TAIPEI -- A total of 12 firms have been approved by the Hsinchu Biomedical Science Park to plant the pioneering stake in the science zone with NT$1.62 billion in investments, park authorities said yesterday. The 12 firms have become the first group of investors to enter the science park, said Hsinchu Science Park (HSP), which currently operates the biomedical park. HSP said the 12 investors will station themselves in the biomedical park's biotech building, in which they will develop technology ranging from artificial tooth roots, orthopedic implants, and drug delivery systems to other high-end medical products. The biotech building, which is able to accommodate 36 manufacturing units, is part of the first-phase of construction of the biomedical park, which covers an area of 5.03 hectares. The biomedical park has previously planned to introduce NT$1.8 billion worth of investments in the first phase of the park's development by the end of 2013. The biomedical park, which is located in northern Hsinchu with transportation links by the Taiwan High Speed Rail, has been listed as one of the island's critical technology innovation development projects. With a total area of 38.1 hectares, the biomedical park will include a hospital, a biotech development and research center, and an industrial incubation center. The park is expected to integrate the resources from government, academia and industry. Construction of the planned hospital will start in 2012 and its operation is scheduled to begin in 2014. The hospital will engage in clinical trials and provide medical services to patients in critical condition. The Council for Economic Planning and Development (CEPD), the top economic planner in Taiwan, approved a budget of NT$399 million for the hospital in its first phase, while the budget plan is pending approval by the Legislative Yuan. The hospital's total NT$1.8 billion budget will be supervised by the Department of Health. As for the biotech R&D center, construction is scheduled to start in 2012 and finish in 2013.
Thursday, September 15, 2011
CEL-SCI's Taiwanese Partner Orient Europharma Presents Development Strategies in Taiwan for Investigational Cancer Therapy Multikine
CEL-SCI's Taiwanese Partner Orient Europharma Presents Development Strategies in Taiwan for Investigational Cancer Therapy Multikine (Leukocyte Interleukin, Injection) at World Orphan Drug Conference Today in Seoul, Korea Sep 15, 2011 (BUSINESSWIRE)CEL-SCICorporation CVM +3.55% announced that its Taiwanese partner Orient Europharma Co. Ltd. ("Orient Europharma") today is presenting its development strategies for CEL-SCI's investigational cancer therapy Multikine(R) (Leukocyte Interleukin, Injection)* in Taiwan, at the World Orphan Drug Congress in Seoul, Korea. Orient Europharma is a development partner of CEL-SCI participating in the investigational cancer therapy Multikine (Leukocyte Interleukin, Injection) Phase III Pivotal global study for head and neck cancer. The presentation, titled: "Developing orphan drugs in Asia: Successful collaborative effort between biotechs & policy makers" will be delivered by Yao Ting Lin, Head, Orient Europharma's Head of Business Development Division and will include a case study of its strategy for developing Multikine (Leukocyte Interleukin, Injection) in Taiwan. Taiwan has a high concentration of reported head and neck cancer cases and is expected to provide a significant number of patients for the CEL-SCI's Phase III trial. Orient Europharma has completed the Site Initiation Visit at all seven clinical centers in Taiwan and expects to enroll patients in the Taiwanese clinical centers this month. Overall the Phase III clinical study is expected to enroll about 880 head and neck cancer patients in about 48 hospitals in 9 countries on 3 continents. CEL-SCI's partner Teva Pharmaceuticals is conducting part of the Phase III study in Israel.
Multikine (Leukocyte Interleukin, Injection) Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of head and neck cancer. Multikine (Leukocyte Interleukin, Injection) has been cleared by the regulators in 9 countries around the world, including the U.S., for a global Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients. This trial is believed to be the largest head and neck cancer clinical study ever conducted. A detailed description of the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1 . It is also thought to be the first Phase III study in the world in which immunotherapy is given to cancer patients first, i.e., prior to their receiving the current conventional treatment for cancer, including surgery, radiation and/or chemotherapy. This is important because conventional therapy may weaken the immune system, and may compromise the benefits of immunotherapy. Because Multikine (Leukocyte Interleukin, Injection) is given before conventional cancer therapy when the immune system is likely to be more intact CEL-SCI believes the potential exists for it to be more successful in activating an anti-tumor immune response under these conditions. However, no definitive conclusions can be drawn from the Company's early data about the potential efficacy profile of this investigational therapy. Further research is required, and these results must be confirmed in a well-controlled Phase III clinical trial of this investigational therapy that is currently in progress. Subject to completion of that Phase III trial and FDA's review of our entire data set on this investigational therapy, CEL-SCI believes that these early-stage clinical trial results indicate the potential for this investigational therapy to be a benefit in the treatment of advanced primary head and neck cancer. The U.S. Food and Drug Administration also granted orphan drug status to Multikine (Leukocyte Interleukin, Injection) in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
About CEL-SCI Corporation CEL-SCI Corporation is developing investigational products that empower immune defenses. Its lead investigational product is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also developing (and investigating) an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. For more information, please visit www.cel-sci.com .
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2010. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
生技股醞釀中…
不敵盤勢，東洋、太醫跌破百元2011-09-15 【時報-台北電】 不敵大盤重挫，百元生技股持續淪陷！昨（14）日多頭指標的東洋（4105）和太醫（4126）百元大關相繼失守，目前生醫股僅剩下精華光（1565）、華廣（4737）和曜亞（4138）三檔個股力守。法人認為，以該族群目前獲利狀況和產業遠景來看，股價有過度反應現象，近日應有機會反彈。 一直被視為市場多頭主流的生醫股，上半年在熱度不斷下，包括精華光、太醫、華廣、台耀、亞諾法、曜亞、杏昌、東洋等8檔個股，股價都躋身百元俱樂部。佳醫、景岳、KY馬光亦都逼近百元大關，在各家公司股價相互輝映下，本益比亦普遍拉高至30倍以上。不過，由於塑化劑風暴衝擊，加上大盤重挫，該族群也領先大盤修正，儘管相較於電子股，跌幅較小，但幅度也都有二至三成。就統計來看，生醫族群上半年營運表現還是相當整齊，有12家公司的EPS都超過1.7元，而在下半年業績都普遍較上半年突出下，預期該高獲利的生技公司今年EPS將由3.5元起跳，而就昨日股價來看，葡萄王、友華、五鼎和旭富股價都偏低。而就基本面分析，精華光上半年已大賺一個資本額，國泰證券分析師王冠穎認為，該公司第3季在日本客戶的彩色片可望開始出貨且進入傳統旺季，預估單季營收可望創下全年最高約9.29億元，單季EPS約6.05元，預估今年營收來自日本市場將由40％提升至45％，年營業額有機會達35.4億元，將再創歷史新高，全年EPS可達22.95元。曜亞則因取得淨化光雷射代理權後，將同步在台灣、中國、香港和澳門同步行銷，對於曜亞在兩岸四地布局的醫美事業將有指標性意義，在大陸、香港等轉投資事業都將出現獲利下，今年獲利將可再創新高。至於也高坐百元俱樂部的華廣，則因主打「GE」品牌的血糖機，第4季起將開始銷售，使未來成長動能也相當可觀。
健保局加成補助有限….!
Wednesday, September 14, 2011
中國醫藥創新由政府給力 ”企業” !!!!
生物醫藥"十二五"首要目標鎖定創新藥 上海證券報 2011-09-12 在七大戰略性新興產業中，生物產業是最古老的產業，也是最現代的產業。"十二五"期間，生物產業將按照20%的增速成長為我國新的經濟增長點。生物產業的體量巨大。據麥肯錫測算，2010年全球生物產業產值已達2800億美元。而中國生物產業產值到2015年將達到4萬億元，到2020年將達到8萬億至10萬億元。而我國目前發展生物產業的核心問題是怎麼做強。 據《上海證券報》記者瞭解，"十二五"期間，生物產業的重點發展方向已經明確，主要分為生物醫藥、生物醫學工程、生物農業和生物製造四大板塊。其中，《生物產業發展"十二五"規劃》將進一步加強生物產業自主創新能力建設，推動生物技術的產業化、集群化和國際化發展，使其成為我國社會經濟發展新的支柱產業。 近年來異常活躍的生物醫藥行業是七大戰略性新興產業中生物產業的"重頭戲"。據中國醫藥企業管理協會會長於明德向記者介紹，生物醫藥將給21世紀經濟與社會發展帶來新的突破，無論從研發還是產業化角度，都將成為生物產業發展的重點。記者瞭解到，生物醫藥的"十二五"發展目標已經明晰：到2015年，我國形成基因工程藥物、新型疫苗、抗體藥物、化學新藥、現代中藥等為代表的一批具有國際水平的新藥開發平臺，企業研發投入強度顯著提高，骨幹企業競爭力明顯增強。同時，記者瞭解到，提高我國新藥創制能力，是生物醫藥的首要戰略目標。 目前，除了正在進行中的重大新藥創制專項，另外還有數十個投資專項規劃和支撐計畫等扶持配套政策正在緊鑼密鼓制訂中，國家將從政策方面持續"給力"醫藥企業創新。
一系列政策重點扶持企業創新 據介紹，加強創新、優化產業結構正是"十二五"生物醫藥產業的重大任務。"十二五"期間，生物醫藥將建成一套創新體系。在這個體系中，不僅要建立國家人類基因資源庫，重點發展以化學藥物製劑技術、動物細胞高效表達與大規模培養、基因重組治療性抗體、多肽類藥物合成、幹細胞治療等技術，還將依託優勢企業建設和完善產、學、研緊密結合的新藥研發平臺。 要實現這些目標，國家將出臺一系列配套政策。據瞭解，除重大新藥創制專項外，數十個投資專項規劃和支撐計畫等扶持配套政策正在緊鑼密鼓制訂中。 "十二五"期間，我國重大新藥創制專項將獲中央財政下撥資金100億，地方配套資金300億元。這是在今年全國生物產業大會上傳出的重大利好。重大新藥創制專項包括創新藥物研究開發、藥物大品種技術改造、創新藥物研究開發技術平臺建設、企業創新藥物孵化基地、新藥技術開發關鍵技術研究和國際合作專案。 "如果不算地方配套資金，僅中央財政提供的重大新藥創制的資金扶持力度較\"十一五\"期間幾乎翻了一番。"中國生物谷線上副總經理楊春向記者介紹。據瞭解，對重大新藥創制專項的扶持將分三個層次：對創新藥物研究開發專案，中央財政對每個課題的資助範圍為300—500萬元；對創新藥物研究開發平臺建設專案，資助範圍為1000—1500萬元；對企業創新藥物孵化基地專案，每個專案的補貼則為500萬元—1200萬元。更值得關注的是，以往對科研機構、高等院校和企業等的共同扶持將逐漸轉變為以扶持企業為重點。對此，上海醫藥工業研究院的相關負責人認為，從國家"十一五"重大新藥創制專項實施的情況來看，該專項獲得了一批新藥研發的成果，而完成項目最好的是企業。因而"十二五"期間的專項扶持將以企業為重點。另外，對生物醫藥的創新扶持並不局限於重大新藥創制這一項政策。據於明德介紹，目前國家正在制訂數十個投資專項規劃和支撐計畫，以落實對不同環節、不同技術的扶持。他樂觀地表示，"可以預期，未來5年，我國的生物醫藥必將實現跨越式發展。"
創新型藥企將成資本市場新寵 醫藥產業在我國將實現高速增長已是不爭的事實。據著名市場調研公司IMS Health預測，2011年日本醫藥行業有5%—7%的增長，美國醫藥行業增長3%—5%，歐洲醫藥行業增長1%—3%，我國醫藥行業則能實現25%—27%的增長，且在未來四到五年將保持同樣增速。而具有療效明顯、不易形成抗藥性、成功率高等優點的生物藥，將有望成為醫藥產業新的利潤增長點。 中國醫藥企業協會會長於明德表示，為實現從醫藥大國到醫藥強國的轉變，現在我國正在大力投入具有自主知識產權的原創生物醫藥的研究開發和產業化。據於明德預計，"十二五"期間，我國將擁有25個原創新藥，其中約15個將是生物藥，如基金工程幽門螺旋桿菌疫苗、基因工程乙肝治療疫苗以及治療眼底黃斑性的KH902等。 擁有國內最大基因工程公司金賽藥業的長春高新和研發實力強大的國內生物藥龍頭雙鷺藥業等上市公司被券商評為受益股。同時，研發創新與營銷能力皆具優勢的恒瑞醫藥、我國首個進入美國FDA臨床III期認證的現代中藥龍頭天士力，以及目前擁有7個美國FDA製劑批文、10個原料藥產品現場認證的華海藥業都被券商研究員一致看好。 創新帶來的好處毋庸置疑。在從容醫療基金合夥人姜廣策看來，醫藥企業必須重視創新帶來的知識產權，以及由此帶來的獨家定價權。"這就構成了巴菲特所說的又寬又深的護城河。"他認為，做到了這一點，企業贏利和股價上升都將水到渠成。醫藥企業也把創新作為了發展要務。中國知名品牌醫藥公司——修正藥業集團就正在耕耘創新之路。據集團董事長修淶貴介紹，醫藥"十二五"規劃使中國醫藥企業面臨新形勢，企業要想有所突破，就必須加強創新。 他的規劃是，"十二五"期間，修正藥業將開發創新尿酸氧化酶、NV-蛋白酶等生物製劑2—3個，中藥複方製劑等創新中藥22個。 在申銀萬國醫藥行業研究員婁聖睿看來，目前中國生物醫藥企業將沿著創新之路前行。回顧日本和印度制藥企業創新歷程，中國藥企創新才處於突破階段。但未來它們的創新能力一定會大幅提升。他認為，具體的創新方式包括以下三種：品種創新—中國專利藥面世；模式創新—虛擬一體化驅動下的中國藥企和跨國藥企全面合作；品牌和渠道創新—中藥企業向藥用消費品拓展，打造品牌知名度和銷售網路。當然，創新並非一蹴而就。中國工程院院士、上海藥物研究所所長丁健認為，中國藥物創新正處於歷史最好時期。不過，"國內藥企面臨諸多機遇的同時，其創新難度也在增加。"
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