Wednesday, September 12, 2012

亞東證券 承銷 創源上櫃 明顯疏失!!!


創源上櫃疏失 承銷商被處分【經濟日報╱記者蕭志忠/台北報導】 2012.09.13 03:47 am 創源生技(4160)初次上櫃前公開申購掀熱潮,昨(11)日電腦抽籤的中籤率僅有1.36%但主辦承銷商亞東證券卻因上櫃送件時有明顯評估疏失,已先被櫃買中心處記缺點高達5點。櫃買中心表示,亞東證券主辦創源生技股票初次上櫃案,由於送件當初並未確實評估出上櫃的訊聯生技對創源生技具有控制力,疏失較為嚴重。因此,依相關承銷商評估報告應行記載事項等規定,在8月處以亞東證缺點5點。【2012/09/13 經濟日報】

Sanofi Pasteur登革熱疫苗 three dengue virus types vaccine: 31000人臨床三期 !!!


Sanofi Pasteur's first efficacy results confirm safety profile of dengue vaccine candidate Wednesday, September 12, 2012, 10:00 Hrs[IST] Sanofi Pasteur, the vaccines divisionof Sanofi, has announced clinical study results showing the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types. The results of the world's first efficacy study confirm the excellent safety profile of Sanofi Pasteur's dengue vaccine candidate.A feature of dengue epidemiology is that the relative prevalence of virus types in a given area is evolving with time. Large-scale phase III clinical studies of Sanofi Pasteur's dengue vaccine candidate are underway with 31,000 children and adolescents in 10 countries in Asia and Latin America. These studies will generate important additional data in a broader population and in a variety of epidemiological settings to define the best conditions to set up vaccination programs in order to protect people at risk of dengue.The study was conducted in 4,002 children aged 4 to 11 years, in partnership with the Mahidol University under the patronage of the Thai Ministry of Public Health in Muang district of the Ratchaburi Province. Sanofi Pasteur's dengue vaccine candidate is a live, attenuated vaccine. The vaccination schedule is 3 doses given 6 months apart (at 0, 6 and 12 months).Dr. Scott Halstead, International Vaccine Institute, Seoul, Republic of Korea., said, "The complexity of dengue virus infection has hampered vaccine research for decades. This is the first time in 50 years of dengue research that I have seen a vaccine that protected a large group of children fromclinical disease caused by dengue viruses. Best yet, the vaccine met the highest safety expectations. These results should be a source of hope for millions of parents whose children are at risk of severe dengue, a life-threatening disease which often requires hospitalization."The full analysis of vaccine efficacy against each serotype, reflecting real-life conditions (intent to treatanalysis) showed vaccine efficacy to be 61.2 per cent against dengue virus type 1, 81.9 per cent against type 3 and 90 per cent against type 4. One of the dengue virus types (serotype 2) eluded the vaccine. Analyses are ongoing to understand the lack of protection for serotype 2 intheparticular epidemiological context of Thailand."Having worked in the field of dengue research for over four decades, with much of my efforts focused on prevention and control, it is very exciting for me to see a safe vaccine candidate that provides protection against 3 of the four dengue serotypes," said Professor Duane Gubler, Program on Emerging Infectious Diseases, Duke-NSU Graduate Medical School, Singapore. "Dengue is a major public healthconcern for over half of the world's population and is a leading cause of hospitalization and deathamong children in endemic countries.Because mosquito control has failed to control this disease, an effective vaccine will be a critical tool that can change the life of millions living in endemic countries. I see this success as the beginning of a new era of effective control."According to Dr. Roberto Tapia Conyer, General Director of the Carlos Slim Health Institute, Former Undersecretary of Health in Mexico, "These dengue vaccine results bring a significant promise in thecontext of the expanding denguedisease burden worldwide and theabsence of specific treatment. Work will continue to study this vaccine and the circulation of dengue viruses globally, but in the meantime, the public health community can now formulate the best possible immunization policies and prepare for implementation of vaccination campaigns in countries heavily affected by dengue."

因華 興櫃28元 健喬將釋股拉高今年EPS (>2)???


健喬 業績衝10年新高【經濟日報╱記者黃文奇/台北報導】 2012.09.12 03:25 am 健喬信元(4114)旗下小金雞因華生技將於今(12)日召開「登錄興櫃前法說會」,健喬表示,隨著因華登錄興櫃,健喬將出脫老股,11月、12月獲利可望獲得釋股挹注,今年受惠於本業、業外雙引擎,營運將創下10年來新高。健喬昨日股價收29元,上漲0.3元。健喬指出,看好因華長期發展,將考慮少量出脫持股,以活絡因華在資本市場交易狀況。法人表示,因華承銷價暫定每股為28元,而健喬持股成本為每股7元,近期可望承銷600張,每股價差超過20元,因此預估潛在釋股收益至少在1,000萬元,最快第4季認列收益。目前,健喬持有因華約1.34萬張,持股比重近四成,完成登錄後持股比重將降至三成左右。分析師表示,今年健喬受惠於本業、業外挹注,不僅營收將躍進兩成以上再創新高,由於轉投資公司因華的挹注,今年每股稅後純益(EPS )也有機會突破2元,改寫近10年新高。【2012/09/12 經濟日報】

基亞募得8.1億元現增 (45元/股)


智擎將掛牌 可望推升基亞股價〔記者陳永吉/台北報導〕由於第2季辦理現金增資,取得8.1億元的資金,使得新藥股基亞生技(3176)每股淨值恢復至10元以上,且已從財務重點專區內剔除,加上近期另一檔重量級新藥股智擎(4162)即將掛牌的比價效應,推升基亞股價創下歷史新高。新藥股多數以研發為主,在產品未授權或未上市之前,幾乎每年只能燒錢,所以導致每股淨值多數都低於10元。基亞第1季的情況也是如此,當時每股淨值只有7.6元,又連續虧損3年,因此被納入財務重點專區。不過第2季基亞現增1800萬股,每股定價45元,募得資金8.1億元,雖然第2季本業仍虧損,但第2季底的每股淨值回升至12.51元,正式脫離財務重點專區。國內新藥股開始陸續進入資本市場,東洋藥品(4105)集團旗下的新藥公司智擎,即將於18日以每股86元掛牌上櫃,目前興櫃價格達120元,市場看好新藥股將有比價效應,因此本週基亞漲幅達12.3%。除了基亞之外,包括台苯(1310)、裕豐(1438)、安鈦克(6276)、鉅明(8928)、眾星(8082)等都因為財務情況改善,負債比降低或營業現金流量轉正,第2季財報出爐後,從財務重點專區中剔除。至於新加入的個股,第2季僅增加錸德(2349),主要是錸德已連續3年虧損,第2季財報出爐後每股淨值為9.97元,符合財務重點專區指標2的規定,而被納入其中。

懷特血寶: FDA orphan drug designation


懷特血寶注射劑 3年後在美上市 中央社 (2012-09-10 09:00) (中央社記者羅秀文台北2012910)懷特(4108)歷經14年研發成功的「懷特血寶注射劑」,向美國FDA申請孤兒藥資格獲通過,可望進入快速審查機制,縮短一半的審查時程,預計3年後上市,進軍美國市場。懷特血寶注射劑是全球唯一抗「癌因性疲憊」處方藥,上市後頗受醫界矚目。此產品新適應症治療原發性血小板低下紫斑症(Idiopathic Thrombocytopenic PurpuraITP)二期臨床試驗已完成,向美國食品藥物管理局(FDA)申請孤兒藥資格認定獲通過,可望進入快速審查機制,至少縮短一半的審查時程,預計3年後上市,進軍美國市場。懷特表示,我國目前僅有基亞生技(3176)與懷特生技擁有通過美國FDA孤兒藥資格認定的產品。未來向美國FDA申請新藥審查時,除了進入快速審查機制、縮短上市時程外,更享有免繳超過100萬美元的審查費、享受稅務優惠,以及市場專賣保護期等優惠措施。

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