蘇州中化 規劃回台掛牌【經濟日報╱記者黃文奇/台北報導】 2012.07.31 03:08 am 中化(1701)總經理孫蔭南昨(30)日宣布,公司啟動曾孫公司蘇州中化未來回台掛牌,已調整蘇州中化投資主體為開曼公司,估計最快蘇州中化2年內可回台上市櫃。中化為國內老牌藥廠,超過60年歷史;該公司今年首季稅後純益約1.03億元,每股稅後純益為0.35元,昨日股價收18.25元,下跌0.15元。中化表示,蘇州中化原本由中化間接投資,亦即由中化100%轉投資公司庫克群島中化控股所完全持有;但為了符合回台掛牌法令標準,因此中化於去年底以3億資本額成立開曼群島中化控股,並以股權交換方式,將庫克股權全數讓予開曼公司,而使蘇州中化的投資主體轉為開曼。組織調整後,蘇州中化為中化的曾孫公司。至於蘇州中化何時回台掛牌,中化說,目前期程規劃希望2年內完成掛牌,而究竟是上市或上櫃,則看獲利狀況而定;預估掛牌時間將落在2014年下半年。此外,基亞方面昨日也傳出喜訊,宣布與新臺生技簽訂合約,取得治療用人類單株抗體技術平台;該公司專注於新藥開發領域,目前有幾項產品已進人體臨床試驗階段。基亞為新藥公司,昨日股價收63.8元,上漲1.4元。【2012/07/31 經濟日報】
Monday, July 30, 2012
基亞與新臺合作抗體藥物 (從癌症藥, IVD, Oncolytic, 疫苗, 到 單株抗體!! 很…衝?!)
基亞跨足人類單株抗體,首發鎖定感染性疾病 2012/07/30 10:02 精實新聞 2012-07-30 10:01:48 記者 蕭燕翔 報導 基亞生技(3176)30日宣布,與新臺生技簽約,取得治療用人類單株抗體技術平台。該公司表示,該技術平台的背後是由哈佛大學及奧地利大學的專科研發團隊組成,預計未來1年將發表1-2個治療感染性疾病的單株抗體,並將逐步擴大至免疫疾病、癌症用藥領域。 基亞指出,根據生技中心報告指出,2009年全球單株抗體藥次市場達355億美元,占生技藥品的32.5%,2015年可望超過600億美元,市場成長快速。而該公司此次取得技術的團隊,來自哈佛大學及奧地利大學的專科研發人才,未來將把該團隊一併納入基亞,成為專案的研發員工。 基亞表示,相較於國內其他同業的單株抗體平台,該技術特殊處一是屬於全人類抗體,因此就發展人類治療用藥來說,相較擬人化抗體可望擁有更好的療效及較低的副作用;二該技術平台並非主打「抗體資料庫」,而是針對特定的疾病篩檢出具特定療效的人類單株抗體,再進行後續研發,提高成功機率。基亞指出,目前該團隊已擁有感染性疾病抗體研發的階段性成果,預計未來1年將發表1-2個感染性疾病治療的單株抗體,爾後還將以抗藥性細菌、自體免疫疾病及癌症做為研究開發標的,除選擇適合自己發展的品項外,並將尋求對外授權機會。 基亞說,目前該公司在新藥發展領域,除PI-88已經進入人體臨床3期試驗外,另也將發展2期臨床的肝癌標靶藥物,而此次整合人類單株抗體平台,算是向新藥研發的上游整合,未來可望有源源不絕的新藥案源,提高研發能量。
中国第一血糖仪雄心: 鱼跃
鱼跃医疗:血糖仪初步开拓医院市场 下半年高增长有望恢复 2012年07月30日16:20 来源:和讯网血糖检测系统打入医院市场,12 年有望实现 4000-5000 万的销售,13 年销售 额有望过亿。公司血糖检测系统定位高端,医院和 OTC 市场两条腿走路,通过 立足医院市场确立行业地位。公司的血糖仪试纸已经通过地区招标,进入杭州 和丹阳市医院,目前订单充足,今年试纸销售已具备确定性。生产方面暂时受 制于试纸的稳定性不足,尚未大规模铺开。公司正在不断调试试纸配方,同时 对产出的试纸做抗老化测试,确保出厂的血糖仪试纸批批合格。预计 8 月底之 前,公司就能解决血糖仪试纸生产技术方面的问题,今年能够实现 4000-5000 万的销售。公司将持续不断地参与全国各地的医院市场招标,预计在未来两年 能完成全国的范围内的招标工作,13 年血糖检测系统销售有望过亿。公司计 划三年内成为国产血糖仪第一品牌。
杏輝 5億元建立癌症針劑廠!!
癌藥商機大戰 生醫業搶建廠 2012-07-30 01:14 工商時報【記者杜蕙蓉/台北報導】全球癌藥市場高達800億美元商機誘人,生醫廠商在研發動能開始展現實力,已陸續啟動授權、代工和研發三方向發展,而且今年神隆、杏輝都新建癌藥針劑新廠,而東洋和晟德轉投資的東曜則在蘇州建立生產基地。另外,繼台灣醣聯、智擎後,台灣微脂體也和全球第一大學名藥廠Teva、安成國際藥業簽定三方合作協議,將攜手搶攻乳癌藥市場,該藥將授權Teva在美國販售,未來也有機會擴大至其他國際市場,也讓台微體明年起將展現強勁爆發力。雖然癌藥市場商機龐大,醫藥消費市場中,癌比重以高達43%居冠,美國FDA去年通過的新藥中,也以癌症新藥的品項居冠,不過,目前符合國際GMP水準的癌症代工藥廠產能卻嚴重缺乏,因此,東洋、杏輝都分別獲國際藥廠代工大單,而由原料藥起家的神隆更進行下游的垂直整合,將斥資11億元興建癌藥針劑廠。神隆總經理馬海怡表示,由於不少歐美針劑廠無法通過日趨嚴格的GMP法規要求,而被FDA警告限期改善,甚至被要求停產,因此,神隆興建的癌症針劑廠,預計2014年即可望投產,未來營運樂觀。 杏輝董事長李志文表示,該公司已於5月間斥資5億元建立癌症製劑第二廠房,該癌藥廠為台灣第一棟全新隔離式自動化癌症針劑廠,預定2013年4月完工投產,未來針劑每年產能最高將可達500萬支,足以面對未來5年杏輝成長的需求。大舉搶進癌藥商機的杏輝集團,近年積極和日本大東製藥聯手投入包括乳癌、非小細胞肺癌、前列腺癌、頭頸癌及胃腺癌、轉移性大腸直腸癌藥物等合計13億美元的市場,另外,也和德國上市公司MediGene聯手搶進乳癌新藥EndoTAG-1開發,該合作案將由子公司杏國與MediGene共同啟動全球人體第三期臨床,而杏輝則可望代工生產行銷全球。 李志文表示,杏國是從原創型新藥出發,累積了經驗後,對於選題和與國際藥廠策略聯盟投入臨床將更得心應手,而杏輝則有完整的通路行銷和生產代工經驗,透過集團資源的整合,將能為跨國性合作創造利基。 目前除了杏輝、東洋和神隆可望為國際廠商代工外,健喬代理五項標靶藥,也為營運添加動能,另外,台灣浩鼎、基亞生技、新東陽轉投資的北極星則致力於新藥的開發,浩鼎由於研發的OPT-822乳癌疫苗成功率高,在潛在市場商機高達200億美元下,最近更掀起美國股東和台灣股東的搶藥風波,在在都突顯國內生醫廠商或可望在癌藥大戰中有機會出頭天。
Too Much Hype in the Mobile Health App World?
Posted: 07/23/2012 12:00 pm The Wild West of mobile health (mHealth) is taking the health care industry by storm, but "there are no rules to the game," said Joseph C. Kvedar, M.D., founder and director at the Center for Connected Health in a recent interview. Mobile health is a "game changer," he added, but there is a lot of hype because there are a lot of people developing health apps just to "get rich quick."According to the U.S. Department of Health and Human Services, mHealth is "the use of mobile and wireless devices to improve health outcomes, healthcare services, and health research." mHealth includes gamification, text messaging, telemedicine/telehealth (remote patient monitoring), electronic health records, and health apps, to name a few.There's a lot of enthusiasm surrounding mHealth -- from mainstream media tapping into the mHealth rage to social networking sites exploding with discussions about mobility in health care. Take a look at the conversations happening on Twitter and you'll observe how popular mHealth really is. Follow the hashtags #mHealth, #HealthIT, #HIT100, #apps, #healthapps, #digitalhealth, #hitsm, and #hcsm; and observe the 140 characters of tweets that soar at an accelerated rate through cyberspace offer fiery information. Paul Sonnier's Linkedin group Digital Health has over 11,000 members to date.Not only is mHealth soaring through the social networking sites, U.S. revenue in the mHealth market earned $230 million is 2010 and it's estimated to reach $392 million in 2015, according to a news release by Frost and Sullivan. Globally, Reseach2Guidance reports that the mHealth market will reach $ 1.3 billion this year. Despite mHealth being in its infancy, the revenue projections are significant.According to a 2011 press release statement from Juniper Research, the number of mobile healthcare and medical app downloads will reach 44 million this year and will reach 142 million globally by 2016.Consumers are downloading apps to help them stay fit, track their pregnancies, monitor their moods, eat healthier, and sleep better. They are also downloading apps for chronic disease management. They can manage their prescriptions, have medication reminders, and monitor blood pressure and sugar levels. Consumers can be empowered to take charge of their health, but right now navigating the array of health apps can be confusing. Consumers lack guidance on choosing a safe, secure, medically sound health app. Trying to navigate the health app craze without direction can be painstakingly difficult.Cleveland Clinic, Nike Fuel Band, American Red Cross, and Walgreens are known in the space, and consumers may find it easy to trust them and download apps associated with them. However, consumers may find it confusing to navigate the mHealth app world from companies that are off the radar. How do consumers know if the apps are safe and reliable?Consumer Safety Is a PriorityThe FDA is prudent on drafting guidelines for developers, but will it stifle innovation? "It may slow innovation, but I don't know that it stifles it. Regulations do create barriers to entry as they set a high bar. But in so doing, they also create significant economic opportunities for those who follow the appropriate processes and win regulatory approval," said Bill Crounse, M.D., Senior Director of Worldwide Health at Microsoft Corporation, in an email. "I do think thoughtful regulation is required in the health industry to protect consumers. This is certainly true related to pharmaceuticals and medical devices to protect consumers from harm.""The primary role of the FDA is to insure consumer safety," notes Kvedar. "Mobile health has the potential to get out of hand if not regulated. For example, there is an app that based on self input of one's carbohydrate count; it will generate insulin dosing suggestions. Clearly this could be dangerous," he added. "While I don't think the FDA process will ever eventuate in a 'consumer report-like' or 'D Powers-like' rating, it will be a filter. If apps get through the filter, we should at least be comfortable that they are safe."Aside from safety concerns, there are "two problems with health apps," said Kvedar. First, after downloading the app, it may be used once or twice and then it's forgotten, he said. "There's no engagement." Secondly, health apps can be prone to error because the data that is self-entered by consumers may not be true. It's a "social diversity bias problem," he said, because the data entered isn't honest and there is no meaningful engagement to help change consumers behavior. After downloading health apps with enthusiasm, the "shiny new toy isn't so shiny anymore," because there's "lack of interest and lack of engagement," said Kvedar.
Health apps need to be engaging and motivating and offer a coaching component."There's a short shelf life, don't expect it to change your life," he said.Happtique, a mobile health application store and total app management solution released a draft of the standards that it will be using to certify medical, health, and fitness apps under Happtique's App Certification Program. The purpose of the program is to help users identify apps that meet high operability, privacy, and security standards and are based on reliable content.David Lee Scher, M.D., a former cardiac electrophysiologist who is presently director at DLS Healthcare Consultants and senior medical advisor to Happtique, said in an email interview:Happtique App Certification Program represents a major step in setting standards for safe and reliable health, fitness, and medical apps. Certification will assure users that the app meets security, usability, privacy, and content standards. Happtique has curated and categorized over 12,000 apps to date in over 300 categories. Mobile technology has allowed consumers to receive information at lightning speed and gives consumers health and wellness apps that can help improve their health care. Mobile technology may help to transform the lives of patients and provide a stronger partnership with health care providers.
Bottom LineConsumers need safe, reliable, trustworthy apps to help guide their health and wellness and help them manage their chronic diseases.The health app world needs guidance. The vast assortment of apps to choose from makes it difficult for consumers to navigate. Which apps are reliable, trustworthy, and medically sound?Joseph Kvedar, M.D., Justin Major and Carol Colman are actively involved in writing a series of books for consumers titled Wellocracy; it's the first in a series of books to help consumers navigate the ever-growing and dizzying array of health apps.So, how do consumers navigate the crowded world of health apps? "Common sense rules," he said. If consumers think it's a "magic app," it probably isn't.In this exciting world of health care where technology rules, one thing is for sure, technology will never replace the doctor/patient relationship (or health provider/patient relationship). Face-to-face communication with health care providers will always be paramount.It doesn't seem as if there is too much hype -- just little guidance. The push to move the mHealth app world forward may be in the power of consumers to clamor for health and wellness apps that are safe, reliable and trustworthy, developed by companies who are not just those looking to "get rich quick," as Kvedar said.
Subscribe to:
Posts (Atom)
alveice Team. Powered by Blogger.




