浩鼎董事長曾達夢: ….將1.5億元推動台灣生醫!!!

新藥獲補助，浩鼎喊發回饋金 2012-12-26 【時報-台北電】台灣浩鼎（4174）開發用於治療轉移性乳癌疫苗OBI-822/821，昨(25)日通過獲經濟部7,500萬元補助其三期臨床，而該公司也承諾未來產品若成功對外授權，將以雙倍即1.5億元金額回饋公益性生醫研究機構，推動國內生醫產業發展。 OPT-822/821是浩鼎自行研發的癌症主動式免疫治療新藥，用於治療末期轉移性乳癌，今年8月獲衛生署食品藥物管理局(FDA)核准進入第三期臨床試驗；該計畫符合國際聯合臨床試驗計畫（GCP）在多國多中心展開；國內15個臨床試驗機構、香港及美國均已開始收募病人，印度、韓國等地亦即將計畫進行。由於OPT-822/821有機會成為全球第一個醣類分子癌症主動式免疫治療新藥，將搶佔全球高達200億美元的乳癌市場商機，年初曾一度引起美國浩鼎覬覦，有意併購，但目前已全數由潤泰集團等台灣股東完全拿下經營權，並推波浩鼎順利登錄興櫃市場，昨日興櫃價為90.5元。 浩鼎創辦人張念慈認為，產業的每一步進展，除了科研人員的心血外，還有許多來自大環境如法規、政策、資金等條件的配合，台灣生技產業發展條件也逐步成熟，未來10年內台灣只要有2、3個新藥成功上市打進國際市場，兆元的生醫產業就不是夢，將有機會主打「台灣牌」新藥。浩鼎董事長曾達夢指出，該公司通過經濟部「業界開發產業技術計畫」審查，獲得7,500萬元補助後，為了進一步回饋國人，未來OPT-822/821產品成功授權後，將提撥所收受簽約金及里程碑金各5％作為回饋金。 回饋金的2％捐贈國內公益性生醫相關研究機構，以充實國內生技醫藥研發經費。另3％作為浩鼎與國內學術研究單位或法人機構合作研發經費，且所有回饋金並不以本補助款為上限，初估將以1.5億做為回饋金總額。（新聞來源：工商時報─記者杜蕙蓉／台北報導）

 

科專核准 浩鼎OPT-822/821 臨床 7500萬元!!

浩鼎乳癌新藥臨床試驗獲補助【聯合晚報╱記者徐睦鈞/台北報導】 2012.12.26 02:42 pm 興櫃生技新兵台灣浩鼎生技(4174)宣布，所研發的OPT-822/821轉移性乳癌疫苗二/三期臨床試驗，通過經濟部「業界開發產業技術計畫」審查，獲政府7500萬元補助。浩鼎承諾，未來產品一旦成功對外授權，將以政府補助款雙倍的金額回饋公益性生醫研究機構，以鼓勵國內生醫產業透過研發、創新，生生不息。台灣浩鼎創辦人張念慈獲知審查結果後強調，再成功的產品，都須經歷長期艱困的研發階段，並感謝政府為鼓勵產業創新所做的努力。OPT-822/821在研發階段即為各界看好，浩鼎全力發展品牌新藥，盼成為「台灣之光」。浩鼎除了希望以新藥造福全球乳癌病患外，董事長曾達孟指出，為了進一步回饋國人，未來OPT-822/821產品成功授權後，將提撥所收受簽約金及里程碑金各5%作為回饋金；回饋金的2%捐贈國內公益性生醫相關研究機構，以充實國內生技醫藥研發經費；另3%作為台灣浩鼎與國內學術研究單位或法人機構合作研發經費，且所有回饋金不以本案補助款為上限，甚至願以本次補助款2倍、1.5億元做為回饋金總額。OPT-822/821是國人自行研發的癌症主動式免疫治療新藥，用於治療末期轉移性乳癌，今年8月獲衛生署食品藥物管理局核准進入第三期臨床試驗。該計畫符合國際聯合臨床試驗計畫(GCP)，在多國多中心展開，國內15個臨床試驗機構、香港及美國均已開始收募病人，印度、韓國等地也將進行，將可藉此一台灣主導的多國多中心臨床試驗，提升台灣臨床試驗水準，建立更完整的臨床試驗體系外，未來若獲上市核可，將成為全球第一個醣類分子癌症主動式免疫治療新藥，預估全球乳癌市場規模為200億美元，可大幅增加生技產值，對台灣生技產業具指標性意義。【2012/12/26 聯合晚報】

 

 

衛生署 核准 冷凍體雕?!

冷凍體雕 3成是大叔【聯合晚報╱記者黃玉芳/台北報導】 2012.12.27 08:35 am中年大叔夯冷凍體雕 / 黃玉芳最近上醫美診所做冷凍體雕的顧客，有三成是中年男性，就怕鮪魚肚不夠man。 報系資料照「中年大叔」愛美，就怕鮪魚肚不夠man，最近上醫美診所做冷凍體雕的顧客中，有三成是中年男性。不過醫師表示，冷凍體雕雖然會讓腰圍縮小，但消除的不是內臟脂肪，還是得搭配飲食、運動，才能遠離代謝症候群。不僅女生怕當小腹婆，男生也怕大肚腩，去年已有多家診所進行冷凍溶脂，利用脂肪細胞不耐冷的特性，以攝氏4至5 度低溫 ，將雕塑部位的脂肪降溫，再代謝掉。衛生署最近已核准這項療法，可以輔助減少腰、腹部脂肪層厚度。儷寶得皮膚科診所院長鄭國良說，有別於年輕男性以痘疤治療或注射玻尿酸、微晶瓷等填充物調整臉型，中年大叔更在意的是發福體態，尤其是一圈的鮪魚肚、兩側腰線等部位。他分析，到診所冷凍體雕的300多名民眾中，三成是30到50歲的「大叔型」顧客。有些是企業老闆，趕上午休美容的風潮，請司機載來診所，下午回公司繼續上班。鄭國良說，冷凍體雕跟最近另一項超音波震碎脂肪的治療類似，都是非侵入性的方式，但因為是「隔空抓油」，因此效果會慢一些，超音波溶脂約在術後的兩周、冷凍體雕約在術後的兩個月，漸漸顯出效果。不過鄭國良也說，冷凍體雕並非是減重、或是治療重度肥胖，主要是針對身材較為均勻，只是局部脂肪較為肥厚的人。同時，雖然冷凍體雕可以讓腰部脂肪消失，看起來腰圍縮小，但鄭國良也說，這些是腹部淺層脂肪，並非與代謝症候群相關的內臟脂肪，因此術後還是要搭配運動、以及正常的飲食，才能有腰身、也有健康。【2012/12/26 聯合晚報】@

 

國維聯科 新任內稽: 吳慧興

國維聯科(4734) 公告本公司內部稽核主管新任案 發言時間 101/12/2615:11:50發言人 張鋒琪 發言人職稱 總經理 發言人電話 02-28865111 主旨 : 公告本公司內部稽核主管新任案符合條款第11款事實發生日101/12/26說明 1.人員變動別（請輸入發言人、代理發言人、財務主管、會計主管、研發主管或內部稽核主管）:內部稽核主管2.發生變動日期:101/12/263.舊任者姓名、級職及簡歷:黃敏玉/稽核副理4.新任者姓名、級職及簡歷:吳慧興/稽核經理5.異動情形（請輸入「辭職」、「職務調整」、「資遣」、「退休」、「死亡」或「新任」）:新任6.異動原因:新任7.生效日期:101/12/268.新任者聯絡電話:02-288651119.其他應敘明事項:本公司內部稽核主管任命案,經101年12月26日董事會通過以上資料均由各公司依發言當時所屬市場別之規定申報後，由本系統對外公佈，資料如有虛偽不實，均由該公司負責.

 

南光 搭生技熱 現金增資33.5元 !!

南光(1752) 本公司董事會決議現金增資發行新股發言時間 101/12/2618:41:57發言人 蔡文泳 發言人職稱 處長 發言人電話 06-5984121分機2286 主旨 : 本公司董事會決議現金增資發行新股符合條款第11款事實發生日101/12/26說明 1.董事會決議日期:101/12/262.增資資金來源:現金增資發行普通股3.發行股數(如屬盈餘轉增資，則不含配發給員工部份):9,000,000股4.每股面額:新台幣10元5.發行總金額:按面額計新台幣90,000,000元6.發行價格:新台幣33.5元(暫定)7.員工認購股數或配發金額:保留發行股數15%予本公司員工承購。8.公開銷售股數:依法提撥發行股數之10%對外公開承銷。9.原股東認購或無償配發比例(請註明暫定每仟股認購或配發股數):發行股數之75%由原股東按認股基準日股東名冊記載之股東及其持有股份比例認購。10.畸零股及逾期未認購股份之處理方式:不足分認一新股者，由原有股東自認股基準日起五日內自行向本公司股務代理機構辦理併湊成整股。原股東及員工放棄認股之股份或併湊不足一股之畸零股，授權董事長洽特定人認購。11.本次發行新股之權利義務:與已發行普通股相同。12.本次增資資金用途:償還銀行貸款13.其他應敘明事項:(1)本次現金增資發行新股所訂之重要內容(如預計發行條件、發行價格、計畫項目、資金運用進度等)暨其他有關文件及事項，如遇法令變更、經主管機關修正或因應客觀環境而需修正時，授權董事長視實際情況全權處理之。(2)為配合本次資金募集作業，擬授權董事長代表本公司簽署一切有關本次現金增資所需之契約及文件，並全權處理未盡事宜。以上資料均由各公司依發言當時所屬市場別之規定申報後，由本系統對外公佈，資料如有虛偽不實，均由該公司負責.

 

景德製藥 微脂體SN-38(科專核准) 對上 台微體 !!!

景德製藥開發抗癌新劑型 獲科專計畫【經濟日報╱記者葉小慧／即時報導】 2012.12.26 10:25 pm 經濟部今（26）日業界科專計畫指導會議中通過8項業界開發產業技術計畫，其中包括景德製藥申請開發SN38高分子奈米微胞抗癌新劑型，將有助於帶動國內奈米生醫(Nanobio)產業的發展，未來相關產品若能進行本土化量產，將可有效降低健保及病人之支出；預估至2022年計畫衍生產值將可達新台幣100億元，並獲9國以上之專利核准。SN-38為市售大腸癌藥物Irinotecan的活性代謝物，其抗癌活性優於Irinotecan 100~1000倍，但難溶於水，導致製劑不易，必須藉助特殊載體系統，改善其溶解度，同時避免水解反應產生。有鑑於此，景德製藥申請的這項計畫，將開發SN38高分子奈米微胞抗癌新劑型，藉由技轉工研院所研發的「SN38高分子奈米微胞新劑型」技術，利用新穎微胞材料及包覆技術改善SN38的臨床使用限制，使SN38成為臨床可使用的注射新劑型，並藉由奈米尺寸，成為抗癌效果更佳、副作用小的新劑型藥物，同時運用具腫瘤標的功能的奈米微胞技術，進行新劑型製程技術開發及臨床前試驗，開發具臨床競爭力的抗癌藥物。【2012/12/26 經濟日報】

 

(住友商事Tomod's攜手三商行)複合模式= 便利店&藥妝店

日商中國大撤退》結合三商行優勢淡化日系色彩 住友台灣練兵下一站攻中國日期：2012-12-26 作者：陳彥淳 出處：財訊 第 413 期 又有日本藥妝店來台發展！這次是住友商事與三商行合作，準備各自發揮經營優勢，推出結合便利店與藥妝店的新業態，除了立足台灣，更將合作放眼亞洲市場。 在全日本擁有近140個據點、隸屬住友商事的Tomod's藥妝店，今年首度跨出海外市場，與三商行各持50％合資成立三友藥妝店，第一家店日前開幕，包括三商行董事陳翔立與住友商事高層都親自出席；住友商事直言，在亞洲國家中，台灣消費者對於藥妝店的接受度極高，是Tomod's跨足海外市場的首選，未來將挾著三商行強大的消費品操作經驗，創造商品差異化，未來更將考慮攜手共同發展亞洲其他市場，當然也包括中國。藥妝店幾乎是每個台灣觀光客到日本必去的朝聖點，住友商事看到商機，再加上日本市場發展已經趨於飽和，決定走向海外，第一站就選擇進入台灣。業界人士分析，日本藥妝店發展已久，但一直到近年才進入台灣，其中一個最大關鍵，在於台灣服務業的水平提升、後勤系統建構趨於完整，足以與日商達到互補的效益，日商能以最低的投入成本、獲取最大的效益，並從中建立合作默契，再共同發展中國市場。

兩大集團資源整合 競爭優勢大幅提升 舉例來說，Tomod's在日本是一家強調專業性與便利性的藥妝店，連一般保存限期短的日配型商品，如麵包、鮮奶等食品，店內都有陳列銷售，換言之，Tomod's競爭的通路，除了藥妝店外，還有便利商店。面對台灣便利商店密度位居全球之冠，這樣的競爭局面，過去一直讓Tomod's卻步，但現在因為有了三商行這個夥伴，一切變得有機會。三友藥妝總經理王建中指出，三商行挾著集團旗下多個零售品牌，包括展店開發、人才招聘、裝潢施工、資訊設備、後勤物流上，都能使用同一套系統；在商品採購上，三商行旗下的美廉社一向訴求的商品量販價，在資源整合的帶動下，「未來在Tomod's內的食品銷售，訂價一定會比便利商店便宜。」雖然還沒有規模優勢，但住友透過與三商行合作，Tomod's已經比自行來台發展，大幅降低經營成本。至於在品牌力與商品差異性上，三商行則仰賴住友的資源。除了將引進Tomod's的自有品牌ＡＰＳ外，也將靠著日本一百多家店鋪每天所掌握的第一手銷售資訊，將當地最新流行商品帶進台灣。王建中觀察，這波日商來台談合作，擁有比過去更大的調整彈性，日商雖然仍舊有所堅持，但也慢慢懂得順應地方文化。例如之前日方建議在店內張貼黑白的向日葵圖案，因為看起來很像菊花，不符合台灣文化，經過解釋與溝通，日本也願意妥協。

 

抗癌藥 無保險負擔 很難熬 !!

癌症醫藥費逾20萬！沒有保險難負擔 財經中心／台北報導 癌症已連續28年高居國人10大死因第1名，知名藝人高凌風近日也傳出罹患血癌的消息。東森保代強調，隨著醫療技術提升，癌症已非不治之症，但醫藥費動輒超過20萬，若沒有保險補貼，常讓病患及其家人難以承受，民眾應經常檢視保單，加強癌症險保障。 根據健保局統計，去(100)年光是10大抗癌用藥，就花了74億元，使用人數約為35,000人，平均每名病患的藥費高達20萬7,000元，若以個別抗癌藥物來計算，費用更高。東森保代指出，藝人或許收入較高，要支付抗癌費用相對容易，但對一般民眾來說，罹癌將大幅增加經濟負擔，撇開營養食品、看護費用不談，光是醫藥費就高得嚇人。東森保代分析，市面上的防癌險有「分項給付型」和「一次給付型」，「分項給付型」會針對不同的治療方式與狀況(例如：住院、化放療、骨隨移植)分別給予給付；「一次給付型」則是保戶經診療確定罹癌，便能獲得一筆理賠金，可供治療及生活開銷使用。東森保代強調，民眾可依照自身需要，經常檢視自己的保單，才能適時增添不足的保障項目，強化保障；如此一來，就算癌症真的找上門，也不用怕。

 

2千億台幣台灣健康照護產業產值(2012年, IEK)

健康護理老來瘋 人口老化為全球趨勢，保健食品&長期照護商機浮現發刊日期：2012.12.21 經濟發展促使醫療技術進步，社會必然走上人口老化這條路。根據聯合國資料顯示，全球老年人口(60歲以上)占總人口比率，2011年已達11％，2050年比重將上升1倍至22％。已開發國家老年人口，將由2011年的2.74億人增至2050年的4.18億人，而開發中國家則是從5.1億人增加至16億人。再以台灣來看，經建會預估2012年65歲以上老年人口為260.2萬人，占總人口比例11.2％，2020年前就會超越世界衛生組織定義「高齡化社會」的14％、2025年突破20％成為「超高齡社會」；接著到2050年，老年人口將升至765.9萬人的高峰，2060年前占總人口比重更逼近4成，人口老化的問題更為嚴重。 健康護理老來瘋 人口老化為全球趨勢，保健食品&長期照護商機浮現 高齡化社會的重點商機1：長照產業老年人口因心血管疾病和慢性病的高染病率，將增加社會醫療成本及健保支出，故各國政策鼓勵使用學名藥以控制醫療支出，同時也會帶動周邊泛生醫產業的發展，故推動健康管理產業發展，已成為全球政府的重大施政方針。包括處於生命週期前端的保健食品、預防醫學，以及後端健全完善的醫療照護服務體系，都會帶來頗為可觀的商機。資策會MIC研究指出，2015年全球健康照護產業的產值將達5970億美元，而台灣的健康照護產業的產值也可達180億美元的規模。台灣進入老齡化社會後，又有少子化的影響，照護人力嚴重不足，突顯長期照護的需求重要性。行政院於2007年核定「我國長期照顧10年計畫」，規劃於10年內挹注817億台幣的資金，建構有效的長期照護制度，並列為2015年經濟發展願景4大新興產業之一。按照工研院IEK及萬寶預估，2012年台灣健康照護產業總產值將突破2千億台幣，而在全天候照護需求快速成長下，健康照護服務的成長性也會高於照護用醫療器材，並逐漸走向精緻化經營，強調飯店式管理、個人化服務等，如臺塑集團的「長庚養生文化村」、佳醫集團於汐止成立的「佳醫護理之家」等，都以聚落規模取勝。除了人員照護外，受惠於網路普及化，居家護理逐漸發展為更高階的遠端醫療照護(Teleclinics&Telehealthcare)，市場統計2011年全球遠距醫療服務市場規模約116億美元，2016年將達273億美元，2011～2016年複合成長率18.6％，更演變成包含醫療器材、電信、資料傳輸、醫院、照護中心等多重產業合作的模式，是未來醫療體系的重大變革之一。舉例來說，監控錄影及動態偵測智慧型安控系統可提高安全性，將帶動安全監控產業的潛在商機；工業電腦的整合平臺與代工能力，應用於醫療產業早已行之有年，在遠距照護產業中也不會缺席；甚至保全業也利用既有人員以及資訊系統，開始拓展居家遠距照護市場，國內2大保全龍頭皆已推出相關係統。

 

按摩乳房 能預防癌症?!!

Squeezing Breasts Could Prevent Cancer, Study Suggests (PICTURES) The Huffington Post/PA|Posted: 17/12/2012 18:10 GMTA little squeeze may be all that it takes to prevent malignant breast cells triggering cancer, research has shown.Laboratory experiments showed that applying physical pressure to the cells guided them back to a normal growth pattern.Scientists do not envisage fighting breast cancer with a new range of compression bras, but they believe the research provides clues that could lead to new treatments."People have known for centuries that physical force can influence our bodies," said Gautham Venugopalan, a leading member of the research team at the University of California in Berkeley, US. "When we lift weights our muscles get bigger.The force of gravity is essential to keeping our bones strong. Here we show that physical force can play a role in the growth - and reversion - of cancer cells."The study involved growing malignant breast epithelial cells within a gel injected into flexible silicone chambers.This allowed the scientists to apply compression during the first stages of cell growth, effectively squashing the cells.Over time, the squeezed malignant cells began to grow in a more normal and organised way.Once the breast tissue structure was formed the cells stopped growing, even when the compressive force was removed.Non-compressed cells continued to display the haphazard and uncontrolled growth that leads to cancer."Malignant cells have not completely forgotten how to be healthy; they just need the right cues to guide them back to a healthy growth pattern," said Mr Venugopalan, a doctoral student.The results were presented today at the annual meeting of the American Society for Cell Biology in San Francisco. Professor Daniel Fletcher, who runs the Berkeley laboratory, said: "We are showing that tissue organisation is sensitive to mechanical inputs from the environment at the beginning stages of growth and development."An early signal, in the form of compression, appears to get these malignant cells back on the right track."He added: "Compression, in and of itself, is not likely to be a therapy. But this does give us new clues to track down the molecules and structures that could eventually be targeted for therapies."Adding a drug that helps to prevent cells adhering to their neighbours reversed the effects of compression, the scientists found. The cells returned to a disorganised, cancerous state despite being compressed.

 

健保局 加強復健科稽核!!!

健保局全面稽核安養院 2012-12-271位87歲老人因骨關節病變及中風入住中部安養機構後，合約醫療院所疑似為了可以申報更多的健保費，無視其身體狀況，持續施以「高強度」、也就是高重量及高頻率的復健，長達3年之久。經健保局稽核發現後，核刪其醫療費用。健保局醫審及藥材組組長沈茂庭表示，今年健保中區業務組調查中部安養機構醫療利用情形，在送審2008件案件中，有795件被核扣，共核減100多萬元，其中又以復健科的核減率最高、達65.07%，其次為內科20.47%。明年起將擴大全國稽核，以國內安養中心1年約申請6億的健保費，1年可以節省1億元的健保支出。（記者魏怡嘉）

 

 

TTY Inaugurates New Anti-cancer Drug Factory in China

2012/11/29 Taipei, Nov. 29, 2012 (CENS)--TTY Biopharm Co., Ltd., a major pharmaceutical maker in Taiwan, recently inaugurated a drug factory in Suzhou, Jiangsu Province of China, operated by TTY`s Chinese subsidiary TOT Biopharm Co., Ltd. At a cost of about US$100 million, the factory mainly produces anti-cancer drug injections, TTY said. In addition, the company`s other new factory producing anti-cancer injections has also kicked off pilot run, and is expected to begin volume shipments by the end of the year after passing related certifications. With the two new facilities, TTY is expected to become a leader in Greater China in supplying anti-cancer injection. TTY established TOT in 2010 to focus on developing and producing anti-cancer drugs, including tablets and solution injections. The firm has passed related certifications to be part of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). TOT`s Suzhou factory is the company`s first-stage investment, and the firm is scheduled to complete third-stage factory construction in the next four years. Currently, TTY is the top-20 maker of anti-cancer drugs in terms of production value. TTY won high international reputation for its taxol anti-cancer drug (with abstraction from Taxus brevifolia tree in 2011), and is stepping into the liposomes anti-drug field. Lin claimed that liposomes is a nano-grade drug delivery technology that contains drugs inside liposomes to extend treatment period and decrease side-effects. R.J. Lin, TTY`s chairman, pointed out that his company`s pilot-run factory in Chungli, northern Taiwan plans annual capacity of 800,000 injections, and as many as one million by 2013. The U.S. Food and Drug Administration (FDA) is expected to carry out plant inspection by the end of this year, when the new factory will soon kick off mass production.(by Quincy Liang)

 

Up to 800 rabbits abused in drug testing: COA

By Ann Yu, The China Post December 5, 2012, 12:17 am TWNThe China Post --A Council of Agriculture (COA) report yesterday claimed that between 400 and 800 rabbits are used by pharmaceutical factories every year for pyrogen testing, with up to 19,500 rabbits likely having undergone the test over the past 30 years.The Environment and Animal Society of Taiwan (EAST, 台灣動物社會研究會) raised concern over the widely performed Rabbit Pyrogen Test (RPT), pointing out that the Monocyte Activation Test (MAT), which instead uses blood drawn from humans, has been approved by the European Pharmacopoeia and the U.S. Food and Drug Administration.Limulus amebocyte lysate (LAL), a widely popular alternative method which requires blood tests on a certain species of horseshoe crabs, has also drawn disapproval from the association.RPT is a drug-testing method developed in the 1930s in which rabbits are injected with pyrogen substances to measure any resulting fevers. As the sensitivity of the immune systems of rabbits is highly similar to the human body, RPT became a widely used method for pyrogen testing.According to EAST Director-General Chu Tseng-hung (朱增宏), rabbits used for testing are individually locked along rows of guillotine-like stands while they receive injections in their ears and have their body temperatures measured every 30 minutes.Without not even enough space to move, the conditions are like torture for the rabbits, Chu said."If unfortunately they become infected, they will suffer a fever, shock or die," he said.According to the Animal Protection Act, the use of live animals for scientific applications should be avoided as much as possible; when there is an inevitable need for the use of animals, it should be limited to as few animals as possible and performed with the smallest amount of pain or harm.However, EAST stated that in a survey taken from 2006 to 2012, 100 percent of pharmaceutical factories were found to use animals for their pyrogen tests. Although 72 percent of the 25 surveyed factories chose the LAL method, there were still seven factories that used both testing programs.EAST also blamed the government for not including the MAT method in the Chinese Pharmacopoeia (中華藥典) yet still widely approving the RPL and LAL methods."We are sorry to see that the government has neglected to actively seek alternatives for these drug tests, silently allowing the abusive usage of animals," said Chu.Although representatives from the National Science Council and Taiwan's Food and Drug Administration all promised to speed up the process of revising a draft law for the protection of animals, legislators expressed some misgivings.Lawmaker Lin Shu-fen (林淑芬) said, "You need to give us a specific plan and the time of execution. Promising to speed things up is not concrete enough," she scolded.

 

Taiwan researchers develop new biopesticide from bacteria

 2012/12/11 20:40:22 Taipei, Dec. 11 (CNA) Taiwan's Council of Agriculture (COA) said Tuesday it has successfully developed a new strain of bacteria that can be used to produce a biopesticide, fertilizer and animal feed.Hsieh Feng-chia, head of the project at the COA's Taiwan Agricultural Chemicals and Toxic Substances Research Institute, said researchers spent five years collecting thousands of bacterial strains from deep mountain soil in Taiwan.They then spent another three years working with the National Science Council to isolate the bacteria and create a novel strain called Bacillus amyloliquefaciens, coded "Ba-BPD1," he said.Director of the research institute Fei Wen-chi said the new strain of bacteria can produce antibiotic substances such as iturin and surfactin that inhibit the growth of fungus and harmful bacteria.It also helps plants absorb higher amounts of phosphorus, which is vital to their growth and health, Fei said.Trials of the biopesticide on strawberries and Chinese cabbage showed that it helps double the crop yield, she said.The biopesticide also protect animals against harmful bacteria, making it a desirable feed additive, the institute said.The new bacterial strain was patented in Taiwan in October and is awaiting patent approval in China and the United States, Fei said.Taiwan Fertilizer Co. has paid NT$1.7 million (US$58,454) for non-exclusive rights to mass produce the natural pesticide, according to the institute.The biopesticide has also attracted the interest of the German chemical and drug group Bayer HealthCare and Japanese pharmaceutical company Dainippon Sumitomo Pharma Co., the institute said.

 

Taiwan imports GM lab mice from mainland China

 Genetically modified lab mice from mainland China's Nanjing University are ready to contribute to biomedical research in Taiwan. (Courtesy of NARL) Publication Date：12/12/2012 Source： Taiwan Today Taiwan's National Applied Research Laboratories signed an agreement Dec. 11 with Nanjing University allowing the import of genetically modified lab mice from mainland China.The NARL noted that such mice were already available from Europe, the U.S., Australia and Japan, while their import from mainland China had been prohibited. Taiwan's global supply network for these laboratory rodents is now complete, the institute added.Genetically modified mice play a key role in biomedical research, especially in connecting laboratory experimentation with clinical applications, the NARL said, making them essential for research institutions and pharmaceutical plants.With the agreement, local researchers will be able to obtain the genetically modified lab mice they need for experimental work in translational medicine related to metabolic disorders, coronary blood vessels, obesity, diabetes, autoimmune diseases and Alzheimer's disease, the NARL said.The completion of Taiwan's linkage with the global supply network for genetically modified mice will bring more attention to Taiwan's original research and increase opportunities for collaboration, according to the NARL.Cryopreservation of mice embryos in its Rodent Model Resource Center helps safeguard research results, prevents redundant development of genetic modifications, and can save an estimated NT$35 million (US$1.2 million) annually in expenses from raising live mice, while sparing the lives of 20,000 lab mice and eliminating the need for 4,000 cages, the institute said.

 

Taiwan’s amended Patent Act set to take effect

 The new-look Patent Act is set to strengthen protections while increasing convenience for inventors and designers. (Courtesy of TIPO) Publication Date：12/13/2012 Source： Taiwan Today The amended Patent Act will come into force Jan. 1, 2013, according to the Intellectual Property Office (TIPO) under the ROC Ministry of Economic Affairs.The revised act will be more compliant with international standards, with more expansive protection for design patents and increased flexibility in application procedures, TIPO said Dec. 12.Major changes regarding application include permission to apply for a patent for an invention that has been disclosed in a publication provided the submission is made within six months of the disclosure, and the limitation of applications in foreign languages to Arabic, English, French, German, Japanese, Korean, Portuguese, Russian and Spanish.In terms of patent examination, the time limit for an applicant to request modifications to the invention description, claims or drawing was removed, while provisions for final notification and correction of mistranslations were added.Patent rights for designs have been expanded to cover icons, graphic user interfaces, generative designs and sets of related items.The amended act clearly requires intent or negligence in the infringement of a patent before damages may be claimed, while related regulations adopt the internationally accepted patent exhaustion doctrine.Compulsory licensing will apply "where the patented invention is exploited noncommercially in the public interest, in response to national emergency or other circumstances of extreme urgency," TIPO explained. New articles covering compulsory licensing when pharmaceutical products are needed to help other countries treat epidemics were also added.TIPO will no longer have the power to invalidate patents itself, and invalidation requests may be filed against one or more individual claims within a patent.The new version incorporates 159 amendments, with 108 articles revised, 36 added and 15 deleted. Eight regulations and five examination standards were also adjusted to bring them in line with the revised law.The text of the amended act and related regulations are available on its website, TIPO said.

Patent cliff to compel global pharma to turn into biotechnology

` Source: IRIS (24-DEC-12) Bio-technology drugs differ from conventional drugs in the sense that they are developed using living cells. Conventional drugs, on the other hand, are chemically synthesized. While biotech drugs are difficult to develop and manufacture, they are often more effective. This is especially true in therapeutic areas like oncology, where conventional drugs perform poorly."Despite the fact that biotech drugs have so far been overshadowed by conventional drugs, we see the patent cliff (and the absence of new conventional drugs) will compel global pharma majors to seriously turn to biotechnology," Sudarshan Padmanabhan, analyst, HDFC Securities.Meanwhile, a biotech patent pipeline worth +USD 75 billion is expiring over the next 6-7 years, comparable to that of conventional drugs. Price erosion in bio-generics will be much lower than conventional generics, as manufacturing barriers will prevent 'generic flooding' post patent expiry. Gilead's acquisition of Pharmasset for a whopping USD 11 billion in 2011 is indicative of the interest that conventional drug makers have in the biotech space, Padmanabhan said.As the US, EU and other countries grapple with ways to cut healthcare expenditure, they are likely to be more accommodative towards bio-generics. The US has recently released draft guidelines for launching bio-generics. While this does not mention any specific time-lines, it shows the intent of the USFDA to ultimately adopt and promote bio-similars, he opined.Recent trends suggest that even companies outside the pharmaceutical world are willing to commit high stakes. In 2011, Samsung entered into a JV with Quintiles (90% owned by Samsung) to form Samsung BioLogics, aiming to provide contract manufacturing for bio-similar drugs. It also paid USD 255 million for 85% stake in a JV with Biogen Idec later that year. Several M&A deals have been struck globally, in pursuit of newer opportunities. While biotechnology has an alluring appeal, there are several barriers. The cost involved in developing bio-similars ranges from USD 20-100 million (excl plant cost), while conventional generics it is USD 1-4 million. Failures abound. Merck was forced to acknowledge that a novel yeast-based protein (Glycofi) that it acquired in 2006 could not produce a bio-similar with structural similarity to the innovator product. After paying USD 400 million to buy Glycofi, Merck termed the project as a 'junk' version of erythropoietin.Disclaimer: IRIS has taken due care and caution in compilation of data for its web site. Information has been obtained by IRIS from sources which it considers reliable. However, IRIS does not guarantee the accuracy, adequacy or completeness of any information and is not responsible for any errors or omissions or for the results obtained from the use of such information. IRIS especially states that it has no financial liability whatsoever to any user on account of the use of information provided on its website.

 

生技類股上櫃審查程序與認定原則 !!!!!

生技業發展 產官描繪藍圖【經濟日報╱記者黃文奇】 2012.12.26 03:02 am

大陸商機大 產值快速成長 李欣 （康聯控股執行長）康聯控股執行長李欣指出，由於老齡化風潮席捲，大陸生技醫療市場在2020年以前可望躍居全球第2大，未來大陸製藥和家庭照護醫材市場產值，都將快速成長，3年內將達到1,262億美元（約新台幣3.66兆元）規模。李欣12月19日受邀出席勤業眾信舉辦「醫療生技產業企業化與轉型實務面面觀」研討會，並針對「中國大陸醫療生技產業發展實務經驗」進行專題分享。他指出，由於大陸生技政策回溫，專利藥物陸續到期的狀況下，大陸食品藥品監管局（SFDA）鼓勵該藥企前5名「首仿」藥物（即原廠藥物到期後首波完成學名藥查驗登記者）藥價可獲優待。但SFDA也要求大陸的學名藥（仿製藥）標準必須和專利藥「評價一致」。李欣指出，由於大陸學名藥審核日趨嚴格，將造成大陸藥企的洗牌效應，演變為大者恆大、強者恆強的局面。李欣指出，以中國大陸市場而言，因應十二五規劃，政府大力投入帶動了產業成長，除了藥品市場，家用醫療器械市場的快速增長也很可觀，尤其是當人口老齡化時，慢性病需要日常護理，以社區和家庭為主醫療模式都有利於家用醫療器械的長期發展。李欣認為，老齡化讓大陸的家用醫材市場不脫市場快速膨脹的局面；他指出2年前大陸家用醫療器械市場產值約人民幣130億元，每年的成長率約27%，未來幾年成長速度上看三成。李欣評估，不僅大型企業集團間的競爭將更加激烈，中小型藥品流通企業也會主動併入大型企業，共用品牌資源，以應對激烈的市場競爭。

台灣前景俏扶植百億大咖 洪輝嵩 （經濟部工業局民生化工組長）醫療生技產業近來在資本市場掀起掛牌熱，整體產業的前景也備受投資人矚目；經濟部工業局民生化工組長洪輝嵩表示，經濟部將於未來10年扶植至少3家營收突破300億元、至少5家達百億元的生技公司。洪輝嵩於12月19日受勤業眾信會計師事務所邀請，於「醫療生技產業企業化與轉型實務面面觀」研討會中，針對「生技類股上櫃審查程序與認定原則」進行專題演講。洪輝嵩指出，目前生技被歸類為科技類，上櫃前須由經濟部工業局民生化工組召集專案小組進行審查。在申請審查條件中，除了可享有擬科技類股「免受成立年限、獲利能力之限制」外，洪輝嵩提醒想要申請上櫃的生技企業，審查條件中「技術前瞻性、市場價值」為關鍵，且審查人都是產學界的專家中的一時之選，企業絕不可抱持輕忽心態。他指出，專家們會針對開發產品的臨床數據、市場潛力等進行各方審驗，若臨床數據低於一般標準，則可能面臨退件不審；其審查嚴謹程度，不下於國際大廠、衛生單位的查驗。洪輝嵩表示，國內當前生技產值約2,400億元，年複合成長率約6%，但經濟部則希望能扶植生技產業年成長率達到9% 。因此，經濟部將以10年為期，扶植國內生技公司至少5家營收名列百億俱樂部，其中至少3家規模在300億元以上；洪輝嵩表示，經濟部將持續引進大型創投公司，投資生技產業；並帶領廠商走上國際，協助企業開發差異化產品，讓企業可以快速成長。【2012/12/26 經濟日報】

 

台灣生技股 本夢比先出局?? 終究回歸EPS !!!

短線High過頭，生醫類股跌跤 2012-12-26 【時報-台北電】果真High過頭？生醫族群在昨日耶誕節中因櫃買中心對基亞 (3176) 、合一 (4743)祭出「預收款券」處置，每30分鐘撮合一次下，多頭氣勢崩潰，類股在大盤上漲逾百點中一枝獨綠。不過，市場認為，該族群籌碼尚未失控，主管機關的「關警閉」動作，是否會變成「創意條款」備受矚目。 多空交戰激烈的生醫類股，由於短線過熱，昨日幾乎是一片慘綠，包括基亞、合一、盛弘、合世、(又又)美、晶宇等多達6檔個股跌停鎖死，總計上市生技類股跌幅1.5％，上櫃生技類股跌幅2.6％，是今年首見的「奇慘」現象。市場主力認為，生醫類股昨日是一蹶不振，但從這些近年強勢的新藥股和近來漲勢較凶的輪動股來看，大部分都是呈現上漲有量、下跌量縮現象，表示籌碼面並未失控。而基本面方面，製藥業有旺季效應、PIC/S光環，醫材業則因生技產業發展條例由新藥放寬至二類醫材，配合立法院將修正藥事法，預期明年醫藥和醫材業都可望享受較高健保價，而兩岸醫藥合作臨床也還如火如荼進行下，題材面預計仍將持續發酵。另外，以資金面來看，由於電子業景氣堪慮，部分資金潮已逐步挪向生醫族群，激勵生醫類的成交量能已達1成以上，而產業面的逐步成氣候，也吸引企業集團願意加碼投資，加上資本市場活絡，不少生醫公司都趕搭掛牌潮下，前仆後繼的動能也讓該類股生生不息。備受市場關注的生醫類股，在遭受警示下，合一生技昨日公佈，自結11月營收162萬元，稅前虧損695萬元，單月每股虧損0.05元，累計10、11月稅前虧損2,043萬元，較去年同期虧損擴大41.93％，每股稅前虧損0.16元。（新聞來源：工商時報─記者杜蕙蓉／台北報導）

聿新 積極佈局上櫃準備 !!!!!

聿新生技(4161) 因應本公司上櫃申請需要委託簽證會計師出具內控專審報告發言時間 101/12/2514:26:34發言人 涂耀仁 發言人職稱 竹科分公司執行長 發言人電話 03-5782999 主旨 : 因應本公司上櫃申請需要委託簽證會計師出具內控專審報告符合條款第25款事實發生日101/12/25說明 1.取得會計師「內部控制專案審查報告」日期:101/12/252.委請會計師執行內部控制專案審查日期:100/10/01~101/09/303.委請會計師執行內部控制專案審查之緣由:因應本公司上櫃申請需要4.申報公告「內部控制專案審查報告」內容之日期:101/12/255.其他應敘明事項:無以上資料均由各公司依發言當時所屬市場別之規定申報後，由本系統對外公佈，資料如有虛偽不實，均由該公司負責.