興櫃交易。 該公司成立於民國94年,是以提供特殊配方與新劑型新藥產品之生技製藥公司,以自行開發之技術平台-OralPASR為核心,進行類新藥與新藥劑型研發,延長現有及未來藥品生命週期,以滿足藥品市場的需求。因華自成立以來秉持著穩健經營的原則,以自行發展之專業技術,陸續於2007年及2009年取得4項國內藥證如顯影劑-嘉多明及嘉多視健、抗感染劑-倍特寧、免疫抑制劑-因睦寧等,且在各項產品研發時程及國內外佈局,皆頗有斬獲,除顯影劑-嘉多明及嘉多視健於2010年與EMP Pharma GmbH簽訂歐盟地區銷售合約,並於20128月完成與Akorn簽訂美國地區之銷售合約。此外,以公司之技術平台OralPASR所研發之GemcitabineOral也於20119月也順利取得美國FDA IND審核通過,進入人體臨床試驗。自國外引進之新成份新藥-Bendamustine(普癌汰)於20119月也正式取得國內藥物許可證。預期未來上述研發成果將為該公司未來其他新劑型新藥的開發奠定良好的基石,未來朝全球化生技製藥公司發展。(劉美恩)

台灣團隊解開SCA22 (22型小腦萎縮症)成因: voltage-gated potassium channel Kv4.3-encoding gene KCND3

Mutations in KCND3 cause spinocerebellar ataxia type 22
Keywords: exome sequencing;next generation sequencing;spinocerebellar ataxia type 22;voltage-gated potassium channel;Kv4.3;KCND3
Objective: To identify the causative gene in SCA22, an autosomal dominant cerebellar ataxia mapped to chromosome 1p21-q23.
Subjects and Methods: We previously characterized a large Chinese family with progressive ataxia designated SCA22, which overlaps with the locus of SCA19. The disease locus in a French family and an Ashkenazi Jewish American family was also mapped to this region. Members from all three families were enrolled. Whole exome sequencing was performed to identify candidate mutations, which were narrowed by linkage analysis and confirmed by Sanger sequencing and co-segregation analyses. Mutational analyses were also performed in 105 Chinese and 55 Japanese families with cerebellar ataxia. Mutant gene products were examined in a heterologous expression system to address the changes in protein localization and electrophysiological functions.
Results: We identified heterozygous mutations in the voltage-gated potassium channel Kv4.3-encoding gene KCND3: an in-frame three-nucleotide deletion c.679_681delTTC p.F227del in both the Chinese and French pedigrees, and a missense mutation c.1034G>T p.G345V in the Ashkenazi Jewish family. Direct sequencing of KCND3 further identified three mutations, c.1034G>T p.G345V, c.1013T>C p.V338E and c.1130C>T p.T377M, in three Japanese kindreds. Immunofluorescence analyses revealed that the mutant p.F227del Kv4.3 subunits were retained in the cytoplasm, consistent with the lack of A-type K+ channel conductance in whole-cell patch-clamp recordings.
Interpretation: Our data identify the cause of SCA19/22 in patients of diverse ethnic origins as mutations in KCND3. These findings further emphasize the important role of ion channels as key regulators of neuronal excitability in the pathogenesis of cerebellar degeneration. Ann Neurol 2012.

領先全球!榮陽團隊突破 找到第22型小腦萎縮症致病基因 陳鈞凱 2012912 16:59台北榮總與陽明大學腦科學研究中心攜手合作,領先全球,找出了第22型小腦萎縮症致病基因。 記者陳鈞凱/台北報導小腦萎縮症患者最怕一代傳一代,悲劇斷不了根!因為小腦萎縮症多達40多型,其中超過3成迄今找不出致病基因,不過最近,台北榮民總醫院神經醫學中心與陽明大學腦科學研究中心攜手合作,領先全球,找出了第22型小腦萎縮症致病基因,不但有利在產前、患者發病前提早篩檢,更替治療小腦萎縮症提供新方向。日劇「一公升的眼淚」、國片「帶一片風景走」,主角罹患小腦萎縮症的故事賺人熱淚,隨病程快慢,嚴重者可能喪失行動能力或無法坐立而臥床,盛行率約為每10萬人中有510人,可分為原因不明的散發型或遺傳型。82歲的林老先生,45歲起就有步履不穩的現象,平衡感不好,容易跌倒受傷,還逐漸出現說話咬字不夠清晰、喝水容易嗆到等症狀,卻直到60多歲才被確診出罹患第22型小腦萎縮症;家族三代人當中,目前也有接近10人出現類似症狀。代代相傳是小腦萎縮症病友的最大恐懼!小腦萎縮症病友協會理事長黃玉春說,全台目前約有2000多人罹患小腦萎縮症,加入協會病友約有400多人,在致病基因不明之下,有不少人發病後四處求神問卜、看風水改運,甚至自覺是上輩子被人下詛咒,還得面對顯性遺傳,一人發病、全家數代人跟著無藥可治的恐懼。

Pluristem向FDA提交其胚胎细胞疗法罕见药申请

发布时间:2012-9-12 来源:药品资讯网信息中心Pluristem医药公司向FDA提交关于胎盘细胞疗法(PLX)的罕见药申请,这是一种用于治疗再生性障碍性贫血的药物。Pluristem早些时候已经获得了关于PLX用于治疗闭塞性血栓性脉管炎的罕见药身份,此次是公司第二次想FDA提交申请。Pluristem公司主席兼首席执行官Zami Aberman说:"对于再生性障碍性贫血少儿患者,PLX的用量要酌情控制。我们现在正在美国、欧洲和以色列建立关于骨髓移植的咨询机构,通过直观的一些经验用于治疗骨髓类疾病和骨髓移植。" 再生性障碍性贫血是由骨髓内造血干细胞的损害引起的一种异常疾病。

寶齡富錦 員工認股(興櫃)


「寶齡」99年度首次員工認股權憑證轉換普通股於2012.09.14上興櫃 2012/9/12鉅亨網提供 一、興櫃股票種類及數量:上開公司之認股權人於101910日提出申請認購寶齡富錦生技股份有限公司普通股2,500股。 二、興櫃股票開始買賣日期:民國101914日。 三、興櫃股票權利與舊股權利義務均相同。 四、興櫃股票代號:1760 興櫃股票簡稱:寶齡。

FDA孤兒藥資格認定 僅基亞與懷特??? 台灣不止才兩項 !!!!!!!


懷特血寶注射劑 FDA孤兒藥認定【聯合晚報╱記者徐睦鈞/即時報導】 2012.09.10 10:25 pm 懷特生技(4108)今宣布,該公司研發的懷特血寶注射劑之新適應症治療原發性血小板低下紫斑症(Idiopathic Thrombocytopenic Purpura,簡稱ITP)之二期臨床試驗已完成,向美國FDA申請孤兒藥資格認定亦欣獲通過,可望進入快速審查機制,至少可縮短一半的審查時程,預計3年後上市,進軍美國市場。懷特表示,我國目前僅有基亞與懷特生技擁有通過美國FDA孤兒藥資格認定的產品,現已確定獲孤兒藥資格認定者未來向美國FDA申請新藥審查時,除了進入快速審查機制、縮短上市時程外,更享有免繳超過美金100萬元之審查費、享受稅務優惠,以及市場專賣保護期等優惠措施。【2012/09/10 聯合晚報】

冷凍胚胎 植入著床率 >30% !!


冷凍卵子卵巢 助癌患保生機 10:49:40 (中央社記者張榮祥台南12日電)26歲未婚王姓女子罹患乳癌,必須開刀及化療,她在治療前做出冷凍卵子及部分卵巢組織的決定,讓自己有生育下一代的可能。王姓女子一直把結婚生子當成人生重要目標,罹癌對她是嚴重打擊,她擔心乳癌治療時間長達數年,療後卵巢功能衰退,受孕率降低,才決定抗癌前,冷凍卵子及部分卵巢組織。成功醫院婦產部醫師周佩宜指出,近年來乳癌有年輕化傾向,年輕女性罹患子宮頸癌、卵巢癌等更時有所聞;雖說罹癌治療後存活率已大幅提升,但療後造成女性卵巢衰竭及生育能力降低,仍是現今醫學無法突破的瓶頸。她說,年輕女性罹癌接受長達數年治療,多數人不願意放棄未來當媽媽的希望及權利,冷凍胚胎、卵子及卵巢組織,是年輕女性保存未來生育能力的選擇。冷凍胚胎是目前冷凍生殖細胞中最有效的冷凍方式,冷凍胚胎解凍後,回復正常活性比例逾95%,植入後著床率可達30%以上,但前提是已婚患者才能施行。未婚女性可選擇冷凍卵子或卵巢組織,等到癌症治療完成或未來組織家庭後,再進行體外受精或卵巢移植。周佩宜表示,根據統計,全球冷凍卵子超過4000個,藉由冷凍卵子出生的嬰兒也有100例以上。全世界也有超過1000名乳癌患者在治療後懷孕,懷孕後流產率及畸胎比率沒有明顯增加。以成醫為例,也有數10例冷凍胚胎、冷凍卵子及卵巢組織。周佩宜說,不只是罹癌女性,甚至事業有成或單身「輕熟女」,也能未雨綢繆冷凍卵子,珍藏一分延續新生的權利。1010912 

CA125巢癌篩檢沒用? 是嗎 !!


卵巢癌篩檢沒用 害多於益?!內診最重要 2012912 22:12 生活中心/綜合報導美國一個癌症專家小組表示,現有的卵巢癌篩檢法,沒有一個可以有效降低死亡率,有時害多於益。國內婦癌專家也贊同的表示,無論是透過抽血還是超音波來檢查卵巢癌,都沒有明顯的效果,不僅傷害受檢婦女,也浪費醫療資源。台北榮總醫師屠乃方今(12)日說,明確診斷卵巢癌,內診還是最重要的方式。美國預防工作小組主席穆易爾表示:「事實上,相當高比例接受卵巢癌篩檢的婦女,得到不實的陽性檢驗結果,可能受到沒有必要的傷害,諸如動重大手術。」美國預防工作小組說,他們不建議沒有出現卵巢癌徵兆,或有突變基因BRCA1BRCA2,而罹患卵巢癌風險較高的婦女,接受例行性篩檢。台北醫學大學附設醫院婦產部主任劉偉民表示,不管是透過抽血或超音波來檢查卵巢癌,根本就沒有多大效果。婦女作健康檢查大都加作抽血驗「CA125」,也就是「卵巢癌指數」,台北榮總醫師屠乃方說,CA125指數異常不見得就有卵巢癌;反之,CA125指數正常也不見得沒有罹卵巢癌,CA125是種指標,異常後仍需透過診斷,內診是最重要的方式。


Accuracy of CA 125 in the diagnosis of ovarian tumors: a quantitative systematic review. Medeiros LR, Rosa DD, da Rosa MI, Bozzetti MC. Source Postgraduate Program in Epidemiology at Federal University of Rio Grande do Sul, Porto Alegre, Brazil. lidia.rosi@terra.com.br Eur J Obstet Gynecol Reprod Biol. 2009 Feb;142(2):99-105. Epub 2008 Nov 7.

Abstract A quantitative systematic review was performed to estimate the accuracy of CA 125 assay in the diagnosis of ovarian tumors. Studies that evaluated CA 125 levels for the diagnosis of ovarian tumors and compared them with paraffin-embedded sections as the diagnostic standard were included. Seventeen studies were analyzed, which included 2374 women. The pooled sensitivity for the diagnosis of borderline tumors or ovarian cancer was 0.80 (I.C. 95% 0.76-0.82) and the specificity was 0.75 (I.C. 95% 0.73-0.77). The diagnostic odds ratio for ovarian cancer and borderline lesions vs. benign lesions was 21.2 (95% C.I., 12-37). Summary receiver operating characteristic curves were constructed due to heterogeneity in the diagnostic odds ratio. For malignant and borderline ovarian tumors vs. benign lesions the area under the curve was 0.8877. A CA 125 level of >or= 35 U/ml is a useful preoperative test for predicting the benign or malignant nature of pelvic masses. The accuracy of CA 125 in the diagnosis of ovarian tumors is high and very important in helping the surgeon to decide what kind of surgery should be performed.

花粉対策製品に認証マーク 産官学の協議会が発足 

サントリーホールディングスや武田薬品工業などが花粉症対策に産官学で協力して取り組む「花粉問題対策事業者協議会」は12日、都内で設立総会を開き、一定の基準を超えた効果を持つ花粉対策製品にお墨付きを与える「認証マーク」の導入を目指すことを決めた。 花粉症は新たな国民病と言われ、各社が健康食品や医薬品、空気清浄器など多くの対策製品を発売しているが、症状の軽減などでの効果を示す統一的な基準はない。各社共通で実験に使う花粉の大きさや種類、認証マークを与える基準などを決め、消費者が製品を選ぶ際の参考にしてもらう。 また10月から会合を毎月開き情報交換するほか、協議会や会員が行う花粉の発生源などについての調査結果を基に花粉飛散を減らすための政策提言も行う。代表理事に選ばれたサントリーの辻村英雄常務執行役員は総会後、「産官学の密接な連携で、1社ではできないより効果的な対策を打ちたい」と述べた。 同協議会の発足時の会員は、ダイキン工業やユニ・チャーム、研究機関の独立行政法人産業技術総合研究所など約10社・団体。

Stem Cell Research...Court Upholds Obama's Embryonic Stem Cell Research Funding

 Tuesday, August 14th, 2012 The U.S. Court of Appeals for the D.C. Circuit upheld a lower court decision throwing out a lawsuit against the funding, which President George W. Bush stopped and Obama resumed soon after taking office. Alliance Defending Freedom Senior Counsel Steven H. Aden issued a statement expressing disappointment in the ruling that upheld the use of taxpayer funds for human embryonic stem cell research. "Americans should not be forced to pay for experiments that destroy human life, have produced no real-world treatments, and violate federal law," he said. Aden also said the law's clear intent had been utterly ignored. "Congress designed that law so that Americans don't pay any more precious taxpayer dollars for needless research made irrelevant by adult stem cell and other research. In the current economic climate, it makes even less sense for the Obama administration to use taxpayer money for this illegal and unethical purpose." The lawsuit argued that Obama's executive order violated the 1996 Dickey-Wicker law that prohibits taxpayer financing of scientific research resulting in the destruction of human embryos. The Associated Press quoted Chief Judge David B. Sentelle, part of the three-judge appeals court panel, as saying, "Dickey-Wicker permits federal funding of research projects that utilize already-derived" embryonic stem cells because no "human embryo or embryos are destroyed" in such projects. "Therefore, unless they have established some `extraordinary circumstance,' the law of the case is established and we will not revisit the issue." In August 2010, U.S. District Judge Royce Lamberth ruled that the executive order likely violated the Dickey-Wicker law. But in April 2011, a federal appeals court ruled Obama can use taxpayers' money to fund embryonic stem cell research. "Embryonic stem cell research relies on the destruction of young human embryos, and that destruction is integral to the research," LifeNews quoted Dr. David Prentice, Family Research Council's Senior Fellow for Life Science s, as saying. "There would be no embryonic stem cells available for federal funding without first harming and destroying a young human embryo, an act that is prohibited by the Dickey-Wicker language which is passed annually," Prentice added. "A plain reading of Dickey-Wicker would eliminate all taxpayer funds for embryonic stem cell research. Federal funding of embryonic stem cell research is a tragic waste of lives as well as taxpayer money, since despite the promises made to gain the federal funding, there is not a single example of a successful treatment. Only adult stem cells have successfully treated any patient, now helping thousands of people for dozens of conditions." Dr. Francis Collins, director of the National Institutes of Health, said in a statement that his department will now "continue to move forward, conducting and funding research in this very promising area of science." The ruling, he said, "affirms our commitment to the patients afflicted by diseases that may one day be treatable using the results of this research." Human embryonic stem cell research, with the present state of technology , involves the creation of a human embryonic stem cell line, which requires the destruction of a human embryo, and raises concerns over the rights and status of the embryo as an early-aged human life. 

注射器使い回し初の調査へ

 B型肝炎検証で厚労省 原告側と国が昨年、和解基本合意したB型肝炎訴訟で、感染拡大の原因とされた集団予防接種の注射器使い回しについて、厚生労働省が初の全国実態調査に乗り出すことが12日、関係者への取材で分かった。 調査対象は国が予防接種を義務付けた1948年から、使い回しを禁じた88年までの期間。年月が経過していることもあり、一連の訴訟でも各地の使い回しの実態や経緯は十分解明されていなかった。 和解基本合意を受け厚労省はことし5月、被害の検証などを目的に、専門家や被害者らでつくる検討会を設置。検証のためには実態調査が必要と判断し、調査を担当する研究班を設けた。

Cell Therapeutics launches Pixuvri in the European Union

 Published on September 11, 2012 at 2:05 AM · Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced the initiation of the commercial launch of Pixuvri® in the European Union ("E.U.") with entry into Sweden, Denmark and Finland in September, to be followed by Austria and Norway in early October 2012 and Germany, United Kingdom and the Netherlands in November 2012. CTI plans to expand availability to France, Italy and Spain as well as other European countries in 2013. Pixuvri was granted conditional marketing authorization by the European Commission in May 2012 and is the first medicinal product licensed in the E.U. to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin Lymphoma ("NHL"). In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL every year."Patients with late-stage aggressive NHL who are not eligible for, or who have not responded to, second line therapy, have very limited treatment options and a bleak outlook, with average survival of less than a year," commented Dr. Ruth Pettengell, Consultant Hemato-Oncologist at St George's Hospital, London and principal investigator of the Phase III EXTEND study. "The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines. By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."In the EXTEND (Expanding the reach of anthracyclines with piXanTronE in relapsed or refractory aggressive NHL Disease) study for Pixuvri, when compared with other active single-agenttreatments, more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived for longer before their disease progressed. Prior to the approval of Pixuvri there was no standard of care for treating patients who failed front line and second line therapy for aggressive B cell NHL. The EXTEND trial is the only randomized controlled clinical study in this patient population establishing the standard of care for this patient population."We are pleased to be able to offer the first meaningful treatment option for physicians treating those patients with multiply relapsed and refractory aggressive NHL," stated James A. Bianco, M.D., President and CEO of CTI. "CTI looks forward to making this innovative product available to healthcare providers across the European Union."

台微體 獲TEVA 2,000萬元milestone !


8月營收/台微體飆283% 康聯增50%【經濟日報╱記者黃文奇/台北報導】 2012.09.11 03:33 am 生醫族群8月營收出爐,台微體(4152)昨(10)日公布營收,受惠於全球最大學名藥廠TEVA里程碑金(milestone)挹注,8月近2,000萬元進帳,月成長達到283%F-康聯8月營收1.49億元,月成長率超過五成。双美、晶宇、寶利徠等昨日也同步公布8月營收,月成長率都達到10 30%。台微體昨日興櫃參考價收108元,上漲1.72元;F-康聯則收71.5 元,上漲0.9元;双美收30.7元,上漲1.1元;晶宇收12.45元,下跌0.05元;寶利徠收39.2元,上漲0.5元。【2012/09/11 經濟日報】

Abcam launches unique range of Epitomics' RabMAbs(R)

September 06, 2012 (PRLEAP.COM) Abcam plc is delighted to announce that following the acquisition of Epitomics, Inc. in April this year, it has launched a unique range of Rabbit Monoclonal antibodies (RabMAbs). RabMAbs provide the combined benefits of superior antigen recognition of the rabbit immune system with the specificity and consistency of a monoclonal antibody, bringing you the highest quality antibody possible.The integration of Epitomics' line of high quality RabMAbs on to Abcam's extensive catalogue now enables most European customers to receive next day delivery.The addition of Epitomics' unique RabMAbs to Abcam's product portfolio, combined with Abcam's powerful e-Commerce capability, helps Abcam achieve its vision of becoming the world's leading supplier of life science research tools.The product range is now integrated into Abcam's website and is available through authorized distributors.Commenting on the announcement, Jonathan Milner, Chief Executive Officer, Abcam plc, said:"We live in a golden age of biology where, almost daily, enormous breakthroughs are being made in mankind's understanding of how cells operate in health and disease. These breakthroughs are possible owing to the rapid growth in understanding at a molecular level of the role of proteins within the cellular environment.Abcam's mission is to help scientists and medical researchers in their quest to unravel the huge complexity of protein function by offering the biggest range of the best life science research tools in the world. Epitomics' best-in-class RabMAbs are superb products that will help propel Abcam towards achieving its mission of enabling the research community to discover more."Guo-Liang Yu, CEO and President of Epitomics - an Abcam Company added:"We are very pleased to have successfully completed the acquisition and excited to be joining Abcam, a leading provider of life science research tools. This acquisition will allow us to continue to develop our line of high quality rabbit monoclonal antibodies and introduce even more researchers to our technology, products and services. It has always been our goal to help advance research by providing best-in-class antibodies and this acquisition only helps to enhance this."About Epitomics Epitomics, Inc. is a biotechnology company dedicated to developing breakthrough rabbit monoclonal antibody technology for research and diagnostic applications. The Company's core technology is its unique and proprietary RabMAb® (Rabbit Monoclonal Antibody) technology which produces antibodies with superior binding affinity and bioactivity in a wide variety of biological assays. Epitomics, Inc. was founded in 2001, headquartered in Burlingame, California, and operates a wholly owned subsidiary in Hangzhou, the People's Republic of China.Epitomics, Inc. is now known as Epitomics - an Abcam Company.

神隆台南部分中間體產品移往常熟廠生產 !!!


神隆8月營收月減近4%,下半年估逐季創高 2012/09/10 10:12 精實新聞 2012-09-10 10:11:45 記者 蕭燕翔 報導 原料藥大廠神隆(1789)公告8月營收4.34億元,月減近4%,法人估計,該公司本季營收可望季增30%以上,創下單季新高,下半年營收可望連2季創下高峰,但因毛利率相對較低的新藥委託代工占比從第1季低點回升,下半年毛利率平均將低於上半年,全年營收上看43億元,每股稅後盈餘約1.5元。神隆上半年營收成長6.59%,主要來自歐美乳癌及卵巢癌銷售增加,下半年包括憂鬱症、漸凍人的委託代工用藥營收貢獻也將恢復成長,加上最受關注的減肥新藥Qsymia7月正式取得藥證,拉貨動能也逐步增加,法人看好該公司下半年營收成長力道,估計單季營收有機會連2季創高。 而神隆最新公布8月營收4.34億元,雖較7月下滑近4%,但較去年同期大增60%,法人估計,該公司本季營收季增率將超過30%,上看11.8-12億元,第4季營收還將登上全年高峰,續創單季歷史新高,全年營收約43億元,年增8-9%。不過,因毛利率較低的委託代工用藥占比增加,法人預期,神隆第3季毛利率仍將維持第2季的46.5%,較首季高峰的50%以上下滑,下半年平均值將低於上半年,今年全年毛利率預估落在48.5%,稅後盈餘逾9.6億元,以目前股本估算,每股稅後盈餘約1.5 而神隆兩岸擴建的新產能也逐步到位,其中常熟1期廠中間體廠已投產,初期將先把台南部分中間體產品移往常熟廠生產,同時該廠也將申請美國FDA查廠,而台南廠新增2條產線可望在年底完工。法人預期,新產能開出多少有助訂單吃緊狀況,2期廠則預計今年底到明年初完工,2014-2015年可望開始貢獻營收,啟動另波新成長。

康聯...搶食中國5000家醫院商機

F-康聯衝!8月營收月增逾5 搶食中國5000家醫院商機 2012/9/11鉅亨網提供中國醫藥銷售平台F-康聯(4144)公告8業績,在合併東北同澤效應逐步顯現,營收達1.5億元,月增51%,年增26%;累計18月營收為10.4億元,年增8%,目前公司積極取併購、策盟和新藥開發3階段發展,擴大營運規模,同時拓展深化23線城市,佈局擴大成長超過5000家醫院,全力搶攻十二五醫改商機。 F-康聯表示,8月在旺季效應,新代理GSK抗生素、B肝用藥銀丁以及糠酸莫米松開始銷售,以及新併購黑龍江同澤藥業的貢獻營收,整體來看,下半年的成長動能將優於上半年。未來康聯將全力衝刺23線城市創造利基,每年至少有1-2個新產品上市,且覆蓋中國醫院客戶滲透率持續攀高,由目前2千多家醫院擴大成長至5000多家醫院。 F-康聯去年年底與英國葛蘭素史克(GSK)合作,取得一級抗菌藥物「阿莫西林克拉維酸鉀(Augmentin)1.2g針劑-力百汀」在中國的獨家銷售推廣權,搶攻中國10億人民幣(約合台幣50億元)商機,目前已開始正式銷售,3年內短期目標達1億人民幣(約合台幣5億元),搶攻中國大陸全身用抗菌藥物(抗生素)藥品市場的商機。除了葛蘭素史克(GSK)外,今年年底將會有第二家國際級大藥廠合作,據了解,此藥廠規模全球前五大,為一家美國跨國企業,合作代理後挹注新成長動能。 法人報告指出,F-康聯今年舊有產品線維持正向成長,上半年表現超乎預期,隨著下半年併入同澤藥業營獲利及GSK明顯挹注,推估營收為18億元,年增率達2成,稅後淨利將調高至4億元,每股稅後純益超過5元。

PRICING PATENTED DRUG

 Wednesday, September 12, 2012, 08:00 Hrs[IST] A fundamental flaw in the current drug pricing policy in India is the absence ofregulation on high priced patented drugs. After the introduction of product patent regime in 2005, multinational drug companies have been importing large number of patented products for marketing in the domestic market. These drugs are being sold at exorbitant prices as the National Pharmaceutical Pricing Authority did not try to bring them under price control as yet. Most of the patented drugs are highly expensive on account of excessive profiteering, loading of huge trade commission and promotional costs. The need to have some kind of price control on patented drugs was felt soon after the new patent law was notified and when MNCs started introducing patented drugs in the Indian market. But the matter dragged on for years. An expert panel was set up by the Department of Pharmaceuticals for the purpose six years ago but no decision was arrived at so far. Even the draft proposal for new drug pricing policy brought out by the government last year leaves out the issue of pricing of patented drugs. Now, NPPA has approached the Department of Pharmaceuticals seeking an amendment of DPCO,1995 to bring pricing of all the imported drugs under its scrutiny and price control. How long this process will take is something to be watched.Apart from excessive pricing of patented drugs, MNCs have been also claiming patent rights for products which are not actually new molecules since 2005. These companieshave been filing applications for patenting different forms of the same drugs, like salt, polymorphs, analogues, crystalline and combinations with other drugs. By doing this, they just tried to corner a broader spectrum of protection for commercially significant forms of the same compound. The patent offices in the country have thus granted patents to dozens of products which do not merit patent protection at all. Filing of multiple patent applications for various forms of the same drug is possible within the framework of the amended Patent Act. A study conducted by Indian Pharmaceutical Alliance in 2009 found that at least 86 cases of patents granted for pharmaceutical products were just minor variations of existing molecules. And between 2005 and 2010, about 13,000 patents have been already issued to various chemicals and pharmaceuticals by Indian patent offices. Obtaining a patent implies an exclusive marketing right for the product for 20 years and if MNCs fix any price for such products without considering socio economic reality of the country that needs to be stopped in the public interest. Granting of patent right for a new drug product and charging a high price for it may be justifiable in case of a non essential drug but that cannot be allowed in case of a life saving drug in India.

亞東證券 承銷 創源上櫃 明顯疏失!!!


創源上櫃疏失 承銷商被處分【經濟日報╱記者蕭志忠/台北報導】 2012.09.13 03:47 am 創源生技(4160)初次上櫃前公開申購掀熱潮,昨(11)日電腦抽籤的中籤率僅有1.36%但主辦承銷商亞東證券卻因上櫃送件時有明顯評估疏失,已先被櫃買中心處記缺點高達5點。櫃買中心表示,亞東證券主辦創源生技股票初次上櫃案,由於送件當初並未確實評估出上櫃的訊聯生技對創源生技具有控制力,疏失較為嚴重。因此,依相關承銷商評估報告應行記載事項等規定,在8月處以亞東證缺點5點。【2012/09/13 經濟日報】

Sanofi Pasteur登革熱疫苗 three dengue virus types vaccine: 31000人臨床三期 !!!


Sanofi Pasteur's first efficacy results confirm safety profile of dengue vaccine candidate Wednesday, September 12, 2012, 10:00 Hrs[IST] Sanofi Pasteur, the vaccines divisionof Sanofi, has announced clinical study results showing the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types. The results of the world's first efficacy study confirm the excellent safety profile of Sanofi Pasteur's dengue vaccine candidate.A feature of dengue epidemiology is that the relative prevalence of virus types in a given area is evolving with time. Large-scale phase III clinical studies of Sanofi Pasteur's dengue vaccine candidate are underway with 31,000 children and adolescents in 10 countries in Asia and Latin America. These studies will generate important additional data in a broader population and in a variety of epidemiological settings to define the best conditions to set up vaccination programs in order to protect people at risk of dengue.The study was conducted in 4,002 children aged 4 to 11 years, in partnership with the Mahidol University under the patronage of the Thai Ministry of Public Health in Muang district of the Ratchaburi Province. Sanofi Pasteur's dengue vaccine candidate is a live, attenuated vaccine. The vaccination schedule is 3 doses given 6 months apart (at 0, 6 and 12 months).Dr. Scott Halstead, International Vaccine Institute, Seoul, Republic of Korea., said, "The complexity of dengue virus infection has hampered vaccine research for decades. This is the first time in 50 years of dengue research that I have seen a vaccine that protected a large group of children fromclinical disease caused by dengue viruses. Best yet, the vaccine met the highest safety expectations. These results should be a source of hope for millions of parents whose children are at risk of severe dengue, a life-threatening disease which often requires hospitalization."The full analysis of vaccine efficacy against each serotype, reflecting real-life conditions (intent to treatanalysis) showed vaccine efficacy to be 61.2 per cent against dengue virus type 1, 81.9 per cent against type 3 and 90 per cent against type 4. One of the dengue virus types (serotype 2) eluded the vaccine. Analyses are ongoing to understand the lack of protection for serotype 2 intheparticular epidemiological context of Thailand."Having worked in the field of dengue research for over four decades, with much of my efforts focused on prevention and control, it is very exciting for me to see a safe vaccine candidate that provides protection against 3 of the four dengue serotypes," said Professor Duane Gubler, Program on Emerging Infectious Diseases, Duke-NSU Graduate Medical School, Singapore. "Dengue is a major public healthconcern for over half of the world's population and is a leading cause of hospitalization and deathamong children in endemic countries.Because mosquito control has failed to control this disease, an effective vaccine will be a critical tool that can change the life of millions living in endemic countries. I see this success as the beginning of a new era of effective control."According to Dr. Roberto Tapia Conyer, General Director of the Carlos Slim Health Institute, Former Undersecretary of Health in Mexico, "These dengue vaccine results bring a significant promise in thecontext of the expanding denguedisease burden worldwide and theabsence of specific treatment. Work will continue to study this vaccine and the circulation of dengue viruses globally, but in the meantime, the public health community can now formulate the best possible immunization policies and prepare for implementation of vaccination campaigns in countries heavily affected by dengue."

因華 興櫃28元 健喬將釋股拉高今年EPS (>2)???


健喬 業績衝10年新高【經濟日報╱記者黃文奇/台北報導】 2012.09.12 03:25 am 健喬信元(4114)旗下小金雞因華生技將於今(12)日召開「登錄興櫃前法說會」,健喬表示,隨著因華登錄興櫃,健喬將出脫老股,11月、12月獲利可望獲得釋股挹注,今年受惠於本業、業外雙引擎,營運將創下10年來新高。健喬昨日股價收29元,上漲0.3元。健喬指出,看好因華長期發展,將考慮少量出脫持股,以活絡因華在資本市場交易狀況。法人表示,因華承銷價暫定每股為28元,而健喬持股成本為每股7元,近期可望承銷600張,每股價差超過20元,因此預估潛在釋股收益至少在1,000萬元,最快第4季認列收益。目前,健喬持有因華約1.34萬張,持股比重近四成,完成登錄後持股比重將降至三成左右。分析師表示,今年健喬受惠於本業、業外挹注,不僅營收將躍進兩成以上再創新高,由於轉投資公司因華的挹注,今年每股稅後純益(EPS )也有機會突破2元,改寫近10年新高。【2012/09/12 經濟日報】

基亞募得8.1億元現增 (45元/股)


智擎將掛牌 可望推升基亞股價〔記者陳永吉/台北報導〕由於第2季辦理現金增資,取得8.1億元的資金,使得新藥股基亞生技(3176)每股淨值恢復至10元以上,且已從財務重點專區內剔除,加上近期另一檔重量級新藥股智擎(4162)即將掛牌的比價效應,推升基亞股價創下歷史新高。新藥股多數以研發為主,在產品未授權或未上市之前,幾乎每年只能燒錢,所以導致每股淨值多數都低於10元。基亞第1季的情況也是如此,當時每股淨值只有7.6元,又連續虧損3年,因此被納入財務重點專區。不過第2季基亞現增1800萬股,每股定價45元,募得資金8.1億元,雖然第2季本業仍虧損,但第2季底的每股淨值回升至12.51元,正式脫離財務重點專區。國內新藥股開始陸續進入資本市場,東洋藥品(4105)集團旗下的新藥公司智擎,即將於18日以每股86元掛牌上櫃,目前興櫃價格達120元,市場看好新藥股將有比價效應,因此本週基亞漲幅達12.3%。除了基亞之外,包括台苯(1310)、裕豐(1438)、安鈦克(6276)、鉅明(8928)、眾星(8082)等都因為財務情況改善,負債比降低或營業現金流量轉正,第2季財報出爐後,從財務重點專區中剔除。至於新加入的個股,第2季僅增加錸德(2349),主要是錸德已連續3年虧損,第2季財報出爐後每股淨值為9.97元,符合財務重點專區指標2的規定,而被納入其中。

懷特血寶: FDA orphan drug designation


懷特血寶注射劑 3年後在美上市 中央社 (2012-09-10 09:00) (中央社記者羅秀文台北2012910)懷特(4108)歷經14年研發成功的「懷特血寶注射劑」,向美國FDA申請孤兒藥資格獲通過,可望進入快速審查機制,縮短一半的審查時程,預計3年後上市,進軍美國市場。懷特血寶注射劑是全球唯一抗「癌因性疲憊」處方藥,上市後頗受醫界矚目。此產品新適應症治療原發性血小板低下紫斑症(Idiopathic Thrombocytopenic PurpuraITP)二期臨床試驗已完成,向美國食品藥物管理局(FDA)申請孤兒藥資格認定獲通過,可望進入快速審查機制,至少縮短一半的審查時程,預計3年後上市,進軍美國市場。懷特表示,我國目前僅有基亞生技(3176)與懷特生技擁有通過美國FDA孤兒藥資格認定的產品。未來向美國FDA申請新藥審查時,除了進入快速審查機制、縮短上市時程外,更享有免繳超過100萬美元的審查費、享受稅務優惠,以及市場專賣保護期等優惠措施。