東洋 新階段世代: 林榮錦 交棒 蕭英鈞/ 抗癌藥營收&權利金 前面嶄露效益 !!

東洋董座 蕭英鈞接任 【經濟日報╱記者黃文奇／台北報導】 2014.06.25 04:32 am東洋（4105）昨（24）日召開股東常會，加派0.17元股票股利，讓2.5元股利也提高至2.67元，共計現金股利2元，股票股利0.67元，會後召開董事會，決議董事長由蕭英鈞接任，為東洋18年來首度更換董事長。 東洋表示，前董事長林榮錦目前仍為公司董事，也是最大股東，由於東洋集團已經逐漸開枝散葉，旗下子公司遍布兩岸，行銷網絡更遍及全球，公司已經達發展新階段，因此進行經營團隊階段重整。 據悉，蕭英鈞為林榮錦北醫同學，早期與東洋共同經營人，攜手努力18年，兩人對於公司經營具有共同目標與願景，因此將進行下階段性分工。 至於林榮錦未來定位，東洋表示，藥證取得、廠房設置、兩岸布局都已經告一個新的段落，未來林榮錦將更聚焦全球布局規劃，加上他個人也轉投資多家生技公司，將為集團的整合、拓展而努力。 東洋昨日股價收90.8元，上漲0.3元。 東洋昨日表示，公司旗下共有三項產品今年將貢獻營運，包括胰臟癌口服化療藥TS-1、癌症止痛劑等藥品都獲健保價，另外接獲國際大廠代工訂單的針劑也密集出貨，此外子公司智擎抗胰臟癌藥證在握，也可望挹注的里程金，將持續貢獻公司營運。 其中，胰臟癌口服化療藥TS-1（愛斯萬膠囊），原為日本大鵬藥品工業株式會社所研發出的藥物，近年授權東洋在台開發銷售，去年8月由東洋取得晚期胰臟癌適應症核准，近期也通過納入全民健康保險藥物給付，商機可期。 據悉，台灣在胰臟癌領域來有顯著成長趨勢，且胰臟癌發現時多為晚期無法以手術切除腫瘤的狀況，病人需接受全身性化學治療。 【2014/06/25 經濟日報】

 

 

健保給付 單焦點人工水晶體

新人工水晶體 看遠近都OK 2014年06月23日【張渝萍╱綜合報導】英國研發出新的人工水晶體「Symfony」，宣稱可讓患者術後看遠近皆清楚且無散光困擾。國內醫師認為目前健保給付的單焦點水晶體效果就不錯，且功能越少的人工水晶體越易適應。

可分辨細微色差 英國《每日郵報》前天報導，英國倫敦眼科醫院日前執行全球首例Symfony人工水晶體移植手術，指該水晶體效果自然，看遠看近都沒問題。一般治療白內障的單焦點人工水晶體缺點是看不清楚近的東西，因此術後仍需戴眼鏡，而多焦點人工水晶體雖可讓病患看遠近皆清楚，但會產生光暈無法順利聚焦。 醫師奎雷西表示，Synfony表面紋路可讓光線直接通過，不會有折射，因此可分辨細微的顏色差異，看見的影像與正常眼睛看到的很接近，九成病患移植Symfony後都不必再戴眼鏡。首名接受Symfony移植的患者皮考克說，術後不必再戴眼鏡，看到的影像質感也很棒。目前這款人工水晶體為塑膠材質，可終生使用，單眼要價三千九百元英鎊（近二十萬元台幣）。

醫師：適應較慢 中國醫藥大學附設醫院眼科部主治醫師陳文祿昨指，目前台灣尚未使用這款新的人工水晶體，其實一般健保給付的單焦點人工水晶體效果就不錯，且好適應，但缺點是看近需戴眼鏡。功能越少的人工水晶體越好適應，多焦點人工水晶體的優點是看遠近皆清楚，但適應較慢。

 

 

(林奏延次長) 醫療專區目的是 “產業發展”!!

示範區國際醫療 扶植產業 中央社-2014年06月22日 下午15:11（中央社記者龍珮寧台北22日電）衛福部表示，推動示範區國際醫療，扶植核心醫療助相關產業；兩岸醫事交流團體也認為，海外患者來台，也幫助醫師留在台灣。 第四屆海峽兩岸醫事交流學術論壇今天在台北世貿一館舉辦。衛生福利部政務次長林奏延說，目前有37家醫療院所進行國際醫療，包括醫美健檢也有特色醫療。自由經濟示範區內的國際醫療專區規畫以簡單醫療在區內執行，如人工關節置換、醫美健檢、顯微手術、顱顏手術或是人工生殖。 至於是否會排擠國人就醫？林奏延說，專區內不使用健保，一律自費，限制是200床內，需求約100名醫師；另規定專區內支援的醫師需報備，限制以20小時為限，這包括醫師支援其他分院或是醫院的時數在內。 林奏延指出，專區的目的是要扶植產業，由核心醫療帶動相關產業，包括藥材業、醫材業、醫療光電業等發展。 台灣海峽兩岸醫事交流協會秘書長張朝凱談到個人對自由經濟示範區的國際醫療專區看法時表示，自由開放是趨勢，台灣市場小，以台灣醫師為主體，外國病患為客戶，將包括海外、中國大陸等病患吸引到台灣就醫，而非被韓國、泰國、中國大陸吸走，也避免台灣醫師外流。 張朝凱說，在示範區國際醫療的醫師，不會開放陸籍醫師，但是國外好的醫師可以納入。

 

 

張念慈 介紹醫材伯樂Shifamed 來台灣尋寶馬

高階醫材躥紅 矽谷商登台覓金主 2014年06月23日 04:10 記者杜蕙蓉／台北報導 新藥展現蓬勃活力，高階醫材緊跟發光，美國矽谷知名醫療器材育成公司Shifamed來台募資，預計合計將募集6,600萬美元（合新台幣19.8億元）育成基金和Shifamed基金旗下二家心律不整電燒術高階醫材公司，由於之前Shifamed已有子公司被收購，18個月回報率20倍成功案例，吸引科技、金控、創投A咖爭相投資。 Shifamed創辦人、執行長Amr Salahieh表示，台灣已累積深厚的半導體與電子基礎，不排除在台灣投資，將Shifamed旗下育成的創新產品在台灣生產，讓台灣與矽谷經驗結合。 創立於2009年的Shifamed，是以開發創新高階醫材為主，標的選擇是以經過科學驗證的產品，該公司因成功育成子公司Maya Medical，開發治療惡性高血壓醫材，從公司成立到被Covidien以2億3千萬美元併購，僅18個月，且回報率高達20倍，而聲名大噪。 引薦Shifamed到台灣的浩鼎董事長張念慈表示，國內的新藥展現能量，但高階醫材的力道較為薄弱，Shifamed有成功開發產品上市經驗，且願意來台投資，將有助於台灣高階醫材的扎根。 Amr Salahieh表示，目前已規劃將募集5千萬美元Shifamed醫療器材育成基金，而Shifamed旗下也有二家公司，由於產品較成熟，也規劃合計募集1,600萬美元，推動產品上市。 其中，進度最快的Kalila Medical公司，開發的心律不整電燒術的血管鞘，已獲得歐盟CE、美國FDA認證，產品將於2個月後上市，目前預計要募資4百萬美元。 另外，Apama Medical公司，開發的下一代心律不整電燒術治療系統，預計明年啟動人體臨床，產品預計2017年在歐洲上市，已規劃募資1千2百萬美元，俾以順利完成產品開發與取得歐盟認證。 Amr Salahieh表示，將募集的5千萬美元的Shifamed醫療器材育成基金，是天使基金的模式，除了投資Kalila Medical和Apama Medical公司外，還有約4家公司規劃中。 不同於新藥開發長達10年的時程，醫材由於開發期短，且成功率高，加上國內有完整的電子產業供應鏈，未來有機會將Shifamed旗下產品導入台灣生產下，包括科技、金控、創投和財團也爭相入股，預期近期將有合作佳音。

Amr Salahieh is a seasoned medical device entrepreneur with more than 20 years of experience. Amr is the founder, president, and CEO of Shifamed, LLC from which Apama Medical, Kalila Medical, Maya Medical and other stealth mode medical device companies have been formed. In April 2012, Maya Medical was acquired by Covidien for $230 million in cash and earn out payments. Amr was also the founding President and CEO of Sadra Medical, a percutaneous aortic valve replacement company that was sold to Boston Scientific for $450 million in January 2011. Previously, Amr and his team at Sobek Medical developed the FilterWire, which was sold to Boston Scientific/EPI and prior to that he was one of the first employees of Cardiothoracic Systems which was sold to Guidant Corporation. Amr is an inventor/co-inventor of 64 US issued patents and 104 pending patent applications. He holds a Bachelor of Science degrees in Biomedical and Electrical Engineering from Case Western Reserve University where he is an Adjunct Professor

 

 

葡萄王集團布局: 曾水照(集團)/ 曾盛陽(中國)/ 曾盛麟(台灣)/ 曾美菁(葡眾)

生技論壇加持／葡萄王訊聯 動能強 【經濟日報╱記者黃文奇／台北報導】 2014.06.23 02:42 am預防保健概念股今年旺，葡萄王（1707）、訊聯、景岳等，受惠於老齡化商機顯現，國人預防保健觀念成熟，帶動公司今年營運逐漸升溫。其中葡萄王推出「即食」產品，為公司營運加入新動能。葡萄王集團下半年將繼續推動轉型，首先將攜手本土超商7-ELEVEN、全家等，正式跨入「健康即食」市場，首波將推樟芝王、LGG特益菌、靈芝王、益菌王等四樣產品，全面搶攻上班族商機。葡萄王在「健康即食」市場規劃已久，此次將推出的四樣小包產品，是將葡萄王原有銷售長紅的產品，拆裝為小包裝，瞄準個人化商機，為葡萄王開拓另一銷售業務。 此外，葡萄王旗下葡眾毛利率與產品價格俱揚，帶動獲利率攀高，法人估，今年葡眾對葡萄王獲利的貢獻，將可望優於去年，有機會推升母公司營運再創新高。 訊聯方面，公司引進「非侵入性胎兒染色體檢測（NIPT）」服務第三年，今年首季收件量年增136%，顯示該市場逐漸成長，未來商機可期。訊聯表示，由於女性懷孕檢測中，孕婦逐漸對「羊膜穿刺」風險意識增加，加上非侵入性的檢驗科技已逐漸成熟，也進一步讓「非侵入式產前檢測」逐步受到重視。 至於景岳，近期併購食品公司白木屋股權，共投資約16億元，而白木屋正式成為景岳100%子公司。 據悉，白木屋目前年營業額約4、5億元，高於去年景岳營收的3.08億元，換言之，白木屋今年起可望陸續挹注母公司景岳合併營收。 【2014/06/23 經濟日報】

葡萄王轉型 跨足健康即食 【經濟日報╱記者黃文奇／台北報導】2014.06.05 03:31 am葡萄王執行副總曾盛麟昨（4）日表示，集團將續推轉型，6月中葡萄王將攜手本土超商7-ELEVEN、全家等，正式跨入「健康即食」市場，首波將推樟芝王、LGG特益菌、靈芝王、益菌王等四樣產品，全面搶攻上班族商機。葡萄王成立迄今45年，是老牌製藥、生技廠，本業為健康飲品、保健食品生產與製造。其子公司葡眾經營突出，占葡萄王總營收比重近八成，每年創造20%以上成長動能，名列國內傳直銷公司第三名，僅次於安麗、美樂家，優於賀寶芙、如新等。曾盛麟表示，葡萄王在「健康即食」市場規劃已久，此次將推出的四樣小包產品，是將葡萄王原有銷售長紅的產品，拆裝為小包裝，瞄準個人化商機。業者指出，小包裝產品在日本行之有年，且廣受歡迎，台日都會區消費者需求相近，將為葡萄王開拓另一銷售業務。此外，有調節血糖功能並有健字號認證的產品「醣安欣」，下半年也將在有藥師駐點的通路開賣。葡萄王今年首季合併營收13.9億元，稅後純益1.95億元，每股稅後純益（EPS）1.49元。市場預估，葡萄王今年EPS有望順利跨越8元，挑戰一個股本。葡萄王指出，葡眾今年來因漲價導致成長趨緩，但旗下產品價格調漲，因此獲利率相對增加，往年葡眾營收年增率目標是10%，但每年的年增率卻在20%以上，去年營收53億元，年增27%，展望今年營運審慎樂觀。今年起，葡眾將開始規劃海外市場，葡萄王表示，這是集團首度將傳銷事業向海外發展，第一個進軍的國家為馬來西亞，因為該國鼓勵傳直銷產業，為此集團正審慎評估當地法規、稅務、營運模式，希望二到三年內進軍東南亞市場。展望今年，葡眾營收成長雖趨緩，但毛利率與產品價格俱揚，讓獲利率也攀高，法人估，今年葡眾對葡萄王獲利的貢獻，將可望優於去年，有機會推升母公司營運再創新高。

第二代 注入營運能量  曾水照 葡萄王由董事長曾水照一手創辦，膝下有三名子女，現在全都在集團內襄助父親擘劃事業，曾水照小兒子、葡萄王執行副總曾盛麟四年前才自英國歸隊，他表示，現在大哥曾盛陽拓展大陸市場，二姊曾美菁負責葡眾，他幫忙母公司業務，兄弟同心要打造「幸福葡萄王」。葡萄王旗下產品大多是台灣人所熟知，舉凡康貝特、靈芝王、樟芝王，近年，葡眾業務蒸蒸日上，調節體質的產品「康貝兒」，占該公司營收三成，更是許多家庭主婦的最愛。業界指出，近年葡萄王第二代注入新血輪，是提升集團營運能量的主因。【2014/06/05 經濟日報】

 

 

鐿鈦 董事林寶彰 (台灣微創醫材董事長)/ 獨董童瑞龍(童綜合副董)

鐿鈦科技：公告本公司103年股東常會決議解除新任董事及其代表人競業禁止限制案 鉅亨網新聞中心　　2014-06-18 19:51:51　第二條　第21款 1.股東會決議日:103/06/182.許可從事競業行為之董事姓名及職稱: 董事長-蔡永芳 董事-林寶彰 董事-鍾兆塤 董事-林春榮 董事-中國信託創業投資(股)公司 代表人：游智元 獨立董事-宋清國 獨立董事-童瑞龍 3.許可從事競業行為之項目: 董事長-蔡永芳 Aoltec International Inc.財務長/董事 台灣微創醫療器材(股)公司法人董事代表 Ever Golden International Limited董事 董事-林寶彰 台灣微創醫療器材(股)公司董事長 Aoltec International Inc.董事長 董事-鍾兆塤 Aoltec International Inc.總經理/董事 董事-林春榮 Aoltec International Inc.祕書長/董事 董事-中國信託創業投資(股)公司及代表人：游智元 波士頓生物科技創業投資(股)公司董事 得藝國際媒體(股)公司監察人 偶動漫娛樂事業(股)公司董事 華研國際音樂(股)公司董事 志氣高電影(股)公司董事 華文創(股)公司董事 台康生技(股)公司董事 一條大路電影(股)公司董事 台灣之星移動電信(股)公司董事 台灣氣立股份有限公司監察人 台灣氣立股份有限公司法人代表監察人 獨立董事-宋清國 匯豐汽車(股)公司法人代表董事 源創產業投資顧問(股)公司監察人 Yusin Holding Corp.獨立董事 獨立董事-童瑞龍 童綜合醫療社團法人副董事長 旭東機械工業(股)公司董事 串合企業(股)公司董事長 尚有利企業(股)公司董事 京傣企業(股)公司董事 4.許可從事競業行為之期間:任職本公司董事職務期間。 5.決議情形（請依公司法第209條說明表決結果）:經主席徵詢全體出席股東無異 議通過。 6.所許可之競業行為如屬大陸地區事業之營業者，董事姓名及職稱（非屬大陸地區事業之 營業者，以下請輸〝不適用〞）:不適用。 7.所擔任該大陸地區事業之公司名稱及職務:不適用。 8.所擔任該大陸地區事業地址:不適用。 9.所擔任該大陸地區事業營業項目:不適用。 10.對本公司財務業務之影響程度:無。 11.董事如有對該大陸地區事業從事投資者，其投資金額及持股比例:不適用。 12.其他應敘明事項:無。Neurology. 2001 Oct 23;57(8):1428-34.

 

柯P衛生政策/ 健保 重視治療 非預防&健康

柯文哲提衛生政策藍圖 2014年06月22日 15:43 中央社 代表在野整合的台北市長參選人柯文哲今天提出衛生政策藍圖，表示要落實「家醫、分級、轉診、論人計酬」。 柯文哲上午受邀出席2014台灣國際醫療展覽會暨第四屆海峽兩岸醫事交流學術論壇，在會中發表台北市衛生政策藍圖。 他說，目前台灣健保只重視醫療，忽略健康，醫院不做公共衛生、社區健康，只注重賺錢的效率，為正視問題，提出台北市衛生政策籃圖。 柯文哲說，擬重建醫療體系，落實運動習慣，以促進健康、公共衛生及社區醫療著眼，對於患者執行居家護理、居家安寧及個案管理，因此未來衛生政策將落實「家醫、分級、轉診、論人計酬」為主。

 

 

鑰孔蟲戚血藍蛋白(keyhole limpet hemocyanin, KLH)載體蛋白 於 醣疫苗運用

Cancer Vaccines from a Blue-Blooded Mollusk Posted on June 2, 2013 by Andrew Porterfield  Megathura crenulata, or the giant keyhole limpet, runs up to 10 inches in size, and uses an unusual molecule for breathing: hemocyanin. Instead of its red-blooded terrestrial oxygen carrier hemoglobin, hemocyanin is blue in color, carries a copper molecule instead of iron, and is used by marine snails and mollusks for gill-based respiration. The molecule is fortuitous not only for the mollusk. Hemocyanin, especially keyhole limpet hemocyanin (KLH), also has long shown potential as a delivery vehicle for vaccines—especially cancer vaccines. Vaccines work by mimicking the actions of a disease-causing cell or other foreign body. As they enter the blood, they'll trigger a response by the body's white blood cells (called T or B cells), which multiply and start to attack the foreign body. Once the vaccine is killed, the immune response will remain strong, often permanent. But anti-cancer antigens are often too small to elicit an immune response. Without such a response, the body won't be able to kill abnormal cells before they become full-fledged tumors. But KLH, which is a very, very large molecule, does elicit a slight immune reaction, resulting in T cells (and sometimes B cells) in the host that are specific to the cancer vaccine molecule. These KLH-vaccine combinations are undergoing clinical trials in a number of research institutions, for follicular lymphoma, non-Hodgkin lymphoma, glioblastoma, and melanoma, and bladder, prostate and ovarian cancer. A biotechnology company in California, Stellar Biotechnologies, is harvesting KLH by farming keyhole limpets, and hopes that KLH will be approved as a drug (or in this case, a vaccine enhancer). While many natural substances are chemically tweaked for better performance, enhanced absorption by the human body, or other factors, KLH seems to work on its own. In addition, Stellar Biotech says, the KLH molecule is so large it defies artificial synthesis. While the cancer-vaccine possibilities of KLH have been studied for years, its molecular structure was discovered only two years ago, which has created more potential for targeted vaccines. KLH is one of the largest carrier molecules in existence: resembling a hollow tube, it is assembled from two 500 kDa polypeptide subunits. By comparison, most proteins top out at about 200 kDa. KLH has eight functional units, each of which carries a single copper active site to reversibly bind to oxygen. This structure, as well as recent studies showing specific B cell homing activity for various KLH-antigen combinations, may finally provide a clinically available vaccine from the giant limpet. The KLH story is a relatively new one in drug discovery. Many possible therapies may arise from organisms living in the ocean, but the discovery of these therapies has only seriously started over the past two decades or so. So, when in California or Mexico and you stumble upon a nearly foot-long flattish shell sticking to a rock, you might consider thanking it.

Keyhole limpet hemocyanin KLH is purified from the hemolymph of Megathura crenulata by a series of steps that typically includes ammonium sulfate precipitation and dialysis, and may involve chromatographic purification to obtain the highest purity. KLH purification may also include endotoxin removal, but this step is often unnecessary because the endotoxin serves as an adjuvant when injected for antibody production. If the protein becomes denatured or if the copper ions are lost in the purification process, the opalescent blue color disappears and the solution becomes a dull grayish color. Denaturation of KLH also results in a tendency of the protein to aggregate and precipitate from solution.

Use in biotechnology Keyhole limpet hemocyanin (KLH) is used extensively as a carrier protein in the production of antibodies for research, biotechnology and therapeutic applications. Haptens are substances with a low molecular weight such as peptides, small proteins and drug molecules that are generally not immunogenic and require the aid of a carrier protein to stimulate a response from the immune system in the form of antibody production.[3] KLH is the most widely employed carrier protein for this purpose. KLH is an effective carrier protein for several reasons. Its large size and numerous epitopes generate a substantial immune response, and abundance of lysine residues for coupling haptens allows a high hapten:carrier protein ratio, increasing the likelihood of generating hapten-specific antibodies. In addition, because KLH is derived from the limpet, a gastropod, it is phylogenetically distant from mammalian proteins, thus reducing false positives in immunologically-based research techniques in mammalian model organisms. KLH can also be a challenging molecule to work with because of its propensity to aggregate and precipitate. Aggregates remain immunogenic, but limit the ability to conjugate haptens, and are difficult to manipulate in the laboratory. A high-quality KLH preparation with clear opalescent blue color is the best indicator of KLH solubility.

Hapten coupling Haptens can be coupled to KLH using several methods. A simple one-step coupling can be performed using the carbodiimide crosslinker EDC to covalently attach carboxyls to primary amines. This method is the simplest to perform and the "random" orientation allows for antibody generation against all possible epitopes, but it generally results in some degree of polymerization, which decreases solubility making the conjugate more difficult to handle. KLH can be activated with the crosslinker Sulfo-SMCC, which converts lysine residues to sulfhydryl-reactive maleimide groups. A sulfhydryl-containing hapten can then be reacted with the KLH to complete the immunogen without causing polymerization. The specificity of this reaction is ideal for situations where the cysteine is located away from the desired epitope (e.g. in peptides where a terminal cysteine can be added to either end of the peptide). Maleimide activated KLH, where the first part of this two step procedure has been completed, is commercially available.

Other carrier proteins Concholepas concholepas hemocyanin (marketed as Blue Carrier) Bovine serum albumin (BSA) Cationized BSA (cBSA) Ovalbumin

Use in cancer therapy KLH is being tested in a variety of cancer vaccines, including non-Hodgkins lymphoma, cutaneous melanoma, breast and bladder cancer. These vaccines contain specific tumor-associated antigens conjugated to KLH to stimulate anti-tumor immune responses which can destroy tumor cells. The rapidly growing interest in therapeutic vaccines (i.e. active immunotherapies) for cancer and the documented efficacy of KLH as a superior carrier protein for cancer vaccines are creating a significant biopharmaceutical market for KLH formulations. Assays to monitor humoral immune responses against KLH in human serum have been developed to facilitate optimal use of biomedical KLH applications.

 

anti-sense (Akt-1) , Archexin, 合併everolimus (Afinitor(R))用於腎癌 (RCC)

Rexahn Initiates Phase IIa Clinical Trial of Archexin® in Patients with Metastatic Renal Cell Carcinoma FDA has Granted Orphan Drug Designation for Renal Cell Carcinoma Business Wire Rexahn Pharmaceuticals, Inc. January 14, 2014 9:00 AMROCKVILLE, Md.--(BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company, announced today the initiation of a Phase IIa clinical proof-of-concept trial to study the safety and efficacy of Archexin® in patients with metastatic renal cell carcinoma (RCC). Archexin was previously granted Orphan Drug Designation for the RCC indication. The Phase IIa Archexin proof-of-concept clinical trial is a multi-center study designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor®) to treat metastatic RCC patients and will be conducted in two stages. Stage 1 will be dose ranging with up to 3 cohorts of 3 RCC patients to determine its maximum tolerated dose in combination with everolimus. Based on previous clinical data the target dose of Archexin is anticipated to be no more than 250 mg/m2 per day. The decision to enroll the next group of patients and escalate the dose will be made after completion of the first 21 day cycle of treatment. Patient assessments will include safety, pharmacokinetics, laboratory and physical exams. Once the maximum tolerated dose of Archexin in combination with everolimus has been determined, thirty RCC patients will be randomized to either Archexin in combination with everolimus or everolimus alone, in a ratio of 2:1. The primary endpoint will be the percentage of progression free patients following eight cycles of therapy. Patients will be scanned (CT or MRI) for the assessment of tumor progression after every 2 cycles of therapy. Secondary endpoints include pharmacokinetic profile, incidence of adverse events, changes in clinical laboratory tests and vital signs over time, tumor response, duration of response, time to response, and response rate. Exploratory endpoints will include blood levels of AKT pathway biomarkers, tumor apoptosis biomarkers or other relevant biomarkers. Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer commented, "The start of the Phase IIa clinical-proof-of-concept trial in RCC patients represents an important milestone for the Archexin clinical development program. The combination of strong scientific data, unmet clinical need, and our Orphan Drug Designation were all driving factors for choosing this indication." Archexin is a specific inhibitor of the cancer cell signaling protein Akt-1. The activated form of Akt-1 (phospho-Akt-1) has been shown to be involved in cancer cell growth, survival, angiogenesis, and drug resistance. Phospho-Akt-1 has been shown to be significantly increased in more than 12 different human cancer cell lines including human renal cell carcinoma cells. Archexin has shown to inhibit the growth of human RCC cells in tissue culture and produce a substantial survival benefit in animal xenograft models of RCC. Archexin also exhibits additive anti-tumor effect when combined with other cancer drugs in inhibiting the growth of human RRC cells in tissue culture. In addition, resistance to the anti-cancer effects of clinically used mTOR inhibitors such as everolimus (Afinitor®), which is used as second line therapy in RCC patients, has been attributed to an increase in Akt-1 activity. Thus, treatment with Archexin may both inhibit the growth/proliferation of RCC and overcome the resistance to mTOR inhibitors such as everolimus, resulting in an increase in efficacy. Dr. Neeraj Agarwal MD, Director, GU Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, "The treatment of patients with metastatic RCC remains a significant unmet medical need. Selective Akt-1 inhibition represents a very promising new mechanism for the treatment of metastatic RCC. The potential to both inhibit the growth of RCC cells and affect the underlying mechanism responsible for the development of tolerance to second line therapies such as everolimus is very promising."

About Archexin® Following a comprehensive scientific, clinical and business analysis of potential cancer indications for a new Phase IIa clinical trial with Archexin, Rexahn decided to pursue metastatic RCC. Metastatic RCC represents an attractive market opportunity with an estimated annual incidence of 90,000 patients world-wide and projected market size of greater than $6 billion. Metastatic RCC patients receiving standard of care treatment have a poor prognosis with an overall survival of less than 2 years. Rexahn has received the U.S. Food and Drug Administration's (FDA) Orphan Drug Designation for Archexin for metastatic RCC as well as four other cancers including pancreatic cancer. Archexin is a unique anti-sense drug candidate that specifically inhibits the cancer cell signaling protein Akt-1. Archexin is the only specific inhibitor of Akt-1 in clinical development. The activated form of Akt-1, which is involved in cancer cell growth, survival, angiogenesis, and drug resistance, has shown to be present or elevated in more than 12 different human cancer cell lines, including pancreatic and renal cell carcinoma. By inhibiting Akt-1, Archexin has shown to both inhibit the growth of human renal cell carcinoma cell lines and exhibit a longer survival benefit in the human renal cell carcinoma animal xenograft model. Thus, while Akt-1 is a very specific anti-cancer target it may have broad therapeutic potential across multiple types of cancer. Archexin has completed a Phase I clinical trial in cancer patients with solid tumors and was shown to be safe and well tolerated. The dose-limiting toxicity was a grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic cancer patients, Archexin in combination with gemcitabine was shown to be safe and well tolerated. It demonstrated a preliminary efficacy signal with a median survival of 9.1 months in evaluable patients.

About Rexahn Pharmaceuticals, Inc. Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing best-in-class therapeutics for the treatment of cancer. Rexahn currently has three clinical stage oncology candidates, Archexin®, RX-3117, and SupinoxinTM (RX-5902), and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of Nano-Polymer-Drug Conjugate Systems (NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information, please visit www.rexahn.com.

Generic Name:       20-mer oligonucleotide complementary to Akt mRNA ■Trade Name:      n/a ■Date Designated:    12-08-2004 ■Orphan Designation:    Treatment of glioblastoma ■Orphan Designation Status:        Designated ■FDA Orphan Approval Status:     Not FDA Approved for Orphan Indication ■Sponsor: Rexahn Corporation 9620 Medical center Drive Rockville, MD 20850

 

 

INO-3112 DNA抗癌疫苗

Inovio Pharmaceuticals Initiates Cervical Cancer Clinical Trial Inovio's Immunotherapy will Treat Women with Inoperable HPV-caused Cancer June 23, 2014, 4:00 a.m. EDT BLUE BELL, Pa., June 23, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (nyse mkt:INO) today announced it has initiated a phase I/IIa clinical trial to evaluate safety, immunogenicity, clinical responses and disease-free survival of its DNA immunotherapy product, INO-3112, in treating human papillomavirus (HPV)-associated cervical cancer. INO-3112 is a combination of Inovio's lead active immunotherapy product, VGX-3100, and its proprietary immune activator expressing interleukin-12 (IL-12). VGX-3100 is currently being evaluated in a randomized phase II efficacy trial for the treatment of high grade cervical dysplasia (pre-cancer). This open-label study, called HPV-004, will evaluate INO-3112 in 20 female subjects with inoperable invasive cervical cancer. Subjects will receive four treatments of INO-3112 every four weeks after completion of a standard chemoradiation regimen. Each INO-3112 treatment will be a combination of 6 mg of VGX-3100 and 1 mg of DNA-based IL-12 delivered together intramuscularly with the CELLECTRA® delivery system. As an exploratory analysis, the study team will evaluate clinical responses at the tumor site (tumor shrinkage or regression) and assess disease-free survival and disease recurrence up to 12 months after the initial immunotherapy with Inovio's INO-3112. Cellular (T cell) immune responses will be analyzed pre- and post-immunotherapy in the tumor tissue as well as in the bloodstream. In a phase I trial of VGX-3100, Inovio demonstrated that this HPV immunotherapy produced high levels of durable T cell immune responses, notably CD8+ T cells, in 78% of all patients. These CD8+ T cells showed the functional ability to kill target cells displaying the antigens E6 and E7. In preclinical animal models, this DNA-based immunotherapy demonstrated 100% protection against HPV E6 and E7-expressing tumors and prevented or delayed the growth of such tumors. The proprietary IL-12 immune activator, called INO-9012, was previously shown to enhance antigen-specific CD4+ and CD8+ T cell immune responses to Inovio's PENNVAX® HIV DNA vaccine in a clinical trial. Inclusion of this DNA-based immune activator in INO-3112 is intended to further strengthen the generation of HPV-specific CD8+ T cells to treat HPV-caused cancer. This cervical cancer study is being conducted at the University of Chicago Medical Center and at the Comprehensive Cancer Center at Silver Cross, IL, where Dr. Yasmin Hasan, Director of Gynecological Radiation Oncology and Brachytherapy, is the principal investigator. Dr. J. Joseph Kim, Inovio's President and CEO, said, "This study extends our pioneering HPV immune-based treatment into cervical cancer, the No. 2 cancer killer of women in the world. Our goal is to fully address the post-HPV infection immune therapeutics markets, targeting not only HPV-related cervical pre-cancer but also cervical cancer as well as head and neck and anogenital cancers." "Cancer immunotherapy is focused on generating cancer fighting T cells and freeing them to attack targeted cancer cells. Inovio has demonstrated that its therapies mobilize more antigen-specific T cells than any other product on the market or in development. We look forward to reporting unblinded cervical dysplasia phase II study data on efficacy and T cell responses by the end of July. Our aim is to have the best and most extensive pipeline of active cancer immunotherapies with the potential to seek out and destroy cancer cells," said Dr. Kim.

HPV and Cervical Cancer Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans and causing almost all cervical cancers. Approximately 12,000 women in the U.S. are diagnosed with cervical cancer annually and more than 4,000 will die from the disease. Worldwide, cervical cancer results in about 275,000 deaths per year. Currently available HPV vaccines are highly effective at prevention; however, they are not intended for women already infected with HPV or those who already have developed dysplasia or cancer. Current treatments include surgery (radical hysterectomy) and/or combination radiation and chemotherapy. These treatments have many potential damaging side effects.

VGX-3100 and INO-3112 for Treating HPV-Caused Diseases  Inovio's lead product, VGX-3100, is a DNA-based immunotherapy for pre-cancers and cancers caused by HPV. This product, without an immune activator, is currently in a randomized, double-blind phase II trial evaluating its efficacy and immune responses against HPV-caused cervical dysplasia. INO-3112 combines this immunotherapy with a DNA-based IL-12 immune activator to further boost the targeted immune response against head and neck cancer, cervical cancer and other cancers.

Inovio's Immune Activators Immune activators can play a vital role in augmenting antigen-specific immune responses such as those generated by Inovio's DNA vaccines. Inovio's portfolio of patent-protected, DNA-based immune boosters vary in their ability to activate and enhance therapeutic T cells or preventive antibodies, modulate the type of immune responses produced by the vaccine, impact durability of immune responses, and drive immune responses to sites of infection, e.g. mucosal surfaces. Different immune activators can therefore play unique roles in achieving desired immune responses generated by DNA immunotherapies and vaccines. Moreover, while some protein-based cytokines and chemokines have been shown to have severe toxicity, likely due to their dosing levels and systemic delivery, Inovio's DNA-based immune activators and immunotherapeutics are delivered together at one injection site with the goal of enabling local production by the body of cytokines or chemokines, along with antigens that drive immune responses with disease modifying benefits and no toxic systemic effects.

About Inovio Pharmaceuticals, Inc. Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines, in combination with its proprietary electroporation delivery, are generating best-in-class immune responses, with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth, and response rate. Human data to date have shown a favorable safety profile. Inovio's lead vaccine, a therapeutic against HPV-caused pre-cancers and cancers, is in phase II. Other phase I and preclinical programs target prostate, breast, and lung cancers as well as HIV, influenza, malaria and hepatitis. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. More information is available at www.inovio.com .

 

抗排斥藥 : Thymoglobulin (alemtuzumab) PK IL2 ab (basiliximab)

 Antibody induction therapy in adult kidney transplantation: A controversy continues.World J Transplant. 2012 Apr 24;2(2):19-26. Antibody induction therapy is frequently used as an adjunct to the maintenance immunosuppression in adult kidney transplant recipients. Published data support antibody induction in patients with immunologic risk to reduce the incidence of acute rejection (AR) and graft loss from rejection. However, the choice of antibody remains controversial as the clinical studies were carried out on patients of different immunologic risk and in the context of varying maintenance regimens. Antibody selection should be guided by a comprehensive assessment of immunologic risk, patient comorbidities, financial burden as well as the maintenance immunosuppressives. Lymphocyte-depleting antibody (thymoglobulin, ATGAM or alemtuzumab) is usually recommended for those with high risk of rejection, although it increases the risk of infection and malignancy. For low risk patients, interleukin-2 receptor antibody (basiliximab or daclizumab) reduces the incidence of AR without much adverse effects, making its balance favorable in most patients. It should also be used in the high risk patients with other medical comorbidities that preclude usage of lymphocyte-depleting antibody safely. There are many patients with very low risk, who may be induced with intravenous steroids without any antibody, as long as combined potent immunosuppressives are kept as maintenance. In these patients, benefits with antibody induction may be too small to outweigh its adverse effects and financial cost. Rituximab can be used in desensitization protocols for ABO and/or HLA incompatible transplants. There are emerging data suggesting that alemtuzumab induction be more successful than other antibody for promoting less intensive maintenance protocols, such as steroid withdrawal, tacrolimus monotherapy or lower doses of tacrolimus and mycophenolic acid. However, the long-term efficacy and safety of these unconventional strategies remains unknown.

 

抗排斥藥 效益/經濟 權衡! 生物製劑 (alemtuzumab) PK X_limus !!

Cost-effective Immunosuppressive Options for Solid Organ Transplantation: A Guide to Lower Cost for the Renal Transplant Recipient in the USA Immunotherapy. 2010;2(6):879-888.

Abstract Of the numerous risks associated with immunotherapy for the prevention of rejection, cost is perhaps the most universal. In the USA and some other countries, the costs of immunosuppression make transplantation unavailable for some medically viable transplant candidates, and for others who receive a transplant, the long-term costs are economically crippling. Minimization and tapering of immunosuppression, use of generics, manipulation of metabolism, infection surveillance instead of prophylaxis, and advantageous routes of administration are some strategies that can be employed to reduce immunotherapy expense. Using these strategies, we describe an immunosuppression regimen for kidney transplantation that might be only a third of the cost of current 'standard' regimens in the USA. Such a regimen might allow some patients who might not otherwise qualify economically to safely receive a kidney transplant. The purpose of creating an alternative, lower-cost immunotherapy regimen is to give patients a choice. Responsible stewardship of scarce donor organs is the primary, and clearly appropriate, limiting factor.

Introduction Solid organ transplantation is one of the remarkable achievements of modern medicine. Patient and kidney graft survival rates at 1 year exceed 95% after living donor kidney transplantation, and life expectancy is substantially increased compared with those patients who remain on dialysis.[1–3] Replacement of lost organ function by transplantation clearly increases longevity and improves quality of life, but at the cost of requisite immunosuppression to prevent allograft rejection. Effective immunosuppression has numerous side effects, including nephrotoxicity, diabetes, anemia, cytopenias, hypertension, neuropathy and manifestations of over immunosuppression, such as infection and malignancy. However, one of the most universal complications of immunosuppressive drugs used in current protocols for solid organ transplantation is the economic burden placed on graft recipients. In the USA, the cost of immunosuppressive drugs and the monitoring required by their administration has been estimated at more than US$30,000 in the first year after transplantation, and approximately US$15,000 per year thereafter.[101] For some potential transplant candidates, the cost of immunosuppression is prohibitive to the medical benefits of transplantation.

A Potential Low-cost Immunotherapy Regimen for Kidney Transplantation The design of a cost-effective immunotherapy regimen would include at least some of the strategies discussed above; surveillance (rather than prophylaxis), use of generics, metabolic manipulation, advantageous use of efficient routes of administration and drug minimization. Table 1 shows the average wholesale price (AWP) of many of the individual drugs that make up the typical immunotherapy regimen for kidney and pancreas transplantation. The most commonly used immunosuppressive regimen includes a brand CNI, MPA, and anti-infectives, including valganciclovir ( Table 3 ). The annual cost of this 'standard' regimen (based on AWP) is approximately US$30,000. Although many current immunosuppression protocols aim to eliminate steroids, prednisone is the least expensive immunotherapeutic agent commonly used in solid organ transplantation ( Table 1 & Table 2 . The overall cost of transplantation might actually be reduced by steroid avoidance, as suggested by Gheith.[43] However, if the ability to receive a transplant is an economic choice based on the cost of the medical regimen to the patient, then use of steroids should be considered. Of the antimetabolites, AZA is by far the least expensive ( Table 1 & Table 2 . Use of AZA instead of MPA derivatives would significantly lower the cost of maintenance immunosuppression compared with standard regimens ( Table 2 , Table 3 & Table 4 ), but might come at a cost in efficacy as suggested by the meta-analysis of studies comparing AZA versus MPA-containing regimens (see earlier). In a randomized study of delayed conversion of MPA to AZA in a sirolimus-based immunotherapy regimen, El-Agroudy found a low risk of acute rejection and substantial cost savings.[44] However, initial use of AZA, instead of MPA, might be reasonable (as compared with current steroid-free regimens) if combined with steroid and a CNI ( Table 4 ). Addition of a T-cell-depleting induction agent, such as alemtuzumab, might further reduce the risk of acute rejection. Recipients at low immunological risk for rejection (low panel reactive antibody titres [PRA], primary kidney transplant only) commonly receive the standard, but expensive, immunotherapy protocol (i.e., CNI and MPA) and an IL-2 receptor-blocking induction agent. No studies have compared this 'high-cost' regimen to a lower-cost regimen of T-cell depletion (alemtuzumab), CNI, AZA and steroid. Other components of a cost-conscious immunotherapy regimen might include Bactrim (if not allergic) and ketoconazole (to boost CNI levels and allow lower CNI doses). Patients who demonstrate immunity to CMV (CMV IgG-positive) could be monitored for CMV infection rather than receive prophylaxis with valganciclovir, and fungal infection could also be treated if it should occur. Based upon AWP, a regimen containing TAC, AZA, prednisone, ketoconazole and Bactrim would be less than a third of the expense of current standard regimens, if all outcomes from its use were similar; a prospect that would require empiric comparison.

 

 

Thymoglobulin (Genzyme) /Atgam (Pfizer)

Summary of FDA Workshop on Ischemia Reperfusion Injury in Kidney Transplantation American Journal of Transplantation Volume 13, Issue 5, pages 1134–1148, May 2013Antibody induction therapy for kidney trasplant Two antithymocyte globulin (ATG) agents licensed for clinical use in the United States are Thymoglobulin (rabbit ATG, rATG, Genzyme) and Atgam (equine ATG, eATG, Pfizer). Thymoglobulin and Atgam are currently licensed for use in the treatment of renal allograft rejection; Atgam is additionally licensed for use in the treatment of aplastic anemia. Both drugs are used in off-label applications, especially as immunosuppression induction agents before and/or during kidney transplantation. An rATG product made by Fresenius is marketed outside of the United States. ATG administration very substantially reduces immune competence in patients with normal immune systems, through a combination of actions, some explicitly understood and some more hypothetical. rATG in particular effects large reductions (through cell lysis) in the number of circulating T-lymphocytes, hence preventing (or at least delaying) the cellular rejection of transplanted organs. However, medical opinion remains divided as to when the benefit of this profound reduction in T-cells outweighs the concomitant increased risks of infection and malignancy. In the United States it is frequently given at the time of the transplant to prevent graft-versus-host disease,[1] although many European centers prefer to reserve its use for the treatment of steroid-resistant acute rejection, as European centres generally serve more homogeneous populations and rejection tends to be less of a problem.

Enlimomab (ICAM-1 antibody) 對出血中風無效反更糟 !!!

Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial.

BACKGROUND: There has been recent interest in the possible role of reperfusion-induced inflammation with neuronal injury after stroke. Enlimomab, a murine intercellular adhesion molecule-1 (ICAM-1) antibody, reduces leukocyte adhesion and infarct size in experimental stroke studies. The purpose of the current clinical trial was to evaluate the use of enlimomab after ischemic stroke.

METHODS: A total of 625 patients with ischemic stroke were randomized to receive either enlimomab (n = 317) or placebo (n = 308) within 6 hours of stroke onset. Treatment was given over 5 days. Patients were evaluated at baseline and on days 5 and 90 after initiation of treatment; long-term assessments were carried out after 6 and 12 months. The primary efficacy endpoint was the response to therapy at 90 days on the Modified Rankin Scale; other endpoints included Barthel Index (BI) and NIH Stroke Scale and survival.

RESULTS: At day 90, the Modified Rankin Scale score was worse in patients treated with enlimomab than with placebo (p = 0.004). Fewer patients had symptom-free recovery on enlimomab than placebo (p = 0.004), and more died (22.2 versus 16.2%). The negative effect of enlimomab was apparent on days 5, 30, and 90 of treatment (p = 0.005). There were significantly more adverse events with enlimomab treatment than placebo, primarily infections and fever. Patients experiencing fever were more likely to have a poor outcome or die.

CONCLUSIONS: The authors conclude that anti-ICAM therapy with enlimomab is not an effective treatment for ischemic stroke in the model studied and, indeed, may significantly worsen stroke outcome.

 

 

陳恒德: 展旺獨立董事

展旺：補充公告本公司改選董事(董事變動達三分之一以上) 鉅亨網／鉅亨網新聞中心-2014年06月11日 上午09:20第三十四條　第6款1.發生變動日期:103/06/102.舊任者姓名及簡歷:董事:徐展平(美國麻省理工學院化工博士)董事:CH & SB Holding Limited董事:啟航創業投資股份有限公司董事:華榮電線電纜股份有限公司董事:留栽生(詮夏化學股份有限公司董事長)董事:潘世賢(美國華盛頓大學化學工程博士)獨立董事:林寶新(PJJS規則公司總裁)獨立董事:顧曼芹(潤惠生技股份有限公司總經理)獨立董事:陳高明(明文彥科技有限公司董事長)3.新任者姓名及簡歷:董事:漢友財務管理顧問股份有限公司董事:CH & SB Holding Limited董事:啟航創業投資股份有限公司代表人呂宗憲董事:華榮電線電纜股份有限公司代表人吳賢明董事:留栽生(詮夏化學股份有限公司董事長)董事:佳駒投資有限公司獨立董事:張日炎(張日炎會計師事務所負責人)獨立董事:陳恒德(生技整合育成中心醫務長)獨立董事:陳高明(明文彥科技有限公司董事長)4.異動情形（請輸入「辭職」、「解任」、「任期屆滿」或「新任」）:解任、新任5.異動原因:103年股東常會提前全面改選董事6.新任董事選任時持股數:董事:漢友財務管理顧問股份有限公司:1,307,440股董事:CH & SB Holding Limited持股數:3,526,000股董事:啟航創業投資股份有限公司代表人呂宗憲持股數:5,497,000股董事:華榮電線電纜股份有限公司持股數代表人吳賢明:4,088,412股董事:留栽生持股數:259,000股董事:佳駒投資有限公司持股數:1,349,720股獨立董事:張日炎持股數:210,250股獨立董事:陳恒德持股數:0股獨立董事:陳高明持股數:0股7.原任期（例xx/xx/xx ~ xx/xx/xx）:102/05/03~105/05/028.新任生效日期:103/06/109.同任期董事變動比率:不適用10.其他應敘明事項:本公司設置審計委員會及薪資報酬委員會

展旺、藥華藥、杏國 各擁題材 2014年06月23日 04:10 記者方明／台北報導 興櫃生技題材眾多，再度成為市場焦點，價量齊揚！展旺（4167）在潤惠總經理顧曼芹加入後，股價一飛衝天，短短5個交易日漲幅達15％；中裕（4147）、藥華藥（6446）、有新藥二、三期臨床；杏國（4192）、浩鼎（4174）、瑞基（4171）則加緊腳步IPO及上櫃核准，在此些題材加持下，預料股價將不寂寞。 顧曼芹先前任職的潤惠生技，為潤泰集團總裁尹衍樑和生技天后許照惠投資，展旺則以原料藥開發為主，主力產品是碳青黴烯類抗生素的Meropenem（美洛培南）及Imipenen（伊諾培南），近年該公司在大股東新力美極力整頓後，今年力拚損平，且由於已獲高科技事業核准函，估第4季可望轉上櫃。 顧曼芹接任展旺董座一職後，其光環對公司大大加分，市場預期有助該公司未來營運布局，激勵該股近期股價向上噴出，周五收盤均價來到45.98元，短短5個交易日漲幅達15％，股價再創新高。 藥華藥今年將有3項藥物處於人體試驗臨床第三期階段，包括真性紅血球增生症於歐洲及美國的試驗，去年9月已收入第1位病人；C型肝炎基因第2型的全球性試驗，預計今年底開始收案。 該公司計畫送件申請科技事業核准函，逐步啟動轉上櫃規畫，近期股價維持高檔整理，周五收盤均價200.29元，仍居興櫃生技股價第3高。 中裕的愛滋新藥TMB-355完成靜脈注射二期臨床，由於目前愛滋病對新藥需求殷切，FDA可望讓中裕補做小臨床或直接讓該公司免做三期臨床，而讓中裕有機會在明年取得藥證。中裕股價自4月一路大漲後，近期也在高檔整理，周五收盤均價180.32元。 而同為新藥的杏國及浩鼎，因新藥廠短期獲利不易，2家公司紛紛申請科技事業核准函，加快上市櫃腳步。其中，杏國已通過高科技事業申請，目前上櫃送件中。目前除技轉國內研調機關的研發成果進入人體臨床試驗外，並入股國際新藥公司，加深策略合作關係，並藉此取得更多潛在開發新藥的能量。 瑞基以農業科技事業申請上櫃，已通過審議會核准，今年第1季營收2,946萬元，稅後虧損1,346萬元，EPS虧損0.44元，周五收盤均價為46.65元。

 

 

禿頭: 植髮筆 (無痕植髮) 拼接案量 !!

FUE植髮不留疤 禿頭患者新救星 【中時健康 楊格非／台北報導】2014.06.23 FUE植髮不留疤 禿頭患者新救星國際旅遊評論網站（Trip Advisor）公布全球各國禿頭率大調查，捷克為禿得最厲害的國家，布拉格有42.7％的男人不是禿頂，就是正在落髮。專家分析，捷克男性禿頭率高的主要原因是飲食習慣不健康，難消化的肉類食用過多，蔬菜則吃太少，且口味偏鹹，加太多調味醬料。明錦健康時尚診所孫增貴院長指出，飲食是造成國人禿髮的重要因素之一，不過台灣氣候悶熱，頭皮容易出油，一旦個人衛生習慣差，更容易導致頭皮毛囊健康出問題，加速掉髮。如能在落髮初期，透過生髮及先進的FUE植髮相互輔助，即可阻止髮線升高，再生濃密髮量。孫增貴院長表示，不少夏季掉髮嚴重個案都為騎機車上下班的男性，由於安全帽內罩沒有定期更換的習慣，加上氣候悶熱潮濕，頭皮流汗出油，如果頭皮偏油性，頭皮毛囊容易阻塞發炎，引發搔癢不慎抓破，造成脂漏性皮膚炎，導致頭皮毛囊健康急遽惡化，掉髮量便會暴增。一旦察覺掉髮量異常增加，最好及早尋求專業醫師協助，找出原因加以治療，千萬不要求助偏方，延誤了禿髮的黃金治療期。目前禿髮治療，主要分為生髮及植髮二類。生髮是借助外抹藥水以及內服藥物的方式，來增強頭皮毛囊的健康，延緩禿髮。而植髮則是從後腦杓摘取健康的頭皮毛囊，移植到毛囊萎縮的頭皮區域，增加毛髮的密度。二者進行前都需要進行一項關鍵步驟──換髮皮。換髮皮並非血淋淋的換頭皮，而是連續4天在頭皮上塗抹藥水，休息2天後，第7天就能從頭皮上剝落一層皮質。換髮皮目的在於讓阻塞的毛孔開放，如此生髮水才能深入滲透，提高療效，而開放的毛孔如同健全的土壤，能使毛囊植入後存活率大增。至於植髮則區分為傳統FUT及新式FUE無痕植髮二種方式，差別在於取得捐贈頭皮毛囊的方式不同。醫師針對禿髮患者的需求，評估出需要移植的毛囊數量後，在患者頭皮上找出適合的捐贈區，若採取FUT，需要割下一小段的頭皮，然後從頭皮上分離出健康的毛囊，植入受贈區。如採取FUE無痕植髮，則不必割頭皮，直接以精密儀器取下健康毛囊，植入受贈區。由於FUT割頭皮常讓許多患者心生畏懼，頭皮不夠柔軟者也不適合此項手術。FUE無痕植髮不需要割頭皮，日後也不必蓄長髮遮蓋疤痕，成為禿髮患者的新救星。不過，FUE適用於小面積植髮，針對雄性禿、圓形禿及髮際線升高等問題，效果較佳，若屬大面積植髮，則需要分兩階段手術。孫增貴院長強調，植髮手術屬於先進的團隊技術，至少需要多名頭皮毛囊分離師以及植髮醫師，彼此合作無間，才能順利完成。因此，禿髮民眾應慎選經驗豐富的專業團隊，才能有高品質的療效。至於接受植髮手術後，患者應維持良好作息不熬夜，飲食清淡，多補充有助毛囊生長的維生素B群、蛋白質及礦物質，提高毛囊移植後的成功存活率，定期回診接受毛囊健康檢查，搭配養髮生髮護理，恢復濃密秀髮將指日可待。一般來說，東方人每平方公分頭皮約含90個毛囊，捐贈區一次可取17個毛囊，留下73個毛囊，整體看來才不致於稀疏。若評估需要移植1000株毛囊，捐贈區約為長寬12公分，高5公分，共有60平方公分大小。孫增貴醫師指出，FUE之所以能做到微創無痕的效果，主要是因為手術使用直徑只有0.06到0.08公分的植髮筆，它的大小剛好能取出完整的毛囊組織，但植入傷口最小，因此可同時達到術後恢復快、疼痛低，且毛囊移植存活率高，不浪費珍貴的毛囊。為了進一步提高毛囊移植存活率，毛囊從捐贈區取下後，會進行軟組織修整，然後浸泡利用患者血液離心製成的PRP「自體再生因子」中，以刺激受贈區萎縮的毛囊再生，提高毛囊植入後的生長機會。患者術後的配合與保養，可提高FUE術後的成效，建議植髮後在毛囊生長穩固關鍵期的二週內，嚴禁各種刺激性飲食如海鮮、辣的食物及菸酒，並定期回診追蹤頭皮健康狀況，視需要加強頭皮養護。

 

由Medtronic併購Covidien 看見中國8萬億元大健康產業板塊位移 (研發/多元/渠道) !!

掘金8萬億大健康產業 聚焦高端醫療器械(附股) 鉅亨網新聞中心　(來源：金融界)　2014-06-23 09:53　 編者按：今年以來，A股公司陸續披露了131起醫藥醫療並購或投資的公告，與文化產業成為A股最熱板塊。在此背景下，PE精英與實業家在日前舉辦的第四屆中國醫療健康產業投資與並購大會上，縱論了8萬億元大健康產業"蛋糕"哪部分"最好吃"。從討論結果看，高階醫療器械、專科連鎖醫院及移動醫療三大領域最受青睞。

大健康產業升級激發潛力 醫療並購基金分食8萬億"健康是一個具有無限發展空間、發展前景的朝陽產業。"國務院參事室特約研究員、中國醫療協會會長王東進日前在第四屆中國醫療健康產業投資與並購大會上表示，"十一五"以來我國基本醫療保險制度建設高歌猛進，廣大群眾長期被壓抑的醫療需求空前釋放，醫療衛生支出每年以20%的速度增長，去年以高達31661.5億元，是"十一五"初的3.2倍。 北京大學國家發展研究院經濟學教授劉國恩預測，到2020年中國醫療衛生健康產業規模將達到8萬億，大健康"盛宴"開啟。 人們基本醫療需求向更高層次保健需求、生命質量需求邁進，為大健康產業提供了巨大的商機和市場，而由此帶來的醫藥、器械、服務市場的"蛋糕"也引得醫療產業並購基金的"垂涎"，醫療並購基金正借助產業投資升級、互聯網加速滲透等多重因素，正獲得前所未有的挖掘潛力。

投資熱情燃燒 2014年以來資本市場眾多VC/PE都在投資業務上做減法，砍去諸多投資部門，但保留最多的就是TMT和醫療健康。清科研究中心統計顯示，2013年VC/PE共投資了210家醫療健康企業，達到2008年以來最高水平。投資金額總計19.9億美元，僅低於"全民PE"火熱的2011年。 "如果一家綜合基金，沒有設立醫療投資部門是無法想象的，"清科集團董事長倪正東認為，擁有巨大需求的醫療健康行業始終會是VC/PE關注的領域。正因為整個醫療健康行業不太受整體經濟環境影響，不論是金融危機還是經濟下滑，醫療健康行業一直呈現穩健增長，尤其在中國伴隨著醫改深入，醫療健康領域機會也會逐步顯現。 而這當中有諸多的細分領域頗受青睞。"現在整個投資界最關心的兩大行業，一個是移動互聯網，一個是醫療健康，所以兩個最熱門的行業的交集，就是移動醫療所以說在未來的三年五年，移動醫療會有巨大的機會。"倪正東坦言，未來的幾年移動互聯網和醫療健康的結合，將有巨大的機會。 其實，目前尚未完善的健康醫療領域給予投資者很多改善空間，如醫療資源不均、醫療服務較差、健康管理不足、醫療成本較高等。從美國移動醫療產業發展經驗來看，移動醫療的病患方需求包括慢性病管理、健康管理，乙方需求則包括醫院內部溝通、患者溝通等。 業內分析人士認為，基於中國擁有全球最大、增長最迅猛的移動用戶群，其多樣化的消費模式給移動醫療提供眾多可選擇市場；中國政府推動的醫療政策改革，在醫療服務的可能性、質量和效率上都進行大規模投入。在上述兩種力量下，中國移動醫療服務市場前景可觀。

並購基金青睞 "對於我們來說，對未來萬億的醫療產業充滿預期的，這其中科技醫療即互聯網醫療、移動醫療服務將受到最廣泛的關注，這就是中融康健資本為什么組建專項醫療並購基金。"中融康健資本董事長禹勃在與會介紹，另外公司還將目光放在基本醫療服務、公共醫療並購領域。 據了解，中融康健與愛爾眼科(行情,問診)日前簽署了"關於共同投資成立中融愛爾眼科醫療投資管理有限公司"的決議，它也將是兩公司牽手打造的規模10億元，關注醫療健康產業投資和公立醫療資產改制方向的公司制產業基金。倪正東介紹，在2013年A股IPO暫停后並購成為VC/PE新的退出選擇，這當中VC/PE參與主導的並購案例最多便發生在醫療健康行業。從歷史數據可知，醫藥領域仍是並購的最大戰場，並購數量占到總數的46%，另外醫療設備、醫療服務分別占比33%和5%。從金額來看，醫藥和醫療設備並購規模分別占67%和23%。在這之中，很多都是上市公司做的戰略性的投資和收購。（.中.國.證.券.報）

全球醫療器械最大並購：美敦力429億美元鯨吞柯惠  生物科技行業的天價並購在這個夏季異常躁動。在制藥業巨頭輝瑞欲以千億美元多輪洽購阿斯利康后，美國當地時間6月15日，全球第二大醫療器械公司美敦力（Medtronic Inc.）又宣布以429億美元的驚人代價並購了全球500強企業柯惠醫療（Covidien Plc），企業並購估值不斷被更新。 當日，美敦力相關聲明中明確表示："美敦力方面已同意以每股93.22美元、合計429億美元的價格收購柯惠醫療，交易將以現金和股票的形式完成。" 無論在全球范圍內還是細分如中國市場，美敦力都與另四大外資醫療器械巨頭GE（通用電氣）、強生醫療器械、西門子以及飛利浦打得難分難解。如今一舉吸納了愛爾蘭手術器械制造商柯惠醫療的業務，美敦力的競爭底氣顯然得以充足。 相較於2012年美國強生斥213億美元收購瑞士醫療器械服務公司辛迪思（Synthes），此番美敦力429億美元收購柯惠醫療的大手筆或使其成為醫療器械領域至今最大的一宗收購案。

鯨吞柯惠醫療 目前，美敦力產品領域主要覆蓋心臟節律疾病、脊柱疾病以及神經外科等疾病治療領域，與柯惠醫療產品線重合度很低。此宗收購也被視為更像是一次新業務的擴容采購，而非豐富公司既有的產品線。 美敦力首席執行官Omar Ishrak（奧馬爾·伊什拉克）表示，這筆交易的主要動機是"戰略和業務定位"，與柯惠醫療的合並主要將加速支援美敦力的三大核心戰略，即治療手段創新、全球化以及提高經濟價值。 "一旦並購交易最終完成，美敦力將極大增強其全球高階醫療器械企業的地位，產品線將大為豐富，所售范圍將涉及更多地域，而利潤的增長也將更加多元化。"公司聲明中指出。 據悉，這宗大型並購完成之后，兩家企業合計總收入將超過270億美元，其中包括來自新興市場的37億美元收入。此外，美敦力方面表示，除卻柯惠的這宗投資，公司承諾在未來十年另外投入100億美元在美國本土科技投資上，主要針對美敦力與柯惠醫療公司現有計劃外的項目（如早期風投、研發等）進行投資。而此前，美敦力方面已對超過80個美國公司合計投資了83億美元。 不過，有不少業內人士對雙方合作尚存疑慮，稱"大型企業間的合並在敲定合作初期難度較小，而真正涉及到兩方員工崗位去留、管理體系合並等后期深度整合的過程中，一系列的決策可能會引發海外員工的抵觸"。 收購后，美敦力公司將在全球超過150個國家擁有約87000名員工，而對於柯惠醫療旗下超過38000 名的員工而言，相當規模的裁員離職似乎已經不可避免。 值得注意的是，與輝瑞洽購阿斯利康並在英國注冊類似，被收購后的柯惠醫療將在愛爾蘭本國進行注冊，美敦力可借此海外並購釋放出約140億美元的現金持有，成功在課稅嚴格的美國境外得以避稅。

 "后並購"時期的美敦力中國 與此前醫療器械行業推崇有機增長法不同，近年來行業大並購成為了巨頭們的共識。而這其中，素有並購機器之稱的美敦力出手頻率相當之高。 "1998年美敦力收購了脊柱疾病公司Sofamor Danek和冠狀動脈支架生產商AVE后，都在這兩個細分領域做到了如今全球第一。2001年收購的胰島素泵公司MiniMed也做到了行業第一，三家並購而來的公司過去十年間共為美敦力帶來超過191億美元的收入。"美敦力方面表示。 而中國市場在這場企業大並購中也扮演著愈發重要的作用。 以柯惠為例，2000年進入中國市場的柯惠醫療，在華的業務正處於發展的攻堅期。相較於前述幾大綜合醫療器械集團，主攻普外醫療器械的柯惠醫療近年來鮮有重大舉措，與集團負責人高調喊出的"要在2016年成為中國第二大醫療器械公司"的雄心相去甚遠，正是理想的並購標的。 "盡管業績增速和體量與前五大外資醫療器械藥企難以匹敵，但十余年來在華深耕的銷售渠道和本地化研發團隊、工廠產能都已日趨成熟，2012年柯惠已對其中國研發中心投資了4500萬美元。因而在完成收購后，美敦力日后發展柯惠在華業務就省下了大量前期資金投入和時間成本。"前述業內人士指出。據了解，2009年至2012年間，柯惠醫療在中國市場的增長率保持在25%-30%左右。 顯然，美敦力對於中國市場的胃口還遠不限於此。早在2007年，美敦力就已與山東威高醫療設備公司（8199.HK）成立合資公司，並收購威高公司15%的股份。在2012年7.55億美元又並購了常州康輝醫療，后者是紐約證交所上市的知名骨科器械生產企業。（.21.世.紀.經.濟.報.道）

國產醫療設備加速進口替代 三類股盡享政策紅包 日前，衛計委發布公告稱，為推進國產醫療設備發展應用，促進相關產業轉型升級、拉動經濟增長，降低醫療成本，衛計委規劃司委派中國醫學裝備協會啟動第一批優秀國產醫療設備產品遴選工作。綜合考慮國產設備產能、市場發展空間和產品利用率等因素，選擇數字化X線機、彩色多普勒超聲波診斷儀和全自動生化分析儀3種基本醫療設備為第一批遴選品目。根據工作安排，適時開展其他品目遴選工作。 受此鼓舞，近期醫療器械股表現較為活躍，6月份以來股價實現逆市上漲的個股達11只（上證指數同期下跌0.43%），占比57.89%。其中，千山藥機(行情,問診)期間累計漲幅居首達到7.92%，冠昊生物(行情,問診)（5.26%）、九安醫療(行情,問診)（4.73%）、陽普醫療(行情,問診)（4.53%）、理邦儀器(行情,問診)（3.09%）、寶萊特(行情,問診)（1.96%）和魚躍醫療(行情,問診)（1.84%）等個股期間累計漲幅均超過1%。 資金流向方面，6月份以來板塊內共有6只概念股實現大單資金凈流入，累計吸金9227.86萬元。其中，理邦儀器大單資金凈流入居首達到3852.21萬元，九安醫療、尚榮醫療(行情,問診)等2只概念股期間累計大單資金凈流入也超過1000萬元，分別為2429.51萬元、1821.11萬元。此外，魚躍醫療（698.49萬元）、冠昊生物（346.9萬元）和寶萊特（79.64萬元）等個股期間也獲得大單資金的青睞。 從官方檔案看，此次遴選工作為衛計委資訊司主辦，中國醫學裝備協會負責遴選。今年上半年遴選上述三個品種，下半年將開始其他品種的遴選，屆時將包括醫療設備、器械和耗材，為今後公立醫院配備醫療器械提供參考。這一遴選將有可能徹底改變國內醫療器械領域外資品牌一家獨大的局面，而且由於其評選標準中企業規模等基本參數占比20%，因此對國內大型企業將較為有利。 需要注意的是，國家領導人曾在5月23日表示，醫療設備是現代醫療業發展的必備手段，現在一些高階醫療設備基層買不起、老百姓用不起，要加快高階醫療設備國產化進程，降低成本，推動民族品牌企業不斷發展。緊接著5月26日晚間，衛計委啟動首批國產醫療設備遴選，這對於國產大型醫療設備企業是一個非常積極的信號。 對此，分析人士指出，盡管近年來我國醫療器械行業增長較快，但目前整體規模依舊較小。2004年至2012年之間，我國醫療器械行業的復合增長率達到27%，遠超全球7%至8%的增長水平；但2012年我國醫療器械市場規模僅占到醫藥總市場的8%，而2009年全球醫療器械的市場規模就已經占到醫藥總市場的42%，可見該行業未來發展空間廣闊。在這種背景下將有三類企業受益。第一，具有研發創新能力的企業，如華潤萬東(行情,問診)、理邦儀器、樂普醫療(行情,問診)；第二，擁有多元化產品線儲備的企業，擁有"已有產品+在研項目+潛在並購"能力，如理邦儀器和魚躍醫療；第三，擁有全球化營銷渠道的企業，如理邦儀器、九安醫療。 投資規則方面，安信證券表示，此次遴選工作充分體現了國家對國產醫療器械設備的鼓勵意圖，預計后續將出臺具體的扶持政策。在政策扶持的背景下，國產優質醫療設備完成進口替代的進程將大大加速。目前涉及的企業主要有魚躍醫療、科華生物、和佳股份(行情,問診)和理邦儀器等，上述企業均有望受益於該政策。不過考慮目前醫療器械板塊整體調整時間並不充分，建議關注基本面突出且已有較大調整幅度的個股，重點推薦和佳股份、魚躍醫療和科華生物。（.證.券.日.報）

東莞證券醫療器械行業2014年下半年投資規則 行業空間廣闊，高增長將持續。醫療器械是技術和資金密集型的朝陽行業。2013年，我國規模醫療器械收入達1889億元，盡管是13年前的20倍，但是占醫藥收入約10%，遠低於全球約44%的平均水平。未來從結構上和總體上均有巨大發展空間。 行業驅動因素多多。1、人口老齡化+消費升級，無疑將使醫療保健行業長期受益；2、龐大的基層（縣級）醫療機構放量；3、政策支援將迎來民營加速發展大潮；4、破除"以藥養醫"，加大醫保覆蓋率和報銷比例，糾正醫藥、器械和醫療服務的不合理結構；5、進口醫械設備占我國高階市場七成，未來在國家政策和企業技術升級的作用下，進口替代潛力大；6、技術創新開辟新需求。 二級市場:高景氣VS高估值。與整體市場低迷相對應的是，醫療器械板塊表現持續強勢。目前板塊動態估值也超過40倍，遠高於市場約11倍的水平。盡管長期空間毋庸置疑，但短期的高估值仍是制約股價表現的主要風險，注意把握節奏。

醫療器械中期規則:關注平臺化公司和景氣細分領域 中長期來看，醫療器械板塊將持續景氣、活躍，下半年機會仍主要來自持續平臺化進程的公司，以及基因測序和智慧醫療等高景氣領域的機會。 並購和平臺化。行業自身特點、一二級市場估值等因素，決定了器械行業並購的持續活躍和平臺化的必然選擇。重點關注未來有望平臺化潛力的公司:理邦儀器、和佳股份、寶萊特、三諾生物(行情,問診)、魚躍醫療。

可顛覆傳統醫療的技術創新--基因測序和智慧醫療 基因測序。基因測序應用廣泛，而二代基因測序技術的商業化將帶來市場規模的爆發性增長。但目前A股公司標的公司較少，且不確定高，相對看好達安基因(行情,問診)（背景深厚、研發實力強、分子診斷主業本身具有安全邊際）。 智慧醫療。主要包括可穿戴醫療設備和移動醫療，將從診斷、監護、治療等各醫療細分領域，開啟智慧化時代，有效設定資源，將個性化醫療推向新高度，應用前景巨大。A股醫療器械上市公司中，也有不少優秀的公司，憑借產品、渠道、資金等優勢，開始進軍可穿戴設備、移動醫療、大數據等新醫療領域。建議重點關注和佳股份、寶萊特、三諾生物和福瑞股份(行情,問診)。（.東.莞.證.券）