ShangPharma (尚華醫藥), an ambitious CRO follows WuXi Pharma Tech biz model

ShangPharma opens Fengxian facility

18-Jan-2011 ShangPharma has opened a multi-purpose pharmaceutical development cGMP manufacturing facility in Fengxian, China, and started operations on the initial phase of production. The pharma and biopharma research and development (R&D) outsourcing company, said its state-of-the-art facility will be named China Gateway Pharmaceutical Development Company and will operate as a wholly owned subsidiary of the firm. The expansion will enable ShangPharma to boost its service offerings in process and formulation R&D, analytical method development and validation and current good manufacturing practice (cGMP) manufacturing of drug intermediates and active pharmaceutical ingredients (APIs) for preclinical development and clinical trials. A ShangPharma spokesperson said: "With the newly added capacity in the Fengxian plant, the company will be able to support its clients' projects all the way through Phase II and into Phase III development." The contract research organisation (CRO) added that further plans may be made to expand the manufacturing facilities to 460,000 sq ft if it experiences a strong demand for commercial manufacturing of FDA – or EMEA – approved drugs. Last year, ShangPharma raised $87m (€65m) through an IPO on the New York Stock Exchange, of which the firm planned to spend $15m on the new Fengxian site. Some of these proceeds have been spent on equipping the Fengxian facility with a pilot plant boasting six separate bays with reactor capacities of 200 to 3,000 litres, as well as other specialty bays for high temperature, cryogenics, and highly toxic and pressurized reactions such as hydrogenation.

Clean room suites and R&D lab  Additionally, ShangPharma said there are two clean room suites rated at class 100,000 for isolation, 10 kilo-lab suites for non-cGMP and cGMP manufacturing, alongside an R&D laboratory for analytical, formulation and process development activities. According to the China-based firm, there is an area of the new facility dedicated to analytical support, and testing of raw materials, intermediates and final products will also be carried out at the site. A separate quality assurance (QA) department has been added to allow the company to ensure materials are manufactured to keep in line with standards set out by cGMP guidelines.

US Chinese Anti Cancer Association facilitated liver metastasis biomarkers cooperation between Peking University & Aushon BioSystems

Aushon BioSystems and Peking University Cancer Hospital Collaboration to Focus on Predictive Diagnostic Biomarkers for Liver Metastases of Colorectal Cancer

Feb 8, 2011 Aushon BioSystems, Inc., a leading provider of multiplex immunoassay products and services announced that it has signed a letter of intent to enter into a diagnostic development collaboration with Peking University Cancer Hospital ("PUCH"), Beijing, China. The primary goal for the collaboration is to develop predictive diagnostic markers for liver metastases of colorectal cancer utilizing Aushon's proprietary suite of protein biomarker detection technologies, and stratification biomarkers for radio-chemotherapy patients. As part of this collaboration, PUCH and Aushon will further negotiate an agreement to grant Aushon exclusive rights In North America and Europe to certain intellectual property generated from the collaboration for diagnostic applications. The research will be conducted under the leadership of Dr. Jin Gu, MD, FACS, Peking University Cancer Hospital, Peking University. Prof. Gu is a world-renowned expert and clinician on colorectal cancer and liver metastasis. He leads a team of scientists and physicians investigating the mechanisms of colorectal cancer metastasis including the identification of biomarkers to predict which patients may develop metastatic disease in liver. Dr. Gu has established a vast library of patient samples, as well as extensive clinical and post-surgery follow-up data that he and his staff have accumulated over the past several years. "We look forward to the opportunity to collaborate with Aushon on this critical clinical research program," said Dr. Gu. "Aushon's technology has already received widespread market acceptance with leading pharmaceutical companies due to its proven reliability and performance in late stage clinical trials, and has the key attributes we identified for a multiplex diagnostic platform. We are very optimistic that this partnership will lead to the discovery and development of predictive diagnostic markers for primary colorectal cancer metastases in liver, and establishment of new treatment strategies to improve outcomes for our patients." "We're extremely excited that Dr. Gu and his exceptional team at the Peking University Cancer Hospital have selected Aushon as a partner for their project," said Joe Blanchard, COO of Aushon. "We believe Aushon's technology and expertise are ideally suited for this diagnostic development program and expect that this will be the first of several such technical collaborations with Peking University Cancer Hospital and other leading research institutions in Asia". The collaboration was initiated and facilitated by the US Chinese Anti-Cancer Association (USCACA). "This collaboration marks another important milestone for USCACA in promoting US-China collaborations in cancer research, drug development, and patient care," remarked Dr. Li Yan, Managing Director of USCACA and adjunct professor at PUCH. "I am thrilled to see PUCH taking a leadership position in the area of personalized medicine, and look forward to the successful results of their collaboration with Aushon." Aushon also recently announced its partnership with LightArray Biotech, a drug development service company located in Wuxi, China. This partnership enables Aushon to provide its multiplex biomarker products and services to pharmaceutical clients in China.

US Chinese Anti Cancer Association facilitated liver metastasis biomarkers cooperation between Peking University & Aushon BioSystems

Aushon BioSystems and Peking University Cancer Hospital Collaboration to Focus on Predictive Diagnostic Biomarkers for Liver Metastases of Colorectal Cancer

Feb 8, 2011 Aushon BioSystems, Inc., a leading provider of multiplex immunoassay products and services announced that it has signed a letter of intent to enter into a diagnostic development collaboration with Peking University Cancer Hospital ("PUCH"), Beijing, China. The primary goal for the collaboration is to develop predictive diagnostic markers for liver metastases of colorectal cancer utilizing Aushon's proprietary suite of protein biomarker detection technologies, and stratification biomarkers for radio-chemotherapy patients. As part of this collaboration, PUCH and Aushon will further negotiate an agreement to grant Aushon exclusive rights In North America and Europe to certain intellectual property generated from the collaboration for diagnostic applications. The research will be conducted under the leadership of Dr. Jin Gu, MD, FACS, Peking University Cancer Hospital, Peking University. Prof. Gu is a world-renowned expert and clinician on colorectal cancer and liver metastasis. He leads a team of scientists and physicians investigating the mechanisms of colorectal cancer metastasis including the identification of biomarkers to predict which patients may develop metastatic disease in liver. Dr. Gu has established a vast library of patient samples, as well as extensive clinical and post-surgery follow-up data that he and his staff have accumulated over the past several years. "We look forward to the opportunity to collaborate with Aushon on this critical clinical research program," said Dr. Gu. "Aushon's technology has already received widespread market acceptance with leading pharmaceutical companies due to its proven reliability and performance in late stage clinical trials, and has the key attributes we identified for a multiplex diagnostic platform. We are very optimistic that this partnership will lead to the discovery and development of predictive diagnostic markers for primary colorectal cancer metastases in liver, and establishment of new treatment strategies to improve outcomes for our patients." "We're extremely excited that Dr. Gu and his exceptional team at the Peking University Cancer Hospital have selected Aushon as a partner for their project," said Joe Blanchard, COO of Aushon. "We believe Aushon's technology and expertise are ideally suited for this diagnostic development program and expect that this will be the first of several such technical collaborations with Peking University Cancer Hospital and other leading research institutions in Asia". The collaboration was initiated and facilitated by the US Chinese Anti-Cancer Association (USCACA). "This collaboration marks another important milestone for USCACA in promoting US-China collaborations in cancer research, drug development, and patient care," remarked Dr. Li Yan, Managing Director of USCACA and adjunct professor at PUCH. "I am thrilled to see PUCH taking a leadership position in the area of personalized medicine, and look forward to the successful results of their collaboration with Aushon." Aushon also recently announced its partnership with LightArray Biotech, a drug development service company located in Wuxi, China. This partnership enables Aushon to provide its multiplex biomarker products and services to pharmaceutical clients in China.

 

About Peking University Cancer Hospital (PUCH) PUCH is one of China's largest and most renowned hospitals focusing specifically on cancer research and treatment. It has 790 hospital beds, 26 clinical departments and 13 medical technological departments. PUCH has been engaged in the diagnosis and treatment of various tumors, including breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer, esophageal carcinoma, malignant lymphoma, gynecological cancer, tumor of head and neck, tumor of urological system, bone tumor and melanoma. The hospital advocates the cooperation of multiple disciplines, integrates the medical sources of all departments, and has established different cooperative groups for mono-disease including breast cancer, gastric cancer, lymphoma, and liver cancer, to provide normalized and individualized combined treatment for the patients. The hospital is also a member of the national base for clinical pharmacology. From 2000 to 2007, our hospital has completed 76 clinical trials, of which 52 were domestic clinical trials, 10 international multi-center clinical trials, and 14 clinical trials for medical equipment. There are currently 35 domestic clinical trials, 11 international multi-center clinical trials, and 4 clinical trials for medical equipment taking place at PUCH.

 

About Aushon BioSystems Aushon BioSystems provides a comprehensive suite of microarray instruments, consumables and services to leading pharmaceutical, biotechnology, academic and diagnostic clients worldwide. Our unique combination of advanced microarray printing technology, robust biomarker content and innovative multiplex immunoassay development and detection systems delivers exceptional performance, quality and reliability that accelerate pre-clinical and clinical biomarker research. Our customers trust us to provide the most reliable protein biomarker data available, which lowers costs and improves research productivity. For more information, please visit www.aushon.com.

 

About US Chinese Anti Cancer Association (USCACA), USCACA is a non-profit professional organization founded in 2009. With a broad membership base spanning academia, industry and government agencies, USCACA facilitates collaborations among cancer researchers and physicians from the United States and China in the areas of cancer research, cancer drug R&D, as well as patient care and support. One of the organization's current focuses is on safely expediting novel cancer drug development by fostering global clinical trial collaborations, sharing best practices and knowledge of clinical trials, and providing education and training opportunities. USCACA collaborates with Chinese Anti-Cancer Association (CACA), Chinese Society for Clinical Oncology (CSCO), and other professional associations. Our mandate is to improve cancer treatments through research, education, and collaboration. For more information, please visit www.uscaca.org

中國直銷業務: 哈藥集團難以掌握 !

鄭鳳強出走 人員轉給三生 哈藥終結直銷業務？ 2011年01月20日 21:16  南方都市報　　去年此時，國內首家上市藥企哈藥以3億元啟動資金和152億元的哈藥品牌價值謀求100億直銷份額的誓言猶在耳畔，而今，這一目標似乎已煙消雲散。記者昨日獲悉，被譽為"中國最具潛力直銷企業C E O"的哈藥顧問鄭鳳強已正式離職，哈藥則在去年10月就與寧波三生達成戰略合作協議，成為國內首單拿牌公司之間的整合案例。 "去年11月初哈藥的資料庫就對三生開放了，20多款下架，只剩2款產品和另外2款三生產品可以報單。加上本月鄭鳳強走，這種所謂的自然過渡我們當然理解為哈藥直銷業務已經終結了。"哈藥經銷商嚴生(化名)向本報記者表示。

哈藥直銷併入三生？  "去年10月，在沒有任何徵兆的情況下，哈藥組織全體經銷商高層在上海開會，與三生共同宣佈進行戰略合作。11月資料庫對三生開放，20多款產品下架，PV值(積分)也從0.8調整為0.5，即獎金下調了37.5%。"在嚴生的看法中，顯然如果以後三生產品的PV值高，就可以誘使經銷商把這部分產品推向哈藥的直銷員。 哈藥方面對此的官方答復為，不同於市場兼併，也不存在誰吞併誰，本次戰略合作是兩企業在行銷管道、行銷人員、銷售產品、生產研發四方面合作。而據記者瞭解，具體到操作形式，哈藥現有直銷員可自願擁有三生會員資格，自主運作，三生業務可按三生制度計算相應獎金；新直銷員可自由選擇在其中一家公司報單。 "我已經正式離開哈藥，現仍為三生顧問。"曾任安利高級業務營運經理、天獅集團中國區總裁、三生大中華區執行總裁及富迪顧問的原哈藥顧問鄭鳳強對記者表示，其目前角色不便評價哈藥與三生合作的實質是否就是哈藥中止直銷業務。記者同時瞭解到，哈藥直銷高管團隊其實在鄭鳳強離職之前已群體跳槽至富迪。

今年或迎整合大潮  "直銷是我們新增的一種銷售方式，也是我們不可能放棄的一種銷售方式。"哈藥股份董秘孟曉東此前曾如是對媒體表示。記者瞭解到，2008年11月哈藥正式拿牌，但此後陷入沉寂，直至2009年12月迎來鄭鳳強的加盟，才在去年1月提出宏大目標。不具名業內人士稱，哈藥身為國企，雖然已確定了生物工程、疫苗和直銷為三大支柱產業，直銷板塊也曾提高到與哈藥三精、哈藥六廠平起平坐的位置，但試水之後負面不斷，面臨巨大風險，企業不願冒著損失品牌的風險下賭，因此有意砍掉直銷業務，但怕經銷商不同意，才有把團隊轉讓給三生的想法。而據記者瞭解，財大氣粗也未能在水深莫測的直銷領域一帆風順的並非只有哈藥。房產巨頭僑鑫集團也曾在2009年發力直銷，旗下全資子公司東方藥林吸納直銷大佬邱錦雲，稱前期投資便高達1.5億美金，後期還有2億美金追加，卻始終未能如願拿牌，隨後邱錦雲跳槽中脈，東方藥林也悄然凍結直銷業務。 世界華人直銷促進會秘書長禹路分析，哈藥原先的直銷戰略定位不清晰，分配制度適合快速啟動市場，很容易將同行的團隊吸收過來，但容易造成不滿，構成壓力。"未來哈藥或許並不會完全放棄直銷，而是轉為電子商務、連鎖店、直銷相結合的三網合一模式。"其同時透露，由於直銷牌照是絕對稀缺資源，市場沒牌的直銷公司有一兩千家，無牌公司向有牌公司靠近將成為常態。今年直銷業界勢必將迎來新一輪的並購整合大潮。

中國生物醫療電子龍頭 (深圳邁瑞; Mindray) 西安研發中心

全球醫療電子巨頭邁瑞研發中心落戶西安

2011年01月12日 昨日下午，深圳邁瑞生物醫療電子公司與高新區舉行公司研發中心暨西北區域總部專案簽約儀式。省委常委、市委書記孫清雲出席簽約儀式並會見邁瑞公司總裁李西廷。市委常委、市委秘書長楊殿鐘，市委常委、高新區管委會主任岳華峰參加會見和簽約儀式。孫清雲首先對深圳邁瑞生物醫療電子公司研發中心暨西北區域總部專案落戶西安表示祝賀。他說，邁瑞公司作為知名醫療器械公司，近年來通過自主創新打造醫療品牌，在國際金融危機衝擊中仍佔據較大市場份額，凸顯出較強的成長性和生命力。孫清雲指出，西安高校和科研院所眾多，科技研發實力雄厚，為生物醫藥企業發展奠定了堅實的人才和技術支撐。西安市將大力支持邁瑞公司的發展，希望加快項目落戶步伐，並圍繞醫療器械生產研發搞好產業配套，延伸產業鏈條，促進西安生物醫藥產業發展壯大。李西廷對我市給予邁瑞公司的大力支持表示感謝。他說，公司十分看重西安的人才優勢，特別是西安市高效快捷的政務服務環境給邁瑞公司留下深刻印象。他表示，邁瑞公司將加快專案建設進度，爭取早日達產，並拓展業務領域，努力為西安經濟社會發展貢獻力量。據悉，深圳邁瑞生物醫療電子公司在中國乃至全球醫療電子設備領域享有盛譽，2006年作為中國首家醫療設備企業在美國紐交所上市。公司研發中心暨西北區域總部專案計畫投資8億元，建成後實現年銷售收入超過10億元，將進一步提升西安醫療設備產業競爭力，並會帶動更多的醫療行業龍頭企業到西安投資發展。

私慕與創投全力鎖定醫療健康產業中國

醫療健康產業基金蜂擁而上 PE機構欲轉身做VC

2011年01月20日 15:28來源：南方網  轉發剛剛過去的2010年，醫療健康產業名列IPO數量最多的四個行業之一，而以截至創業板上市一周年的資料來看，各行業企業IPO平均帳面投資回報率最高的行業是醫療健康，平均投資回報率為18.68倍。各類醫療健康產業基金先後成立，專案爭奪戰硝煙四起。在醫療健康產業進入白熱化爭奪戰的關口，該如何投資？"我們去年完成了三個醫療健康產業項目的投資，投資金額接近兩億，項目前移，專注細分行業同時不放棄後端項目。"前日上午，深圳市高特佳投資集團董事長蔡達建接受南都記者專訪時認為，多做VC，做專業化的VC。

醫療產業需求還將進一步放大  按照ChinaVenture投中集團統計的資料，從行業分佈來看，2010年IPO中國企業分佈於19個行業，案例數量最多的四個行業分別是製造業、IT及能源行業和醫療健康。創業板一周年的資料顯示，醫療健康和TM T最受投資者關注，V C／PE背景企業所占比例分別為76.9%和72.5%。"我們從2003年就開始對健康產業進行佈局了。"蔡達建說，除了投資醫療器械的邁瑞醫療外，僅在2010年，公司就投資了三家醫療健康產業的公司。截至去年年底，深圳市高特佳投資集團已在醫療健康領域投資了7家企業。蔡達建認為，隨著醫改方案的出臺，中國老百姓在醫療方面的潛在需求被釋放後，醫療產業的需求會被進一步放大，這個行業的增長空間還很大。此前，建銀醫療基金有關人士也表示，非常看好全國性和區域性的藥品流通龍頭企業，將支持它們通過兼併重組等方式繼續做大做強，向下延伸銷售網路，實現基層網路的有效覆蓋。"我們的戰略是，專注於行業研究和產業鏈的打通，發現企業，培養企業，但同時不會放棄後端項目的投資。"蔡達建告訴南都記者，公司去年投資了6個億的後期項目，今年也不會少於這個數字，但主要的精力則放在行業研究和細分機會的挖掘上。在跟蹤了長達三年之後，去年10月，深圳市高特佳投資集團約4000萬投資了醫療服務企業深圳市眾安康後勤服務有限公司。據介紹，這是一家1999年成立的綜合性現代後勤管理服務專業機構，主要從事醫院後勤管理服務，已經接管了數十家大型醫院，能夠把醫院的後期服務全部帶下來，也可以專門外包某一塊業務。

醫療三子行業受關注  "這周跑了五個城市，得出結論如下：1)不分南北，每個城市的天氣都很冷。2)不分東西，每個城市的投資都很熱。3)不分早晚，每個城市的項目都很貴……"業內人士不久前在微博中的一段話正是對當前投資領域的真實寫照。2010年的中國，想找一個比創投更熱的行業似乎很難，PE這碗飯不好吃了，怎麼辦？蔡達建給出的答案是多做V C，做專業化的V C。蔡達建特別看好醫療器械、生物制藥與中藥行業。醫療改革政策出來之後，大家都知道行業有好的機會，但如何去把握？蔡達建認為，從創投的思路來看，比較集中的是兩個方面，一方面主要是後期項目的爭奪；一方面是做V C的角色，培育項目。"過去幾年生物制藥的複合增長率達到了40%左右，中成藥30%左右，仿製藥也有了20%以上，這都是最市場化的一些細分。"蔡達建說。2010年，深圳市高特佳投資集團投資的另外一家醫藥企業是深圳市貝斯達醫療器械有限公司。貝斯達主要生產核磁共振為主的醫療設備，"我們投資了約6000萬"，蔡達建介紹，投資邁瑞醫療之後，公司對醫療器械行業的關注增多，有10多名專門的團隊成員進行研究。具體到中藥類企業，蔡達建強調，首先要有獨到的品種，技術方面門檻不高，但是行銷管道、品牌形象很重要。拿2010年投資的海南一家制藥有限公司為例，"市場非常重要，對中藥企業來說，相比而言，生物制藥則對技術要求高很多。"

創投進入分化期  事實上，"專業專注"這在金融危機前夕就一直是創投行業一直在說的話題，創業板開啟後，眾多資本一湧而上，項目的爭奪戰激烈啟動。在白熱化中，後期項目擠壓的空間越來越小，項目前移被迫提前。"未來是一個行業分化的時期，PE與VC的劃分將更加明確，對PE的資金要求更高一些，V C則越來越強調專業化。"蔡達建告訴南都記者，公司的做法是，更多的精力花在行業主題專案的研究與選擇。依靠這樣的策略，深圳市高特佳投資集團在2010年投資了16個專案，鄭煤機[41.77 0.65%]、山東礦機[23.95 0.55%]掛牌上市且分別取得了近10倍的收益。"專注前期但不放棄後期專案的投資是目前比較明智的選擇，但我們長遠的規劃主要在中前期專案相關的主題基金的佈局。"蔡達建說。事實上，已經有眾多機構開始佈局主題基金，關注專業領域的機會，如九鼎投資于2009年底成立關注民營醫藥行業的投資基金，達晨創投的文化產業基金等等。ChinaVenture指出，對於VC／PE機構而言，成立專業化基金，能夠以更專業的團隊、更關注的投資戰略形成在某個細分行業的競爭優勢；對企業而言，則能夠利用專業化基金有效地整合產業鏈，以增強企業競爭力及塑造品牌。專業化基金將成為未來股權投資基金尤其是創投基金市場的一個重要發展趨勢。

 

複星醫藥: 瞄準中國醫療保險產業&高端醫療門診

複星醫藥總裁姚方：藥品降價是今年藥企最大風險

發佈時間：2011-01-12上海複星醫藥股份有限公司總裁姚方昨日在接受早報記者採訪時透露，2011年國內醫藥行業面臨的最大風險是藥品降價。他表示，國內醫藥產業較分散，藥品降價將促使行業進入淘汰過程。 "藥品進入《國家基本藥品目錄》對企業來說是喜憂參半的。"姚方表示，基本藥品長期降價趨勢明顯，對於進入《目錄》的企業來說，一方面銷售容易上規模，一方面也將壓縮企業利潤。據瞭解，衛生部已確定，到2011年底初步建立國家基本藥物制度，基本覆蓋政府辦基層醫療衛生機構，實行零差率銷售。業內人士分析，新醫改的思路就是一方面擴大基本藥物銷售，一方面促使基本藥物降價。姚方認為，在藥品原料漲價和基本藥物降價的雙重壓力下，將逐步淘汰小規模藥企，促使產業集中度提高。姚方認為，在新醫改推進過程中，仿製藥和醫療器械是機會最大的領域，特別是面向二、三線城市的中端醫療器械市場潛力巨大。上月，複星醫藥與美中互利公司整合了旗下醫療器械業務，成立了一家新的合資公司美中互利醫療有限公司，其中，複星醫藥占合資公司51%股權。今年複星醫藥還將加大醫療服務領域的投入。姚方透露，在多次增持美中互利後，正推動其旗下高端醫療服務品牌——"和睦家"在中國的網點數量，同時複星醫藥還將與新加坡百匯合作，在國內開設高端醫療門診。"2011年還準備進入醫療保險領域。" 姚方表示，醫療保險將是醫療服務領域最終的一塊，但姚方沒有透露具體的計畫。複星醫藥還將加大投資力度。姚方表示，複星醫藥控股和參股的眾多企業中大部分企業都已上市或有上市計畫，而複星醫藥投資的研發類企業或選擇在美國納斯達克上市。同時，姚方透露了複星醫藥側重投資海外上市的中國醫藥企業的戰略。目前複星醫藥正在推動在紐交所上市的同濟堂藥業私有化，同時還通過美國二級市場投資了先聲藥業，但複星醫藥沒有透露持有先聲藥業股份的具體比例。

 

台灣神隆幫Clinical Data代工生產抗憂鬱原料藥 (Viibryd: a serotonin reuptake inhibitor)

統一旗下 神隆「藥」攻10億美元商機

【2011/02/09 經濟日報】統一（1216）集團轉投資台灣神隆昨（8）日宣布，由該公司代工生產及研發的抗憂鬱症新藥維拉佐酮（Viibryd），已通過美國食品藥物管理局（FDA）批准，可搶攻每年10億美元市場商機。台灣神隆是國內最大原料藥廠，實收資本額61億元，統一集團持股逾六成，該公司去年前三季營收27.72億元，前三季稅後純益7.6億元，年增率27.45%，神隆規畫今年下半年掛牌上市。除了神隆之外，另一家原料藥廠台耀化學（4746）更計畫在3月初掛牌上市，法人估計，累計到今年為止，國內已掛牌的上市櫃原料藥廠將達到七家。神隆表示，維拉佐酮是由美商Clinical Data生技公司所擁有的專利新藥，這項治療憂鬱症的藥品進入人體臨床第三期後，開始委託神隆代工生產及研發，直到今年元月正式通過FDA許可上市。根據市場分析師預測，隨著憂鬱症患者日漸增加，維拉佐酮在美國市場規模可達10億美元以上，並有助於台灣神隆代工生產規模。神隆表示，該公司代工生產及研發新藥的項目已超過60項，其中已有三項產品上市，另有四項產品已進入三期臨床試驗，有助於公司的業務成長。依據世界衛生組織預估，憂鬱症的盛行率是全球總人口數的3%，大約近2億人深受其苦，全球抗憂鬱藥物市場約120億美元。隨著環境及生活壓力增加，憂鬱、焦慮及失眠等疾病罹患率增加，維拉佐酮上市後，業績將逐年成長。神隆並表示，該公司新建位於江蘇常熟的工廠，將於今年第三季開始生產關鍵中間體，透過常熟廠的營運，更能提供國際藥廠委外生產及技術支援。市場預期，神隆透過台灣及常熟兩地的生產，可在五年內成為全球前五大原料藥廠。

台灣神隆代工研發新藥 通過美審查

【2011/02/08 聯合報】台灣神隆輔助美國生技新藥公司Clinical Data生產技術所完成的新型中樞神經藥物維拉佐酮 (Viibryd)，日前通過美國食品藥物管理局FDA審查批准，正式取得在美銷售資格。台灣神隆表示，維拉佐酮是Clinical Data公司的專利新型抗憂鬱藥物，由台灣神隆優化生產技術，提供臨床第三期實驗所需藥物。

FDA approves Clinical Data's Viibryd for major depressive disorder

24. January 2011 06:25 Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year. "It is also the first drug that the Company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.""When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient," said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego. "Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile." The mechanism of the antidepressant effect of Viibryd is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd's antidepressant effect are unknown.

杏輝 (杏國生技) 還有經費發展另一個NCE( new chemical entity)嗎?

杏輝骨質疏鬆症醫藥原料獲得加拿大專利核准

2011-02-08 【時報】杏輝藥品(1734)用於治療婦女骨質疏鬆症的醫藥組合物原料已獲得加拿大專利核准。杏輝spa-2之研發，源自傳統中藥經過分離、純化、結構確認之單一新化合物，該化合物以動物試驗，發現在低劑量下，可使卵巢摘除模擬婦女停經後因缺乏雌激素(estrogen)所引起之骨質疏鬆症，有治療與改善的效果。日前本項發明已取得韓國、台灣、中國、日本、美國等國家專利，獲得智慧財產權的保障。

台灣生技業CFO觀點!

生技創業菁英養成學苑-錢進2011,財務長秘笈分享(2011/2/23)

2011-02-08生技產業為創新研發型之高附加價值產業，為繼電子資訊產業後，全球產業升級發展的重心，但生技產業主流族群多為研發成本高、獲利所需時間長，因此生技企業如何有效進行財務規劃與管理，將是生技企業尋求穩定發展的重要課題之一。根據99 年度臺北市生技產業調查分析報告指出，50％生技產業業者認為在經營上所遭遇的困難主要來自資金面，所以要如何進入資本市場取得資金活水挹注，讓公司永續發展就顯得重要。有鑑於此，經濟部中小企業處南港生技育成中心在今年籌辦之生技創業菁英養成學苑，第一場就特別舉辦「錢進2011,財務長秘笈分享」，將邀請佰研生化科技股份有限公司劉福安財務長、基亞生物科技股份有限公司歐朝銓處長，以及台灣微脂體股份有限公司林如芸財務長等三位國內知名生技公司的財務長，分別就該公司財務管理之實務經驗與各界進行交流分享。此機會難得，歡迎各界踴躍報名參加！座位有限，請及早報名，以免向隅。主辦單位：經濟部中小企業處  執行單位：南港生技育成中心  舉辦日期：中華民國100年2月23日（三）下午1:30-5:10活動地點：台北市南港區園區街3號F棟17樓(南港生技育成中心)報名方式：線上報名，2/18止。報名網址： http://www.nbic.org.tw/classsignup.aspx?COURSE_NO=349費用：免費洽詢專線：李佳玲02-26558633分機8006

 

議程：

時間	主題	主講人
13:30-13:55	報到
13:55-14:00	致歡迎詞	南港生技育成中心 夏尚樸 博士
14:00-15:00	生技公司股票上櫃之路經驗分享	佰研生化科技股份有限公司劉福安 財務長
15:00-16:00	生技公司投資融資規劃-基亞生技經驗分享	基亞生物科技股份有限公司 歐朝銓 處長
16:00-16:10	休息/茶點
16:10-17:10	When Taiwan Corporation meets US term sheet .. to do or not to do!	台灣微脂體股份有限公司 林如芸 財務長