膠原蛋白廠 搶進海外市場2011-08-01 工商時報 在知名旅美醫材專家張有德的TMF創投可望成軍，國內高階再生醫材膠原蛋白廠乘勝追擊，積極布建海外市場，和康生技與美國Nasdaq上市公司NuVasive策盟，而雙美則與大陸普瑞森、五洲集團聯手進軍中國，而柏登的生物眼角膜明年進入人體臨床，亦將躋身國際競技場。和康生技董事長張立言表示，國際醫材廠近年重新大洗牌，美國保健暨消費品巨擘嬌生集團（Johnson ＆ Johnson）以213億美元的價碼，併購瑞士醫療設備製造商Synthes，穩穩坐擁龍頭寶座，另外，Stryker也以3.16億美元買下Orthovita，醫材廠的競爭白熱化，也將導致廠商的結盟將成趨勢。目前和康是與全球市佔率居第五的NuVasive策盟搶攻美國市場。張立言表示，NuVasive專注於骨科及脊椎微創醫材產品的開發與行銷公司，2009年投資入股和康，約持有10％股權，目前雙方的合作初期鎖定是骨科材料，未來則將延伸至牙科和眼科等材質。另外，為了創造公司的營收，和康近年也積極主打碧芙蕾詩（BIOFLASH）系列、黛諾（Dr.Neo）等自有品牌，開發醫學美容保養品，已開始打進康是美、屈臣氏等通路，並將為國內頂級觀光旅遊景點設計系列美容保養產品。除了和康搶攻美國市場，柏登開發以膠原蛋白為材質的組織修復產品則專攻歐美市場。柏登董事長賴弘基表示，該公司主打的ologen自有品牌，已開發出世界第一個眼組織修復產品，目前全球已累積超過16,000例自費手術使用，該產品去年並得到捷克及瑞典的健保給付，預計明年有機會取得美國及德國的保險給付許可。賴弘基認為，柏登未來最大的利基在於研發中的生物眼角膜，在荷蘭及中國的動物試驗已經成功下，明年將進入人體試驗，未來的商機十分可觀。國內投入膠原蛋白廠商已漸成氣候，除了和康、柏登和雙美已有產品上市外，已於2009年8月併入海昌國際的生立生技，也是投入眼科生醫材料，目前正藉由海昌通路，拓展至國際市場。另外，目前是國內最大的膠原蛋白原料後加工廠的大江生醫，其產品廣泛用於保養品、保健食品及機能性飲料，一年進口量超過90公噸，約占台灣總量的三分之二。大江副董事長關淑君表示，在看好膠原蛋白前景，大江已規劃設立自己的膠原蛋白生產基地，並就近從屏東獲得最高等級的黑鮪魚中，萃取膠原蛋白，預計年底開始動工，該產品將用於美容保養品。不同於大江生醫的膠原蛋白是以黑鮪魚為主，和康的原料是牛筋，而雙美則是自己開發S.P.F（無特定病源感染）等級的豬體皮，是全球唯一用豬皮生產膠原蛋白的廠商。雙美已於2009年取得中國第一張SFDA膠原蛋白皮膚植入劑上市許可證照，並拿下普瑞森四年23億元膠原蛋白訂單，去年因為被中國課徵消費稅，導致業績受到衝擊，不過，今年在與代理商協調後，營運已回復常軌，雙美董事長王進富表示，該公司今年上半年已獲利，正式擺脫虧損命運。目前雙美除了和普瑞森集團合作搶進大陸市場外，也將和中國知名的五洲集團聯手進軍醫美領域，初期會先以植牙及牙腔美容等領域為主，未來再延伸至眼科、骨科等事業。
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Sunday, July 31, 2011
國光生技疫苗充填問題將徹底解決!!
土銀主辦國光生技40億授信2011-08-01 工商時報 土地銀行主辦國光生物科技股份有限公司新臺幣40億元聯貸案，已成功完成募集，於日前舉行聯貸簽約儀式，由土地銀行王耀興董事長代表銀行團與國光生物科技股份有限公司詹啟賢董事長簽訂聯合授信合約。該聯貸案資金用途為國光生物科技股份有限公司為償還銀行借款、建置廠房附屬設施、購置機器設備暨其附屬設備、充實營運週轉金所需，募集15年期總金額35億元聯貸案，經參貸銀行超額認購，總金額達新臺幣41億元，最終以40億元結案。國光生物科技股份有限公司設立於民國54年，從事疫苗及檢驗試劑之研發製造銷售，主要產品為日本腦炎疫苗、結核菌素純化蛋白衍生物、破傷風類毒素疫苗、流行性感冒疫苗等，為國內唯一、全球少數具有量產新型流感（H1N1）疫苗能力之公司，位居國內疫苗產業龍頭地位，所生產之流行性感冒疫苗、日本腦炎疫苗、破傷風類毒素等，其品質受到衛生署的肯定。國光生技為拓展外銷業務，將以本案資金興建符合美國食品藥物管理局（FDA）規格之充填線，預計今年內可以完工、明年上線生產，將有助於該公司進軍國際市場。國光生技在董事長詹啟賢先生的領導下，一步一腳印的全力打造全球頂尖的疫苗王國，未來營運成長力道可期。
廣達 生產醫療電子和器材GMP廠
林百里：看好ICT產業 進軍醫療電子 【2011/07/28 聯合晚報】 時代基金會今日舉辦資訊科技、創新醫療高峰論壇暨技術展，邀請多位麻省理工學院(MIT)學者專家來台演講。時代基金會董事長林百里於致詞時表示，看好台灣ICT產業發展成功，具備進軍醫療電子的優勢，相信在和MIT等產官學界的合作之下，能夠朝高價值的電子醫療裝置發展，加速台灣電子產業升級。時代基金會是由麻省理工學院院長梭羅(Lester C.Thurow)和台灣企業大老共同成立，以「推動知識經濟的橋梁」自期，為台灣經濟發展尋找利基。其中，醫療產業也是台灣高科技產業升級的一大重點。林百里最近多次強調，廣達(2382)正從技術密集產業，升級為知識密集產業，因此持續加速布局雲端、醫療相關領域。在雲端業務上，廣達已有明顯展獲，而醫療領域的成果則還需要等待，可望在這幾年會推出相關產品。廣達布局醫療電子領域多年，廣達的醫療電子團隊2008年獲得經濟部通過「醫療級骨科診斷裝置技術開發計畫」，在ICT大廠中位居領先群。2009年廣達更取得衛生署GMP認證，具備生產醫療電子和器材產品的資格。2010年，廣達再投資英國的醫療用無線通訊科技廠商Toumaz Technology，取得該公司超過1%的股權，加強在醫療性電子產業的佈局。
皇將靠生產製藥設備獲利 還需等嗎?
Polaris begins phase III HCC trial
Polaris Group Doses First Patient in Pivotal Phase 3 Clinical Trial of Lead Therapeutic Candidate ADI-PEG 20 for the Treatment of Hepatocellular Carcinoma Company Advances Into Late-Stage Development a Biologic That Systemically Depletes Circulating Arginine Needed by Certain Cancer Cells to Survive SAN DIEGO, July 28, 2011 /PRNewswire/ -- Polaris Group (Polaris) today announced that it has dosed the first patient in a pivotal Phase 3 clinical trial evaluating its lead cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in hepatocellular carcinoma (HCC) patients. Over 600 patients who have failed prior systemic therapy will be enrolled in the randomized, double-blind, placebo-controlled study at sites in China, Taiwan, the United States, Italy and the U.K.. Patients will receive weekly intramuscular injections of ADI-PEG 20 until disease progression. The primary endpoint of the study is overall survival, and secondary endpoints will include progression-free survival and time to progression. "Based on our recently approved Special Protocol Assessment from the FDA, this pivotal Phase 3 study is significant as it will hopefully serve as the basis for approval in the U.S.," said John Bomalaski, M.D., executive vice president, medical affairs, of Polaris. "We believe ADI-PEG 20 is a promising cancer therapeutic not only for HCC, but also other arginine-dependent cancers such as leukemia, lymphoma, sarcoma and prostate cancer. We look forward to continuing clinical development in all of these areas to understand the full potential for this therapeutic."Ghassan Abou-Alfa, M.D., of Memorial Sloan-Kettering Cancer Center in New York, the principal investigator of the study, said, "We are delighted to be involved in a pivotal study for ADI-PEG 20, which has the potential to become a much needed treatment option for HCC patients. There is no currently approved therapeutic for HCC patients who have failed first line therapy. Thus there is a significant unmet need in this patient population."Additional information about the trial can be found online at www.clinicaltrials.gov/ct2/show/NCT01287585?term=polaris+group&rank=1 .
About Hepatocellular Carcinoma Hepatocellular carcinoma (primary liver cancer) is one of the most common cancers worldwide, resulting in approximately 700,000 deaths annually. Infection with hepatitis B or C and alcohol consumption are highly associated with the development of hepatocellular carcinoma. The prognosis for patients with this disease is poor because chemotherapy often does not result in prolonged survival, and liver transplantation only increases the survival of selected patients. Despite all forms of current treatment, life expectancy for most patients is less than one year post-diagnosis.
About ADI-PEG 20 ADI-PEG 20 is a biologic being developed by Polaris to treat cancers carrying a major metabolic defect that renders them, unlike normal cells, unable to make arginine internally. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 works by systemically depleting the external supply of arginine, which causes these arginine-dependent cancer cells to die while leaving the normal cells unharmed.Multiple cancers have been reported to have a high degree of arginine-dependency. Phase 2 clinical trials of ADI-PEG 20 have yielded positive results in patients with hepatocellular carcinoma or metastatic melanoma, and Phase 2 trials for small cell lung cancer and mesothelioma are currently ongoing. Polaris also plans to initiate clinical studies in prostate cancer, pancreatic cancer, leukemia, lymphoma and sarcoma this year.
About Polaris Group Polaris Group is a privately held multinational biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company's lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris is also investigating ADI-PEG 20 as a treatment for other arginine-dependent cancers, such as melanoma, prostate cancer, leukemia, lymphoma, sarcoma and pancreatic cancer. In addition to the ADI-PEG 20 project, Polaris is researching and developing other biotherapeutic agents and has a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.
Wong Chi-huey: “at least 60 new drugs developed by Taiwanese companies are undergoing clinical testing”….!!!
Academia Sinica paves the way for Taiwan's biotech industry Wong Chi-huey, head of Academia Sinica, expects research and development efforts backed by the institution to help upgrade Taiwan's biotechnology industry. 07/29/2011 Source： Taiwan Today Academia Sinica, Taiwan's top research institution, has maintained a reputation as a powerhouse in the production of leading scholars and cutting-edge research for over 80 years. In the 21st century, however, its president sees the institution's mission as broader than ever before, with direct participation in practical applications. "Research generates the greatest benefit for humanity when it is transformed into products that common people can use," Wong Chi-huey told Taiwan Today July 11. A specialist in synthetic chemistry and biocatalysis, Wong speaks from experience. He has created several important vaccines, including the world's first breast cancer vaccine developed with glycoprotein technology. The drug, currently in the final stages of clinical trials in Hong Kong, Singapore and Taiwan, is expected to be ready for the market within two to three years. "The practical benefits of a study are more important than any accolades it may receive," said Wong, who has been directing Academia Sinica, Taiwan's top research institution, since 2006. The institute has been an incubator for advanced studies in areas ranging from stem cells, DNA sequencing and atomic sciences to history, literature and linguistics. It is in the vanguard of promoting Taiwan's biotechnology sector, named one of the six emerging industries by the government in 2009. A Cabinet-level action plan will boost biotech development through the establishment of the Taiwan Medtech Fund, an NT$60 billion (US$2.08 billion) joint public-private venture capital company; the Supra Incubation Center to provide patent consulting services and market analysis; and the Taiwan Food and Drug Administration (TFDA), which will bring the country's pharmaceutical sector in line with international standards. Wong believes the five-year program will serve as the desperately needed connection between research and production. "Taiwan's higher education and research institutions have exhibited stunning potential in biotech research, and the action plan aims to transform exciting discoveries into marketable products," he said. Pharmaceutical innovation could be the engine for the entire biotech sector, Wong stressed. As new drugs are developed, he explained, other aspects of the industry, such as instrument manufacturers, lab testing facilities and standardization developers will be mobilized as a result. "Once a brand-name drug becomes successful, the royalties collected worldwide can provide robust backing for drug developers, making them self-sustaining, provided that a strong support mechanism for researchers is in place."Chang Tse-wen, an antibody engineering expert at Academia Sinica's Genomics Research Center, presents a case in point with his anti-allergy drug Xolair, approved in the U.S. and EU in 2003 and 2005, respectively, for treating severe allergic asthma. The journey to such success is so long, however, that it will intimidate any research team without solid backing. "It took us 16 years to take the drug from a lab concept to a marketable product," Chang said. "But it was all worthwhile, as our brainchild is now actually helping patients." According to Wong, at least 60 new drugs developed by Taiwanese companies are undergoing clinical testing, with 30 complying with U.S. Food and Drug Administration standards. These efforts include an antibody for HIV by TaiMed Biologics Inc. and antibiotics targeting cancer by TaiGen Biotechnology Co. Ltd. Numerous new drugs coming from Taiwan should appear on the market in the next few years, he said. Wong believes such drug development efforts will enjoy better resources as the government moves to provide a more encouraging environment, a key part of which will be a biotech park proposed by Academia Sinica. To facilitate a cluster effect for drug development, which typically consists of drug discovery, preclinical research and clinical trials on humans, the new park adjacent to the institute in Taipei's Nangang District is set to become headquarters for key participants in drug discovery and testing. Sitting on a 25-hectare section of what used to be the No. 202 Munitions Works Plant, the park, slated to open in 2017, will be home to Taiwan's leading research in translational medicine—the process of converting pharmaceutical discoveries into products that actually cure patients or prevent diseases. Representative offices of the National Science Council, Ministry of Economic Affairs, National Laboratory Animal Center and TFDA, under the Department of Health, will provide on-site support for the NT$22.5 billion initiative, Wong said. "We are working to build a biotech park that harbors innovation and creativity, rather than a string of biotech factories that copy and produce the same generic drugs," he said. Given the biodiversity in the park and its surroundings, totaling over 180 hectares, preservation is another concern the institute values. "Office buildings will take up merely 9.6 hectares, and we plan to rehabilitate the entire area, which used to be wetlands," Wong said. "We seek to create the most benefits for humans and the natural environment." The plans to help drug companies will also lead to an environment more conducive to the cultivation of biotech talent. "People with key expertise are crucial to a knowledge-based industry such as biotechnology," Wong said. "Only when the industry chain is fully integrated and supported will the best brains have a stage to shine on," he said, stressing that people are the most important asset for building Taiwan's biotech future. (THN)
佳醫3千床銀髮照護 強化Aisa Best Healthcare（ABH）登興櫃!
佳醫登陸，攻銀髮、醫美市場2011-07-30工商時報 佳醫（4104）與大陸國藥合資的「御佳醫療」的第一家醫療通路最快年底前將在北京成立，加上合資成立的五官醫院納入醫保後也轉盈，雖然有亮麗的利多題材，但該股在大盤重挫中，卻出現貼息走勢。28日除息的佳醫，現金股息是2.5元，雖然填息勢不如預期，不過，自營商昨日買超150張。御佳醫療由佳醫與中國國藥合資成立，額定資本額為5億人民幣，目前實收資本額為2億人民幣，佳醫持股49％。第一家醫療通路將設在北京，已拿到公司許可，預計7月拿到各項營業執照，最快年底正 式開業，將設立醫美及眼、牙、皮膚科等。至於醫美部分則將結合曜亞（4138）的資源，共同搶進大陸龐大商機，未來雙方將陸續在上海、瀋陽、天津、杭州、福建、廣州等地開設據點，爭取醫改商機。另外，該公司搶攻的銀髮醫療照護商機的Aisa Best Healthcare（ABH），去年已開始獲利，今年目標達3千床，預計明年第1季底登錄興櫃，成為另一隻金雞母。