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Thursday, June 4, 2015

Microlife(百略) : Atrial Fibrillation心房顫動血壓計專利障礙 免同業混戰!!!

百略殺手級血壓計 出貨飆 2015-06-01 03:36:05 經濟日報 記者高行/台北報導血壓計龍頭百略進入下半年旺季,副董事長許盛信指出,旺季效應將帶動心房顫動血壓計全年出貨年增10%20%,電毯也有10%的成長力道。法人預估,該公司今年總體營收及獲利將呈現雙位數成長,每股稅後純益(EPS)看到6元以上,締造15年來最佳水準。上半年向來是百略淡季,主因指向占公司營收比重四成的血壓計產品,其銷售節奏和3C電子產品一致,另占公司營收比重三成的電毯產品,也因季節因素集中下半年出貨。許盛信表示,隨時序進入第4季電子消費旺季,歐美客戶拉貨潮湧現,下半年在手訂單無虞,訂單能見度看到年底。特別是百略旗下毛利高達50%的心房顫動血壓計,去年首度全球鋪貨創下40萬台佳績,今年下半年追單力道強勁,許盛信預估,今年出貨有望創下4448萬台的新高紀錄,由於毛利較傳統血壓計高出許多,對獲利挹注的效果更為明顯。據了解,百略心房顫動血壓計可有效提示民眾心肌梗塞(中風)風險,全球銷售爆量,近期有國際龍頭大廠緊跟打出「偵測心房顫動」的宣傳招牌,但都被百略以專利權檔住,可說獨家掌握全球市場的銷售權。百略獨門技術在於建立心律規則模型偵測心律不整情況,預警心肌梗塞風險,被市場視為新一代「殺手級」居家檢測產品。占百略營收三成比重的電毯,基於冬季需求,目前客戶開始啟動首波拉貨潮。今年百略主打無電磁波電毯,加上在材質美觀上進一步改良,產品力十足,預計全年出貨將有10%的成長力度;另體溫計產品出貨則持穩。法人表示,在新產品帶動下,百略下半年旺季出貨展望佳,全年營運倒吃甘蔗。

專利心房顫動偵測技術(Afib Detection) Microlife website

什麼是心房顫動,它的成因為何?各種心律不整中,心房顫動〈Atrial Fibrillation,簡稱AF〉是最常見的,同時也與中風最相關,因此臨床上最受重視。正常成年人口中約1-2%有心房顫動(65歲以上約5~7%75歲以上高達10%),年紀愈大發生機會愈高,台灣地區約有二十萬名心房顫動的患者。引起心房顫動的原因很多,常見如高血壓、糖尿病、冠狀動脈疾病、心衰竭、過量酒精、甲狀腺疾病...等,都可能造成心房異常放電,導致心房快速而穩亂地跳動(>400/分鐘),即所謂的「顫動」;而此時心室的跳動(心跳)也會變得很不規則且忽快忽慢。

心房顫動會有什麼症狀?該如何早期發現?心房顫動的病人雖然心房在「顫動」,但心室跳動速度卻可能過慢(<60/分鐘)、正常(60~100/分鐘)、或過快(>100/分鐘)。由於症狀主要取決於心室的跳動狀況,因此當心跳(心室跳動)速度正常時,患者不見得會有症狀,甚至不少人是發生中風時才知道自己有心房顫動。而心跳過慢或過快時,則可能的症狀包括心悸、疲倦、眩暈/昏厥、胸痛/胸悶、或呼吸困難等。 如何早期發現心房顫動(尤其是沒有症狀的病人),是臨床上的重要課題,傳統上是靠醫師診脈進行篩檢,而以心電圖(ECG)來確定診斷。現在,百略科技(Microlife)的創新電子血壓計,則提供民眾另一種便利有效的方式,能隨時自我篩檢是否出現心房顫動。

為什麼心房顫動會引發中風?該如何預防?心房顫動患者發生中風的機會是一般人的5倍,而心血管死亡風險則是兩倍。腦中風是台灣地區十大死因的第三名,台灣每年約有七萬人發生腦中風,其中約有9,500人肇因於心房顫動。心房顫動的病人,其心房進行高速但無效的收縮,因此心房內的血液流動變得不順暢甚至鬱積,而容易產生小血塊(血栓);當這些血栓漂出心臟,隨著血流進入腦部而卡在腦血管內,會造成局部腦細胞缺氧壞死,就是所謂腦梗塞(腦中風)。因心房顫動而引發的腦中風,大部分其實可透過適當治療來加以預防(主要是以抗凝血劑來避免血栓形成),因此早期診斷早期治療是極為重要。

Patent: US 7,680,532/ US 7,020,514/ US 7,706,868     


 

中研院 薛一蘋: Clioquinol 治療自閉症 潛力《自然通訊》

基因研究-鋅離子改善自閉症 動物實驗證明 20150604 04:10 湯雅雯/台北報導 中央研究院分子生物研究所研究員薛一蘋研究團隊去年耗時9年,找到自閉症的關鍵基因,今年進一步證實增進鋅離子可改善自閉症,研究成果日前登上《自然通訊》期刊。薛一蘋表示,根據2011年國際知名期刊《科學報導》中的研究顯示,針對1967名自閉症兒童的頭髮進行分析,證實近3成自閉症兒童有鋅缺乏的情形薛一蘋去年以動物模式證實肺結核藥物「D-環絲胺酸」,可有效治療自閉症小鼠後,昨再度發表抗生素「氯碘奎醇」(Cq),可抓住並載運鋅離子,糾正自閉症的基因缺陷。薛一蘋分析,這2種基因突變小鼠的共同特徵,就是神經細胞訊息傳導接觸後,離子通道(NMDAR)的活性會變差,施用抗生素氯碘奎醇(Cq)可以有效改善小鼠的社交行為缺陷,讓不喜歡接近新朋友的自閉症小鼠回復到野生型,變得喜歡交朋友。由於國內自閉症兒童比率越來越高,但目前自閉症仍無藥可醫,只能仰賴行為治療。薛一蘋表示,這項研究成果為自閉症臨床治療上與「鋅缺乏」的關連,未來提供可能的學理依據。她指出,海鮮類牡蠣與蛋白質高的肉類,都有助於幫助鋅離子吸收,可活化離子通道(NMDAR)活性低落的自閉症患者,但自閉症成因可分為5大類,鋅缺乏患者只占3成。最重要的還是依照病人不同病因對症下藥。

Clioquinol  Use in neurodegenerative diseases (WIKI) Research at UCSF indicates that clioquinol appears to block the genetic action of Huntington's disease in mice and in cell culture. Evidence from phase 2 clinical trials suggested that clioquinol could halt cognitive decline in Alzheimer's disease, possibly owing to its ability to act as a chelator for copper and zinc ions. This led to development of analogs including PBT2 as potential therapeutic compounds for the treatment of Alzheimer's disease. Recent animal studies have shown that clioquinol can reverse the progression of Alzheimer's, Parkinson's and Huntington's diseases. According to Dr. Siegfried Hekimi and colleagues at McGill's Department of Biology, clioquinol acts directly on a protein called Clk-1, often informally called "clock-1," and might slow down the aging process. They theorize that this may explain the apparent ability of the drug to be effective in the above conditions, but warn against individuals experimenting with this drug.

Clioquinol (iodochlorhydroxyquin) is an antifungal drug and antiprotozoal drug. It is neurotoxic in large doses. It is a member of a family of drugs called hydroxyquinolines which inhibit certain enzymes related to DNA replication. The drugs have been found to have activity against both viral and protozoal infections.

 

(PNAS) 基因調控Healthspan(健齡) 更勝lifespan(壽命) : Active Aging樂齡

Altered genes may give longer life but not necessarily healthier one: New Study Monday, 2 February 2015 - In a new study, scientists have suggested that if you alter you genes to have a longer lifespan, it doesn't necessarily mean that it would be a healthier one too. In a new study, scientists have suggested that if you alter you genes to have a longer lifespan, it doesn't necessarily mean that it would be a healthier one too. A study of long-lived mutant C elegans by scientists at the University of Massachusetts Medical School shows that the genetically altered worms spend a greater portion of their life in a frail state and exhibit less activity as they age then typical nematodes. Principal investigator of the study Heidi A Tissenbaum, PhD, said that to find the genes that help people remain physically active during ageing, they may have to look beyond longevity as the sole criteria, and start looking at new genes that might play a part in 'healthspan'. Dr Tissenbaum and colleagues sought to investigate how healthy long-lived C elegans mutants were as they aged. Identifying both frailty and movement as measurable physical attributes that declined in the nematode with age and that could be tested, Ankita Bansal, PhD, , took four different C elegans mutant specimen (daf-2, eat-2, ife-2 and clk-1) known to live longer than typical nematodes and measured their resistance to heat stress, oxidative stress and activity levels on solids and in liquids as they aged. They compared these results with wild-type nematodes they found that all the animals--wild-type and mutants--declined physically as they aged. And depending on the mutant specimen and trait being measured, each declined at different rates. Overall they found that the mutant worms, despite having longer lifespans, spent a greater percentage of their lives at less than 50% of measured maximum function when compared to wild-type nematodes. The increased lifespan experienced by the mutants was spent, instead, in a frail and debilitated state. The results are published in the Proceedings of the National Academy of Sciences.
U.S. Lifespan Surges, 'Healthspan' Not So Much: CDC  Jan 6, 2014 06:12 PM By John Ericson As the average life expectancy continues to rise in developed nations across the globe, Americans are enjoying longer lives than ever, with federal health officials reporting a 0.6-year increase between 2008 and 2009. Experts from the Centers for Disease Control and Prevention (CDC) said on Monday that children born in 2009 can expect to die just shy of their 80th birthday –– 78.7 years, to be exact. In 2008, the figure was 78.1. The positive trend, which has remained steady for the past 50 years, is thought to be the result of better treatment strategies against cardiovascular disease and other global killers."Improvements in heart disease and stroke mortality have had a big impact," Robert Anderson, chief of the Mortality Statistics Branch at the CDC's National Center for Health Statistics, told reporters. "That's a large proportion of total deaths and that's where the action really is in terms of improved life expectancy. That's really what's driving the trend." According to David Katz, director of the Yale University Prevention Research Center, the increase is not limited to a particular demographic set. "To the extent that we all want a bounty of years in life, this report conveys encouraging news," he said, speaking to HealthDay. "Life expectancy at birth in the U.S. is rising for all groups." Better disease control notwithstanding, the gender discrepancy is expected to persist. While the increase is virtually the same for both sexes, men born in 2009 will still die a little earlier than their female counterparts, who can expect to live well into their 80th year. Similar differences were observed across ethnical groups, with data from African-Americans and Hispanics indicating a new life expectancy of 74.5 and 81.2 years respectively.
Good News And Bad News  However, Katz and other experts are quick to point out that a longer life does not necessarily mean a better life. "More importantly, this report is only about years in life, not about life in years," he said. "A long life with a high burden of chronic disease — such as diabetes, heart disease, and chronic obstructive pulmonary disease (COPD) — means more time living with illness and disability." In fact, the rising life expectancy is currently considered the primary factor behind the growing number of dementia cases and other age-related disorders. At the G8 dementia summit in London last December, researchers projected a threefold increase in Alzheimer's diagnoses by 2050, driving the number of patients up from 44 million to 135 million. "It's a global epidemic and it is only getting worse," he said, speaking to BBC News. "If we look into the future the numbers of elderly people will rise dramatically."
Lifespan Vs. Healthspan It follows that life expectancy may no longer be the best indicator of public health. While advancements in medicine and technology may have resulted in an increased overall lifespan, a widespread adherence to exercise, dieting, and other healthy lifestyle elements may be necessary to obtain a comparable increase in "healthspan." "The next chapter in medical advance will need to be as much about lifestyle as medicine if we are to add life to years along with years to life," Katz told reporters.

老爺大酒店+高階健檢/醫美: 台北國際醫旅 (蔡清標: 2年損益平衡/ 許朝程: 觀光醫療 常醫糾)

國際醫旅發展觀光 盼當領頭羊 2015-06-04 08:01:29 聯合報 記者郭逸君/台北報導 台北國際醫旅影像醫學檢查室,配合柔和燈光減低民眾檢查時的壓迫感。 記者郭逸君/台北市議會市政考察昨到台北國際醫旅,北投健康管理醫院院長蔡清標表示,去年底開始營運後,因初期知名度較低,加上受限醫療法不能進行醫療廣告行銷,開發客源不易,每個月高階健康檢查人次尚未達到預期目標。國內首家結合健康管理、醫學美容與飯店的台北國際醫旅,客群鎖定海外華人市場,希望能吸引旅客入住酒店,來台旅遊同時做健檢。蔡清標表示,鄰近的新加坡、韓國等國都積極發展觀光醫療產業,台北國際醫旅希望做領頭羊,振興台灣觀光醫療發展。副院長蔡才灣表示,北投健康管理醫院剛起步,現在平均每月有270人至350人來醫院做健檢,其中15%旅客在健檢外,也會同時住飯店。台北國際醫旅15樓是北投健康管理醫院,612樓為北投老爺大酒店。北投健康管理醫院主打高階健檢,也附設醫學美容,而老爺酒店融合健康元素,餐點皆健康取向。蔡清標分析,全球觀光醫療產業都在急速發展,台灣醫療水平高,但因醫療廣告受到限制,主管機關缺乏有效引導觀光醫療產業發展,影響多數業者投入觀光醫療產業的意願,但他對北投健康管理醫院發展有信心,預計兩年內可以達到收支損益平衡。北市衛生局主秘許朝程說,國內想發展觀光醫療產業,卻因法規不合時宜造成侷限,且他國發展觀光醫療產業,也常衍生醫療糾紛,法規如何適度開放、保障國外旅客在台接受醫療的權利義務,都要仔細思考。不過,議員高嘉瑜並不看好,她說,台北國際商旅本來就是失敗政策,政府動用醫療基金、用納稅人的錢,為財團建立品牌,當初選在北投就是錯誤的,健檢、住酒店人數少,可以預見。

治療HIV病患 聯生藥UB-421 將取代雞尾酒療法?! 2015 phaseII (開始)/ 2016 phaseIII (申請)

衛福部點頭!聯生藥愛滋抗體新藥執行二期臨床 明年底進三期 鉅亨網/鉅亨網記者張旭宏 台北-20150603 下午13:10 新藥廠聯生藥(6471-TW)旗下抗體新藥UB-421應用於愛滋病雞尾酒藥物取代性療法第二期臨床試驗,已獲衛福部食藥署(TFDA)核准執行,預計2016年底申請第三期臨床試驗。聯生藥表示,此次申請二期臨床試驗,將穩定使用雞尾酒療法HIV病患暫時停止使用雞尾酒療法,並改以每週或隔週施打UB-421單一藥物連續816週,探討單一使用UB-421有效控制病患體內愛滋病毒量可行性,提供長期使用雞尾酒療法的病患一個新的簡易治療選項,此次試驗本月開始收案,為期1年,預計於2016年底申請第三期臨床試驗。聯生藥指出,雞尾酒取代性療法是目前愛滋病藥物發展的熱門方向之一,UB-421若能成功發展出雞尾酒取代性療法的新適應症,將開啟愛滋病治療的新里程,創造新的愛滋病藥物市場。

To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults 

ClinicalTrials.gov Identifier: NCT02369146/ This study is not yet open for participant recruitment. Last updated: February 15, 2015  This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 28 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

UB-421   is a monoclonal antibody (mAb) dB4C7 immunotherapty of HIV infection (AIDS). UB-421 is primarily intended for treatment of infected patients who are experiencing HIV viremia and are not responding to other anti-retroviral drugs. UB-421 works by binding to cell-surface CD4 where it blocks or displaces HIV viruses, and has been shown to block entry by all major primary strains of HIV into susceptible human host cells. UB-421 has successfully completed clinical Phase I study, demonstrating safety and tolerability. Analysis of secondary endpoints shows significant reduction in viral load. UBI is initiating a Phase IIa study. The primary markets are in the most developed regions of the world having approximately 4% of the world's HIV/AIDS patients. Over one-third of the HIV-positive individuals in these regions are failing the current anti-viral therapies. This segment of the market will be seeking new treatments, particularly new HIV entry inhibitor drugs.

 

中裕 委託 台裕化學 生產TMB-607 (anti-HIV小分子奈米劑型)

中裕新藥多箭齊發 愛滋新藥明年在美上市 Q3完成上櫃 鉅亨網新聞中心  2015-06-0312:38 興櫃新藥廠中裕新藥(4147-TW)(3)日召開股東常會,總經理張念原表示,今年全力加速TMB-355靜脈注射劑型最後階段的開發,並在美申請藥證核准,目標明年在美上市;並完成TMB-355肌肉注射劑型的臨床二期試驗、啟動TMB-607臨床一期試驗,並完成與跨國大藥廠洽談結盟合作,預計第三季完成上櫃計畫。張念原指出,擁有孤兒藥資格認定的TMB-355,去年4月獲FDA核准使用藥明康德生產的第一批符合GMP規範藥品,另外開始進行臨床前開發第二代單株抗體(TMB-360) ,並與台康生技簽署生產合約,去年8月獲台灣醫藥品查驗中心(CDE)選定為指標案件。連同原先的TMB-355 TMB-607,中裕目前進行的3個研發計畫都已被選定為指標案件。目前中裕的帳上現金為15億元,從20079月成立至今,累積虧損已超過實收資本額一半,但經由去年3月的現金增資,2014年底時,中裕每股淨值已由1年前的3.39元增加至8.45元。張念原指出,TMB-355孤兒藥資格加持下,對藥物安全資料庫的要求相對大幅較少,目標2016TMB-355靜脈注射劑型在美國獲BLA核准上市,另外每月注射一次的TMB-355 肌肉注射劑型也已進行到臨床二期,目前已在陸續募集台灣愛滋病患進行下一階段劑量選擇的二期臨床。張念原進一步指出,第二代的ibalizumabTMB-360/365,經改造後具有更優越的藥物安定性、藥動特性及抗藥性,目前台康生技已完成株系選擇,現正在建立種源細胞庫,在中裕自有的GMP實驗室中進行分析方法的自主開發,為增加研發能量,去年積極招募新進員工,今年還會再擴充。張念原強調,目前的規劃是在台灣進行第一批GMP生產、GLP毒理試驗、臨床試驗審查(IND)申請及臨床一期試驗,2016年申請INDTMB-607為治療HIV 感染的小分子蛋白酶抑制劑,目前正在台進行奈米劑型的臨床前實驗及GMP生產,此計畫由台灣生技整合育成中心(Si2C)輔導並獲經濟部科專補助。目前已完成狗的GLP 毒理試驗,並在台裕化學進行GMP 生產,預計今年在台申請臨床試驗審查(IND)

中天 接棒C肝新藥 臨床試驗 (國衛院 陳志豪開發DBPR110/ MB110)

國衛院技轉C肝新藥 防範多種型別 中央社-20150603 下午20:35 (中央社記者陳清芳台北3日電)治療C肝進入口服藥物的新頁,國家衛生研究院不落人後,專利技術「脯胺酸衍生物」技轉生技業者,能抑制更多種C肝病毒,預計3年內能夠臨床試驗。國衛院生技與藥物研究所研究人員陳志豪指出,在數百個「脯胺酸衍生物」中,找到候選藥物DBPR110 (現稱MB110) ,各項臨床前試驗均已執行完畢,其中包含毒性以及安全藥理試驗等,結果顯示,非常適合以低劑量、每天口服給藥一次的方式進行治療。已有3家跨國藥廠準備在台上市C肝新藥,估計一個完整的療程12週,定價8萬美元;陳志豪認為,C肝病毒至少有6種型別。脯胺酸衍生物MB110能夠防範的型別比較多,這是競爭優勢。脯胺酸衍生物MB110是一種新穎小分子藥物,可以抑制C型肝炎病的複製作用,在民國103年「國家發明創作獎」獲將發明獎金牌,已獲得國外內10個國家及地區的專利,並在2年前技轉給國內的中天生技,準備在美國及我國進行治療C肝的人體臨床試驗

喬本 研發副總 曾煥中 辭職!!!

喬本生醫:更正-研發副總及代理發言人職務異動 鉅亨網/鉅亨網新聞中心-20150603 上午09:20 第三十四條 第111.人員變動別(請輸入發言人、代理發言人、重要營運主管、財務主管、會計主管、研發主管或內部稽核主管):研發副總經理兼代理發言人2.發生變動日期:104/05/293.舊任者姓名、級職及簡歷: 研發副總兼代理發言人 / 曾煥中,本公司研發副總經理4.新任者姓名、級職及簡歷: 研發副總 / 無,由事業部門主管,直接對總經理報告 代理發言人 / 無,待人選確定後另行公告5.異動情形(請輸入「辭職」、「職務調整」、「資遣」、「退休」、「死亡」或「新任」):辭職6.異動原因:辭職7.生效日期:104/06/018.新任者聯絡電話:無。9.其他應敘明事項:無。