三星 抗體相似藥SAIT101滑鐵盧 能走得下去嗎?

歐美改規則！三星生物相似藥測試喊卡，進度恐落後 2012/10/18 10:54 精實新聞 2012-10-18 10:54:26 記者 郭妍希 報導 致力開發生技、製藥產品以尋找新興成長動能的三星電子(Samsung Electronics)最近對生物相似性藥品(biosimilar)的研究似乎面臨了挑戰。韓國時報(Korea Times)17日報導，三星一位不願具名的主管表示，該公司已暫停生物相似性藥品「SAIT101」的臨床測試作業。三星原本希望透過SAIT101對抗癌症「霍杰金氏病(Hodgkin`s disease)」。 三星內部人士表示，SAIT101自去(2011)年3月起就在該公司位於全球各地的實驗室中進行臨床測試，但後來卻因為一些內部因素而暫停了測試作業。三星原本在16個國家測試這款藥物，當中包括台灣、南韓、英國、西班牙、捷克、加拿大、巴西與南非。根據報導，三星似乎是因為歐洲、美國更改了藥品安全標準而被迫重新進行測試。美國最近剛宣布了最新的生物醫藥品(biopharmaceuticals)研究指導原則。 上述三星主管表示，該公司正在與美國食品暨藥物管理局(FDA)洽談，將重新設定SAIT101的臨床測試條件。他說，三星原本計畫加快歐洲認證的腳步，因此這個狀況肯定會使進度落後。 三星計畫在2020年底前對生物相似性藥品領域投入超過20億美元，該公司相信這部分的營運最終將能媲美目前的手機、消費性電子產品、半導體與面板業務。 三星生物(Samsung Biologics Co.)、美國生技製藥公司Biogen Idec Inc.於2011年12月5日發布聯合新聞稿宣布，雙方將攜手投資3億美元成立合資企業，將開發、製造並行銷生產生物相似性藥品。三星在合資企業扮演主導角色，而Biogen Idec則將貢獻該公司在蛋白質工程(protein engineering)以及生物製劑製造(biologics manufacturing)方面的專長。Samsung Biologics是三星在2011年創立的企業，主要從事生物醫藥品的製造業務。 三星集團(Samsung Group)曾在2011年2月25日宣布，將與美國製藥商昆泰(Quintiles Transnational Corp.)成立生技醫藥合資企業，以便尋找新的成長動能。其中，三星集團將持有90%合資企業股權，當中40%股權是三星電子(Samsung Electronics Co., Ltd)所有，其餘10%股權則歸昆泰。這個合資企業是三星集團跨入生技醫藥領域的第一步。三星計畫在相關領域擴充業務，並在2016年開始生產生物醫藥品。

Samsung halts clinical tests for biosimilar 10-17-2012 17:48 By Kim Yoo-chulSamsung Electronics' aspirations to find a new growth engine in biotechnology and pharmaceuticals appear to have hit a speed bump. Company officials admit that it has halted clinical tests for SAIT101, a material it hoped would create more effective drugs to fight Hodgkin's disease.``We have been conducting clinical tests for SAIT101 in our labs in different locations around the word since March last year. However, the testing has stopped due to some internal reasons,'' said one Samsung source, asking not be identified. The company had been testing the potential drug material with scientists in 16 countries, including Britain, Spain, Czech Republic, Canada, Brazil, South Africa and Taiwan aside of Korea. It appears that Samsung is being forced to redo the tests from scratch due to changes in safety requirements in Europe and the United States. The U.S. in particular has recently announced new guidelines for the research of biopharmaceuticals, or medical drugs produced using biotechnology. The Samsung source, who is close to the projects, said that the company is in talks with the U.S. Food and Drug Administration to reset the conditions for the SAIT101 clinical tests. ``We had vowed to get quicker approval in Europe, so this will definitely put us behind our original schedule. There was also a need to better prepare for testing in the U.S. which is even a larger market. We will eventually be fine,'' he said. Samsung plans to invest more than $2 billion by 2020 in the area of biotechnology and advanced pharmaceuticals, a market it calls as ``bio-similar,'' which it believes will eventually grow to complement its main cash cows of mobile phones, consumer electronics, semiconductors and flat screens. Samsung Electronics Chairman Lee Kun-hee has been vocal about the company carving a position in biopharmaceuticals, which he believes would be a good fit for Samsung's traditional business model based on manufacturing prowess and brute strength. The global market for biopharmaceuticals is seen currently at around $30 billion and expected to maintain annual growth rate of over 50 percent during 2010-15 period. The market will be propelled by upcoming patent expiries of leading biologics and a financial crisis coupled with increasing health care costs that has required systems in almost all developed countries to look for low-cost alternatives, Samsung officials said.