隱形眼鏡高透水性的舒適度與方便性 進一步帶動隱形眼鏡市場成長機會 大成報-2015年05月01日 上午09:23 【大成報記者羅蔚舟/新竹報導】科技部新竹科學工業園區管理局於4月30日發布「台灣潛力品項-隱形眼鏡市場發展分析」電子報指出,隨著經濟狀況好轉,也帶動民眾對於美麗時尚價值觀的提升,因此,原本以矯正功能為訴求的視力保健產品,已從強調實用功能轉而兼顧到流行美觀的發展方向。不僅市場主力的傳統鏡框眼鏡(Spectacles)開始強調鏡框的流行時尚,高成長潛力的隱形眼鏡也陸續開發出兼具矯正與美觀的角膜變色鏡片與彩妝鏡片;此外,隨著高齡化社會來臨,具視力保健需求的老化族群也將持續增加,加上隱形眼鏡材料發展大有斬獲,隱形眼鏡高透水性所帶來的舒適度與方便性,也將進一步帶動隱形眼鏡市場的成長機會。「台灣潛力品項-隱形眼鏡市場發展分析」電子報指出,依據各大研究資訊推估視力保健產品市場,2012年全球視力保健產品達284億美元,預估2017年將成長至330億美元,2012~2017年之年複合成長率約3%,主要是受到光學鏡片2012-2017年之年複合成長率僅達2.2%,成長幅度趨緩的影響所致;2012年全球隱形眼鏡產品市場規模約72億美元,2012-2017年之年複合成長率則高達6%,受到隱形眼鏡新產品,如角膜變色隱形眼鏡與矽膠高透氧隱形眼鏡等開發速度加快,以及市場接受度持續增加的影響,未來仍具成長潛力。進一步分析區域市場概況可知,2012年歐美市場市佔率達69.4%,是隱形眼鏡產品的主要消費市場,配戴習慣養成後的定期採購消費模式,將帶動後續產品銷售機會;2012年亞洲區域市場占有率約占18.5%,預估2017年市佔率將成長至22.1%,2012-2017年的年複合成長率高達9%,主要是因中國大陸、印尼、菲律賓與印度等亞洲新興國家的隱形眼鏡市場滲透率仍低於10%,未來隨著個人所得成長,以及隱形眼鏡技術精進後的價格下降,都將會提高未來新興市場的消費量與接受度,未來亞洲市場的成長率可期,值得廠商積極佈局。依據2014年Euromonitor的資料顯示,2012年隱形眼鏡品牌市佔率仍以國際大廠為主,第一大品牌為嬌生公司(Johnson & Johnson)Acuvue,市佔率達31.6%,其次為諾華集團(Novartis) CIBA Vision,市佔率為13.7%,再者為酷柏(Cooper Cos) CooperVision、博士倫(Bausch & Lomb) Bausch & Lomb,以及諾華集團(Novartis) Air Optix,市佔率分佔6.8%、5.3%與4.5%。本資料也指出,台灣廠商精華光學帝康 (Ticon) 品牌占有率約為0.4%,金可國際集團的海昌(Hydron)品牌占有率約0.8%,而上海衛康公司旗下的衛康品牌占有率約0.3%左右。若進一步整合各品牌市佔資料,進行全球隱形眼鏡公司之市佔有率分析可發現,前四大廠商市佔率已超過80%,分別為嬌生公司(Johnson & Johnson)、諾華集團(Novartis AG)、酷柏公司(Cooper Cos )與博士倫(Bausch & Lomb),市佔率分佔37.9%、20.1%、11.6%與11.1%。而日本Menicon公司排名第五大,市佔率為2.7%。 受到氣候與價格等各面向的影響,各區域市場的使用習慣也不盡相同,也反映在產品配戴週期的接受度上。如因歐美市場氣候普遍乾燥,較偏好訴求高保濕的長周期性隱形眼鏡產品,而亞洲氣候與歐美不同,對於價格也較敏感,短周期性的日拋式隱形眼鏡產品更受青睞。有鑑於此,各廠商也特別針對隱形眼鏡原料進行開發,希望能夠在透氧性、保水度上有更佳配戴效果。據2013年Contact Lens 的研究資料顯示,2012年用於軟性隱形眼鏡的矽水膠材料比重達64%,一般水凝膠(Hydrogel)約24%,而硬式隱形眼鏡原料RGP(Rigid Gas Pereable)則佔9%。由於矽水膠(Silicone Hydrogel)可提供更高的透氧性,讓氧氣可通過鏡片到達眼角膜,進而可減輕眼睛乾澀與紅眼等現象,因此歐美國際大廠皆持續推出矽水膠隱形眼鏡產品。對於隱形眼鏡等消費型產品而言,消費者的使用經驗與觀感相對重要,因此未來在高透氧性、高保濕性等訴求仍是重點,但多樣化的角膜變色鏡片與增艷變色彩妝片,也將是成長趨動力之一。分析台灣近三年來的出口數據可知,隱形眼鏡已成為台灣除了血糖監測產品之外的另一優勢品項,在本業廠商因應訂單持續擴大產線,以及異業廠商看好市場潛力積極投入之下,隱形眼鏡的出口金額表現持續亮眼,已從2010年台灣醫材出口第五大,比重僅6%,之後快速攀升,2012年已成為出口第二大產品,占總出口比重也成長至9%。依據2013年1~8月海關出口資料顯示,隱形眼鏡的出口比重已經高達10.2%,和出口排名第一、出口比重11.9%的血糖試片,差距已經逐漸拉近中,隱形眼鏡儼然已經成為台灣下一波具產業規模與亮點的出口重點品項,預估2013年台灣隱形眼鏡產值可達100億新台幣。「台灣潛力品項-隱形眼鏡市場發展分析」電子報指出,綜觀台灣數十年的發展,投入隱形眼鏡產業的廠商可分為兩大類型,一是長期深耕隱形眼鏡的專注型廠商,長期在技術上精進良率,以穩定的產品品質維持毛利率與市佔率;有些廠商獲得國際大廠肯定,以代工模式切入市場,有些廠商有鑑於產品技術穩定,也以台灣市場作為發展自我品牌的試金石,開始有多元化的發展。包含精華光學、優你康、加美、昕琦、昱嘉、永勝(海昌品牌)、金可國際、視茂、視陽、視全…等公司,皆屬於此類廠商;精華光學代工訂單穩定,憑藉著高良率維持高營收機會;金可國際公司在台購併永勝公司成為該集團在台投資子公司,以購併美國品牌之Hydron海昌品牌積極在台灣與中國大陸行銷,擴大華人市場市佔率。在這些年產業深耕下,台灣目前已有製造廠可進行隱形眼鏡的製模、製鏡、脫模、水化等前半段過程的代工,累積的技術成熟優勢也將持續帶動台灣隱形眼鏡產業的成長機會。第二大類型是近年來看好隱形眼鏡成長潛力,憑藉以往彈性製造、高良率的他業經驗能力,應用在隱形眼鏡領域,以做為擴大本業的成長動能,包含精碟科技公司早期即轉投資進入隱形眼鏡毛胚製造領域,大立光公司透過旗下持股子公司間接投資星歐光學(Largan Med),進軍隱形眼鏡新事業,而明基材料也憑藉材料產業優勢,開發高透氧矽水膠日拋產品與彩色放大片,以美若康品牌佈局市場。而近期投入的廠商晶碩光學與精能光學等公司,也開始不同於以往的經營模式。如晶碩光學是和碩聯合科技及景碩科技共同轉投資的子公司,有別於以往廠商多以代工為主,反是透過經營自有品牌晶碩,並以自營通路的方式來擴大台灣的市佔率,也透過會員制維持客戶的回購率;而由應華精密與日本精工技研轉投資的隱形眼鏡公司精能光學(原精鼎光學),則主推iLens愛能視品牌,其非以傳統眼鏡行為通路,而以藥局作為通路佈局重點,如透過代理商進入中國大陸連鎖藥局,也與台灣博登藥局簽約,正式進入醫藥品通路。這些不同以往的經營模式,擴大了消費者接觸隱形眼鏡品牌的機會,透過不同經銷體系的銷售思維,也期待能為台灣隱形眼鏡帶來新的成長機會。整體觀之,全球隱形眼鏡的需求仍將持續攀升,掌握商機將是台灣再創高峰的機會。未來產品除持續朝向高透氧性、高保濕性等方向發展外,老花片、彩妝片等產品亦是未來許多廠商布局重點。從韓國隱形產業的發展來看,近年來出口持續成長,雖然韓國的隱形眼鏡產業發展尚不及台灣,但韓國廠商積極拓銷新興市場成為帶動該國產業的趨動力值得借鏡,如韓國出口至東南亞各國約佔20%、金磚四國約佔25%,中東地區則佔10%,在新興市場需求湧現的需求下,建議廠商可加強對新興市場的布局,進而開拓更寬闊的市場。
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Saturday, May 2, 2015
明達醫 獨董提名人: 黃恩旭/ 林宛瑩/ 陳盛穩
明達醫:公告本公司104年股東常會獨立董事被提名人名單 鉅亨網/鉅亨網新聞中心-2015年04月30日 下午19:08 第三十四條 第42款1.事實發生日:104/04/302.公司名稱:明達醫學科技股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司,請填不適用):不適用5.發生緣由:本公司104年股東常會獨立董事被提名人名單相關資料公告如下:(1)被提名人姓名:陳盛穩學歷:美國馬里蘭大學電機博士經歷:明基網通事業部總經理 美國高通(Qualcomm)研發主管 GE Electronics Lab COMSAT Lab現職:台大經濟系博士候選人持有股份數額:0股 所代表之政府或法人名稱:不適用其他相關資料:無(2)被提名人姓名:黃恩旭學歷:美國康乃爾大學(Cornell Law School)法學碩士經歷:佳世達科技股份有限公司法務長 義守大學講師 理律法律事務所資深律師 中華民國及美國紐約州律師執業資格現職:聯華電子股份有限公司智權法務處資深處長持有股份數額:0股 所代表之政府或法人名稱:不適用其他相關資料:無(3)被提名人姓名:林宛瑩學歷:美國波士頓大學會計學系博士 國立政治大學會計學系碩士經歷:政治大學會計系專任副教授現職:政治大學會計系專任副教授持有股份數額:0股 所代表之政府或法人名稱:不適用其他相關資料:無6.因應措施:不適用。7.其他應敘明事項:無。
展旺 上櫃過關 (資本額17.2億/ 營入10.18億/ 淨損3.55億/ 每股虧2.12元)
櫃買通過 展旺申請上櫃案 2015年 05月 01日 【經濟日報記者王奐敏/30日電】櫃買中心於今(30)日召開上櫃審議委員會,通過展旺生命科技股份有限公司(4167)申請上櫃案。 展旺以科技事業申請上櫃,申請時資本額17.2億元,董事長為顧曼芹,推薦證券商為康和綜合證券、元大寶來證券、宏遠證券、富邦綜合證券、群益金鼎證券、華南永昌綜合證券及第一金證券。 展旺生命科技股份有限公司102年度之營業收入為10.0億元,稅後淨損為2.28億元,每股虧損為1.48元。103年度之營業收入為10.18億元,稅後淨損為3.55億元,每股虧損為2.12元。
互聯網實現醫療o2o : 整合 微信支付與京醫通卡(儲值/ 掛號/ 繳費)
京醫通微信合體 攻第三方支付 2015-05-01 03:14:42 經濟日報 記者葉又瑋/綜合報導 北京銀行昨(30)日公告稱,已與騰訊簽署戰略合作協議,北京銀行將向騰訊提供意向性授信人民幣100億元(約新台幣500億元),雙方將共建「互聯網+京醫通(實名制就診卡制度)」的創新金融產品。根據合作協議,雙方將在「京醫通」項目、第三方支付、集團現金流量管理、零售金融等領域展開深入合作。例如京醫通將與微信支付合作,透過「京醫通」平台,利用「微信支付+微信公眾賬號」模式達到線上申辦京醫通卡、儲值、預約掛號、繳費、業務查詢等功能。路透報導,「京醫通」作為北京銀行參與支持建設的惠民金融工程,自2012年上線以來,透過發放京醫通卡,實現了跨院診療結算一卡通。截至目前,該卡服務範圍已包含北京世紀壇醫院、同仁醫院、首兒所、西苑醫院、望京醫院等在內的多家三級甲等醫院,累計發卡量逾310萬張。公告指出,這次合作將醫療業務延伸至個人行動裝置,打破傳統跨院診療系統不具備線上業務辦理能力的困局,使患者隨時隨地均可輕鬆掛號、繳費,而就診提示、就診路線導航等多項功能也可透過微信輕鬆搞定。香港文匯報援引北京銀行董事長閆冰竹表示,北京銀行將積極貫徹「互聯網+」的發展戰略,與騰訊在網路金融及「智慧城市」建設等領域持續合作,打造「全能智慧銀行」。
京医通"卡是北京市卫生局、市医院管理局与北京银行联合发行的具有电子钱包功能的实名制IC就诊卡,可在医院作为就诊卡使用,并实现小额支付功能,适用于北京非医保患者和外地患者。"京医通"卡的样子类似银行卡,上面有唯一编码,它的使用对象是非医保人群和外地患者,为实名制办理,内含患者信息,同时具电子钱包功能,可充值并划卡缴费。2012年4月,京医通卡在北京同仁医院、首儿所和朝阳医院等市属大医院启用。京医通卡和北京市参加医保人员已发放的社保卡,共同实现了覆盖北京市全部患者的"一卡通"体系。2011年北京市各医疗机构中就诊的外地患者已经超过了5000万人次。他们到北京各大医院就诊时,都需要先办理一张就诊卡,各家医院的就诊卡还不能通用。今后,随着开通"京医通"系统的医院不断增加,京医通卡将逐步替代原来各医院自行发放的各类诊疗卡,实现市属医院间"一卡通用"。使用京医通卡的患者,在任一家市属医院登记办卡后,到其他市属医院就诊时不需再重复办理各医院的就诊卡。"京医通"系统能够直接读取二代身份证,卡内存储了患者相关实名就诊信息,这不仅有助医生分析疾病过程,还有助于打击"号贩子"。
騰訊 醫療大軍 掌握近2000萬張醫療資訊 (1600萬張醫保卡+ 310萬張京醫通卡)
北京銀行停牌牽手騰訊 互聯網+醫療是合作重點 北京新浪網 (2015-04-30 19:12)記者 周鵬峰 編輯 浦泓毅 繼小米、360公司后,北京銀行攜手互聯網巨頭騰訊。根據該行昨日與騰訊簽署的全面戰略合作協議,北京銀行將向騰訊提供意向性授信100億,雙方將圍繞京醫通項目、第三方支付、集團現金管理、零售金融等領域開展業務合作。為待該合作落地,北京銀行已停牌兩日。作為此次雙方合作的重點,京醫通微信公眾賬號的開通是京醫通平台首次與第三方支付平台進行對接,打破了傳統跨院診療系統不具備線上業務辦理能力的困局,使患者足不出戶即可實現繳費、就診提示、就診路線導航等多項便利功能,打通診療信息傳遞的「最後一公里」障礙,將醫療業務延伸至個人移動終端。出席此次發布會的騰訊董事會主席兼CEO馬化騰說,京醫通和微信的合作,是「互聯網+醫療」的一次重要嘗試,希望未來雙方能夠在醫療以外的其他民生領域開展合作,通過騰訊在線下積累的成熟解決方案,給用戶帶來更多便利。馬化騰的出席可見騰訊對此次合作頗為重視。馬化騰說,通過一次合作綁定1600萬張醫保卡、310萬張京醫通卡,于騰訊是首次。來自北京銀行的信息,北京銀行參与發起的京醫通項目覆蓋北京地區近50%三甲醫院,累計發卡量突破310萬張;該行獨家出資與北京市人力資源和社會保障局共同建設的北京市社會保障卡項目,目前累計發行社保卡超過1600萬張。在「互聯網+」浪潮下,雙方對此次合作都寄予頗高期望。為表重視,昨日北京銀行董事長閆冰竹攜高管團隊出席了該次發布會,閆冰竹說,北京銀行將積極貫徹「互聯網+」發展戰略,與騰訊公司在互聯網金融及「智慧城市」建設等領域開展深入合作,打造「全能智慧銀行」,主動迎接「大眾創業、萬眾創新」的嶄新時代。閆冰竹昨日還笑言「北京銀行停牌兩天了,抓住了馬化騰就能抓住錢」。馬化騰則回應,「停牌兩天,壓力特別大。」此前與小米、360公司兩大互聯網巨頭簽署合作協議時,北京銀行股票並未停牌,與小米公司的合作曾推動該行股價漲停。
快~上櫃為重! 中裕 與Si2C 合作長效小分子HIV藥針劑(Rilpivirine) 兩大巨人前(Johnson/Tibotec, TMC278 LA) 後(GSK, GSK1265744)夾擊
申請上櫃 中裕愛滋新藥 拚明年在美上市 2015年05月01日 04:10 記者杜蕙蓉/台北報導 中裕新藥(4147)TMB-355靜脈注射劑型取得美國FDA突破性治療資格,預期在進行一個不到30人的三期臨床後,有機會力拚2016年在美獲准並上市下,該公司也乘勝追擊,昨(30)日正式向櫃買中心(OTC)提出上櫃申請。此外,備受矚目的TMB-355肌肉注射劑型,也預計今年4月開始募集台灣愛滋病患,進行下一階段劑量選擇的二期臨床。至於開始進行臨床前開發的第二代單株抗體(TMB-360),中裕也與台康生技(ErGenix)簽署生產合約。此計畫於去年八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和TMB-607,中裕目前進行的三個研發計畫都已被選定為指標案件。TMB-607為治療HIV感染的小分子蛋白酶抑制劑,此計畫由台灣生技整合育成中心(Si 2C)輔導並獲經濟部科專補助。由於此劑型具有獨特的藥動特性、安定性、且使用新賦形劑,經由與藥品查驗中心密切的諮詢和討論,目前已完成狗的GLP毒理試驗,並在台耀化學進行GMP生產,預計2015年在台灣申請臨床試驗審查(IND)。中裕表示,今年在藥物研發有顯著的進展,TMB-355在獲得美國孤兒藥資格之後,已經與FDA進行密切的討論,以利藥物儘速獲得BLA(生物製劑許可證)核准。截至2014年底,中裕的現金餘額約為新台幣15億元。該公司累計從2007年九月成立至今,虧損已超過實收資本額一半。但因2014年三月的現金增資,也帶動中裕每股淨值已由一年前的3.39元增加至8.45元。
Rilpivirine is non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used for the treatment of HIV-1 infections in treatment-naive patients. It is a diarylpyrimidine, a class of molecules that resemble pyrimidine nucleotides found in DNA. Because of its flexible chemical structure, resistance of rilpivirine is less likely to develop than other NNRTI's. FDA approved on May 20, 2011.
Rilpivirine (Edurant) (Source: http://www.aidsmap.com) Rilpivirine (Edurant), previously known as TMC278) is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), developed by Johnson & Johnson/Tibotec. Rilpivirine was submitted for licensing in the United States in November 2010 and received approval for use as first-line treatment in May 2011. European marketing approval followed in November 2011. It has also been combined in a once-daily tablet (Eviplera) with Gilead's drugs tenofovir and FTC, which received marketing approval in the EU in November 2011. This combination tablet is marketed as Complera in the US. Researchers are also working on an injectable form of this drug that utilises nanoparticles and would only need to be taken once a month.1 In a 96-week randomised phase II study with over 350 treatment-naive participants, rilpivirine suppressed viral load and increased CD4 counts in similar numbers to efavirenz. This was a dose-ranging study comparing three blinded, once-daily doses of rilpivirine to open-label once-daily efavirenz (600mg), in combination with either AZT/3TC (Combivir; 76%) or tenofovir/FTC (Truvada, 24%). In a time to loss of virological response (TLOVR) analysis, 73% of patients in all three rilpivirine arms combined achieved viral loads below 50 copies/ml, compared with 71% in the efavirenz arm. Rilpivirine was active against wild-type and NNRTI-resistant virus. Very few participants (6% rilpivirine arms vs 7% efavirenz) experienced virological failure. When NNRTI resistance emerged, rates were broadly similar across all study arms. Most of the virological failures in the rilpivirine arm were related to mutations at 184V and 138K. However, patients in the rilpivirine combined arms group (all doses) had higher numbers of grade 3 to 4 adverse events (27 vs 21% EFV) and grade 3-4 laboratory abnormalities (27 vs 24% EFV arm). 2 A pooled analysis of 48-week data has been presented from two international phase III studies, ECHO and THRIVE, each of which compared rilpivirine 25mg once daily to efavirenz 600mg once daily, in combination with two nucleoside analogues, in treatment-naive individuals.3 The ECHO study randomised 690 patients, and all received a nucleoside analogue backbone of tenofovir and emtricitabine. THRIVE randomised 678 patients, with the nucleoside backbone chosen by the patient's doctor: around 60% of participants received tenofovir/FTC, 30% received AZT/3TC and 10% received abacavir/3TC. Participants had relatively low CD4 counts (a median of around 250), and high viral load (median 5 log, or 100,000 copies/ml). After 48 weeks of treatment the proportions with viral load below 50 copies/ml were almost identical (84.3% in the rilpivirine arm, 82.3% in the efavirenz arm), demonstrating non-inferiority. Virological failures (defined as two viral loads above 50 copies/ml even if viral load was suppressed again at week 48) were more frequent in the rilpivirine arm (9 vs 4.8%), and this difference was largely driven by the higher failure rate in the ECHO study (11 vs 4.4%). The statistical significance of this difference was not reported, but the difference did not vary according to nucleoside backbone, nor by baseline viral load. Patients taking rilpivirine who experienced virological failure tended to develop the E138K mutation that causes resistance to the second-line NNRTI etravirine. Half of those who experienced treatment failure while taking rilpivirine developed resistance to the drug, and of them, 90% developed resistance to etravirine too. As in the phase II studies, discontinuations due to adverse events were significantly more common in the efavirenz group (6.7 vs 2%), and central nervous system adverse events (such as dizziness and abnormal dreams) were significantly more common, occurring two to three times more often in these patients (overall frequency 38 vs 17%). Rash was also more common in efavirenz-treated patients.
References
Van t'Klooster G et al. Long-acting TMC278, a parenteral-depot formulation delivering therapeutic NNRTI concentrations in preclinical and clinical settings. Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 134, 2008
Santoscoy M et al. TMC278 (rilpivirine), a next-generation NNRTI, demonstrates long-term efficacy and tolerability in ARV-naïve patients: 96-week results of study C204. XVII International AIDS Conference, Mexico City, abstract TUAB0103, 2008
Cohen C et al. The single-tablet, fixed-dose regimen of elvitegravir/GS-9350/emtricitabine/tenofovir DF (Quad) achieves a high rate of virologic suppression and GS-9350 is an effective booster. Seventeenth Conference on Retroviruses and Opportunistic Infections, abstract 58LB, San Francisco, 2010
Long-acting injectable antiretrovirals for HIV treatment and prevention Curr Opin HIV AIDS. 2013 Nov; 8(6): 565–571. TMC278 LA injection is the investigational nanosuspension formulation of RPV. The oral tablet formulation of RPV was approved in 2011, in combination with other ARV drugs, for treatment of patients with HIV-1 infection who are ARV-naive with an HIV-1 RNA level of 100 000 copies/ml or less at the start of therapy. In addition, a fixed-dose combination of RPV/TDF/TFC is approved for the same indication. Baert et al.[24▪] have published on the development of TMC278 LA nanosuspension injection. RPV free base is a stable crystalline polymorphic drug substance with very low water solubility (<0.1 mg/ml). Rilpivirine drug crystals are nanosized by a continuous wet milling process and suspended in aqueous vehicle with hydrophilic surfactant. In preclinical proof-of-concept studies, single injections of nano-formulated drug gave sustained release of RPV in plasma over 3 months in dogs and 3 weeks in mice. Further preclinical investigation of TMC278 LA 200 nmol/l injectable nanosuspension in rats and dogs included plasma pharmacokinetics, injection site concentrations and disposition to lymphoid tissues [25▪▪]. Rilpivirine plasma concentrations confirmed sustained and dose-proportional release lasting more than 2 months in rats and more than 6 months in dogs. Absolute bioavailability approached 100%, indicating complete release from the injection site. In dog, drug concentrations in the lymph nodes draining the intramuscular injection site exceeded plasma concentrations by over 100-fold 1 month after administration, while concentrations in lymphoid tissues decreased to 3-fold to 6-fold of the plasma concentrations beyond 3 months. A subsequent phase I study of TMC278 LA 300 mg/ml nanosuspension evaluated the pharmacokinetics and safety of single gluteal intramuscular or abdominal subcutaneous injections in 51 HIV-negative adult patients at doses of 200, 400 and 600 mg, or vehicle (placebo) [26]. An additional nine patients received a single 400-mg injection into deltoid muscle. Consistent with the preclinical experience, rilpivirine was slowly released from the injection site into plasma, with drug concentrations of more than 10 ng/ml for 12–26 weeks. Dose proportionality and similar plasma concentration–time profiles were observed for both subcutaneous and gluteal intramuscular injections. ISRs consisted of redness, bruising, pain and to a lesser extent, induration, and were more frequent with active drug injections versus placebo. There was a greater frequency of ISRs with subcutaneous as compared to intramuscular administration. Among intramuscular injections, gluteal injections were better tolerated than deltoid injections. There were no serious adverse events or grade 3 or 4 adverse events. Jackson et al.[27] reported results of a phase I clinical study of TMC278 LA pharmacokinetics in plasma, female genital tract and male rectum in HIV-negative adults. The investigators enrolled 20 women per dose group and evaluated single doses of 300, 600 and 1200 mg, while a sub-study enrolled six men who each received a single 600-mg dose. Blood and genital/rectal fluids were sampled to 84 days, and tissue biopsies were taken at three time points during the initial 28 days. All doses gave prolonged plasma and female genital tract and male rectum drug exposure. Among females, RPV concentrations in genital tract fluid were generally comparable to plasma drug concentrations, while vaginal tissue drug concentrations were 50% or more of the corresponding plasma measurement. In male patients, rectal fluid to blood plasma drug concentration ratios were 28 and 7% at Cmax and last observed concentration (Day 84), respectively. However, drug concentrations in rectal tissue were markedly higher and generally similar to blood plasma at study days 7 and 14. In total, these results support further evaluation of TMC278 LA as a potential PrEP strategy.
GSK1265744 is an HIV-1 INSTI and analogue of the inhibitor dolutegravir ([16,17]; ViiV Healthcare, unpublished data). The free acid of GSK1265744 has very low water solubility (<10 μg/ml). It is under clinical evaluation as both oral and long-acting injectable formulations. The drug is a subnanomolar inhibitor of HIV-1 integrase-catalyzed viral cDNA strand transfer with an in-vitro half maximal inhibitory concentration (IC50) of 0.22 and 0.34 nmol/l against HIV-1 BAL and NL432 in peripheral blood mononuclear cells, respectively. GSK1265744 is highly protein bound to serum albumin, resulting in a protein-adjusted 90% inhibitory concentration (PA-IC90) of 166 ng/ml. It has a plasma half-life of approximately 40 h following oral administration, allowing for once-daily dosing. In double-blind, placebo-controlled proof-of-concept studies of GSK1265744 monotherapy in HIV-1-infected individuals receiving 5 or 30 mg once daily for 10 days, the drug significantly reduced plasma HIV-1 RNA from baseline to day 11 versus placebo (P < 0.001); mean decrease was 2.2–2.3 log10 copies/ml, respectively [18,19]. GSK1265744 was generally well tolerated, with no clinically relevant trends in laboratory values, vital signs or electrocardiograms. A phase IIb, randomized, oral dose-ranging study is ongoing [20]. A total of 243 HIV-infected subjects were randomized to a blinded dose of GSK1265744 (10, 30 or 60 mg per day) or a control arm of efavirenz; all groups receive an investigator-selected backbone regimen of abacavir/lamivudine or TDF/FTC. After 24 weeks of triple therapy, patients randomized to GSK1265744 who achieved a plasma HIV-1 RNA level of less than 50 copies/ml enter a maintenance phase and modify their regimen to oral GSK1265744 and oral RPV 25 mg per day for an additional 72 weeks. Thus, the study evaluates a two-drug, two-class regimen of oral GSK1265744 and oral RPV for maintenance of virologic suppression. Study results will inform future trials using the long-acting injectable formulations. The long-acting injectable nanosuspension of GSK1265744 is composed of crystalline active drug, milled to a median particle size of 200 nm, along with surfactant, polymer, tonicity agent and water for injection (ViiV Healthcare, unpublished data). The nanoparticles are essentially 100% active drug in contrast to matrix nanoparticles consisting of drug encased within a polymer or lipid matrix. This enables higher drug loading into the formulation (200 mg/ml) and a reduced injection volume. Two phase I studies have reported the tolerability, safety and pharmacokinetics of GSK1265744 long-acting injection [19,21]. In a randomized, placebo-controlled, double-blinded, single-dose study, 56 HIV-uninfected adults received GSK1265744 as a gluteal intramuscular injection of 100, 200, 400 or 800 mg or an subcutaneous abdominal injection of 100, 200 or 400 mg or placebo injection vehicle. Following single intramuscular or subcutaneous injection, plasma drug concentrations increased rapidly over the first week, with sustained mean plasma concentrations above the PA–IC90 for approximately 24 weeks or longer for doses of at least 200 mg, as shown in Fig. 1. Mean plasma levels of GSK1265744 over time following single-dose administration of long-acting formulation [19]. GSK1265744 (200 mg/ml) was administered as a single IM (gluteal) or SC (abdominal) injection or equally divided IM or SC injection. GSK1265744 was detected in plasma to 48 weeks. Mean absorption-limited apparent terminal-phase half-life ranged from 21 to 50 days as compared to approximately 40 h following single-dose oral administration. This longer apparent half-life following injection is a result of low solubility of the nanoparticle and inherent low tissue perfusion, prompting a slow absorption rate of drug from the injectable formulation with no change in the plasma elimination half-life of the dissolved active drug. When the injectable formulation was administered as two equally divided (split dosing) injections (Cohort 4, 400 mg × 2 intramuscular and Cohort 7, 200 mg × 2 subcutaneous), total drug release was increased so that the maximum observed plasma concentration (Cmax) was greater than dose proportional and there was a more pronounced decay in drug concentrations over time. However, overall extent of exposure [area under the curve (AUC) from time zero to infinity] did not change. The most common adverse event was a self-limited injection site reaction (ISR). ISRs were generally mild, with pain and erythema at the injection site reported as the most common findings. There were no systemic serious or grade 3 to 4 adverse events.Two additional cohorts were included to evaluate drug distribution into rectal and cervicovaginal tissue to gain insight into the potential application of GSK1265744 for PrEP [22].
基亞子公司 (德必碁廈門&台灣/Texas BioGene) 全數轉換成 Progen澳洲持股!!!( 101723仟股/ 1:1) !!!
基亞:基亞董事會決議子公司TBG Inc.與澳洲Progen公司進行股份轉換 鉅亨網/鉅亨網新聞中心-2015年04月30日 下午21:08 第二條 第11款1.併購種類(如合併、分割、收購或股份受讓):子公司TBG股份轉換2.事實發生日:104/4/303.參與併購公司名稱(如合併另一方公司、分割新設公司、收購或受讓股份標的公司之名稱:本公司持股100%之子公司TBG Inc. (開曼)4.交易相對人(如合併另一方公司、分割讓與他公司、收購或受讓股份之交易對象):Progen Pharmaceuticals Limited5.交易相對人為關係人:否6.交易相對人與公司之關係(本公司轉投資持股達XX%之被投資公司),並說明選定收購、受讓他公司股份之對象為關係企業或關係人之原因及是否不影響股東權益:Progen公司為澳洲上市公司, 本公司持有股份19.7%, 非本公司之關係人。7.併購目的:透過股份轉換建立策略聯盟。8.併購後預計產生之效益:於澳洲資本市場籌措長期資金,並運用澳洲當地研發能量發展檢驗試劑業務。9.併購對每股淨值及每股盈餘之影響:股份交換完成後, 資源共用與整合更具效益, 有助於子公司長期營運發展, 對未來每股淨值及盈餘應有正面之影響。10.換股比例及其計算依據:Progen公司與TBG 公司之換股比例為1:1, Progen公司發行101,723仟股新股予本公司,交換本公司持有之TBG公司全數股份。換股比例計算係依據雙方近期財務報表,並參酌業務、經營、淨值、市價等,並委請會計師就換股比例出具合理性意見書後定之。11.預定完成日程:股份轉換基準日暫定為民國104年9月1日,再視實際作業進度由董事會決定確定之基準日。12.既存或新設公司承受消滅(或分割)公司權利義務相關事項(註一):不適用13.參與合併公司之基本資料(註二):1. TBG Inc. 於2006年設立登記於開曼群島, 基亞生技公司持股100%。TBG公司定位為檢驗試劑業務之海外控股公司, 轉投資包含持股100%之德必碁(廈門)公司、德必碁(台灣)公司及Texas BioGene Inc.(美國)。2. Progen Pharmaceuticals Limited成立於1989年,為澳洲證券交易所(ASX)上市之生技公司, 主要業務為新藥研發。14.分割之相關事項(含預定讓與既存公司或新設公司之營業、資產之評價價值;被分割公司或其股東所取得股份之總數、種類及數量;被分割公司資本減少時,其資本減少有關事項)(註:若非分割公告時,則不適用):不適用15.併購股份未來移轉之條件及限制:不適用16.其他重要約定事:不適用17.本次交易,董事有無異議:否18.其他敘明事項:1.股份轉換完成後, 本公司持有Progen公司股份將由原19.7%增加至71.7%, 未來將變更Progen公司名稱為TBG Inc., 致力於檢驗試劑及設備之業務。2.本股份轉換案併同Progen公司進行現金增資(預定增資金額為澳幣800-1000萬)。3.本案業經本公司董事會特別決議通過。4.本交易須取得澳洲證券交易所及相關主管機關同意。註一、既存或新設公司承受消滅公司權利義務相關事項,包括庫藏股及已發行具有股權性質有價證券之處理原則。註二:參與合併公司之基本資料包括公司名稱及所營業務之主要內容。
普生林宗慶 布局早期”肝癌” 預防篩檢IVD (蘇益仁/黃溫雅: Pre-S突變基因晶片)
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