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Friday, October 5, 2012

萬寶週刊 王榮旭… 利基槓桿台灣生技 舉起世界眼光 !!!


生技新藥開始黃金十年發刊日期:2012.10.05智擎(3176)掛牌前開始我在本刊連載3期分析看好,智擎86元上櫃後大漲翻倍到上週逼近200元,跌破市場眼鏡,有愈來愈多人認同生技但還不夠多,就如當年IC設計股剛抬頭,市場還是愛做傳產金融,等到大家看到IC設計亮眼的EPS,才一窩蜂衝進來,最好賺最甜蜜的那一段已經過去了。生技股股本比IC設計股小,毛利比IC設計股高,只缺營收,EPS就會暴衝,古希臘哲學家阿基米德說:「給我一個支點,我就能舉起地球。」點出了槓桿的威力,生技股就是「以小搏大」最好的模式,今日我看到很多人用投資電子股的方法來投資生技,這是錯的,保證賺不到錢,甚至會虧錢,再污名化生技太投機,這是用錯方法,不是股票的問題,想瞭解更多生技投資方法,可參考我的新書:《以小擊大魔球投資術》,內有對生技的投資評估方法做深入的剖析。
生技新藥開始黃金十年 近年歐美藥廠股價不斷走高,美國那斯達克生技指數今年大漲36.9%,台灣生技股漲只不過跟上國際趨勢而以,何況基亞已虧三年,今年上半年EPS還虧0.89元,股價從去年掛牌2030元漲到百元,用投機來解釋生技股近1年來的大漲有失偏頗,試問投機行情如何讓基亞連漲11個月?智擎漲勢從興櫃延續到上櫃也超過1年了20102012歐美大藥廠專利藥紛紛到期,給予台灣不論是學名藥或是新藥搶食市場的機會,台灣又有地利之便,透過兩岸生醫搭橋,已有多家新藥公司取得優先審核的資格,加速新藥在中國大陸上市時間,這是歐美藥廠無法享受的優勢,台灣生技股迎接黃金十年,不要錯過。
投信剛要建立智擎庫存 生技股份類很廣,有新藥、學名藥、原料藥、保健食品、醫材、醫美及通路,各有利基,但最看好的還是新藥,在生技族群中最具有爆發力,目前上市櫃、興櫃全部生技股高過百元共10檔,其中就有一半以上是新藥公司,這些百元新藥股不一定都賺錢,有些都還是虧錢,新藥開發利益愈大,股價就愈高。智擎抗胰髒癌新藥PEP02獲得授權金未來陸續會對EPS貢獻超過80元,而這款新藥當初是輝瑞用來治療大直腸癌用藥,但副作用太大,所以賣給智擎,智擎用到奈米等級微脂體包覆技術讓藥物直攻癌細胞,剛好解決了負作用的難題,既能在胰髒癌有療效,回過頭再去適應大直腸癌,市場商機可是胰髒癌的10倍以上,難怪投信不畏追高積極建立庫存,必然也是看到大商機。【完整內容請見《萬寶週刊》988期】【撰文/王榮旭】

全球整型手術 南韓&台灣 氣味相同!!


醫美Q&A/哪國狂愛整? 全球「整型7小龍」大揭祕! 2012104 16:53 嘉仕美整形外科診所張格彰醫師揭祕全球「整型7小龍」。記者方齡/專題報導 愛美是人的天性,自從了解美醜的定義之後,人們總是竭盡所能追求理想中的完美外貌,加上近年來醫美整形風潮席捲各國,讓愛美人士有更多元的選擇,大街上正妹型男的數量也隨之增加。然而,全世界究竟是哪個國家最愛整型呢?嘉仕美整形外科診所張格彰醫師表示,根據統計,2011年全球整型手術、醫美手術總數高居排行榜第一名的,是引領亞洲醫美整型風潮的南韓,緊追在後的則是希臘、義大利、巴西、哥倫比亞、美國;而近來微整型風氣極盛的台灣,也登上全球最愛整型國家排行榜的第7名,擠進「整型7小龍」的行列。 但張格彰醫師表示,儘管整型風潮征服以上7個國家,但因審美觀不同,各國愛美人士指定進行的手術類型也截然不同。南韓及台灣等亞洲國家,主要以雙眼皮、隆鼻等修飾五官的整型手術為主;中南美洲國家如巴西、哥倫比亞等,較重視身型上的雕塑,例如抽脂、豐臀手術,美國則是以隆乳、抽脂為最多。 另外,張格彰醫師也特別提到,巴西在今(2012)年通過一項特別的法令,同意進行整型手術的費用可以從個人所得稅中扣除,達到節稅的目的;相信此消息對於巴西的愛美人士來說,無非是一項福音。

幹細變為卵子 & 精子 !!


幹細胞育卵 生殖技術大突破 07:45 〔中央社〕日本科學家已將老鼠幹細轉變為卵子,並生產小老鼠,這項技術若成功運用在人類,將讓未來女性不必再擔心她們的生理時鐘限制生育能力,甚至可能協助夫妻培育「訂製娃娃」。根據今天刊登在「科學」雜誌(Science)的研究報告,這項技術可能用於治療某些種類的不孕症。有些專家認為,這可能幫助數以百萬計婦女,她們或是因為健康狀況或接受癌症治療,或是因為年紀太大,無法自行產出能存活的卵子。美聯社報導,美國史丹佛大學(Stanford University)法律系教授葛律利(Hank Greely)專門研究生物醫學科技造成的影響,他表示:「這可能意味女性不再受制於生育時鐘。」葛律利並猜測,在2040年內,這項技術就可能讓夫妻更願意接受以體外人工受精方式生產試管嬰兒,因為他們可以藉此選擇胎兒的特性。屆時,父母可先對胚胎進行基因分析,再選擇植入那個胚胎,分析資料不僅能顯示胎兒罹患各種疾病的風險,甚至可選擇諸如眼睛顏色等特徵或是特殊才能。加州大學洛杉磯分校(University of California, Los Angeles)的專家克拉克(Amander Clark)說:「我想這是下一代女性生殖科技的很大進展。」她主張,「必須現在就開始」討論相關政策和法規。法新社報導,雖然這種培育卵子的方法距離可能應用在人類身上還很遙遠,但確實已克服生殖醫學一項關鍵挑戰:如何為無法自行產卵的女性培育能存活的卵子。這項研究植基於去年公布的一項研究,當時同一批研究人員曾誘使幹細胞演變成活跳跳的精子。京都大學這些研究人員對幹細胞進行基因改造,使它們轉變得非常類似原生殖細胞。原生殖細胞在男性體內會生成精子,在女性體內則會生成卵細胞,也就是卵子。他們接著將「重建卵巢」植入活老鼠體內,這些細胞在裡面發育成為成熟的卵子。研究人員取出成熟的卵細胞,讓它們在試管內受精,然後植入代理孕母老鼠。小老鼠出生時很健康,成長後甚至能繁殖下一代。研究報告主要撰稿人林克彥(Katsuhiko Hayashi)在報告中說:「我們的系統可供作堅定的基礎,用來調查和進一步重新設定試管內的雌性種系發育,這不只適用在老鼠,也適用於其他哺孔類動物,包括人類。」

台灣醫藥中國夢?!!


F-康聯李欣:中國醫材複成長優於藥品 增加代理 2012/10/04 11:26 精實新聞 2012-10-04 11:25:44 記者 蕭燕翔 報導 F-康聯(4144)總經理李欣4日指出,看好未來幾年中國醫材複合成長將優於藥品,因此該公司未來也將逐步增加醫材的代理占比。他也勸懷有「中國夢」的台灣醫藥業者,即使2020年中國醫藥市場有機會變成全球次大,未來幾年複合成長可達13-22%,但因招投標規定及註冊程序,假設沒法成為學名藥的前三大,乾脆就別去了!李欣指出,去年中國藥品新註冊申報量年增20%,其中,新藥略有增加,改劑型及仿製藥申報量年增34%;以核准量分析,去年總計核准718個藥品註冊,已較2005年高峰動輒逾萬個明顯壓縮,獲准上市的藥品之中新藥件數達124件,占比較前年增加6個百分點至19%,當中1.1類新藥共計批准10件,均較20092010年顯著成長。他表示,不論是根據外資機構或中國泛官方的南方醫藥研究所預估,2010-2019年都會是中國醫藥的黃金十年,預估醫藥工業產值複合年增長將有13-22%水準。不過,相較於藥品市場自2011年成長開始趨緩,反而比較看好醫材產業的產值成長機會,因而原以藥品代理為主的康聯,未來幾年也會增加醫材的代理比重,以跟上這個趨勢。 李欣也表示,中國醫藥市場即使還在成長趨勢上,但進入不易,包括中國暢銷品種與世界大國不同、繁雜的註冊程序、差別定價難、招投標網絡複雜等,包括招投標一等往往就等上一、兩年,且一家醫院同種產品僅能進兩家,因此有意進入中國市場的台灣業者,如果沒辦法做到中國學名藥的前三大,乾脆別做了。

必翔..整合通路商 (福康醫療+合力興)


必翔搶攻健康照護商機!跨足輔具通路市場 2012/10/4鉅亨網提供 必翔(1729)瞄準健康照護商機,積極進行上下游整合,董事會決議跨足台灣健康照護輔具通路市場,投資台灣福康醫療輔具租賃2000萬元,取得50%持股,除結合台灣福康目前超過100家經銷網路外,也規劃一年內設立6-8家直營展示店,提供國人更完整快速的健康照護輔具服務。 必翔今年3月間,已投資合力興股份有限公司,而合力興為必翔電動代步車、電動輪椅產品的台灣總代理,取得43.67%股權,今天又更進一步,投資台灣福康醫療輔具租賃,繼續擴大輔具通路版圖,必翔總經理蔣清明指出,近期也將把合力興、台灣福康等2家通路公司合併,由台灣福康為存續公司,合併後資本額為台幣6800萬,必翔將持有一半以上的股權。根據蔣清明規劃,未來合併後的台灣福康將提供全系列的行動輔具(如電動輪椅、電動代步車、手動輪椅等)、生活輔具(如衛浴器具、電動病床、保健用品等)、醫療復健輔具(如呼吸照護、復健照護等),供民眾選擇購買或租賃。必翔指出,行政院已將健康照護產業規劃為六大新興產業之一,且2017年台灣高齡人口比例將超過14%,達320萬人,對於健康照護相關產品與服務需求殷切,商機龐大,因此積極進行產品、通路上下游整合,進行「卡位」動作。


英研究:孩童常吃速食 智商較低

  孩童主食調查 新鮮食物有益智商 2012/10/5 喜歡吃速食的小朋友要注意了,英國研究指出,在成長過程中,吃比較多速食的孩童,智商會比常吃新鮮烹調食物的孩童來的低 調查發現,這些孩童在智力測驗中,得到比較低的分數,在學校學習時也比較辛苦。而且研究還進一步發現,社經地位比較高的父母,也比較常給孩子吃新鮮的食物,這對智商也有正面影響。

登革熱通報愈快 防疫加倍

 自由時報-20121005 上午05:15 〔自由時報記者孟慶慈、吳俊鋒/台南報導〕台南市登革熱疫情持續擴大,至四日止入夏以來本土病例數累計四百廿六例,疫情嚴峻,市府昨天依傳染病防治法成立「台南市登革熱流行疫情指揮中心」,市長賴清德擔任召集人;賴清德強調,近日病例通報數略降,但不能鬆懈,依經驗十、十一月是疫情高峰期,稍不慎疫情將大反撲。衛生局人員指出,登革熱傳染期為發燒的前一天及後五天,若平均通報時間四、五天,意味著病人在最具傳染力時,防疫人員未介入,疫情的蔓延可想而知。現已降為一、二天,對疫情控制大有幫助。衛生局人員不諱言,醫師通報愈多,防疫人員的工作量就愈大,但站在防疫的立場,還是鼓勵醫師,只要專業判斷患者疑似感染登革熱就通報。衛生局長林聖哲指出,控制登革熱疫情平均要花一個月才看得到成效,九月疫情嚴重的安南區,近一、二週病例數已降,陽性容器率也由九成降為七成;十月若能有效控制疫情,十一月不致出大狀況,否則民國九十六年病例數多達一千多例的大流行恐重演。賴清德呼籲,登革熱病例數通報目前雖然趨緩,不像九月一天增數十例,但防疫絕不能鬆懈,若今年為暖冬,疫情恐跨年。

Taiwan set for PIC/S membership in 2013

Taiwan-made drugs could soon be filling the shelves of pharmacies worldwide after the country becomes a member of PIC/S early next year. (Photo: Huang Chung-hsin) Publication Date10/04/2012 Source Taiwan Today ByMeg Chang Taiwan will join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) beginning 2013, providing a major boost to the local drug manufacturing and R&D industries.Kang Jaw-jou, director-general of the ROC Food and Drug Administration, said Oct. 3 that membership in PIC/S is a vote of confidence in Taiwan's pharmaceutical regulation and inspection procedures."Participating in the scheme allows Taiwan to access the latest drug data and better safeguard the health of its people," he said. "This information will also sharpen local manufacturers' global competitiveness, attracting international heavyweights to contract out production or even set up shop on the island."Sources familiar with the matter believe membership in PIC/S will slash the time required for local manufacturers to obtain certification in Canada, Europe and the U.S., while helping establish tie-ups with overseas industry giants searching for outsourcing partners.Taiwan applied to join PIC/S in June 2010. During the comprehensive review process, which included on-site visits, 89 performance indicators were satisfied, including good manufacturing practices, inspection staff management and quality control systems."We also completed revisions to the Pharmaceutical Affairs Act and promoted the implementation of good manufacturing practices in Taiwan firms to bring them on par with global standards," Kang said.These efforts paid off Oct. 2 when PIC/S unanimously approved Taiwan's application, along with that of New Zealand, during its annual seminar in Kiev, Ukraine.The admission of Taiwan and New Zealand early next year brings the number of PIC/S members to 43. Japan and South Korea also lodged their applications in March and April this year, respectively.Established in 1995, Geneva-based PIC/S is an international pharmaceutical inspection system that develops, implements and maintains globalized good manufacturing practices and quality control systems. (JSM)

Possible Cure for Dementia Found by Taiwan Researchers

 Sept. 28, 2012, 5:56 a.m. EDT TAINAN, Taiwan, Sep 28, 2012 (BUSINESS WIRE) -- A southern Taiwan-based National Cheng Kung University (NCKU) research team has discovered that rapamycin, a drug as a autophagy activator is a possible treatment to alleviating frontotemporal lobar degeneration (FTLD), one of the mainly causes of dementia, and so far no medication can be used.The medical breakthrough made by the team led by Kuen-Jer Tsai, professor of the Institute of Clinical Medicine and Institute of Basic Medical Science, NCKU, was published in Proceedings of the National Academy of Sciences of the United States of America, PNAS on September 11th.To activate autophagy, the process of self-digestion by a cell, is the crucial discovery of the research, according to Tsai adding that autophagy activators rescue and alleviate pathogensis of a mouse model with protein pathies of the TAR DNA-binding protein 43 (TDP-43), a neuronal activity, which is the main syndrome of FTLD."The pathological and clinical syndrome of FTLD including the brain atrophy of frontal and temporal lobe, memory loss, speechless, neuromotor disorders, even would be complicating with motor neuron disease," said Kuen-Jer Tsai.In the elderly population over the age of 65, FTLD is the fourth most common reasons of dementia, only after Alzheimer's disease, Lewy body dementia and vascular dementia.However, FTLD is the second common reasons of dementia just next to Alzheimer's disease in the populations less than 65 years old, according to the team.Recent studies have found the mis-metabolism of a protein, which can affect TDP-43, is correlated to several neurodegenerative diseases, including FTLD and amyotrophic lateral sclerosis, ALS.In the earlier stage, Kuen-Jer Tsai's team had transgenically overexpressed TDP-43 in the forebrain of a mouse, successfully development an animal model existing phenotypic characteristics mimicking of FTLD.Tsai's team applied the animal models give autophagy activator in the early stage of pathology, discovering that not only maintaining the learning/memory ability of the animal model but also slow down the loss the motor function, and reducing cytosolic overexpression TDP-43 and its abnormally aggregation, therefore ameliorating the proteinopathy-induced neuronal apoptosis.Delivering the autophagy activators at the late stage of disease progression can ameliorate the motor function, according to Tsai.The team has also showed that spermidine, carbamazepine, and tamoxifen are autophagy activators like rapamycin could also be used to the treatment of FTLD.SOURCE: National Cheng Kung University


QPS Qualitix Opens China Office

BEIJING, Oct. 2, 2012 /NEWS.GNOM.ES/ – QPS Holdings, LLC, a leading full-service Clinical Research Organization, today announced the launch of its QPS Qualitix China Office, built to service the unique needs of the Chinese biopharmaceutical industry and multinational biopharma companies operating in China. The move into China continues QPS' expansion into the Asia Pacific region and builds upon its existing presence in Taiwan and India.Capitalizing on its experience conducting clinical trials through partners in China, the QPS Qualitix China Office will focus on developing customized solutions to help local and global biopharma companies achieve successful registration of new medicines in China.The expansion into China continues QPS' development of its worldwide capabilities and focus on emerging markets.The QPS Qualitix China Office will provide a full range of knowledge-based contract research services, including comprehensive clinical trial management and regulatory submission preparation. The new China Office will tap QPS' global resources and expertise to develop customized offerings in key therapeutic areas, along with phase II-IV studies, biostatistics, data management, medical writing, vaccines, medical devices and diagnostics. "The QPS Qualitix China Office will leverage QPS' quality and training systems to offer customized, high-quality drug development solutions best suited for local Chinese biopharma, as well as global biopharma's local affiliates," says Vincent Yen, general manager of QPS Qualitix China. "We have an aggressive growth plan for China and anticipate increasing QPS' total staff there during 2012 as we look to provide our customers with the solutions they need to succeed in one of the world's most dynamic marketplaces."The new QPS Qualitix China Office is located in the Chao Yang District, near the World Trade Center of Beijing. The office will be headed by David Hsu, who brings years of experience in the clinical research industry, with both global pharmaceutical companies and CROs.QPS Qualitix is one of Asia's leading providers of biopharmaceutical services and has had a presence in the Asia/Pacific region for over nine years. With more than 280 employees operating from two regional offices in Asia, QPS Qualitix is the partner of choice for both global and local biopharmaceutical companies to conduct drug development in China.
About QPS QPS is a GLP/GCP-compliant CRO that supports discovery, preclinical, and clinical drug development. We provide quality services in CNS Pharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, and Early Stage & Phase II – IV Clinical Research to clients worldwide. Our regional facilities and offices are located in the USA, China, Taiwan, India, Netherlands, Austria, Czech Republic, Croatia, Slovenia, Serbia, Bosnia, Hungary, Spain, Germany and the United Kingdom. Business development offices are maintained throughout the US, Europe, and Asia. For more information, please visit www.qps.com.SOURCE QPS Holdings, LLC

Taiwan CDE Sets Up Cross-Strait Medicinal Product Cooperation Promotion Office

2012/10/03 Taipei, Oct. 3, 2012 (CENS)--To realize the "Cross-Strait Agreement of Medicinal Product Cooperation Project", the Taiwan Food and Drug Administration (TFDA) under Department of Health (DOH) of the Executive Yuan recently commissioned the Center for Drug Evaluation (CDE) to set up a promotion office for the cross-strait cooperation scheme. At the office inauguration ceremony, Chiu Wen-ta, Minister of DOH, encouraged the new unit to help TFDA deal with future`s cross-strait affairs and help establish a cross-strait compunction and consulting platform for the biotechnology, pharmaceutical and medical device industries on the both sides of the Taiwan Strait. The office is expected to help companies on the two sides solve problems on pharmaceutical registration and commercialization. J.J. Kang, Director General of TFDA, said that he anticipated the CDE to utilize its accumulated capability in food and drug inspection, abundant experiences in consultancy and understanding of international regulations to further expand its services to the medicinal product industry. The establishment of the cross-strait cooperation promotion office, he added, is expected to more actively serve related industries, as well as collect information for TFDA, so as to achieve a win-win status for both Taiwan and China`s medicinal product industry. CDE`s CEO Kao Chuen-hsiu pointed out that the promotion office would provide more services to help makers know more about how to venture into the Chinese market during new drugs` R&D, clinical trial and registration stages.(by Quincy Liang)

 

Takeda initiates Phase III lung cancer trial in four Asian countries

Oct 03, 2012 (Datamonitor via COMTEX) -- Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company have announced that Takeda Bio Development Center Limited has initiated a Phase III clinical trial in Japan, Hong Kong, South Korea and Taiwan, evaluating motesanib in combination with chemotherapy in patients with advanced non-squamous non-small cell lung cancer, or NSCLC. Motesanib is an investigational, orally administered small molecule antagonist of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptors, and stem cell factor receptor. Takeda's decision to initiate this new Phase III trial is based on the prospectively-defined Asian subgroup analysis of the MONET1 pivotal Phase III trial evaluating motesanib in 1,090 patients with advanced NSCLC. Although the MONET1 trial did not meet its primary objective of demonstrating a statistically significant improvement in overall survival (OS), an exploratory analysis revealed significant and consistent findings in the Asian population for OS, progression-free survival, and objective response rate. The results of the Asian subgroup analysis were presented at the annual meeting of the American Society of Clinical Oncology (ASCO). Takeda also announced that Takeda and Amgen have entered into a new agreement which provides Takeda with the rights to independently develop, manufacture and commercialize motesanib. In 2008, the two companies had entered into a co-development and profit share arrangement for motesanib, under which Takeda had the development and commercialization rights to motesanib in Japan and the two companies were to share profits outside of Japan. Amgen will receive an up-front payment and is eligible to receive milestones and net sales royalties. Specific financial terms of the new agreement were not disclosed. "Based on the encouraging results of the Asian subgroup analysis of the MONET1 study presented at ASCO, we are pleased to initiate the Phase III clinical trial of motesanib in this Asian patient population," said Karen Ferrante, M.D., Chief Medical Officer, Millennium: The Takeda Oncology Company. http://www.datamonitor.com Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon

 

 

TaiGen and Medigen of Taiwan to be in Cross-strait Drug Project

 2012/10/02 Taipei, Oct.2, 2012 (CENS)--TaiGen Biotechnology Co. and Medigen Biotechnology Corp., both reinvestment companies by Yuen Foong Yu Paper Mfg. Co. (YFY), Ltd., are selected by DOH (Department of Health Taiwan) to be the first companies to apply for new-drug certification simultaneously in Taiwan and China under the ECFA (Economic Cooperation Framework Agreement). A reliable source says the DOH has announced TaiGen's "Nemonoxacin", a novel broad-spectrum antibiotic, and Medigen's "PI-88", an anti-relapse medicine for liver cancer surgery, are selected for a cross-strait pharmaceutical R&D project. Such cooperation project will help new drugs go to market simultaneously in China and Taiwan. Medigen's PI-88 is currently undergoing third phase clinical trials in 23 medical centers in Taiwan, S. Korea, and China. A representative of TaiGen says the Phase-3, cross-strait clinical trial for Nemonoxacin has been completed in August this year, with the drug to be certified in 2013 and on market in 2014. M.C. Hsu, chairman of TaiGen, emphasized that Nemonoxacin complies with regulations in China to significantly reducing the time to go to market, adding that other new drugs as Burixafor and TG-2349 will follow Nemonoxacin's model for clinical trials and go to market in Taiwan and China at the same time.(by Andrew Wang)

 

中國信託證券積極佈局輔導生技業!!!


生技產業高峰早餐會,50家業者參與 2012-10-04 【時報記者任珮云台北報導】中國信託綜合證券與安永聯合會計師事務所於今(4)日聯合舉行「2012年生技產業高峰早餐會」,由中國信託綜合證券總經理陸子元、安永聯合會計師事務所董事長王金來共同主持,邀請首家海外醫藥企業回臺上市的康聯藥業有限公司創辦人暨現任執行長李欣,以「臺灣生技業進軍大陸市場之障礙及開展」為題發表演講,邀請國內50家生技業者代表與會,針對國內生技醫療產業界目前面臨的法規與資金籌措問題尋找解決方案。中國信託綜合證券總經理陸子元表示,相較大陸本地藥廠或醫材商,臺灣業者在關鍵技術研發、知識與智慧財產權、經營佈局及生產方面的技術水準仍有一定優勢,而中國信託長期與生技產業往來,深刻體會業者需求,積極扮演產業輔導角色,並提供最優質的財務解決方案。中國信託綜合證券企業理財部副總經理陳香如則指出,生技產業競爭日趨激烈,除了加強本身特色外,也往區域化和大型化發展,而在企業發展的過程中,特別是進軍中國大陸市場,在資金稅務、法規資訊及市場實務上需要多方面考量,中國信託專業團隊將提供業者金融理財加值服務,以成為資本市場中企業最佳服務夥伴。 目前中國信託證券輔導的生技企業,包括在肝臟疾病與植物新藥研發有顯著成就的泰宗生物科技股份有限公司,以及馬來西亞保健飲品龍頭的康樂生技股份有限公司,該公司所生產之機能飲品與膠原蛋白飲料頗受市場矚目。

 

公費流感疫苗 國光/ 巴斯德/ 諾華 有得選嗎?????


國產、進口疫苗一樣好 衛署打包票 2012-10-03 中國時報 黃天如/台北報導 相關新聞 國光流感疫苗 獲歐盟藥證  衛生署表示,不論是國產或是進口疫苗,政府採購的一定都是生產過程符合科學標準,並經人體臨床試驗證明安全有效的疫苗,呼籲民眾保持理性,配合公費疫苗接種政策。衛生署今年總共採購二九七萬五千劑公費流感疫苗,其中的廿四萬劑是供六個月至三歲幼兒施打的○.二五西西劑型,經過公開招標,分別購入國光生技國產疫苗九萬六千劑,以及法國巴斯德疫苗十四萬四千劑。疾病管制局副局長周志浩強調,國光生技雖是首度供應公費流感幼兒劑型疫苗,但該公司生產、供應成人流感疫苗多年,幼兒與成人劑型疫苗製造方式、過程完全相同。唯一差別只有劑量,幼兒是○.二五西西、成人是○.五西西,還有政府發給藥證「背書」,安全性絕對無虞。另針對有民眾質疑國光流感疫苗是以雞胚胎培養病毒製造,周志浩強調,目前全球各大藥廠生產流感疫苗均以雞胚胎培養為大宗,僅極少數藥廠改採細胞培養生產疫苗,產量根本不足供應市場所需。以台灣今年採購的近三百萬劑公費流感染疫苗為例,製造方式就全都是雞胚胎培養。周志浩說,為確保公費流感疫苗供貨無虞,以及配合世界貿易組織(WTO)的「政府採購協定」,即使是公開招標最低價的疫苗也不能「通吃」,只能取得較大的供貨比例。疾管局發給各縣市的疫苗採「隨機分配」,實在無法讓民眾自由選擇廠牌。除了幼兒劑型疫苗,衛生署今年採購的成人劑型公費流感疫苗也涵蓋三家廠牌,以國光疫苗占六成為大宗,其次依序是進口的巴斯德及諾華疫苗。

 

 

南光: 預充填針劑 !!


蛻變中的老牌針劑廠發刊日期:2012.10.05生技新兵今年表現非常搶眼,本刊長期推薦的基亞(3176)即使掛牌後一度跌破承銷價,但近期股價又創117.5元新高,飆漲4倍;同樣看好的智擎(4162),掛牌後以唯一有獲利的新藥股之姿漲到近200元,訊聯轉投資的創源(4160)也拉出一波漲勢,接下來還有先前本刊專訪過的鐿鈦(4163),以及醣聯(4168)等,都將在年底前掛牌,可望再掀起一波生技熱。但除了新股表現亮眼外,生技產業也悄悄吹起一波復古風,除了中化(1701)股價創21.7元波段新高外,又以老牌學名藥針劑廠南光(1752)走勢最吸睛,股價衝到38.5元的兩年來新高。從獲利來看,南光不僅在上半年繳出E P S0.77元的成績,是2007年以來最好的半年報表現,投信更是從8月底以來持續拉高持股,纍計買超逾1700張。這家成立將滿50年的企業,究竟有何重現活力的秘訣?本期特別專訪南光總經理王玉杯,為讀者一窺究竟。

蛻變中的老牌針劑廠 談到待了4 3 年的公司,王總始終對自家產品相當有信心,而她最津津樂道的核心競爭力,就是「技術」和「領先市場開發」。以南光主力產品大型注射液為例,公司早在1996年就領先市場採用環保和無毒的PP材質包裝,而市面上其他產品到目前仍使用PVC材質,生產時必須添加DEHP(塑化劑的一種),且會隨著滅菌過程中的高溫、存放時間逐漸溶出,同時廢棄後燃燒也會產生劇毒戴奧辛,造成產品和環境的二度污染。此外,公司在2010年引進第二代德國生產設備,並使用自行研發的「船型袋頸設計」專利,可有效防止藥物漏液問題,將產品附加價值進一步提升。

堅持領先市場佈局 而在醫療院所相當常見的針筒注射,南光同樣領先同業開發預充填產品,目前主要與臺大醫院合作,包括無菌鹽水針等已陸續獲得採用。王總表示,將針劑預充在針筒內,除了省去一道抽取的手續、提高方便性外,還可有效預防抽取時可能面臨的院內感染;更重要的是,產品具有清楚藥物標示,能將給藥錯誤機率壓到最低,並減少不必要的醫療器材浪費。根據使用過的醫護人員經驗談,都表示「用過就回不去了」!不過,雖然預充填針筒在國外行之有年,但國內只有南光有能力生產,目前還是以自費為主,未來如果成為健保核准用藥,屆時營收成長性才會比較大。

 

康聯 加大中國醫材代理


康聯今年EPS 5元起跳 2012-10-05 【時報-台北電】F-康聯(4144)總經理李欣4日指出,兩岸醫藥衛生合作協議大開新藥登陸大門,讓康聯可望搶佔商機,營運逐步邁入豐收。另外,看好中國醫材複合成長將優於藥品,未來將增加醫材的代理占比,讓公司獲利動能快速增加。康聯上半年已交出每股稅後盈餘2.56元佳績,下半年在新代理GSK抗生素、B肝用藥銀丁以及糠酸莫米松開始銷售,而新併購黑龍江同澤藥業的貢獻營收下,成長動能將比上半年出色,法人預估其年度每股稅後盈餘將由5元起跳。李欣表示,台灣食品藥物管理局(TFDA)與中國藥監局(SFDA)重啟合作大門,合作機制回歸至「兩岸醫藥衛生合作協議」,未來在新藥研發和臨床試驗的認定上,將採取同一套標準,並相互證下,將可大幅縮短上市時間,由於中國比台灣人口高出60倍以上,未來商機無限。不過,他也對懷有「中國夢」的台灣醫藥業者,要慎重考量實力和策略,即使2020年中國醫藥市場有機會變成全球次大,未來幾年複合成長可達13-22%,但因招投標規定及註冊程序,假設沒法成為學名藥的前三大,將很難競爭。李欣指出,去年中國藥品新註冊申報量年增20%,其中,新藥略有增加,改劑型及仿製藥申報量年增34%;以核准量分析,去年總計核准718個藥品註冊,已較2005年高峰動輒逾萬個明顯壓縮,獲准上市的藥品之中新藥件數達124件,占比較前年增加6個百分點至19%,當中1.1類新藥共計批准10件,均較20092010年顯著成長。他表示,不論是根據外資機構或中國泛官方的南方醫藥研究所預估,2010-2019年都會是中國醫藥的黃金十年,預估醫藥工業產值複合年增長將有13-22%水準。不過,相較於藥品市場自2011年成長開始趨緩,反而比較看好醫材產業的產值成長機會,因而原以藥品代理為主的康聯,未來幾年也會增加醫材的代理比重,以跟上這個趨勢。(新聞來源:工商時報─記者杜蕙蓉/台北報導)

 

PIC/S採行 藥廠資本戰拉鋸戰 !!!


生達、永信 銷歐盟添利多【經濟日報╱記者黃文奇/台北報導】 2012.10.05 02:43 am 台灣通過歐盟「國際醫藥品稽查協約組織」(PICS)認可,明年起正式成為會員國;製藥工會表示,這對國內製藥廠生達(1720)、永信、中化、杏輝、國光等未來藥品外銷歐盟市場將出現利多,短期內將可具體推升國內製藥產業外銷產值。衛生署近年來積極推動本土藥廠生產線必須符合PICS規格,目前已有多家上市櫃藥廠都已達標,但這項符合歐盟制定的規範,台灣雖然積極落實,但一直未獲歐盟的認可。製藥公會表示,成為PIC/S會員顯示國內藥廠GMP法規與管理制度,及稽查水準受國際認可,可提升我國製藥產業國際競爭力,而透過平台與他國建立GMP相互認證,得以免除藥品上市之重複查驗,有助國產藥品拓展歐盟為主的外銷市場,更能吸引外資來台投資設廠或委託國內藥廠製造。據悉,目前PIC/S現有41個會員,其中以歐盟最多,其次為東南亞等;明年台灣、紐西蘭同步加入後,將使會員成長到43個;目前日本、南韓、巴西等國家也正申請中。其中,台灣通過PIC/S認證的藥廠超過40家,生達表示,若這些廠中目前或未來有外銷業務,而合作的對方又是PIC/S會員國,則將縮短雙方查驗的時程。生達說,過去台灣不是會員國,進口國還得派人來台查廠,而且查廠的費用還是由出口國負擔,費用平均數十萬到上百萬元不等,不僅費時費工而且所費不貲。此外,永信、國光等藥廠也都表示,未來取得PIC/S會員國,對國內藥廠再外銷業務方面,確實頗有幫助;但永信也指出,取得「國際入場券」這僅是第一步,台灣藥廠品質已經愈來愈好,但國內衛生單位還是必須進一步和國際接軌,才能幫助製藥產業再上層樓。生達昨日股價收25.9元,下跌0.05元;永信收42.3元,上漲0.25元。【2012/10/05 經濟日報】

 

無薪假 台欣生技 !


台欣生技實施無薪假至年底 2012-10-05 【時報-台北電】竹科今年度第一家實施無薪假的台欣生物科技(4134),昨(4)日發布重大訊息指出,因今年第3季較去年同期衰退26%,考量財務節流及人力規劃,將實施為期3個月的無薪假。台欣生技表示,該公司自100年第4季起至101年第2季,營業狀況快速成長,累計10116月業績仍較去年同期成長42%。用人數也從100年第4季的100人,擴增至101年第2季的132人。1017月起因新客戶認證、法規流程及歐債風暴影響客戶健保給付申請等問題,今年第3季較去年同期衰退26%,但19月仍比去年同期成長21%。台欣生技表示,自101至今年1231止,將實施3個月每月23天之短暫輪值無薪假,相當於減少薪資6.7%至10%,輪值無薪假人數為92人。台欣並指出,公司將利用此期間調節產能,將原輪班制之星期六、日停止生產,恢復每周正常5個工作天。(新聞來源:工商時報─記者王志煌/新竹報導)