亞諾法進軍中國醫學檢驗服務 2017-09-12 〔記者陳永吉／台北報導〕亞諾法生技（4133）昨天宣布，將透過100%轉投資中國子公司東莞懷慷基因，正式跨入中國第三方獨立醫學檢驗服務市場，將專攻精準醫療腫瘤液態活檢與分子檢測服務領域。亞諾法表示，已透過懷慷基因與中國東莞最大三級甲等醫院—東莞市人民醫院達成共建「液態活檢精準醫學中心」的戰略合作協議，未來雙方將結合彼此資源優勢，在腫瘤檢測診斷及臨床應用共同攜手合作。亞諾法指出，將以先進的CTC循環腫瘤細胞檢測平台技術與抗體試劑資源，提供腫瘤液態活檢及基因分子檢測的完整解決方案，而東莞市人民醫院每年有超過五千名腫瘤就診患者，提供其臨床醫療上的輔助診斷、術後即時監控與用藥指導項目，可協助推動新一代腫瘤檢測診斷技術在中國發展。亞諾法表示，根據2016年12月中國國家衛計委的新政策，鼓勵民營資本設立獨立醫學檢驗中心。隨著分級診療的推進，將部分檢驗業務外包到檢測項目齊全、質量可靠的第三方獨立醫學檢驗中心，將可實現區域資源共享，解決基層醫療機構資源不足、檢測能力不夠的問題。目前在全世界，美國獨立醫學檢驗市場已發展得相當成熟，獨立醫學檢驗機構約佔35%的醫學檢驗市場比重，在德國和日本，獨立醫學檢驗機構的市場佔有率均超過60%。而中國獨立醫學檢驗機構仍處於發展初期階段，目前僅佔中國醫學檢驗市場的2%，相較於美國或德國、日本，未來在新政策推波助瀾下將孕育龐大的發展商機，尤其對技術障礙更高的精準醫療腫瘤檢測診斷服務，將存在明顯的成長空間。
Wednesday, September 13, 2017
邦特 洗腎BIOTEQ品牌 行銷全球5大洲85個國家
剛性需求醫材類股 跌深就是最大利多 2017-09-11 09:07理財周刊 【文．馮泉富】【理財周刊第889期】 近期北韓政權持續挑釁美國等主要國家的忍受底線，連氫彈都拿來試爆了，還引起六級以上的人為地震，南韓隨即以軍演射擊回應。不過，雖然區域衝突風險大幅升高，美股雖然重挫補跌卻未失守季線，待清洗浮額後可望持續碎步盤堅的慣性走勢。
台股逢北韓核試 終將回歸基本面 檢視北韓過去五次核試爆，台股多半經過壓力測試後先下後上，這回適逢新閣揆上任又內閣大改組，急欲展現新氣象的政府，從官股券商連日買超可見眉角，而內資加碼點火動作，從科技股轉向蟄伏已久的傳產、綠電及生醫股，頗有遍地開花企圖，面對道瓊補跌兩百多點的利空，九月六月一度重挫近百點但尾盤跌幅收斂，顯見新閣上路對台灣資本市場，有只能加分不能扣分的壓力。目前不論道瓊指數、S&P500指數、NASDAQ指數或與台股連動較高的費半指數，都十分接近歷史高點，隨時都有再創新高的可能；而亞洲則有大中華區股市，展現超強的免疫力來互相輝映，除了上證綜合指數、深圳綜合指數領先再創波段新高以外，台灣加權指數截稿前也創收盤價波段新高。顯然，除了市場資金充沛的因素以外，目前參與者的信心明顯高過地緣衝突的利空。觀察幾項重要因素，確實也相對有利於多方。首先，我們一再提過的重點指標，美元指數，仍舊處於弱勢整理，由此推測外資繼續滯留台股的機率大，在美元未明顯轉強以前，國際資金就無回流美元資產的誘因；只要資金不撤出亞洲，台股加權指數就可持續維持萬點常態。
美國經濟仰賴消費支出 最新數據增添市場信心 再者，美國商務部公布的七月個人支出月增0.3％，創下四月以來最大增幅；七月個人所得也月增0.4％，創下二月以來最大增幅。眾所周知，美國經濟產值有三分之二仰賴消費支出，因此這個數據讓市場對經濟基本面增添了不少信心。投資人也許想問，既然如此是否會讓FED加速升息呢？觀察被聯準會視為通膨指標的個人消費支出物價指數PCE，七月指數僅月增0.1％，較去年同期年增僅1.4％，遠低於聯準會設定的2％通膨目標，七月核心PCE物價指數已創下2015年十二月以來最小年增幅。
外資沒有大幅撤出之前 個股表現資金充沛無虞 以上的數據猶如鬼斧神工，控制得剛剛好，既有基本面的強度支撐市場信心，又不至於觸發FED加速升息的痛點，讓FED有更多的緩衝觀察時間，這就是目前全球股市所處的環境狀態。 如前所述，股市的多方格局暫時沒有太大的危機，但畢竟九月份是多事之秋，川普政權的信任危機，隱約成為金融市場最大的威脅，除了各方關注的川普稅改順不順利以外，還有九月十九日美國將召開的公開市場操作委員會(FOMC)會議，「升息」與「縮表」的看法將牽動全球股、債兩市的波動。另外，美國即將面臨的債務上限已經迫在眉睫，若美國國會九月三十日未能通過預算法案，聯邦政府許多非緊急部門可能立即停擺，股市也有可能提前反映政治風暴，總而言之，投資人需要常存風險意識。現階段台股的指數空間必須觀察外資態度，而近期外資買賣超金額不大，也無連續性，可見外資操作上是以換股為主，指數波動空間預估不大，市場波動結構將以個股表現為主。股市只要多方格局沒被破壞以前，在資金充沛無虞之下，聰明錢自己會找出口，所以從台股萬點常態化以來，個股波動的活潑度，隨著權值股外溢的資金擴散而加大，這是傳統內資「市場中實戶」最愛的行情結構。
低基期又具剛性需求 醫材股跌深就是利多 近期輪動的特徵，大部分由股價基期低，或經過中段整理，加上基本面可能轉佳的題材，市場就賦予不小的股價波動空間。若以類股族群觀察，生技族群的基期最低，除非公司無法獲利，否則股價跌深就是最大的利多，尤其是具有剛性需求的醫材股。例如太醫(4126)，為醫療耗材廠，主要產品包括手術房專用拋棄式管類、袋類、瓶類、相關儀器儀表，及醫院氣體輸送相關工程管線。上半年醫療耗材佔營收比例為92％，儀器占6％。自有品牌約占49％，以台灣、中國、新興區域為主；代工占51％，以歐美日等先進國家客戶為主。銷售區域分布，今年上半內銷佔19％，日本占21％、歐洲占20％、美洲占12％，中國占11％。其六月～七月營收年增率開始翻正，六月營收年增39.2％，七月營收年增11.6％，但股價已由2016年的125元修正到72元附近。
太醫銷售動能持續轉強 高毛利新產品線將量產 太醫目前進入旺季，而匯率影響可望較上半年縮減，太醫新廠已於去年底完工，未來年產能將由營收十八億增加至四十億左右，目前正陸續將舊廠設備搬遷及新增新產線設備，台灣GMP認證預期將於第四季取得，歐美、中國等重要市場認證將落在2018年上半，日本認證落在2018下半年。新廠啟用後，公司將有更大訂單承接能力，同時一些高毛利新產品線也將進入量產，預期各國認證陸續完成後，2018～2019年銷售動能可望持續轉強。法人預估2017年因有業外匯兌損失，估稅後淨利2.66億元，EPS約4.03元。2018年新廠認證陸續完成，新產品將開始放量，法人預估EPS約5.01元，年增率約24％。醫材的屬性原本就有其剛性需求，在類股輪動的結構裡，股價跌深就容易吸引市場買盤。再舉一具有剛性需求的例子，例如邦特(4107)，為國內血液透析相關醫療耗材的製造商，以自有品牌BIOTEQ行銷全球五大洲超過八五個國家。銷售地區為內銷占22％、亞洲占29％、美洲占17％、非洲占11％、歐洲占11％、中國占10％。
洗腎耗材成長能見度高 邦特多項產品市佔率大 目前邦特產品已逐漸由血液透析領域，轉往單價、毛利率較高的微創手術導管，產品線包括體內導管(含TPU)占25％、血液迴路管BTS占22％、藥用軟袋占19％、外科管占10％、AVF穿刺針占10％、關鍵零組件占8％。
國光生技 董事 丁詩同 退／陳瑞杰（北醫院長）接
國光生技 發言日期 106/09/12 發言時間 14:27:10 發言人 潘飛 發言人職稱 法務長 發言人電話02-27093833*5204 主旨 公告本公司法人董事代表人異動 符合條款 第6款 事實發生日106/09/12 說明 1.發生變動日期:106/09/12 2.法人名稱:行政院國家發展基金管理會 3.舊任者姓名及簡歷:丁詩同先生/行政院科技會報辦公室副執行秘書 4.新任者姓名及簡歷:陳瑞杰先生/台北醫學大學附設醫院院長5.異動原因:改派代表人6.原任期（例xx/xx/xx至xx/xx/xx）:106/06/29~109/06/28 7.新任生效日期:106/09/12 8.其他應敘明事項:無
醣基CHO-H01 醣均化抗體PK 單株抗體Rituxan
醣基9／27登興櫃 抗癌新藥拚進美國一期臨床 2017年09月12日 杜蕙蓉／台北報導 由中研院主導，鑽石投資基金注資成立的醣基生醫，預計9月27日登錄興櫃。醣基專攻全球創新的醣分子與蛋白質新藥，旗下進度最快以淋巴癌為治療標的醣重組均相化抗癌抗體新藥CHO-H01，已獲美國食藥局（FDA）核准一期臨床，該公司預計2～3年內將陸續有兩項創新藥完成臨床前試驗並提出IND（臨床試驗審查）申請。被視為生技公司重磅級的醣基生醫，成立於2013年，最大股東為中研院，持有37％股權，其為富邦、台新、潤泰與中天共同成立的鑽石生技投資。醣基目前實收資本額18億元，昨（11）日未上市行情約70元，不過，法人以該公司可望成為全球首創的醣均相化抗體新藥，認為未來興櫃價格有挑戰百元價位機會。醣基目前有六個以上新藥開發中，第一個產品CHO-H01將開始進入人體臨床試驗。據最新市場報告顯示，全球淋巴癌抗體藥物治療市場預估至2020年將成長至92億美元，年複合成長率為7.4％。全球抗癌藥物銷售龍頭，羅氏藥廠所開發可用於淋巴癌治療的Rituxan單株抗體（台名莫須瘤），過去五年，其每年銷售額均在70億美元以上。醣基表示，CHO-H01除了可治療淋巴癌外，對於其他適應症如類風濕性關節炎亦有效果。與既有藥物相比，該公司運用其特有的醣重組技術增強其功效，將可提供臨床用藥更佳選擇。(工商時報)
Alexion 裁員600人 專注Soliris (eculizumab ,Anti-C5補體抗體)新適應症
Alexion cost cutting is 'all about building pipeline' by Phil Taylor | Sep 12, 2017 Alexion is slashing its workforce by around 20% and closing sites in a bid to save $250 million a year, with R&D bearing the brunt and accounting for around two-thirds of the cost cutting. The restructuring will claim around 600 jobs and, according to senior management, is intended to answer a "critical need to rebuild pipeline" as Alexion starts to prepare for the loss of patent protection for cash cow drug Soliris (eculizumab)—which currently accounts for the bulk of the company's revenues—within the next few years. Alexion first revealed its intention to revamp the business earlier this year under new CEO Ludwig Hantson and CFO Paul Clancy, and has already pared down R&D to four key areas, namely hematology, nephrology, neurologic and metabolic disorders, and scrapped a series of partnership deals. Around $100 million of the savings will be routed back into R&D and business development, said Alexion, with the biotech expecting to make a series of licensing, partnerships and bolt-on acquisition deals to add to its current R&D portfolio. It wants to be spending 18%-19% of sales on R&D by 2018-2019, according to Clancy, who also said that the new deals are expected to be relatively small and not add too much debt. Among the other big decisions is the relocation of its headquarters from New Haven to Boston within the next 12 months, with Boston having around 400 positions and New Haven retaining around 450 staff, including 150 focusing on lab and process development work for Alexion's top priority complement R&D program. Explaining the HQ move, Hantson said on a conference call that it is important to be close to Boston hub to tap into talent pool and future partners. Complement—and specifically lead candidate ALXN1210, an anti-C5 antibody in late-stage development for paroxysmal nocturnal hemoglobinuria (PNH)—is now the key R&D focus, he said. The company also confirmed it is "eliminating the spend and headcount" in lower priority programs including enzyme replacement drug ALXN1101 for molybdenum cofactor deficiency (MoCD) Type A and cancer candidate ALXN6000 (samalizumab). Hantson said on the call that the company's research focus is "moving from ultrarare to rare, but staying in the orphan disease space." As it stands, ALXN1210 is the main focus, and head of R&D John Orloff, M.D., told analysts on the call that a trial in untreated PNH patients and a second in patients switched from other medicines are now fully enrolled and due to generate results in the first half of 2018, setting up possible approvals a year later. The shake-up at the firm followed sales fraud investigations involving Soliris that resulted in the resignation of long-serving CEO David Hallal. Other initiatives include the closure of a Rhode Island manufacturing plant and shuttering of multiple offices worldwide, with the total cost of the downsizing expected to come in at between $340 million and $440 million.
Alexion Pharma (ALXN) Granted New Indication for Soliris (Eculizumab) for the Treatment of Patients with Refractory Generalized Myasthenia Gravis by EU Commission (StreetInsider) August 21, 2017 Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced today that the European Commission (EC) approved the extension of the indication for Soliris® (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris is the first and only complement-based therapy approved in the European Union (EU) for this ultra-rare subset of patients.1-4 Patients with refractory gMG can have difficulties walking, talking, swallowing and breathing normally despite therapies currently used for MG. Exacerbations and crises of their disease may require hospitalization and intensive care and may be life-threatening.5-7 Soliris will be launched for this new indication initially in Germany, and Alexion is evaluating launches in additional EU countries."Patients with refractory gMG have exhausted multiple therapies and continue to suffer from severe symptoms and complications that markedly impact their daily lives," said Renato Mantegazza, MD, from the Department of Neuroimmunology and Neuromuscular Diseases, at the Istituto Neurologico Carlo Besta in Milan, Italy, and an investigator in the Phase 3 REGAIN study. "There is an urgent need for therapy for these patients, and it's exciting to have a product such as Soliris available that has demonstrated in clinical studies that it improves patients' symptoms and their ability to undertake daily activities." Chronic uncontrolled activation of the complement cascade, a part of the immune system, can play a major role in the debilitating symptoms and potentially life-threatening complications of refractory gMG.8-10 Soliris is a first-in-class complement inhibitor that specifically and effectively inhibits the terminal part of the complement cascade."Our deep understanding of complement-mediated diseases enabled us to develop Soliris for the treatment of patients with refractory gMG," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "We are grateful to the investigators and patients who participated in our clinical program, and we are excited about the opportunity to bring Soliris to patients who continue to suffer from this debilitating disease despite current therapies." The EC based its approval of the extended indication for Soliris on comprehensive clinical data from the Phase 3 REGAIN study (MG-301) and its long-term open-label extension study (MG-302). Alexion's supplemental Biologics License Application (sBLA) in the U.S. and a supplemental new drug application in Japan for Soliris as a treatment for patients with anti-AChR antibody-positive refractory gMG have been accepted for review by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW), respectively. Soliris has received Orphan Drug Designation (ODD) for the treatment of patients with MG in the U.S. and EU, and for the treatment of patients with refractory gMG in Japan.
About Refractory Generalized Myasthenia Gravis Patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive represent an ultra-rare subset of MG patients1-4 who continue to suffer from severe disease symptoms and complications despite therapies currently used for MG.1-2,11 MG is a debilitating, chronic and progressive autoimmune neuromuscular disease that can occur at any age but most commonly begins for women before the age of 40 and men after the age of 60.5,6,12,13 It typically begins with weakness in the muscles that control the movements of the eyeballs and eyelids, and often progresses to the more severe and generalized form, known as gMG with weakness of the head, neck, trunk, limb and respiratory muscles.13 While most symptoms in patients with gMG are managed with therapies for MG, 10% to 15% of patients are considered refractory—meaning they do not respond to multiple therapies for MG and continue to suffer profound muscle weakness, and severe disease symptoms that limit function.1-2,11 Patients with refractory gMG can suffer from slurred speech; impaired swallowing; double or blurred vision; disabling fatigue; immobility requiring assistance; shortness of breath, and episodes of respiratory failure. Complications, exacerbations and myasthenic crises can require hospital and intensive care unit admissions with prolonged stays and can be life-threatening.5-7 In patients with anti-AChR antibody-positive MG, the body's own immune system turns on itself to produce antibodies against AChR, a receptor located on muscle cells in the neuromuscular junction (NMJ) and used by nerve cells to communicate with the muscles these nerves control.5,6 The binding of these antibodies to AChR activates the complement cascade, another part of the immune system, which leads to a localized destruction of the NMJ. As a result, the communication between nerve and muscle is impaired, which in turn leads to a loss of normal muscle function.8-10,14
About Soliris® (eculizumab) Soliris® is a first-in-class complement inhibitor that works by inhibiting the terminal part of the complement cascade, a part of the immune system that, when activated in an uncontrolled manner, plays a role in serious ultra-rare disorders like paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and anti-acetylcholine receptor (AChR) antibody-positive refractory generalized myasthenia gravis (gMG). Soliris is approved in the U.S., EU, Japan and other countries as the first and only treatment for patients with PNH and aHUS, and in the EU as the first and only treatment for refractory gMG in patients who are anti-AChR antibody-positive. Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). Alexion and Soliris have received some of the pharmaceutical industry's highest honors for the medical innovation in complement inhibition: the Prix Galien USA (2008, Best Biotechnology Product) and France (2009, Rare Disease Treatment).
陣發性夜間血紅素尿症--疾病介紹成因：陣發性夜間血紅素尿症（簡稱PNH；paroxysmal nocturnal hemoglobinuria）是一種罕見而複雜的血液疾病，民國99年3月19日經衛生署公告為罕見疾病。重要特徵包括：慢性溶血、造血機能異常、血栓等。患者體內某些造血幹細胞帶有X染色體上PIGA基因的突變，且出現異常增生現象，造成很多紅血球缺乏CD55和CD59兩種表面蛋白質，容易受到補體系統攻擊破裂，引發慢性溶血並反覆發作。PNH雖罕見，不過世界上許多族群都有相關報告：發病年齡從6到82歲都有可能，通常在40到50歲間診斷；女性患者似乎比男性多一點點，但我國長庚醫院過去的較大規模報告中則以男性居多。此疾病是體細胞突變後造成，並沒有家族遺傳的傾向。
症狀：患者睡覺時較容易發生溶血，推測是睡眠時體內二氧化碳濃度較高或水分較少的緣故，目前還沒有定論。溶血會釋出血紅素，並經腎臟排到尿液中，因此半夜起來小便，尤其是剛睡醒後第一泡尿，會出現異常的紅色、茶色甚至黑色，讓人嚇一大跳！由於溶血現象時好時壞，夜間小便顏色異常一陣子後又會恢復正常，故歐洲醫師19世紀發現此疾病時，將它命名為「陣發性夜間血紅素尿症」。夜間血紅素尿現象雖然很能令人警覺，但其實只有約四分之一的患者曾出現典型血紅素尿。大部分病患最初的症狀，都與溶血或貧血有關，例如腹絞痛、下背痛、頭痛、倦怠感，甚至發燒等，小便顏色未必真的有什麼不對勁。此外，約有30%的PNH患者還有其他血球（血液細胞）數目的異常，甚至出現相關症狀：白血球偏低時可能容易感染、血小板不足時皮膚上出現紫斑等。這時需懷疑合併其他骨髓造血機能異常，例如PNH再生不良性貧血（aplastic anemia；AA）、PNH骨髓生成不良症候群（myelodysplastic syndrome；MDS）等，應做骨髓檢查。血管栓塞，特別是靜脈血栓，是一種比較少見但可能相當嚴重的併發症，會增加疾病的危險程度。常影響部位有腹部、皮膚、腦部靜脈，此外也有15-30%患者出現肝臟靜脈栓塞（Budd-Chiari症），故患者需特別注意是否有頭痛、肚子痛、噁心、嘔吐、黃疸、腹部積水、胃或食道靜脈區張出血、肝功能指數異常等現象。台大醫院曾報告過PNH造成罕見的腦部血管炎（moyamoya症）個案，故當有不明原因或特殊部位的血栓，又合併溶血或其他血球數目異常時，也要將PNH列入考量。其他症狀如：溶血引起腎功能異常、吞嚥困難或疼痛、勃起障礙等。
診斷：當醫師懷疑血紅素尿或溶血現象時，會做詳細的問診與身體檢查，看看是否有黃疸、肝臟腫大、脾臟腫大、紫斑等現象。初步的驗血包括全血球記數與分類（CBC/DC）、溶血相關生化與血液檢查（包括乳酸去氫酶）、腎功能檢查、鐵含量、尿液分析等。血中的乳酸去氫酶（LDH）是一種非專一性的指標，通常可作為溶血嚴重程度的重要參考。一旦確實懷疑PNH，需再抽血做「流式細胞儀（flow cytometry）」分析，檢查紅血球、白血球細胞表面是否缺乏CD55和CD59等用來穩定補體系統的蛋白質，並測定異常細胞的比例以判斷疾病嚴重程度。此外若有血管栓塞症狀，需安排相關腹部或腦部影像檢查。合併血球異常的患者，則應做骨髓檢查搭配細胞染色體檢查，以確實查明病因。
治療：PNH的治療以症狀處理為主：針對貧血，必要時需輸血，並考慮補充鐵質和葉酸，少數患者可能對雄性激素或皮質類固醇治療有反應；出現靜脈血栓的病人，應考慮接受抗凝血治療。美國食品藥物管理局（FDA）在民國96年核准上市的新藥eculizumab（商品名SolirisR），能透過抑制C5補體來阻止溶血，有效地減輕症狀、減少輸血、改善生活品質、降低靜脈血栓發生率。在我國需透過醫師與醫院向衛生署申請專案分批進口，經核准後以自費方式使用。使用前需接種流行性腦膜炎疫苗，以預防因補體下降而增加的感染風險。目前，只有異體骨髓或周邊造血幹細胞移植可以完全治好PNH，對於年紀較輕或合併血球數目異常的患者，若有白血球抗原配對相合的兄弟姊妹，值得考慮。不過其風險較高，對大部分症狀不嚴重的病人來說似乎顯得太過危險。
預後：PNH患者約有四分之一能存活超過25年，主要的危險性來自血管栓塞，以及合併血球下降後的出血和感染。一旦診斷確定，務必要長期規則追蹤，並隨時注意是否有疼痛、血尿、神經症狀等與溶血或栓塞有關的表現，以便儘早對相關併發症作適當的處理。
參考文獻：1. Brodsky RA: How I treat paroxysmal nocturnal hemoglobinuria. Blood 2009;113:6522-7.2. Parker C, Omine M, Richards S, et al.: Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood 2005;106:3699-3709.3. Lin HC, Chen RL, Wang PJ: Paroxysmal nocturnal hemoglobinuria presenting as moyamoya syndrome. Brain Dev 1996;18(2):157-9.4. Dunn P, Shih LY, Liaw SJ: Paroxysmal nocturnal hemoglobinuria: analysis of 40 cases. J Formos Med Assoc. 1991 Sep;90(9):831-5. 撰文：劉彥麟、楊永立、顏玎安文章出處: 罕見疾病基金會
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