Tuesday, June 4, 2013

炒作生技?? 現金增資生效 ???

徐玉君:新藥股的多事之秋發刊日期:2013.06.03今年申辦現金增資的生醫股共計有十檔,這當中有三檔新藥股一再被證期局發函停止申報生效,原因為何?頗耐人尋味!近來生醫產業受惠立法院率先初審通過「第三等級醫材」、「經臨床試驗核准的第二等級醫材」可獲投資抵減案,讓醫材類股紅光滿面;但是市場引頸期盼的新藥產業,針對新成分、新療效複方或新使用途徑能夠一併修正的部分,卻未如預期通過。這說明了為何近期新藥股的現金增資申請案,一再被停止生效的部分原因。 新藥業進入多事之秋 新藥股自基亞掛牌以來,因股價從二二.九五元低檔一路走揚最高到二三一.五元的掛牌以來新高價,這段期間一直有傳聞說市場主力傾全力押寶新藥股,因為基亞的表現,讓後續掛牌的新藥股,包括東生華、智擎、醣聯、臺微體等的新股蜜月期,都表現得強強滾。 也因此市場陸續爆出炒作疑雲,近日傳得沸沸揚揚的,就是某市場知名大金主配合幾家投信經理人涉嫌炒股,該大金主配合檢調辦案,部分投信因此也被檢調單位搜尋。即便這些涉及案情的大金主與投信經理人都加以否認,不過在生技產業黑函滿天飛的情況下,燒錢、又沒有基本獲利保護的新藥股,自然也成為主管機關頭痛的問題。 小心駛得萬年船!既然這些新藥股都還沒有穩定的獲利,授權的效應也因為臨床中的新藥還沒有拿到藥證而未見成效,這讓主管機關有了好藉口,得以發函停止現增申報生效;理由很簡單,就是現增用途說明細項,因主管機關還有待公司提出更具體的說明來釐清,待說明檔案備妥重新送件,再重新起算二十個交易日,如無異議,則申報生效。

博鰲 樂城島休閑養生 先行區!!!

博鰲樂城醫療旅遊先行區開工在即北京新浪網 (2013-05-29 03:13)⊙記者 黃智勇 ○編輯 邱江備受矚目的博鰲樂城醫療旅遊先行區各項前期規劃已經初步完成,樣板工程三個月內將開工建設。值得關注的是,羅頓發展在該區域內擁有1800多畝土地,海南博鰲樂城國際醫療旅遊先行區位於博鰲鎮樂城,博鰲亞洲論壇年會所在地的中心地帶,規劃面積20.14平方公里,投資規模達數百億元。該先行區是一個集康復養生、節能環保、休閑度假和綠色國際組織基地為一體的綜合性低碳生態項目,以萬泉河為生態廊道,形成「一河兩岸、四區五組團」的整體空間結構,包括世界頂級醫院、國際組織基地、高端購物中心、特色體驗居住區四大功能區以及由5個醫療養生組團構成的健康長廊。樂城島規劃區是整個博鰲樂城國際醫療旅遊項目的先行樣板工程,目前項目已完成首期738畝地的徵地。樂城島區域內的核心工程——生命養護中心已於今年48啟動,目前已進入地表清理階段。項目相關負責人表示,這個項目計劃在3個月內動工,並將在兩年內投入運營。據悉,海南博鰲樂城開發控股有限公司已與中國建築工程總公司達成框架性合作協議,未來中國建築工程總公司將全程負責樂城國際醫療旅遊先行區的基礎設施建設。此外,作為配套工程之一,博鰲機場總體規劃近日獲批,並進入建設階段。瓊海博鰲機場定位為小型(支線)機場,其主要服務功能包括地方旅遊、公務商務活動和為參加博鰲亞洲論壇會議的國內外政要提供航空運輸保障,建成后可起降波音737-800和空客A320等客機和公務機、專機。值得一提的是,羅頓發展在上述區域內擁有1800多畝土地。公司董秘韋勝杭早前在接受媒體採訪時坦言,博鰲樂城醫療旅遊先行區建設對公司來說是一件好事。

亞洲首例 台大完成機器手臂換肝手術

2013-06-01 中國時報 邱俐穎/台北報導捐肝救父不再留賓士疤!五十歲吳先生因罹患多囊性肝合併肝衰竭,產生大量腹水,肚子脹大如懷胎十月,廿二歲兒子勇敢捐肝救父,透過機器手臂微創手術,僅在腹部留下五個小傷口及一道八到十公分的傷口取肝,父子兩人捐肝、移植手術順利完成,吳先生將於明天出院。台大醫院昨宣布完成亞洲首例機器手臂活體右肝捐贈微創手術。台大醫院外科部主治醫師吳耀銘表示,傳統手術肝臟移植手術傷口大,約會留下三道、長達四十公分的「賓士形」傷口。但機器手臂微創手術只需在肚子上開五個、約○.八至一.二公分的傷口,就能進入腹腔進行右肝捐贈切除,後再從下腹部切八至十公分傷口取肝,除傷口小、減少感染、沾黏的機率,更能大幅減少捐贈者術後疼痛。吳耀銘說,吳先生術前因大量腹水,大腹便便如同孕婦,連肚臍都凸了出來,漏出腹水。換肝移植手術前後歷經十小時,抽出的腹水及肝臟重達十.五公斤,術後吳先生腰圍從一一八公分恢復到八十八公分。吳先生兒子二話不說捐出自己六十%、八百公克的右肝,透過機器人手臂,在切除手術過程中,完全不必輸血,僅失血二百CC,術後第六天就順利出院。相較於傳統微創手術只能直進直出,吳耀銘說,機器手臂就如同外科醫師手的延伸,甚至可旋轉五四○度,操刀醫師就如同在玩電動一樣。去年至今,台大微創肝臟手術已完成七十二例,過去只有十%至廿%肝癌患者可使用微創手術,現提升至四十四%,吳耀銘說,克服技術門檻,很難的手術也能完成,但患者是否適用機器手臂微創手術,仍須由醫師專業評估。

台灣自由經濟示範區 與 海西特區、平潭島 合作???

衝刺自經區 國際醫療專區 落腳航空城2013-05-30 01:35工商時報【記者呂雪彗/台北報導】衛生署昨天向行政院報告,在第一階段自由經濟示範區上路後,首座國際醫療專區的營運模式,將在桃園航空城的產專區落腳作為示範區,衛生署將為業者投資量身訂製,排除投資障礙。而經濟部在國際合作模式中則提出,兩岸區對區對接的合作,未來不排除推動海西區、平潭島的產業合作;而製造與服務業整合模式,則規劃成立智財權管理公司,及最終產品驗證服務公司。衛生署昨天在行政院召開推動自經區第一次專案小組會議中,提出在桃園航空城規劃國際醫療營運模式示範區的構想,第一階段以社團法人經營,吸引國外人士來台接受健檢、醫美等服務,但也不排除重症,床位至少200床。至於要排除那些法規,將為投資人量身打造,鬆綁各項行政命令,衛生署也會主動尋找潛在可能的投資業者,進駐桃園航城。官員說,桃園縣府近期內就會劃定航空城蛋白區內的產專區土地,供作自經區的國際醫療專區,將會選擇近機場捷運,交通便利及生活機能較好的區位。衛生署也建議,盼產專區內有生技產業及醫材產業進駐支援,由於第一階段並未立特別法,無法投資公司型態的醫療機構,要尋找國內業者或外資投資,專門為國際醫療專區打造的醫療機構,挑戰甚大,衛生署有心理準備。官員說,第二階外資可投資公司型態國際醫療機構,外籍董事比例不逾1/3;透過ECFA協商,擬在第二階段開放陸資來台投資,至於是否承認大陸醫療人員學歷或只要認可其執業執照將再討論。經部在產業合作方面,規劃跨國合作、製造與服務業整合二大主軸。跨國合作主要鎖定台日、台美合作,及兩岸特區對特區合作,未來將與大陸協商經濟「特區」對接合作,包括平潭島、古雷半島或海西等產業合作,陸資可比照外資進駐我示範區投資。製造與服務業整合模式,經部規劃成立智財權管理公司,及最終產品驗證服務公司,官員說,成立專利智財管理公司,也有助科技產業因應國際專利大戰。一旦特區對接合作,以面板為例,可結合日本技術,利用大陸家電市場,促使大陸對我面板業提前零關稅待遇,大陸面板進入自經區參股投資,也可望取消比例限制。

與保險業推醫療卡 國際轉介

(中央社記者龍瑞雲台北15日電)衛生署偕同醫院與保險集團簽約,外國人來台就醫出示特殊醫療卡節省就醫不便,讓醫療費用高昂國家的病人來台就醫。衛生署國際醫療管理工作小組偕同台大醫院、中山醫院等11家醫院與信諾保險集團(CIGNA InternationalCorporation),共同簽署建立國際醫療轉介合作管道。衛生署國際醫療管理工作小組執行長吳明彥說,信諾保險集團看重台灣醫療服務品質,及該集團在中國與華人市場蓬勃發展,兩岸人民往來頻繁,對於醫療需求增加。未來在自由經濟示範區成立國際醫療機構也是具有發展性,吳明彥說,可藉此發展「醫療外包(medical outsourcing)」,也就是透過保險公司,將醫療費用高昂國家的病人送到台灣就醫。信諾保險集團東北亞區主任鄧英穎(Amy Tang)說,目前台灣會員有3000人、中國大陸的會員有35000人、香港11000人、新加坡16000人。她說,去年在台灣醫療保險給付支出共計150萬美元,主要是支付住院給付,相較前年,去年台灣市場成長35%,估計今年還會成長20%30%。她說,集團客戶會有一張如同健保卡的醫療卡,持卡在簽約醫療院所就醫,若是保險給付範圍都直接由保險給付,不過,給付不包括醫美療程、選擇性墮胎及工作傷害。信諾保險集團是最大國際企業醫療服務機構,總部設在美國,在多國都設有據點,全球前百大企業中有4成都是客戶,並與90萬家醫療機構簽有合作協議,為所屬跨國企業客戶的80萬名海外員工提供醫療服務。1020515

 

中醫藥服務貿易骨干企業

中醫藥骨干企業扶持政策發布,地方藥企將獲重點支持 鉅亨網新聞中心(來源:財華社)2013-05-31 09:25:02上海證券報報導,昨日,商務部和國家中醫藥管理局聯合召開發布會,公布《關於開展中醫藥服務貿易重點項目、骨干企業和重點區域建設工作的通知》,其中明確,未來將通過財稅、金融和進出口等相關扶持政策,計劃經過3年努力建設一批中醫藥服務貿易骨干企業。上海近日已下發《上海市中醫藥服務貿易發展規劃綱要》,並確定成立全國首個中醫藥服務貿易專業服務平臺,未來將在上海市服務貿易發展專項資金中給予支援,通過設立專項項目、創業投資引導基金和建立多元化投入機制,鼓勵本地區中醫藥產業發展。

 

KOSMOGEL丙烯醯胺 隆乳起訴

致癌藥隆乳 史亞平夫起訴 台灣新聞組/台中1日電 June 01, 2013 06:00 AM外交部常務次長史亞平夫婿、台中市優健萌葳診所負責人郝治華,涉嫌以含有丙烯醯胺的KOSMOGEL藥物為女性隆乳,佯稱是注射玻尿酸,造成被害人雙手無力、胸部劇痛的神經毒性病變;台中地檢署昨依詐欺、違反藥事法等罪,將郝等六人起訴。檢察官說,KOSMOGEL是德國製的醫療藥劑,未經主管機關衛生署核准輸入,主要成分是丙烯醯胺,易經由血液散布至各器官,影響基因及蛋白質的功能,可能造成致癌性、基因突變、繁殖毒性、及神經系統毒性等影響。 檢察官查出, 11名被害人在病變發生後,其中四人與郝治華達成和解,賠償金額110萬至150萬不等,其他部分被害人的賠償問題,雙方協調中。 起訴書指出,郝治華只領有耳鼻喉專科醫師證書,未領有整型外科專科醫師證書,在台中市經營優健萌葳診所,設置科別為西醫一般科,並非整型外科。 2001年間,郝治華搭機到德國柏林開會,結識KOSMOGEL醫療藥劑的發明人,即以每毫升600元價格,先後購買50毫升裝的110瓶醫療藥劑。 郝治華明知主管機關核准的隆乳方式,僅有鹽水袋填充生理食鹽水、凝聚性矽膠等兩種產品,未核准以玻尿酸、丙烯醯胺產品作為隆乳使用。但郝卻向隆乳者稱有先進技術,以注射玻尿酸隆乳,不必開刀,傷口小復元快,效果良好,從2002年至2006年間以KOSMOGEL藥劑為客戶隆乳。 被害人葉女等11人胸部發生病變後,就醫後取出胸部組織異物,經送工研院鑑定,鑑定結果含有丙烯醯胺成分,經葉女等提告,檢方將郝治華及合夥人、秘書、護士共六人起訴。 郝治華在檢方偵訊時,坦承販賣KOSMOGEL醫療藥劑,為需求者注射隆乳;但辯稱他向需求者說注射玻尿酸,卻是按照KOSMOGEL的價格販賣,沒有不法得利。

Taiwan's electronic medicine outperforms drugs

 R Colin Johnson 5/30/2013 12:43 AM EDTTAIPEI--Taiwan is perhaps best known for its expertise in consumer electronics, but by pioneering solutions to pressing problems in medicine, the island country hopes to take the lead in medical electronics too. At its National Taiwan Hospital located on the campus of National Taiwan University (NTU), Taiwan's national aspirations to become a medical electronics leader are taking shape.Clinical trials at NTH--a teaching hospital for the Taipei Imperial University Medical School--have become the proving ground for NTU's medical electronics. Many medial diagnostics advances have been proven out at NTH already, but perhaps its most synergistic accomplishment to date is a wireless sensor pod, including an electrocardiograph (EKG) sensor, that will spearhead a nation-wide wireless medical monitoring facility that is currently in clinical testing at NTH. Designed by principle investigator Shey-Shi Lu, the inconspicuous sensor pod is monitored by medical staff 24/7, and can also be accessed from any smartphone, allowing both doctors and concerned family members to monitor the heart-health, activity level and pharmaceutical conformance of elderly loved ones who often "forget" to take their pharmaceutical-and exercise-regimes seriously.NTU's pain-relieving medical implant is a system-on-chip (SoC) that accepts radio frequency (RF) input from outside the body, which powers a micro-controller that uses digital signal processing to immediately stop pain without drugs or their side effects.

 At the beginning of the innovation cycle is Lu's latest prototype--an experimental wireless medical implant that cures chronic pain with a system-on-chip (SoC) that injects electrical signals into the affected nerves on-demand. Once implanted at the base of the spine, the patient stops pain with a handheld activator--about the size of a smartphone--that sends radio frequency (RF) to an antenna on the implant. The RF energy wakes-up a micro-controller which injects the appropriate anti-pain signal directly into the nerve, stopping the pain instantly without the need for drugs."Today this type of therapy requires a surgical procedure that exposes the nerve so that doctors can inject the pain relieving signal into it," said Lu. "Unfortunately, relief only lasts a few months at most, after which the procedure has to be repeated. With our pain-relieving SoC a patient can administer the same therapy themselves whenever they have pain."The pain-relieving SoC, which can be left in the patient indefinitely (since it has no battery) is currently being passivated to keep the body from rejecting it. After receiving medical approval from Taiwan's equivalent of the FDA, it will enter clinical testing at NTH and eventually be licensed to a Taiwan medical electronics company for marketing worldwide.Hi-resolution ultra-sound Another non-invasive therapy using ultrasound instead of electricity, is being pioneered by IEEE Fellow Pai-Chu Li, who has worked with medical equipment giant Genesis Logic to refine ultrasound to 30 micron resolution enabling cheap accurate noninvasive realtime diagnostics. By harnessing the computational power of graphics processor units (GPUs) already resident in laptops and tablets, Li has created image analysis tools capable of measuring the size of tumors as wells as map out their exact location in 3-D space. However Li's most novel research project to date uses ultrasound to realize wireless power transfer to implants, such as neural stimulators that mitigate the effects of Alzheimer's, epilepsy and, like professor Lu's implants, theelimination of chronic pain with digital signal processing."The advantage of ultrasound over radio frequencies is that ultrasound can be focused very precisely in order to transfer more energy in a shorter amount of time," said Li. Ultrasound can be focused to a depth of about eight inches, enabling it to directly stimulate an implant, or to recharge the batteries of a pacemaker without surgery. Li's lab has also developed a microchip that can receive coded ultrasound signals that program attached micro-controllers, so that smart implants can be reprogrammed thought the skin.

Hi-resolution MRI'sMagnetic resonance imaging (MRI) is already higher resolution than ultrasound, but requires a million-dollar room-filling device to make it work. Unfortunately, all that bulk and expense is being powered by 20th century electronics, according to NTU professors Jyh-Horng Chen and Tzi-Dar Chiueh. By upgrading the encoding of the MRI signal from narrow-band amplitude-modulation (AM) to wide-band frequency-modulation (FM)--where different types of tissues resonant at different frequencies, Chen and Chiueh, have been able to increase the resolution of MRI's by 10-times while simultaneously reducing the scan times by 4-to-8 times.

Endoscope in a pillAnther non-invasive technology being pioneered at NTU puts an endoscope--a tiny video camera for inspecting the inside of the stomach, intestines and veins--inside a pill that can be swallowed. Other endoscopes-in-a-pill have been designed elsewhere, but their effectiveness is hit-or-miss, since they cannot be controlled once swallowed. However, NTU professors Chih-Wen Liu, Cheng-Long Chuang and Joe-Air Jiang, have designed a magnetic wand that allows it to turn, twist and perform fine navigation manipulations of their endoscope-in-a pill, allowing physicians to hunt down tumors, ulcers and other medical problems while watching on monitors in realtime. The team has also adapted the method to navigate tethered encoscopes during colonoscopies, thus cutting down the examination time and increasing the reliability of results.


MOEA, DOH deny hiding poison data

By Joy Lee, The China Post May 23, 2013, 12:01 am TWNTAIPEI, Taiwan --Ministry of Economic Affairs (MOEA) chief Chang Chia-chu (張家祝) yesterday denied a report that the ministry has hidden research showing that antrodia camphorate (牛樟芝) could contain poison that might harm humans. According to reports, the Development Center for Biotechnology was sponsored by the MOEA to conduct research that revealed Antrodia camphorata may contain poison that can harm the liver, kidney and ovaries. The MOEA and the Department of Health (DOH), however, chose not to publish the research that was finished last February, the reports claimed. Chang said that if the research is not finished or only done partially, government officials cannot publish the data. "Research organizations have the right to decide if they want to publish their research," Chang said, "so it is not up to the MOEA to decide if we want to publish the findings." Wang Hui-ying (王慧英) of the DOH's Food and Drug Administration (FDA) said that the DOH received the research this April instead of last February as reported. "The FDA will ask the Development Center for Biotechnology to provide more details regarding the research like all observations, the conclusions of the study and the source of the test samples," said Wang. "Meanwhile," Wang said, "the FDA will collect all related information and send it to the food safety committee for discussion." If the FDA can confirm that antrodia camphorata does do harm to human bodies, Wang said, the administration will immediately take measures to control antrodia camphorata products."There are only three Antrodia camphorata products that are approved by the DOH," Wang said, "and they are all mycelial Antrodia camphorata products that have passed toxicant and safety tests." Lin Ja-liang (林杰樑), head of the Department of Nephrology and the Division of Clinical Toxicology at Linkou Chang Gung Memorial Hospital, said that antrodia camphorata could be toxic as one of his uremic patients's uremia index increased dramatically after taking antrodia camphorate. Antrodia camphorata, also known as stout camphor fungus, is a species of fungi in the genus Taiwanofungus. It is a highly valued medicinal mushroom that is commonly used to fight cancer and allergies and protect the liver in traditional medicine in Taiwan. The price for 37.5 grams of Antrodia camphorata once reached NT$100,000 when it was first introduced to the public. Researcher's Response The spokeswoman for the Development Center for Biotechnology Kuo Mei-hui (郭美慧) said that even though the research did show that Antrodia camphorate may do harm to human bodies, this is only an initial finding that no confirmed conclusion can be made from. Wang Chia-lin (汪嘉林), the CEO of the Development Center for Biotechnology, also said that the toxicant experiment of Antrodia camphorata was only done once, so the center cannot come up with a confirmed conclusion solely from this single test result.

Diabetes Poses Greatest Kidney Risk

By Kristina Fiore, Staff Writer, MedPage Today Published: May 31, 2013Note that these review articles report that chronic kidney disease is highly prevalent, and increasing worldwide. Be aware that aristolochic acid (a nephrotoxin) is a major cause of kidney disease in certain Asian countries, but can be found in herbal medicines worldwide. Diabetes is the most common cause of chronic kidney disease worldwide, though herbal and environmental toxins are also to blame, especially in developing countries, researchers found.Diabetes is behind at least a third of chronic kidney disease cases in countries such as the U.S., Australia, and Japan, Vivekanand Jha, MD, of the George Institute for Global Health in New Delhi in India, and colleagues wrote online May 31 in The Lancet.

But in countries such as Taiwan and China, many cases appear to be tied to aristolochic acid, a compound used to promote weight loss, they wrote in an article published as part of the journal's global series on kidney disease."Aristolochic-acid nephropathy is a progressive interstitial nephritis that leads to end-stage kidney disease and urothelial malignant disease," they wrote. "It was first reported in 1993, in young women who received a regimen containing an herb later identified as Aristolochia fangchi in Belgian slimming clinics. Epidemiological data from Taiwan and China show an association between use of herbs containing aristolochic acid and chronic kidney disease."Other herbal supplements in Asia and Africa are also thought to be the cause of many chronic kidney disease cases, they added: "In Asian countries, traditional medicines are very popular and pharmaceutical medicines are frequently substituted or supplemented by botanical products that include herbs containing aristolochic acid."In the report, the researchers found that Taiwan has the highest prevalence of end-stage kidney disease, at about 2,500 cases per million population, followed by Japan at about 2,300 cases and the U.S. at just under 2,000 cases per million population.Chronic kidney disease is also quickly working its way up the global cause of death league table, moving from number 27 in 1990 to 18 in 2010, the researchers reported.In a second study in the series, Kai-Uwe Eckardt, MD, of the University of Erlangen-Nürnberg in Germany, and colleagues noted that the global population prevalence of chronic kidney disease exceeds 10% in most countries, and is more than 50% in certain high-risk subpopulations.That prevalence increases with age, they wrote, exceeding 20% in patients over age 60 and topping 35% in those over 70.However, they noted that one in 25 patients age 20 to 39 also has chronic kidney disease, and black patients are twice as likely as white patients to develop it.Also, the highest prevalence of chronic kidney disease is in patients with diabetes and cardiovascular disease, reaching 50% or higher, they wrote.

TWi Pharmaceuticals' Manufacturing Site for the Generic Version of Lidoderm(R) (Lidocane 5% patch) Passes US FDA cGMP Audit and Pre-Approval Inspection

Published: May 29, 2013By TWi Pharmaceuticals, Inc.TAIPEI, Taiwan, May 29, 2013 — /PRNewswire/ -- TWi Pharmaceuticals, Inc., today announced that Teh Seng Pharmaceutical Mfg. Co. (Teh Seng), the manufacturing partner for its generic version of Lidoderm® (5% lidocaine patch) located in Taiwan, has completed the cGMP audit and pre-approval inspection (PAI) by US Food and Drug Administration (FDA) and been granted "acceptable" status under the FDA's regulatory guidelines. "We are pleased to know Teh Seng has received the 'acceptable' status upon the completion of cGMP audit and PAI by US FDA," said Calvin C. Chen, President of TWi Pharmaceuticals. "TWi has worked closely with our manufacturing partner on meeting FDA's regulatory requirement for our lidocaine patch product. Getting the 'acceptable' status not only shows TWi and its manufacturing partner's continuing commitment to the high standard production quality, but also brings TWi one step closer to getting the ANDA approval and launching this important product in the US."Lidocaine patch is currently marketed under trade name Lidoderm® by Endo Pharmaceuticals Inc. in the US and has been approved for relieving post-herpetic neuralgia. According to IMS Health data, in 2012, the total sales figure of Lideoderm® in the US is over US$ 1.2 billion.

About TWi Pharmaceuticals, Inc.TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.

About Teh Seng Pharmaceutical Mfg. Co., Ltd.Teh Seng Pharmaceutical is among the global leaders of topical patch manufacturing. Located in Tainan,Taiwan, the company has developed and manufactured over sixty patch products for various medical and cosmetic applications. The products are distributed in several countries across Asia, Europe and in the United States.For more information of Teh Seng Pharmaceutical, please visit www.tehseng.com

MediGene AG : gains SynCore as global EndoTAG(R)-1 partner and strategic core investor

 05/27/2013| 02:10am US/EasternMartinsried/Munich, May 27, 2013. Medigene AG: http://www.medigene.de/ (MDG, Frankfurt, Prime Standard) announces that an exclusive global license and development agreement for the drug candidate EndoTAG®-1 was signed with its existing partner, SynCore Biotechnology Co., Ltd. ("SynCore"), a member of the Sinphar Pharmaceutical Group (Taiwan stock exchange, symbol: 1734). This agreement constitutes a major extension of the July 2012 EndoTAG®-1 agreement, which covered Asia, Australia, and New Zealand and will allow financing of a planned global pivotal phase III clinical trial of EndoTAG®-1 in triple-negative breast cancer (TNBC). Moreover, Syncore will enter into a strategic alliance with Medigene, acquiring 6.09% of Medigene shares. This investment makes SynCore a strategic core investor and one of the largest shareholders of Medigene. Within the scope of the new license agreement, SynCore will provide complete financing of the planned phase III clinical trial of EndoTAG®-1, and will in turn receive the global marketing rights to EndoTAG®-1. Medigene receives an upfront payment from SynCore and is eligible to payments upon certain development and approval milestones as well as royalties after market approval of EndoTAG®-1. The partners expect to start the phase III clinical trial in the second half of 2014.To substantiate the partnership with Medigene, Syncore will acquire 2,405,800 newly issued shares from authorized capital of Medigene AG at a price of EUR 1.00 per share. SynCore will be subject to a lock-up period of 12 months for the shares, which underscores the strategic aspect of this investment. In the course of this capital increase, Medigene receives proceeds of EUR 2,405,800.00.Dr. Frank Mathias, Chief Executive Officer of Medigene AG, comments: "The global EndoTAG®-1 partnership and our strategic alliance signifies important progress for Medigene. We are now in a position to expedite the clinical development of EndoTAG®-1 in an indication with high medical need by conducting a pivotal clinical trial. This is good news for the patients affected, their families, and physicians in charge. Patients suffering from TNBC tend to have a poor prognosis, and there are only very limited treatment options available. Previous clinical trials and the most recent data published on the occasion of the ASCO meeting support the potential of our drug candidate and our shared aim of establishing a new treatment option for this severe illness."Tim C.W. Lee, Chairman of SynCore Biotechnology, comments: "With this investment and our EndoTAG®-1 license agreement, we would like to participate in Medigene's attractive development potential and expertise. We value Medigene as a successful drug developer and as a competent partner within our existing partnerships for Veregen® and EndoTAG®-1. With Medigene, we found a qualified and experienced partner for the further development of an interesting clinical phase III candidate. EndoTAG®-1 pursues an innovative approach and excellently supplements with our current oncologic product portfolio. The expansion of our existing license agreement for EndoTAG®-1 also opens up interesting marketing opportunities beyond Asia. This investment announced today marks our first step into Europe and is therefore strengthening our international strategy."Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, adds: "We are delighted to further strengthen our existing partnership with SynCore, and to intensify it both financially and in terms of substance. In SynCore, Medigene has gained a core investor who actively supports the further development of our company in funding the phase III trial and stabilizes our shareholder structure. As a strategic partner, SynCore will also be instrumental in creating new opportunities for our operations in Asia."

About EndoTAG®-1: The clinical drug candidate EndoTAG®-1 is a novel composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. Because of the positively charged lipids, EndoTAG®-1 interacts with newly developed, negatively charged endothelial cells, which are particularly required for the generation of tumor blood vessels. The EndoTAG®-1 paclitaxel component attacks the endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the blood supply to healthy tissue. By doing this, EndoTAG®-1 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth. Medigene has successfully completed two clinical phase II trials of EndoTAG®-1 in pancreatic cancer and triple-negative breast cancer (TNBC). The drug candidate has also shown positive results in a recently concluded investigator-initiated trial (IIT) in HER2-negative breast cancer.

About SynCore: SynCore Biotechnology Co., Ltd, a joint venture between Sinphar Pharmaceutical Co., Ltd and the National Health Research Institute of Taiwan, is focused on the development of new drugs. Currently, SynCore has five products under development in different stages of clinical trial. Additionally, SynCore has been granted the exclusive development and marketing right in Asia for a new drug for the treatment of dry AMD (age-related macular degeneration) from MacuCLEAR, an US-based biotech company; the drug received approval to enter into phase II/III clinical trial in the US and Taiwan. For further information, please visit www.syncorebio.com: http://www.syncorebio.com/.

About Sinphar Pharmaceutical: Sinphar Pharmaceutical Co, Ltd (Taiwan Stock Exchange, symbol: 1734), with subsidiaries in China and Canada, specializes in the sales and marketing of pharmaceutical products and dietary supplements as well as contract manufacture for several global pharma companies such as Johnson & Johnson, Takeda, Shionogi, and Astellas. Additionally, Sinphar is one of the major producers of paclitaxel (Phyxol®) in Asia. It is also involved in the research and development of botanical new drugs. Further information can be obtained at: www.sinphar.com: http://www.sinphar.com/.

Medigene AG (Frankfurt: MDG, Prime Standard) is a publicly listed biotech company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to generate revenues from a marketed product (Veregen®), which is distributed by partner companies. Medigene also has two drug candidates undergoing clinical trials, EndoTAG®-1 und RhuDex®, and is developing an innovative vaccine technology. For further details, please visit www.medigene.com: http://www.medigene.com/

TWi Biotechnology Receives Patent Allowance for Its Lead Drug Candidate AC-201 in China .

TAIPEI, Taiwan, May 30, 2013 /PRNewswire/ -- TWi Biotechnology, Inc. today announced that it has received an official notification of patent allowance for AC-201, TWi Biotechnology's lead drug candidate, from China State Intellectual Property Office of Patent. The granted patent claims cover AC-201's composition of matter and uses to treat various inflammatory, autoimmune diseases such as Type I/II diabetes, osteoarthritis and the complications of these diseases. The patent is part of TWi Biotechnology's broad intellectual property portfolio for AC-201. "We are very pleased with the issuance of this patent in China for AC-201," said Dr. Calvin C. Chen, President of TWi Biotechnology. "This patent issuance provides TWi Biotechnology the intellectual property protection for AC-201 in a market that is experiencing remarkable growth and of which we intend to capitalize on.AC-201 has demonstrated its efficacy of reducing HbA1c levels in type 2 diabetic patients in two phase II clinical trials. TWi Biotechnology will be presenting the results of a 259-patients multinational phase IIb study in the upcoming ADA conference (American Diabetes Association 73rd Scientific Sections) in Chicago, USA."

About AC-201 AC-201 is a first-in-class, orally available small molecule which has shown the ability to inhibit the production and activity of the cytokine IL-1Beta and to down-regulate the IL-1Beta receptors. Inhibition of IL-1Beta signaling has been demonstrated to be effective in treating a variety of diseases including arthritis and diabetic mellitus (DM). The active ingredient of AC-201 has been approved for treating patients with chronic rheumatic diseases in France and subsequently in other EU and Middle Eastern countries such as Spain and Italy since mid-1990. TWi Biotechnology holds two US INDs for AC-201 -- one for controlling blood glucose in type 2 diabetic patients and the other for gout flare prevention in patients under urate-lowering therapy. In addition to the good safety record of its active ingredient used in treating another chronic disease, AC-201 has gone through several human clinical trials including two phase II trials with 6 months treatment period with satisfied safety profile.

About Type 2 Diabetes Diabetes is one of the most common metabolic diseases worldwide. According to a June 2011 Lancet publication by Danaei and colleagues, the number of adult diagnosed with diabetes worldwide in 2008 is a staggering 347 million and this number is expected to rise to 472 million by 2030.World Health Organization (WHO) has defined type 2 diabetes as results of the body's ineffective use of insulin. Type 2 diabetes comprises 90% of people with diabetes around the world, and is largely caused by excess body weight and physical inactivity. The American Diabetes Association estimated that in 2012, the total cost associated with diabetes in US was US$245 billion of which US$176 billion was direct medical cost while US$69 billion was loss due to reduced productivity.

微創產業研發聯盟 布局 全球微創醫材市場908.7億美元

微創市場成長強,鐿鈦/聯合/鈺緯受惠 精實新聞 2013-05-29 12:23:45 記者 陳怡潔 報導微創手術由於具備傷口小、可降低感染風險、復原速度快等優點,使微創產業之發展儼然已成為全球政府生技醫療產業推動政策的趨勢,研究機構預估,2013年全球微創醫材市場將超過700億美元,到了2015年更將上看908億美元,也是台灣醫材產業的重要新藍海,而微創手術器械廠鐿鈦(4163)、骨材廠聯合骨科(4129)、手術用顯示器廠鈺緯(4153)、以及正在規劃上市櫃的骨材與牙材廠商台微醫,都將是這波成長趨勢的受惠者。經濟部工業局指出,微創手術由於具備傷口小、流血少、可降低感染風險、且患者術後疼痛減少、復原速度快、增加醫療院所病床的使用率等優點,使得微創產業的發展儼然已成為全球政府生技醫療產業推動政策的趨勢。根據研究公司Marketsand Markets預估,在20112015年間全球微創醫材市場都將以年複合成長率9.8%的速度成長,2013年全球微創醫材市場產值將超過700億美元,到了2015年更將上看908.7億美元。 而在微創醫材中,內視鏡與器械是執行微創手術的基本設備,也是現階段微創醫材市場大宗,佔整體微創醫材市場約三成,MarketsandMarkets預估,內視鏡與器械全球產值在20112015年間的年複合成長率為9.3%,且微創手術器械基本上都是一次性使用器材;微創醫材的另一大宗則是耗材的導管,占比亦約三成,預估20112015年間的年複合成長率為11%;而成長潛力最大的則是手術機器人,雖然目前手術機器人佔全球微創醫材市場僅1%,但預估20112015年間會以26.4%的年複合成長率高速成長。而在微創手術的應用市場方面,微創手術可應用於胸腔、心臟、神經、肝膽腸胃、骨科、耳鼻喉科等廣泛用途,其中腹腔鏡手術(主要為婦科與腸胃科)是目前最大宗的應用市場,占比超過三成,骨科微創手術則是成長力道最強的應用市場。微創手術的應用日漸廣泛,經濟部工業局亦積極推廣協助台灣生技業發展微創市場,並於528成立微創產業研發聯盟,工業局指出,台灣過去醫材產品多以居家用消費型產品居多,微創醫材產品全球市占率僅1%。然而,台灣具備優秀的醫療及研發人才,以及一流的精密機械、光電應用和資訊工業整合之競爭優勢,若能整合國內產、官、學、研、醫界,將研究發明成果變成產品,將可增加產值,帶動微創產業市場的發展,使台灣醫療器材產業邁進高值化。微創手術市場有望成為台灣醫材業的下一個新藍海,微創手術器械廠鐿鈦將是這波成長趨勢的受惠者,鐿鈦與美商嬌生(Johnson & Johnson)於去年共同開發之新型微波微創手術器械,已進入量產階段且客戶端取貨暢旺,嬌生的第二代微波微創手術器械目前亦正在開發中,預期第二季將開始生產、第三季放量。鐿鈦今年第一季合併稅後盈餘達5,953萬元,年增率172.38%,稅後EPS 1.48元;法人預期,在第二代微波微創器械即將出貨帶動下,鐿鈦營收將在7月攀新高,今年獲利也將挑戰歷史新高,全年EPS可望超過6元。另外,鐿鈦與工研院合作成立的台微醫,目前已經越過損平點而開始獲利,且正在規劃IPO;台微醫以銷售牙科與骨科材料為主,骨科植入物已經在台灣北部部分醫療院所銷售,預期今年骨科植入物可大量出貨,骨科將是台微醫今年成長主要動力。而受惠微創膝關節等微創骨科手術的市佔率持續成長,骨材大廠聯合骨科也是微創手術趨勢的受惠者。此外,上週甫掛牌的專業醫療用與工業用顯示器製造商鈺緯科技,除了其加護病房臨床監測用顯示器產品為全球領導醫療設備品牌廠商GE Healthcare的唯一供應者,在全球市占率達2成,目前也搶進微創手術顯示器等新應用,預期鈺緯也可受惠微創市場的成長。

Taiwan's biotech sector seen as ripe for growth

CNA April 28, 2013, 12:03 am TWNTAIPEI--Taiwan's biotechnology will continue to expand, in terms of both investment and business turnover, as the global market grows, the Ministry of Economic Affairs said yesterday. Investment in Taiwan's biotechnology sector rose 18.66 percent year-on-year in 2012 to NT$39.53 billion (US$1.34 billion), and sales rose 6.1 percent to NT$255 billion, the ministry said. The upward trend will continue, the ministry said, in line with a forecast by Datamonitor that the global biotechnology market will continue to expand at a significant pace. The forecast expected the global biotechnology market's turnover to reach US$288.2 billion in 2013, up 10 percent from the previous year. In 2014, the global market will likely grow another 10.5 percent, according to the projection. The ministry said it would continue to solicit both local and foreign investment in Taiwan's biotechnology sector, and it expected sales to hit NT$350 billion in 2015 and NT$500 billion in 2020, respectively.

生醫產業 打通任督二脈

 工商時報 杜蕙蓉 20130531 05:39生醫產業在台大陳培哲、陳定信肝病研究團隊與嬌生藥廠策略聯盟,啟動新藥合作開發機制後,此早期新藥開發即獲國際藥廠青睞的合作案,算是打通產業的任督二脈!業界認為,配合CRO、臨床、生產和新藥上市,台灣藥廠已陸續和國際藥廠接軌,初步架構完整的生醫產業供應鏈。除了最上游已有嬌生與台大合作、SIC找案源標的外,醣聯在動物實驗中的大腸癌新藥即以2億美元授權日本大塚藥廠。最強的CRO臨床部分,2007Parexel就以每股高達85元價格收購國際精鼎(更名為百瑞精鼎),2年前美商QPS也併購健亞生技轉投資的華鼎生技。今年57生技醫藥國家型科技計畫(NRPB)也與葛蘭素史克(GSK)藥廠簽訂CRO臨床合作意向書,在鞏固台灣亞太臨床研發中心的領導地位中,預計將掀起昆泰(全球最大CRO公司)、輝瑞、諾華等國際大藥廠來台合作。另外,在人體臨床部分,杏國近日入股德國MG藥廠,主導新藥全球三期臨床主導,也被認為指標意義濃厚。生產技術部分,我國已成為PIC/S會員國,吸引國際藥廠來台合作。東洋集團董事長林榮錦認為,生產也必須創造技術門檻,例如東洋的微脂體生產技術,已獲原藥廠肯定,為了掌握自己的關鍵技術,該集團為國際藥廠代工的條件都簽有2千萬美元的賠償條款,也就是如果國際藥廠要轉單,就必須支付2千萬美元的權利金。林榮錦認為,新藥必須全球化,而全球化須挑戰「黃金療法」,搶攻35%專利數據的利潤才能創造契機。國內藥廠陸續有新藥進入三期臨床,若掌握了關鍵技術,加上有產業供應鏈的整合,台灣的生醫產業能量是相當被看好的。

 

藥華蛋白質廠TFDA認證; 長效型干擾素P1101/ EMA FDA phaseIII

藥華醫藥攜手凱基證 進入資本市場!旗下新藥年底歐美3期臨床 鉅亨網記者張旭宏 台北2013-05-29 17:05:12 蛋白質新藥大廠藥華醫藥宣布攜手凱基證券,簽約上市櫃輔導契約,預計今年底前登錄興櫃,明年申請股票上市櫃,旗下P1101將再年底前同步遞件申請歐洲及美國的3期臨床成為國內唯一擁有兩地3期臨床新藥。藥華成立於2003年成立,為旅美生技專家林國鐘所創立,大股東包括國發基金、經濟部耀華玻璃、中鋼、宏亞食品家族、閎泰投資等。另外,光寶科技董事長宋恭源也看好該公司新藥發展,日前也以個人名義投資,持股5%以下。藥華醫藥總經理林國鐘表示,藥華醫藥自創立迄今已開發出一系列長效蛋白質藥,其中長效型干擾素P1101是進展最快的新藥,長效型干擾素P1101,從選題目、動物實驗、專利申請、IND申請、1期臨床及2期臨床等,都是自行獨立完成的,與其他業者向外取得授權-開發-再向外授權的營運模式並不相同。藥華醫藥成立之初,就以Amgen等國際大廠為師, 因此希望台灣也能夠從頭到尾自行開發出新藥,由台灣團隊主導、用台灣人的資金投入研發,真正做到運用台灣資源進行生技藥品的發展,其研發成果,吸引奧地利AOP 的目光,雙方在2009年簽訂授權合約,將P1101由原本以慢性肝炎為適應症的研發主軸,擴及血液疾病的適應症,P1101也在2011年及2012年分別獲得歐洲EMA及美國FDA的孤兒藥認證(Orphan Drug Designation),並享有當地市場為期分別達10年及7年的獨賣權。林國鐘表示,P1101以專利長效型高分子鏈結法,提有效成份的純度,目前在2期臨床實驗數據顯示,受試者兩週注射1次癒程,副作用降低但藥效良好,今年年底即將啟動3期臨床作業,包括在歐洲及美國同步進行血液疾病的試驗作業,及在台灣進行慢性肝炎的試驗,藥華期盼在血液疾病、慢性肝炎及皮膚病等適應症上,推出更有效的治療方案。藥華醫藥除了開發藥品外,所投資3億元設置的台中蛋白質廠已獲得台灣衛生署認證,是首座由國人自行打造、符合歐盟法規的蛋白質藥廠,未來所開發的P1101新藥,其原料藥來源都將由台中廠進行生產,並銷售全球。林國鐘強調,根據Phrma2013年的資料,每一支FDA核准的新藥,平均需要進行10年以上的開發期,總投入金額超過10億美金,但眾多的新藥研發案件中,真正成功上市的機會只有1/10000,惟藥品開發成功後,則能夠享受鉅大的市場銷售商機,因此吸引許多藥廠持續投入。

東生華落脂膜衣錠 獲健保價

東生華 營運越來越看好 工商時報 記者杜蕙蓉/台北報導 20130603 05:40 東生華(8432)改良劑型降血脂藥落脂膜衣錠已通過健保局內部核定,法人預估最快6月上旬可望取得健保藥價,第3季起營收將重回成長軌道,而明年的成長力道頗有想像空間。法人表示,一般新藥銷售約在拿到健保核價後的第2年或第3年達到銷售高峰,上市第2年成長幅度約300%,第3年約50100%,以降血脂藥國內市場規模約8億來看,落脂膜衣錠若能搶占30%市場,其可貢獻的營收將達2.4億元。東生華為利基學名藥廠,善於利用組合、長效及緩釋技術,提高學名藥的價值。技轉來自於居正和健亞開發的落脂膜衣錠,是將既有兩組單方搭配而成的新複方藥,除降低慢性病患的藥品服用顆數外,也可能有效節省健保支出,成為該產品的重點訴求。東生華今年因少了代理亞培的產品收入,導致第1季在營收衰退逾一成下,稅後盈餘3,310萬元,年減28%,每股稅後盈餘0.95元。

Five Promising Cancer Drug Results

1.Pazopanib, a GlaxoSmithKline pill approved for kidney cancer, showed positive results in a study of 940 women who had disease that had not gotten worse after five or more rounds of chemotherapy. The median time to disease worsening was 17.9 months in the pazopanib group versus 12.3 months for placebo. Carol Aghajanian, an gynecologic oncologist commenting for ASCO, said that the results were positive and indicated that drugs that work by starving tumors of blood, as pazopanib does, could play a key role in treating ovarian cancer. Roche's Avastin, which works similarly, has also shown positive results in ovarian cancer.

2.Are two drugs that stimulate the immune system to attack cancer better than one? Wall Street is focused on this question with regard to Bristol-Myers Squibb's Yervoy and its experimental drug targeting PD-1. But a study showed adding Leukine, or GM-CSF, to Yervoy boosted its effectiveness, allowing patients to live a median 17.5 months compared to 12.7 months for those who got Yervoy alone. There also seemed to be fewer side effects. Both drugs are available now, said Lynn Schuchter, an ASCO spokeswoman and melanoma expert, but its not clear whether this small (245 patients) study will be enough to moving the combo to everyday use. Regardless, it bodes well for the strategy of combining immunotherapies.

3.Results of Bristol's anti-PD-1 drug, nivolumab, were also presented, showing a median survival of 16.8 months in a single-arm study. That's as good or better as any previous melanoma drug. Thirty-one percent of patients saw tumors shrink (41% of those at the dose that will be used in further trials) and the response can keep working even after the drug was stopped. Seventeen of 33 patients stopped treatment, and 12 of them continued responding to the drug for four months or more. This continues to support the benefit of this experimental medicine. Merck and Roche are developing competitors.

4.Selumetinib, from Array Biopharma and AstraZeneca,also showed positive results. Results from a late-stage study showed that in uveal melanoma (that's melanoma of the eye) patients were likely to see their tumors shrink on this new drug, but not on the older melanoma treatment temozolomide. It took 15.9 weeks for their disease to worse, versus 7 for the older drug.

5."I think the study in uveal melanoma will ultimately be practice changing," said Schucter. "This has been a very difficult disease to treat." 6.Another study, funded by the German Merck KgaA (not to be confused with the U.S. drugmaker) compared Eli Lilly's Erbitux and Roche's Avastin as treatments for metastatic colorectal cancer that does not have a mutation in the gene KRAS. (That mutation is used to select drugs for treatment.) This was on top of a slightly different chemotherapy regimen than the one used in the U.S Erbitux made tumors shrink more; there was no difference in how long it took the cancer to worsen or tumors to grow. But the patients who received Erbitux lived 23% longer. The study's author, Volker Heinemann of the University of Munich, suggested that this might mean that patients and doctors should be more likely to use Erbitux. Richard M. Goldberg, an gastrointestinal cancer expert and ASCO spokesman, disagreed somewhat. "Patients have options. There's no clear winner from my perspective from this," he said.

SI2C公佈營運方向/ 新藥醫材投資標的

台生醫廠 接連走向國際 工商時報 記者杜蕙蓉/台北報導 20130531 05:39生醫產業與國際接軌漸具雛型,繼東洋、杏國、永昕都陸續和國際藥廠展開合作計劃外,友霖、因華研發中的新劑型新藥具有授權相,鑽石基金則啟動投資案,SIC則將於1314日公佈營運方向和遴選新藥和醫材投資標的。另外,除了國內藥廠吸引全球大藥廠的策略聯盟外,國內外藥廠也有基於國內資本市場活絡,有意來台掛牌或投資。目前除了哈佛大學精神科權威蔡果荃回台創立心悅生醫,並吸引健亞、富邦、國碩、中鋼等公司投資,心悅搶進精神分裂用藥「SR-01」亦可望通過美國食品藥物管理局(FDA)認證為孤兒藥;原本預計來台掛牌的Epitomics(宜佰有康)公司後以1.7億美元被美國Abcam公司收購後,創辦人余國良也結合本土資金成立新藥公司來台上市。至於本土廠商部分,友霖研發的抑制口水症新藥OP014,進入美國FDA二期臨床第一階段效果頗佳後,亦可望吸引國際藥廠爭取海外授權,而因華研發治療癌症的新劑型新藥D07001,也因是由針劑改為口服,在方便生下,吸引國際藥廠有意授權,成為國內藥廠第二波授權選秀新星。另外,在看準國內生醫產業能量,日前才因技轉中研院包醣蛋白、醣晶片等系列產品專利成立醣基生醫聲名大噪的鑽石基金,也已啟動投資計劃。鑽石基金規模達40億元,是由中天、台新、富邦和潤泰集團合資成立,該基金已分別在海外內相中投資標的。

研華智能 台北榮民總醫院、國軍花蓮總醫院、基隆長庚合作

研華智能再深化醫療領域,添3合作案例 精實新聞 2013-05-31 18:22:20 記者 楊舒晴 報導研華(2395)持續推動智能地球策略,今年將公司組織改為3大事業體,其中,研華智能為提供智能服務解決方案業者,而研華智能持續深化醫療領域,近期又完成與台北榮民總醫院、國軍花蓮總醫院、基隆長庚紀念醫院的合作,在醫院合作案再添3例。研華從今年起將公司組織調整為3大事業體,包含服務自動化系統整合商的AASECO、服務設備製造商的Embedded Design-in、智能服務解決方案業者的iService(研華智能)等。繼研華智能於上月才打入花蓮門諾醫院及國軍花蓮醫院體系後,研華智能5月再添3個合作案例,包含台北榮民總醫院的看診進度查詢APP、國軍花蓮總醫院的自助醫療資訊導覽機、基隆長庚紀念醫院的數位看板公播系統等。 研華智能指出,根據資策會預測2015年台灣智慧型手機普及率將達60-70%,平板裝置預期達 30%,未來個人行動裝置前景服務商機無限,因此透過研華智能與台北榮總合作的APP,病患可藉此查詢所需的各項資訊,也快速地讓病患或家屬了解醫院狀況。研華智能指出,國軍花蓮總醫院合作案部分,主要是於醫院大廳提供就診民眾新型態i-service「自助醫療資訊導覽機」,民眾可直接進行自助掛號並獲得多媒體醫療資訊,也是醫院宣傳品牌形象最佳工具;基隆長庚醫院則是全院架設超過30ARK-DS520多媒體播放主機,提供各診叫號進度、衛教影片,院內跑馬燈快報等資訊給等候民眾,方便病患在全院掌握看診進度,使全院資訊更流通。

Bristol-Myers' immunotherapy drug nivolumab takes center stage at ASCO

June 1, 2013 | By John Carroll CHICAGO--Bristol-Myers Squibb ($BMY) arrived at ASCO with one of the most closely watched experimental immunotherapy drugs in the pipeline. And racing against some major league rivals, the biopharma company will leave with its frontrunner reputation for nivolumab intact.Nivolumab's claim to fame as a breakthrough melanoma therapy was enhanced by long-term results from their Phase I study, which show that the PD-1 drug demonstrated durable responses among a significant group of patients with Stage 4 melanoma. Close to a third of the patients in the study experienced tumor shrinkage, compared to a historical trend rate of 5% to 10% for Yervoy, Bristol-Myers' pioneering immunotherapy for this disease.Researcher Mario Sznol spelled out the data on Saturday, highlighting the 33 of 107 patients whose tumors shrank at least 30%. There was a rapid response among 45% of the patients and the median duration of response was two years, says Sznol. The median overall survival for patients was 16.8 months, with the optimal dose being used in subsequent studies hitting an impressive OS rate of 20.3 months. (Yervoy manages about half of that rate.) There was no comparison arm in the Phase I study, but Sznol noted that OS rates clearly exceeded anything seen in newly approved melanoma therapies.

 

 

 

 

科技農夫打擊傳統農夫!!! 鴻海/ 英業達: 植物工廠

植物工廠有錢景?專家憂 高耗能 中國時報 羅浚濱/竹縣報導 20130601 05:39科技和農業結合的植物工廠,有四季生產及不受天候影響的優點,讓學術界樂觀認為是台灣農業未來的發展趨勢,但農業界對此高度質疑,認為高耗能的植物工廠不可盲目擴張,避免重蹈水耕蔬菜全軍覆沒的情形。國內已有鴻海、英業達等科技大廠,在廠區改裝植物工廠(見圖,羅浚濱攝),主要是因應未來每個國家若排放過量二氧化碳,要依《京都議定書》向其他國家購買碳匯權所設,也有製造LED等科技廠投入植物工廠,以水耕方式生產作物,「錢」景似乎看好。「植物工廠是美國太空總署NASA,為太空人在太空站缺乏蔬菜食用,研究出來的!」竹北市農會總幹事陳楷棟說,植物工廠適合在缺乏土地及植物的環境設置,他認為台灣生產蔬菜的農地不缺,並不適合推廣植物工廠。新竹縣政府農業處長范國銓說,台灣在八十年代曾推動溫室水耕蔬菜,沒幾年全軍覆沒,除易含有硝酸鹽及口感不佳問題外,液體肥料循環使用,若有細菌、真菌及病害,很快全部感染,水耕蔬菜技術尚有未能克服的問題。雖然科技業者聲稱水耕技術沒有問題,但范國銓強調農業是不可控制,要遵循自然法則,蔬果經由光合作用並安全用藥,吃起來才有口感,可控制就不是農業。近來,不少從事植物工廠的業者,在媒體報導時均稱生產的是健康的有機蔬菜,但在農業專家眼中,這種非有機的水耕蔬菜,算是「一眼貨」!更重要的是,植物工廠投資動輒上億元,使用人工光源及空調更是耗費能源,以新豐鄉現有百坪大的植物工廠而言,每個月電費就要十二萬元,不是傳統農民所能負擔。陳楷棟說,植物工廠屬高耗能產業,牽涉國家能源分配問題,如果政府政策支持,「科技農夫」將打擊傳統農夫,將是台灣農業的大災難!

長青藥局 布局中國通路 (復興藥業&中國醫藥集團) !!!

長青藥局攻減重 兩岸並進 【經濟日報╱記者宋健生/台中報導】 2013.05.31 06:16 am 國內最大連鎖藥局通路「長青藥局」積極轉型跨足減重市場,總經理黃維德昨(30)日宣布,旗下祐慈減重診所預計三年內要在全台開出20家據點,長青並訂出2015年登錄興櫃,2016年申請上市櫃。長青也瞄準中國大陸一年人民幣500億元(約新台幣2,447億元)減重市場的商機,預計明年在北京廣安門醫院開設減重門診,相關減重保健產品也將在大陸主要藥房通路上架販售,預計三年後大陸年營收可達人民幣3億至5億元。 黃維德表示,目前國內藥局通路市場一年規模約1,200億元,減重市場商機有600億元。他指出,屈臣氏、康是美等大型連鎖藥妝店通路,嚴重壓縮傳統藥局發展空間,長青推動轉型,希望開發出新的藍海市場。總部設在台北的長青藥局,目前在全台擁有185家連鎖藥局,其中五家為直營店、去年營收8,000多萬元;其餘為加盟店,全年整體供貨金額逾6億元。另外,集團還有三家祐慈減重診所,其中二家是與醫院合作,一家為獨立診所,年營收逾3,000萬元。 黃維德指出,長青在2008年和中山醫院合作開立祐慈診所,並與工研院資通所合作開發「減重管理健康數位平台」,標榜採用漢方保健品來調整體質,和其他減重診所有所區隔,並計劃三年全台目標要開20家診所。 黃維德表示,祐慈減重診所已建立10種減重體系、100種症狀的龐大資料庫,透過專業醫師、藥師及營養師,可以在最短時間內判斷消費者的減重曲線,以及提供適宜的減重方法,這也是祐慈最大的競爭利基。 長青未來並計劃聯合其他通路品牌、共600家藥局通路,建立「台灣健康大聯盟」,以共同採購、品牌行銷為訴求,聯手主導成熟的獲利通路、掌握藥箋與銷貨系統,和大型藥妝通路品牌一較高下。 在大陸方面,長青已取得大陸保健食品批准證書,可在大陸販售減重產品;也和中國中醫科學院產學合作,進行減重臨床實驗,預計第3季完成臨床實驗後,明年正式在北京廣安門醫院開設減重診所門診。另長青也積極布局大陸藥妝、美容SPA等通路。黃維德說,長青正與大陸復興藥業及中國醫藥集團洽談通路合作。2013/05/31 經濟日報】@

長青總座黃維德求變 拚三次轉型【經濟日報╱記者宋健生/台中報導】 2013.05.31 06:22 am長青連鎖藥局總經理黃維德雖然是藥專畢業,但對市場行銷有一套,懂得引領市場潮流,也不怕改變,連續帶領長青推動三次轉型,進而建立國內最大的連鎖藥局通路,並將進軍資本市場。20年前,嘉南藥專畢業的黃維德和老婆蘇小鳳在板橋市區開了一間不到30的小藥局,夫妻攜手打拚創業。黃維德負責拓展藥局連鎖通路,蘇小鳳則對外行銷。 黃維德表示,長青創業初期,選擇和開藥局的學長結盟,共同推動聯合採購;另外,結盟的藥局招牌也都掛上長青藥局名字,靠著打團體戰模式,迅速建立品牌知名度。但傳統藥局有一個瓶頸,就是只賣藥品與部分保健食品,營業額無法衝高。 黃維德發現問題所在後,將婦女、嬰兒用品導入藥局,讓藥局更「貼近」消費者的日常生活。尤其長青以嬰兒奶粉為主力,徹底改變嬰兒奶粉的通路業態,受到女性消費者歡迎,也讓營運規模得以迅速擴大。為發展商品配送服務,長青在土城成立聯源物流倉儲中心,加速發展連鎖系統。 長青藥局第二次轉型是面對全民健保上路、醫藥分業後,由於藥局不能開立處方藥,民眾大小病都往醫院跑,造成長青營業額下滑。 黃維德後來決定發展生技事業,自行研發營養保健食品,結合藥師、營養師的專業背景,並選擇GMP藥廠代工生產,再次走出新道路。近幾年國內連鎖藥局又面臨洗牌壓力。為另尋藍海,長青決定推動第三次轉型,跨足減重市場,開設祐慈減重診所。黃維德強調,祐慈採漢方保健品調整體質,和市面上利尿等方式區隔,以提升市場競爭力。【2013/05/31 經濟日報】

晶發半導體: 植物工廠

晶發植物工廠 可客製化 工商時報 魏益權 20130604 05:40「植物工廠」被認為是21世紀解決人口、資源、環境問題的重要途徑,也是未來航太工程、月球和其他星球探索過程中實現食物自給的重要手段。台灣挾LED先進技術發展植物工廠多年,目前已有完整供應鏈成形,包括:LED光源、光譜控制的IC設計、LED成長燈模組廠、農業技術植栽。晶發半導體挾IC設計優勢,推出多段全光譜LED驅動IC,帶領國內學術界二所農業專精科技大學共同研發植物照明技術、並與產業界「智慧節能科技公司」的農植物技術做結合,將LED燈照明功能應用推向嶄新的旅程。其中關鍵技術是由晶發半導體研發適合植物行光合作用的電源控制晶片,並促進農植物快速生長茂盛。該產品採用生產光譜範圍較大光源,並以多種光源組合,智慧調控,滿足多種植物同時需求。晶發LED植物燈為室內專用,DIY植物景觀組合,也可為客戶量身打造的客製化植物工廠。其中內建六種植物生長模式,24小時自動定時循環操作;並搭配選擇的特殊波長,可幫助植物快速成長,適合大小綠色葉菜、紅色葉菜、水耕、根莖類植物,輕鬆選擇控制器的設定。

克麗緹娜 (實體通路) 與克緹 (直銷) 不同商業模式

克麗緹娜 站穩大陸、搶灘越泰 【經濟日報╱記者何蕙安、林茂仁/台北報導】 2013.06.03 02:25 am 克麗緹娜董事長陳碧華1997年正式接班帶領公司進入上海市場,目前在大陸擁3,000多家美容院。她成功撐起家族事業,靠的是父親、克緹總裁陳武剛的信任與傳承。以台灣為起點,在大陸茁壯的克麗緹娜,逐步放眼全球。克麗緹娜董事長陳碧華表示,明年將先進入東南亞市場,首波瞄準泰國與越南,正培訓人才。外界對於「克麗緹娜」與「克緹」的業務異同仍有些混淆。陳碧華解釋,克麗緹娜來自克緹,如今各自獨立、擁有不同商業模式。克緹以產品與直銷通路為主,而克麗緹娜除產品外,主要利潤來自美容護膚服務,著重於實體通路的經營。「不管是店銷,還是直銷,只要管道暢通,就是贏家。」陳碧華強調,重點在通路,只要能把研發生產的產品送到消費者手上,什麼通路她都願意嘗試。 在品牌打出知名度前,她也曾嘗試在百貨商場設專櫃,但很快就認知到這並非最適合的做法。為了避免未來與歐美品牌設櫃競爭,陳碧華於是果決撤櫃,努力開發新的連鎖據點。憑藉著台灣同文同種的優勢,與親切專業的服務,克麗緹娜迅速地打入大陸市場。陳碧華自承不做金字塔頂端客層,而是定位在社區型,強調「美麗沒有距離與壓力」,希望客戶只要有問題,就可到家附近的美容院諮詢,讓「進到店裡」變成很自然的一件事。對克麗緹娜來說,一家美容院平均要有300個會員,才算成功據點。若以3,000家通路計算,已有近百萬會員。克麗緹娜基本的10堂護膚課程約人民幣5,000元(約新台幣2.4萬元)。儘管在對岸市場取得成功,在大陸的工廠與培訓學院也頗具規模,但陳碧華有感於台灣對人文的關懷與重視,一些創新概念還是希望能從家鄉做起。例如克麗緹娜的第一個綠色工廠,就打算建在新竹牛埔。目前她也著手台灣100多間門店的改造,強調從店招牌到美容師的形象將全部調整,「今年很快就會看到我們全新的樣貌。」

接棒總座 陳碧華:遺傳到挑戰DNA1997年,37歲的陳碧華正式繼承父業,帶領克麗緹娜進入上海市場。從「女兒」到「員工」,她的心情有了微妙變化。到上海前,陳碧華陪著孩子在新加坡念書,同時懷著創業心一邊從事股票與房地產投資。五年自由的星國生活直到1997年香港回歸,她感受到大陸經濟將一躍而起,判斷大有可為。陳碧華還記得初見上海像個大工地的剎那,內心的興奮與雀躍。儘管整個浦東是一望無際的大農田,但她覺得充滿希望。一直是克緹總裁陳武剛最疼的大女兒,陳碧華原本想在上海繼續投資股票與房地產,卻意外接到父親的一紙「任命書」。陳武剛正在找人開拓大陸市場,遷徙到上海的女兒順勢成為最佳人選。「(當初接下任命)不是因為我有經驗或書念得多,是這個充滿機會與挑戰的市場吸引我。」回想當時,陳碧華直說毫無準備,但或許是遺傳自陳武剛那勇於挑戰的DNA,她毅然決然出任克麗緹娜總經理一職。在十多年前大陸美容行業仍不成熟之際切入市場,克麗緹娜迅速做大做強,曾以每月新增百家美容院的高速擴張,如今通路遍及大陸31個省市,包括西藏、新疆,擁有3,000多家連鎖加盟據點,培訓過逾20萬名美容師。「以前不知道苦,現在回頭看,覺得蠻辛苦的。」她回顧這十多年的闖蕩,曾經面對公司高度成長,有極大焦慮。她明白無序的增長對品牌沒有加分,2006年開始管控,每年關掉或重整數百家美容院,讓門店隨著城市發展的步伐升級2011年底,克麗緹娜取得中國馳名商標,穩坐美容第一品牌。「我一直覺得自己工作的想法是自由的,決策也是自由的。」在父親的光環下,陳碧華自認受到完全信任,總能放手一搏。但仔細想想,或許父親早已給她一個無形的框框。陳碧華說,父親交給她「兩個重要原則」。首先,不要亂槍打鳥。大陸很大,經營一個地方就已經很了不起,如果浙江沒做好就不要去東北。第二是:要發揮漣漪效應。先鞏固好華東地區,再將影響力延伸到華南與華北,接著再擴散到西南、東北。陳碧華記得1999年第一家上海淮海路旗艦店開張,裝潢採用了很新潮的洞石設計,陳武剛看了滿臉懷疑。結果他一屁股坐下,沾了滿身灰,淡淡地丟了一句,「如果不容易複製,加盟店就不會成功。」「還是要聽老人家的話,這次父親又對了。」陳碧華回憶。陳碧華將與父親的關係的變化定位為「從女兒變小李子」。曾經有些蠻橫任性的她,隨著進入父親打造的企業王國,有機會從另外一個角度觀察父親,進而崇拜、尊敬他。陳武剛很忙,陳碧華只能利用清晨6點左右的空檔跟父親討論事業上遇到的問題。陳武剛喜歡透過逛菜市場了解大陸民眾的生活水平變化,她就幫父親提包包,跟著觀察。「父親給我很多機會,讓我可以用不同的方式看這個世界,豐富我的生命。」坐在克緹大樓內,迎著灑下的日光,陳碧華受訪時感恩地說。 克麗緹娜董事長陳碧華1997年正式接班帶領公司進入上海市場,目前在大陸擁3,000多家美容院。她成功撐起家族事業,靠的是父親、克緹總裁陳武剛的信任與傳承。 / 克麗緹娜/提供/ 2013/06/03 經濟日報】@

飛捷 醫療 中電集團合作!

飛捷 衝刺醫療應用【經濟日報╱記者王皓正/台北報導】 2013.06.01 05:11 am 工業電腦廠飛捷(6206)昨(31)日表示,第2季整體營運狀況優於首季;另外,看好醫療應用所擁有的龐大商機,飛捷也成立新的事業群專責發展,全力衝刺醫療應用市場。飛捷首季獲利創歷史新高,本季營運逐月走揚,毛利率也將維持高檔表現,後市展望持續樂觀。飛捷表示,自與大陸中電集團合作之後,飛捷首季大陸業績效益顯現,隨著布局效益放大,今年大陸占比也將提升。法人估計,飛捷今年總營收將突破40億元,大陸約將貢獻1.2億元。 2013/06/01 經濟日報】@

檢測基因!! 是計謀?

乳癌檢測基因熱 生技公司計謀? 【聯合晚報╱記者李樹人/台北報導】 2013.06.03 02:48 pm母親死於卵巢癌,好萊塢女星安潔莉娜裘莉得知自己也有BRCA1突變基因後,因為擔心罹患乳癌、卵巢癌的機率高,接受預防性切除手術。消息一出轟動全球,但後來有部分網友流傳,這可能是生技公司的計謀,為的是背後的龐大商機,且傳出後來的商業動機論是從台灣傳出。外電報導裘莉預防性切除雙乳新聞後,引發媒體大篇幅刊登,也引起不少女性關注。國內一家研發遺傳性乳癌基因晶片檢測的生技公司,更是詢問電話不斷,不少乳癌高危險群女性,想花錢檢測基因。但裘莉切除雙乳的消息曝光沒幾天,就有網友認為可能是假新聞,甚至懷疑是台灣業者發動。但業者自清指出,美國只有一家公司提供該項服務,且該家公司早已申請專利保護,在亞太地區並無代理。國內生技業者推出的遺傳性乳癌基因晶片檢測,是國內自行開發。 國建局統計顯示,家族內如有四人或四人以上成員在60歲以前罹患乳癌,則該家族女性八成機率有此基因突變。 國健局癌症防治組長吳建遠指出,大部分的乳癌和卵巢癌是偶發的,目前仍不清楚致病原因,因此女性不需過度緊張去做這項自費篩檢。至於有高危險家族史者,基因檢測確實可作為預測乳癌或卵巢癌罹患的重要參考。【2013/06/03 聯合晚報】@

B肝新藥 土撥鼠先試!!

根治B肝有譜! 新藥研發再等10 2013/06/03 18:58 楊依嘉 魏台復 報導地區:台北市報導肝臟是沉默的器官,全台又有240萬的B肝帶原者,現在的醫療技術,只能吃藥壓抑病毒,卻不能把B型肝炎治好,病患得當藥罐子,造成健保負擔。不過台大醫學院臨床研究教授,將用土撥鼠研發新藥,希望可以找出治療B肝的解藥。可愛的土撥鼠,動作跟萌樣,很討喜。不過土撥鼠對我們人類,不只是可愛而已,牠們也負責找出B型肝炎治癒方法。小白鼠跟豬不會感染肝炎,土撥鼠才會,我們會跟配合的幾個藥,看是不是能清除病毒。B型肝炎患者如果病情嚴重,將導致肝硬化,甚至肝癌,目前健保藥費每年花在B肝上,高達20億,如果這個實驗順利,能把土撥鼠身上的病毒清除,可望治好B型肝炎,也減輕健保負擔。不過專家評估,新藥研發還須要10年,進入人體實驗後最快五年,如果可以治好沈默的器官肝臟,就可以減輕全台240萬人的負擔。

 

 

陳培哲…B肝NCE (台大/嬌生投資2億元)

台大嬌生 合攻B肝用藥【經濟日報╱記者黃文奇/台北報導】 2013.06.04 02:25 am國際生技大廠嬌生與國內生技業擴大深度合作。台大醫院、嬌生昨(3)日共同宣布,將合作開發B肝用藥,由嬌生在台子公司楊森投資2億元,共同在未來三年內,推動B肝新藥進入人體臨床試驗;國內製劑廠東洋也宣布,正式接獲嬌生抗癌針劑訂單,出貨量逐年看增。 關於與台大的合作,嬌生表示,將合作開發B肝新藥,由台大負責動物試驗等臨床前開發,以及後續在台臨床試驗程序。主導該藥品開發的台灣大學臨床研究所教授陳培哲表示,該藥品最快三年內可找到候選藥物,八年內可望問世 據悉,嬌生與台大合作開發的B肝新藥,目前仍為嶄新化合物階段,未來將有機會開發成小分子藥物、單株抗體,以及治療性疫苗等藥物型態,若新藥開發成功,未來不排除結合台廠在台生產。 業界表示,若是小分子藥物,在台製劑廠包括生達、永信、東洋等,符合國際醫藥稽核查廠標準(PICs GMP)製造標準的藥廠都能受惠,若是單株抗體等型態的蛋白質藥物,國內藥華、永昕、台康等蛋白質藥廠,可望參與。 東洋昨日也宣布,正式接獲嬌生訂單,雙方將合作生產重量級抗癌藥品DoxilCaelyx;東洋表示,該合作計畫經過一年的磨合期,終獲合作廠商下單,切入嬌生供應鏈。【2013/06/04 經濟日報】@

東洋微脂體劑型8億元擴廠 打入 國際抗癌供應鏈

攜手嬌生 東洋抗癌藥9月出貨 20130604 【姚惠珍╱台北報導】台灣東洋(4105)昨公告與國際大廠嬌生的抗癌微脂體藥品Doxil/Caelyx合作生產案,拍板定案,預訂9月開始出貨。 法人指出,該項藥品包含原廠藥及學名藥針劑,需求1年上看80萬劑,今年出貨量有機會上看20萬劑,未來可望取得6成市場,出貨量上看50萬劑,貢獻未來營運成長。 根據東洋指出,Doxil/Caelyx因採特殊的微脂體包覆劑型,在製程設計上及臨床實驗執行上具有相當難度,加上生產過程中,必須掌握高階的量產及化學穩定度技術,才能通過在藥物傳輸系統上的藥物動力學審查。

2年砸8億建產線 全世界有能力跨入該領域的藥廠微乎其微,這也是為何該藥品有3項適應症雖已過專利保護期,卻鮮有藥廠能推出學名藥與原廠競爭。 東洋為搶進抗癌微脂體藥品Doxil/Caelyx市場,近2年投入8億元,於中壢廠及六堵廠興建新產線。其中,中壢廠未來主要生產Doxil/Caelyx,初估今年將可出20萬劑,對東洋每股稅後純益(Earnings Per ShareEPS)貢獻度逾0.5元。 Doxil/Caelyx原為嬌生大藥廠的專利藥品,1995年開始上市,主要使用者包括愛滋病引起的卡波西氏肉瘤(AIDS RELATED KAPOSI'S SARCOMA)病人、有心臟疾病風險的轉移性乳癌患者、接受過至少1種治療方式且已接受骨髓移植的進展性多發性骨髓瘤病人,以及曾接受第一線含PLATINUMPACLITAXEL化學治療而失敗者或復發的轉移性卵巢癌病人。

創舉!! 東洋微脂體劑型PIC/s GMP 打入 國際抗癌供應鏈

台灣東洋獲日藥廠訂單【聯合晚報╱記者徐睦鈞/即時報導】 2013.06.04 06:54 am台灣東洋製藥 (4105) (3)宣布,正式接獲國際知名醫藥大廠訂單,與其合作生產重量級抗癌藥品Doxil/Caelyx。此合作計畫業經一年磨合,終獲令人欣慰的成果,也讓台灣東洋多年來致力於特殊藥品劑型的研發,得到歐美先進製藥國家的肯定,並順利切入國際重量級抗癌藥物的供應鏈,此一合作案將持續多年,訂購量亦將逐年遞增。 Doxil/Caelyx原為嬌生大藥廠的專利藥品,1995年開始上市,主要適應症有:一、用於治療因愛滋病引起的卡波西氏肉瘤 (AIDS RELATED KAPOSI'S SARCOMA)病人。二、用於單一治療有心臟疾病風險考量之轉移性乳癌患者。三、用於治療曾接受過至少一種治療方式且已經接受或不適宜接受骨髓移植的進展性多發性骨髓瘤病人。四、用於治療曾接受第一線含PLATINUMPACLITAXEL化學治療而失敗者或再復發之進行性或轉移性卵巢癌病人。 Doxil/Caelyx因為採用特殊的微脂體包覆劑型,在製程設計上及臨床實驗執行上具相當難度,加上生產過程中必須掌握高階的量產及化學穩定度技術,才能通過在藥物傳輸系統上的藥物動力學 (PK)審查,因此全世界有能力跨入該領域的藥廠微乎其微。其中該藥品的前三項適應症雖已過專利保護期,卻鮮有藥廠能正式推出學名藥與之競爭,其原因即在於上述。 2011年嬌生因為原合作廠商Ben Venue laboratories Inc.公司 (隸屬德國大廠Boehringer Ingelheim,生產基地位於美國俄亥俄州貝德福德地區 (Bedford,Ohio, factory)),在為其生產Doxil/Caelyx藥物過程中,發生產程汙染問題,並發生多起藥品嚴重不良事件 (SAE),導致美國總統歐巴馬下令調查,國會並為此舉行聽證會;該廠最終被迫停產,並迫使嬌生公司對外尋求解決方案及其他長期合作夥伴。 台灣東洋多年來致力發展微脂體技術 (Liposomal Technology)及微球體技術 (Microsphere Technology)等高障礙藥物的開發。除了擁有自己的製劑研發中心、針劑試製廠與癌症轉譯中心之外,其生產設施更是台灣第一家通過歐洲官方PIC/s GMP認證之癌症全品項認證藥廠。近兩年業已投入8億台幣用於其中壢廠及六堵廠的新生產線建置,持續擴充產能以滿足未來市場需求。 由於要通過歐盟EMEA及美國FDA的生產認證之難度與成本均相當高,加上微脂體劑型藥物在技術上的高障礙性,台灣東洋中壢廠將成為全球重要抗癌藥品Doxil/Caelyx的全球主要供應商。【2013/06/04 聯合晚報】

 

 

智擎 發行普通股 停止生效

智擎生技申報發行普通股案停止生效【經濟日報╱記者邱金蘭/即時報導】 2013.06.03 06:33 pm金管會今天下午表示,智擎生技製藥公司申報發行普通股案,停止生效。 金管會表示,智擎生技製藥公司(上櫃公司,4162申報發行普通股800萬股,每股面額新台幣10元,共計8,000萬元案,因公司有申報書件應記載事項不充分情事,經金管會依「發行人募集與發行有價證券處理準則」第15條第1款規定,自即日(10263日)起停止申報生效。【2013/06/03 經濟日報】@

1年產業博士後訓練 拼政績!!

海外博士級人才 可加入生技訓儲菁英行列 (中央社訊息服務20130530 14:27:49)台灣行政院科技會報辦公室為培訓生技產業所需人才進而促進產業發展,推動「生技高階人才培訓與就業計畫」,預計33億元培訓與輔導300名博士級人才,投入生技產業參與研發、專利智財、以及生醫相關行銷管理等工作。過去,台灣博士後研究的訓練機會只提供從事學術研究為主,本計畫首次將博士後加值訓練結合產業發展所需。透過台灣法人及學研機構結合廠商及醫學中心的合作計畫,提供加值訓練機會,為台灣生技產業的發展挹注高階創新研發人力資源。是新嘗試,也是學研產業接軌的新作法。海外博士級人才經錄取成為生技訓儲菁英者,培訓單位將給予為期 1年的博士後訓練,並協助投入生技產業職涯發展。培訓領域主要聚焦於藥品、醫療器材、醫療管理等產業相關職能的實戰訓練,並透過培訓單位所邀集的合作廠商或醫學中心,提供至少6個月的產業核心職能實習訓練機會。若屬海外役男者,須依據「歸化我國國籍者及歸國僑民服役辦法」辦理。102年度參與本項計畫的13家培訓單位,按單位筆畫順序排列,有中央研究院、財團法人工業技術研究院、財團法人生技醫療科技政策研究中心、財團法人生物技術開發中心、財團法人金屬工業研究發展中心、財團法人國家實驗研究院、財團法人國家衛生研究院、財團法人醫藥工業技術發展中心、財團法人醫藥品查驗中心、國立成功大學、國立清華大學、國立台灣大學、臺北醫學大學等。將聯合甄選100名博士級生技訓儲菁英進行為期一年的博士後在職訓練(on-the-job training)。凡海內外博士級人才,具備中華民國國籍、教育部認可國內外公私立大學或獨立學院博士學位且有意申請本計畫者,可上網查詢或索取相關資料。(http://phd-ojt.org.tw)。洽詢電話:0800-881-099


大江生醫申請上櫃案通過

 精實新聞 2013-05-29 07:41:32 記者 林詩茵 報導櫃買中心於昨(28)日召開上櫃審議委員會,審議結果同意10票,不同意0票,通過大江生醫(8436)申請上櫃案。大江生醫申請上櫃時資本額2.98億元,董事長為楊武男,推薦證券商富邦證券、第一金證券及凱基證券。該公司2012年度營收為115344萬元,稅前純益為13578萬元,每股盈餘為4.59元;今年第1季營收為31014萬元,稅後純益為3613萬元,每股盈餘為1.21元。

 

癌症基因檢測價昂 健保給付

 記者陳慈暉/洛杉磯報導 June 02, 2013 09:10 AM 近期好萊塢女星安琪琳娜裘莉在媒體,公開自己透過BRCA1BRCA2癌症基因檢測,得知自身為罹患乳癌的高風險族群,並採行預防性雙乳切除術的心路歷程,不僅引發大眾熱議,也引起一般人對是否須透過癌症基因檢測,瞭解自身的罹癌風險,產生好奇與關心。仁愛醫療集團國際癌症中心主任徐義峰表示,BRCA1BRCA2基因是抑癌基因的一種,若BRCA1BRCA2基因產生突變,人體就會產生罹癌風險,但並非所有癌症的罹癌風險,都可透過BRCA1BRCA2癌症基因檢測來分析,目前BRCA1BRCA2的基因檢測主要是針對乳癌,大腸癌的罹癌風險則是透過Familial Adenomatous Polyposis(簡稱FAP)基因檢測。 徐義峰說,經由BRCA1癌症基因檢測,被檢測者若發現基因突變,一生罹患乳癌的最高風險為80%,罹患卵巢癌、子宮頸癌、子宮癌、胰臟癌、大腸癌的風險,比一般人高。BRCA2癌症基因檢測,被檢測者若發現基因突變,一生罹患乳癌的最高風險為40%50%,罹患卵巢癌、胰臟癌、胃癌、膽囊癌的風險,比一般人高。 角聲癌症協會資深主任楊王惠真,本身有兩次罹患乳癌的經歷。她表示,根據醫學研究,乳癌或卵巢癌與BRCA1BRCA2的關聯性,高於家族病史,如果婦女遺傳到突變的BRCA1BRCA2基因,得到乳癌或卵巢癌的機會大增。 因此,楊王惠真完成第二次乳癌治療後,決定進行BRCA1BRCA2癌症基因檢測,並確定本身BRCA1BRCA2基因未突變,才放下可能遺傳給子女的心頭大石。 坊間BRCA基因檢測收費高昂,在3000元至4000元間,而且絕大多數健保都不給付。一般擔心本身罹癌風險的民眾,是否有做相關基因檢測的必要? 徐義峰表示,通常醫師會建議有罹患乳癌高風險的族群,進行BRCA1BRCA2癌症基因檢測。所謂高風險族群,包括家人做BRCA1BRCA2基因檢測,得知有基因突變情形,其兄弟姊妹或子女,就有做基因檢測的必要。同時,家族中有兩個以上成員罹患乳癌,尤其有人是在50歲以前就罹患乳癌,其兄弟姊妹或子女也有必要檢測。 保險經紀林大衛表示,過去一般健保給付大都不涵蓋BRCA檢測,美國政府推動的健保改革法案(Affordable Care Act)於2010323通過後,即要求各健保公司須為罹患乳癌高風險投保人,提供BRCA諮詢門診的福利,近期更具體明文規定,須為罹患乳癌高風險族群保戶,提供免費的BRCA基因檢測。林大衛說,凡2012323以後購買的健保,或是2012323以前所購保單,但於近期進行計畫變更,只要本身為罹患乳癌高風險族群,均可透過健保獲得免費的BRCA基因檢測。 至於透過BRCA基因檢測,發現本身有相關基因突變,想進行預防性乳房切除及重建,林大衛說,只要保戶能提出詳盡報告,證明有施行預防性手術必要,大多數健保也涵蓋預防性手術、乳房重建及住院的給付,但視個人保單內容不同,保戶有其一定的自付額及共付額。
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