藥華 治療C肝 (HCV Genotype 2) 韓MFDS同意收案

藥華醫藥:公告本公司新藥P1101用於治療C型肝炎病毒基因體 第二型之第三期臨床試驗申請，已獲韓國食品藥物管理 署(MFDS)同意進行 鉅亨網新聞中心　(來源：台灣證券交易所)　2016-03-10第三十四條　第42款1.事實發生日:105/03/10 2.公司名稱:藥華醫藥股份有限公司 3.與公司關係(請輸入本公司或聯屬公司):本公司 4.相互持3股比例(若前項為本公司，請填不適用):不適用 5.發生緣由: 依本公司新藥P1101用於治療C型肝炎病毒基因體第二型之第三期臨床試驗， 傾獲韓國食品藥物管理署(Ministry of Food and Drug Safety簡稱MFDS)核 准同意進行。本第三期臨床試驗已可正式於台灣及韓國兩地同時進行人體試 驗。 6.因應措施:發佈重大訊息公告於公開資訊觀測站 7.其他應敘明事項: (1)研發新藥代號或名稱：P1101(INN: Ropeginterferon alfa-2b) (2)用途：P1101係新一代PEG長效型α干擾素藥物(Ropeginterferon alfa-2b)， 在治療C型肝炎病毒基因體第二型第二期臨床試驗已完成，另C型肝炎病毒基 因體第一型、真性紅血球增生症、早期原發性骨髓纖維化等臨床試驗正持續 進行中。 (3)預計進行之所有研發階段：本第三期人體臨床試驗正式於台灣及韓國兩地同 步進行，預估可按原計畫時程完成收案目標後，經資料統計分析試驗結果報 告後，向台灣TFDA及韓國MFDS申請新藥查驗登記，使公司造福兩地肝炎病患 之目標將更進一步。 (4)目前進行中之研發階段： (一)提出申請/通過核准/不通過核准：第三期臨床試驗申請獲韓國食品藥物 管理署(MFDS)核准進行。 (二)未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用 (三)已通過目的事業主管許可者，未來經營方向：不適用 (四)已投入之累積研發費用：本公司累積已投入該臨床試驗之相關費用約 65,987千元 (5)將再進行之下一研發階段： A.預計完成時間：本臨床試驗為多國多中心第三期臨床試驗，將於台灣及韓國 兩地同步進行收案，總收案人數至少240人，預估於2017年完成試驗。 B.預計應負擔之義務：本公司將支付執行臨床試驗及申請新藥查驗登記之相關 費用。 (6)新藥開發時程長、投入經費高且並未保證能一定成功，此等可能使投資面臨風 險，投資人應審慎判斷謹慎投資。

An Open-label, Randomized, Active Control Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of P1101 + Ribavirin in Treatment-Naïve Subjects With HCV Genotype 1 Infection, Last verified: April 2012, Estimated Enrollment: 208 /Study Start Date:       October 2011 / Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure) National Taiwan University Hospital        Recruiting (NCT01587586)

UCAB 聯合 mAbXience 開發低價 呼吸道融合細胞病毒藥品(Lunamab, palivizumab) 後轉移 基亞 /中東SPIMACO/南美LIBBS

基亞組聯盟 攻生物製劑 2016-03-11 02:53 經濟日報 記者高行／台北報導 基亞生（6547）昨（10）日與荷蘭UCAB研發中心及MABXIENCE等三家國際藥廠簽訂生物相似性藥品開發聯盟合約，鎖定蛋白質藥物研發及生產，強化生物製劑領域布局。基亞生昨日和荷蘭UCAB研發中心、歐洲MABXIENCE、中東SPIMACO及南美洲LIBBS等國際藥廠結盟，簽訂生物相似性藥品開發聯盟合約，進軍預防嬰幼兒呼吸道融合細胞病毒（RSV）感染的生物相似藥品。公司指出，新成立的研發聯盟由全球知名的非營利醫藥研發機構UCAB中心統籌全案並主導臨床試驗，擅長於蛋白質藥物生產的MABXIENCE藥廠負責生產製造及後續技術移轉，以確保藥物開發及生產品質。聯盟各成員共同分擔研發費用及共享研發及臨床成果，並於各自取得區域申請藥證、生產及銷售權利。

基亞生與3藥廠簽約　共同開發藥品2016年03月10日16:08 基亞生(6547)宣布，與UCAB研發中心及歐洲MABXIENCE公司、中東SPIMACO公司及南美洲LIBBS公司三家國際藥廠簽訂聯盟合約，將共同開發預防嬰幼兒呼吸道融合細胞病毒（RSV）感染之生物相似藥品。本研發聯盟由全球知名的非營利醫藥研發機構UCAB中心統籌全案，聯盟各成員共同分擔研發費用及共享研發及臨床成果，並於各自取得之區域申請藥證、生產及銷售。本案由UCAB主導臨床試驗，擅長於蛋白質藥物生產的MABXIENCE公司負責生產製造及後續的技術移轉，以確保藥物開發及生產品質。 基亞生(6547)取得本案於台灣及亞洲區主要國家之銷售、技術移轉及生產等商業權利，未來將參與聯盟研發及臨床試驗活動，並移轉生物相似藥物生產技術至竹北生醫園區之生物製劑廠。 透過此聯盟合作開發案，基亞生表示，除了原有的細胞培養疫苗業務外，再納入蛋白質藥物研發及生產，強化公司生物製劑領域佈局。此外，與國際性研發機構及大型藥廠策略結盟，將有助於公司提升研發及生產能量，並得以進入主流之國際醫藥社群。(江俞庭／台北報導)

基亞生與荷蘭UCAB研發中心等三家國際藥廠簽訂生物相似性藥品開發聯盟合約 2016/03/10 15:21 證交所重大訊息公告(6547)基亞生-本公司與荷蘭UCAB研發中心及MABXIENCE等三家國際藥廠簽訂生物相似性藥品開發聯盟合約1.事實發生日:105/03/10 2.契約或承諾相對人:荷蘭UCAB研發中心及歐洲MABXIENCE公司、中東SPIMACO公司及南美洲LIBBS公司等三家國際藥廠。 3.與公司關係:無。 4.契約或承諾起迄日期(或解除日期):105/03/10 5.主要內容(解除者不適用): 本公司與上述機構簽訂研發聯盟合約，開發用以預防嬰幼兒呼吸道融合細胞病毒(RSV)感染之生物相似藥品。本研發聯盟由全球知名的非營利醫藥研發機構UCAB中心（Utrecht Centre of Excellence for Affordable Biotherapeutics for public health）統籌全案並主導臨床試驗，擅長於蛋白質藥物生產的MABXIENCE公司負責生產製造及後續的技術移轉，以確保藥物開發及生產品質；另聯盟各成員共同分擔研發費用及共享研發及臨床成果，並於各自取得之區域申請藥證、生產及銷售。本公司取得本案於台灣及亞洲區主要國家之銷售、技術移轉及生產等 商業權利，未來將參與聯盟研發及臨床試驗活動，並移轉生物相似藥物生產技術至竹北生醫園區之生物製劑廠。 6.限制條款(解除者不適用):無。 7.對公司財務、業務之影響(解除者不適用):本公司在產品研發期間依約需共同分擔費用，如產品研發成功，將對公司之財務及業務具有正面影響。 8.具體目的(解除者不適用):透過此聯盟合作開發案，本公司除了原有的細胞培養疫苗業務外，再納入蛋白質藥物研發及生產，強化公司生物製劑領域佈局。此外，與國際性研發機構及大型藥廠策略結盟，將有助於公司提升研發及生產能量，並得以進入主流之國際醫藥社群。 9.其他應敘明事項: UCAB中心網址：http://www.uu.nl/en/organisation/utrecht-centre-of-excellence-for-affordable-biotherapeuticsMABXIENCE 網址：http://www.mabxience.comSPIMACO網址：http://www.spimaco.com.sa/網址：http://www.libbs.com.br/en/about-us/who-we-are/

First consortium of local manufacturers to make affordable biosimilars available for low income countries  At the initiative of the World Health Organization, and with the support of Utrecht University, local manufacturers in low income countries will collaborate to bring a biological drug to market for the lowest possible price. The drug, called palivizumab, protects against the common virus RSV. According to the World Health Organization (WHO), this virus is the second most common cause of death in children up to one years of age in low income countries. The four companies, mAbXience, Libbs, Medigen and SPIMACO, have signed a contract for the production of this drug with Utrecht University and the WHO on Wednesday, 9 March.

"This is the first time that commercial parties in low income countries will deal with a global health issue on their own", explains project founder and Professor of Pharmaceutical Biotechnology at Utrecht University, Huub Schellekens. By sharing the development costs, the companies in the consortium will be able to offer the drug for a much lower price. Utrecht University and University Medical Centre Utrecht will be responsible for the pre-clinical and clinical research and for quality control of the locally produced medicines.

#RSV The cold virus RSV can cause serious respiratory tract infections, especially in premature infants. The disease occasionally requires treatment in a hospital, even in the high income countries. In low income countries, the number of premature births is much higher than in more prosperous countries; around 20% of all births. Unfortunately, prevention is impossible due to the high price of the drug palivizumab, so according to the WHO tens of thousands of children die of the disease every year.

#Biosimilars The active substances in palivizumab are natural proteins of the type that have been used in biological pharmaceuticals available on the market since the early 1990s. As soon as a patent for a biological pharmaceutical expires, other companies release a cheaper biosimilar version of the drug to the market. Unfortunately, local pharmaceutical manufacturers in low income countries often lack the biotechnological knowledge to produce these biosimilars, so they must be imported and remain too expensive for the people who need them.

#UCAB To address this problem, the World Health Organization went looking for a university that had the biotechnological expertise to produce the biosimilars, and that was willing to transfer that knowledge. The WHO chose Utrecht University's Department of Pharmaceutical Sciences in part due to its leading position in the field. Utrecht University in turn set up the UCAB Foundation to implement the project.

#Lunamab The biosimilar for palivizumab will be developed by UCAB and the pharmaceutical company mAbXience. They will then transfer the necessary technology and knowledge to the other partners in the consortium. UCAB will also arrange for the drug to be approved for release to market in the low income countries. The drug will be named Lunamab, after Prof. Huub Schellekens' granddaughter Luna. He expects that the drug will be available on the market in the first countries by late 2017.

#mAbXience  mAbXience is a subsidiary of the international pharmaceutical firm Chemo. Chemo founder and CEO Hugo Sigman van Chemo has supported Prof. Schellekens' initiative from the very beginning. The other partners are the Brazilian Libbs, the Taiwanese Medigen and the Saudi Arabian SPIMACO.

Life Sciences : This research is closely related to Utrecht University's strategic research theme Life Sciences. Contact: Monica van der Garde, Press Spokesperson, 31 (0)6 13 66 14 38; m.vandergarde@uu.nl Roy Keeris, Press Spokesperson, +31 (0)30 253 24 11;  r.b.keeris@uu.nl

 

水晶體幹細胞 用於 幼兒 白內障 治療

幹細胞再生治療白內障 獲重大突破 2016年03月10日 09:26 林芳如／綜合報導 治療白內障重大突破！大陸中山大學和美國加州大學聖地亞哥分校科學家最新研究，利用幹細胞再生技術，在眼睛內長出新的水晶體，成功地為大陸兒童治療白內障。據英國BBC報導，全世界有大約2000萬人因白內障失明，這種疾病好發於年長者，年紀大老化是最常見的原因，另有部分兒童患有先天性的白內障。目前傳統治療方法多用超聲波將水晶體乳化後吸出，隨後再植入人工晶狀體。但這種手術易在兒童身上出現併發症。科學家最新治療方法，是通過一個微小切口取出混濁水晶體，但保持水晶體囊外層完好無損，水晶體囊上有很多皮膜幹細胞，具修複損傷功能。保存這些幹細胞進行水晶體再生。該研究首先在兔子和猴子身上試驗成功，接著又對12名大陸兒童進行試驗，由於兒童的水晶體皮膜幹細胞相當年輕，容易再生，8個月後，重新長出的水晶體已達到一般尺寸。張康博士說，這是第一次再生完整的水晶體，但在應用於標凖治療前，還需更大規模試驗。不過，白內障患者仍以老年人居多，科學家已開始針對年長者進行試驗，結果令人鼓舞。倫敦國王學院幹細胞科學家埃利克博士（Dr Dusko Ilic）表示，這是迄今為止再生醫學領域最好的成果之一。本研究結果發表於《自然》雜誌。(中時即時)

Lens regeneration using endogenous stem cells with gain of visual function

Nature (2016) doi:10.1038/nature17181, Received 13 October 2014 Accepted 29 January 2016 Published online 09 March , The repair and regeneration of tissues using endogenous stem cells represents an ultimate goal in regenerative medicine. To our knowledge, human lens regeneration has not yet been demonstrated. Currently, the only treatment for cataracts, the leading cause of blindness worldwide, is to extract the cataractous lens and implant an artificial intraocular lens. However, this procedure poses notable risks of complications. Here we isolate lens epithelial stem/progenitor cells (LECs) in mammals and show that Pax6 and Bmi1 are required for LEC renewal. We design a surgical method of cataract removal that preserves endogenous LECs and achieves functional lens regeneration in rabbits and macaques, as well as in human infants with cataracts. Our method differs conceptually from current practice, as it preserves endogenous LECs and their natural environment maximally, and regenerates lenses with visual function. Our approach demonstrates a novel treatment strategy for cataracts and provides a new paradigm for tissue regeneration using endogenous stem cells.

Cataracts can be cured by using a patient's own stem cells to regrow a 'living lens' in their eye, restoring sight in just three months, scientists have shown.

In research described as 'remarkable,' surgeons reversed blindness in 12 infants born with congenital cataracts by removing the damaged lens and coaxing nearby cells to repair the damage. It could pave the way for millions of older people in Britain having their sight restored using their own cells. Currently, cataracts are treated by inserting an artificial plastic lens into the eye, but that can lead to infections, inflammation and a night time halo effect in vision. For babies the risks from surgery are even greater because the eye is still developing. But using the new technology scientists at the University of California, San Diego, showed that cataracts without the need for a transplant. They now plan to start work on age-related cataracts which occur when clumps of protein build up over time, creating a clouding effect. "An ultimate goal of stem cell research is to turn on the regenerative potential of one's own stem cells for tissue and organ repair and disease therapy," said Dr Kang Zhang, chief of Ophthalmic Genetics and founding director of the Institute for Genomic Medicine at UC San Diego School of Medicine. "The success of this work represents a new approach in how new human tissue or organ can be regenerated and human disease can be treated, and may have a broad impact on regenerative therapies by harnessing the regenerative power of our own body. Cataract surgery is now the most common surgical procedure undertaken in England with around 300,000 operations performed annually on the NHS. The procedure involves removing the clouded lens and inserting an artificial plastic version, called at intraocular lens. But a large number of patients undergoing surgery are left with poor vision and still need to wear glasses for driving or reading a book. The new technique removes the lens but leaves behind the lens capsule - a membrane that helps give the lens its required shape to function. Nearby regenerative stem cells are then moved to the membrane where they begin to grow into a new, fully functioning and transparent lens. The procedure was carried out on 12 infants under the age of two who healed far more quickly and without complication compared with a group of 25 youngsters who had a traditional plastic lens fitted After three months, a clear, regenerated curved lens have developed in all of the trial patients' eyes. Nearly 300 babies are born with congential cataracts each year in Britain. Dr Dusko Ilic, Reader in Stem Cell Science, King's College London, described the trial as a 'remarkable accomplishment.'"This is one of the finest achievements in the field of regenerative medicine until now," said. "The basic science research led to the hypothesis that preserving and stimulating stem cells in the eye might promote regeneration of a surgically removed lens."And indeed, their hypothesis was true. They proved it first by testing a new surgical approach in rabbits and primates before successfully treating 12 infants. It is science at its best." Prof Graham McGeown, Deputy Head of the School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, said the research could lead to 'an important new treatment.'"They showed that this new approach dramatically reduced the risk of sight damaging side effects when compared with the current 'best practice' treatment, which involves more destructive surgery followed by implantation of an artificial lens." In a separate study, scientist at Cardiff University and Osaka University in Japan showed that they could use stem cells to regenerate several types of tissue from the eye in one go. When transplanted into a rabbit, the tissue was shown to reverse blindness, paving the way for human trials, which could see vision restored in people with a range of sight problems. Professor Andrew Quantock, of Cardiff University, said: "This research shows that various types of human stem cells are able to take on the characteristics of the cornea, lens and retina."Importantly, it demonstrates that one cell type - the corneal epithelium - could be further grown in the lab and then transplanted on to a rabbit's eye where it was functional, achieving recovered vision." Around 4000 corneal grafts are performed by the NHS annually, which rely on human organ donation. Prof Julie Daniels, of UCL, said: "These two studies illustrate the remarkable regenerative and therapeutic potential of stem cells. Lens regeneration might also turn out to be possible in ageing adults." Both studies were published in the journal Nature.

北京順天德中醫 王承德: 中醫毒性藥 治 西醫治不了 疑難雜症

政協委員：中藥越毒越好　網友：毒死人最好？2016年03月10日11:55 身兼中國政協委員的北京順天德中醫醫院院長王承德，昨日一席「有毒中藥才是好藥」的說法引起一片譁然。不少網友批，難道要把人醫死了最好？華商報報導，王承德昨日在政協醫界別聯組會議上表示：「凡是藥都有毒性，越是有毒的藥越是好藥。」王承德還說，中醫的毒性藥治了許多西醫治不了的疑難雜症，他舉了名醫張仲景用砒霜為患者治病的例子，認為現在各種管理限制越來越多，使得三分之一的中醫毒性藥沒有了，「（一旦）發生了中藥中毒的事，公安法院來管，有你醫療主管部門什麼事？」 對此言論，不少網友猛批：「『越是有毒的中藥越是好藥』顯示是個邏輯悖論，怎麼證明？用藥者先被毒掛了，怎麼證明是好藥？」、「一定要注意，有些人打著中醫藥的幌子幹著坑害老百姓的勾當！有毒的東西還是好藥，天理難容！先把你令人信服的科學道理拿出來再說話也不遲！」、「此言論嚴重違背科學精神！！反智，反文明」（大陸中心／綜合報導）

 

嘉南 林維炤 組 化粧品聯盟 (台鹽/耐斯/台灣新日化/美麗徠/蕾迪詩/露絲貝兒…)

嘉南藥大化粧品系 簽產學合作 2016年03月11日 04:09 周榮發 嘉南藥理大學化粧品應用與管理系，為了縮短學用落差，促進產學合作，於今（10）與15家國內重要化粧品公司在該校國際會議廳舉辦策略聯盟簽約儀式，規模相當盛大。嘉藥今年適逢創校50週年，在歡慶之際，能與多家知名廠商簽署產學策略聯盟，足見辦學績效深獲業界肯定。此次參與的15家廠商，均為國內化粧品產業的領頭羊，如台鹽實業、耐斯企業以及以化粧品原料開發為主的台灣新日化公司，另美麗徠化粧品公司、蕾迪詩生技與露絲貝兒生技則為國內重要的化粧品OEM與ODM廠商，曼都國際則是國內最大的髮型造型專業公司。嘉藥化粧品系主任林維炤表示，此次參與的廠商涵蓋粧品產業各個領域，且在化粧品業各執牛耳，頗具份量，能邀請他們共同推動策略聯盟，不僅可強化產學合作效能，也提供本系業師協同教學及學生實習、就業機會，有效縮短學用落差，並促進化粧品產業發展。(工商時報)