創源 成為GVK Biosciences經銷商

GVK Biosciences Pvt. Ltd. Announces New Distributor in Taiwan HYDERABAD, India, Feb 25, 2013 (BUSINESS WIRE) -- GVK Biosciences Pvt. Ltd., a leading provider of databases and services to the Life Sciences industry, has selected GGA as its distributor for its Informatics Database products and services in Taiwan. "Genesis Genetics Asia Corp. is recognized as the premier distributor in the Life Sciences industry in Taiwan and we are pleased to work with a high caliber sales team that will help expand our customer base in the region," said Sreeni Devidas, Vice President, Business Development, Informatics, GVK Biosciences Pvt. Ltd. "GGA will be responsible for distribution of the SAR, Biomarker and Clinical Outcomes databases and would also promote the BioIT and Data Curation services offered by GVK BIO.""GVK BIO's comprehensive products and superior BioIT services are powerful additions to GGA's portfolio in informatics business. We are pleased to become GVK BIO's distribution partner as it will enable our company to provide researchers in the Taiwanese pharma-biotech industries with such great tools," said Dr. Pei-Li Li, Vice President, Molecular Science Center, Genesis Genetics Asia Corp. "The ability to search for the desired biomarkers; make queries and compare drug structures and activities; analyze, design and predict the successful outcome in clinical trials will give impetus to Taiwan's pharmaceutical industry in progressing ahead."

About GVK Biosciences Pvt Ltd GVK Biosciences (GVK BIO) is Asia's leading Discovery, Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. Our discovery services comprise of Chemistry, Biology and Informatics; the development services include Clinical Research, Clinical Pharmacology and Process R&D. GVK BIO's diverse portfolio and prestigious clientele comprising of more than 200 customers includes some of the world's largest pharmaceutical, biotechnology, agro, life-sciences companies and leading academic institutions. Please visit us at www.gvkbio.com to know more.

About GGA Genesis Genetics Asia Corp. (GGA) (tpo:4160) is one of the premier genetic diagnosis and research hubs in Asia and a leading scientific informatics solution provider in Taiwan. Armed with cutting-edge diagnostic technologies, GGA's genetics lab has helped free many new-born babies from incurable genetic disorder diseases. GGA's informatics business arm, Molecular Science Center (MSC), has been progressing further in pharma-biotech research using advanced scientific informatics technologies and premium contents in Taiwan as well as in other Asia Pacific countries since 2004. Together GGA's wet and dry labs aim to help discover the causes and the relevant solutions for improving the quality of life.

 

依凡．麥可羅: 生技產業三大優勢 !

併購熱點燃生技股 投信：鎖定中小型企業、孤兒藥與C肝議題2013/2/26鉅亨網提供併購熱潮果真燒熱生技股價，讓美國那斯達克生技指數去(2012)年飆漲逾3成。 德盛全球生技大壩基金經理人傅子平認為，今(2013)年生技併購火種仍不熄滅，還是有機會推升生技指數走揚，建議可鎖定中小型企業、孤兒藥與C肝議題加以布局。近期包括生技大廠Biogen Iden宣布以32.5億美元買下與生技公司Elan合作開發多發性硬化症藥品Tysabri藥品所有權利，而Tysabri去年銷售達16億美元，市場評估此次交易將有助於擴大Biogen Idec在多發性硬化症領域的藥品影響能力。此外，小型孤兒藥生技廠商Protalix傳出將可能被全球製藥大廠Pfizer大幅溢價併購，顯示併購不僅持續增溫，更已將孤兒藥領域納入併購範圍內。百達投顧指出，目前全球共有高達5408種生技新藥正在臨床研發中，以目前全球高達833藥品位於第三期臨床實驗來看，估計今年可望持續傳出新藥進入審核階段甚至獲得核准的利多。富蘭克林坦伯頓生技領航基金經理人依凡．麥可羅分析，生技產業更具「新藥多」、「題材多」與「商機多」等三多優勢，尤其全球高齡化已成態勢，加上新興市場醫療需求不減，長線趨勢正面。另外，中小型生技股後市也不容忽視，依凡．麥可羅指出，中小型生技股可望在併購題材、第三階段測試及審核加速，以及資本市場環境有利等因素支持下，讓企業不斷創新，自然有助於股價走揚。投資佈局方面，傅子平則認為，考量近期中小型生技公司仍是被併購的主角，因此可多加著墨相關題材。此外，去年極熱門的C肝議題、孤兒藥也可留意的方向。富蘭克林華美坦伯頓全球股票組合基金經理人陳韻如強調，生技產業具有較高的盈餘成長水準，且走勢也不向一般成長型股價格波動大，適合透過長線布局以掌握人口老化與新興國家醫療需求成長的投資契機。

 

TCM grower takes a greener approach

Updated: 2013-02-22 08:43By Wang Chao (China Daily) With traditional Chinese medicine experiencing a revival, herbal flowers have become hot commodities on the market.A particular plant, known as dendrobium officinale, is believed to have cancer-fighting powers and is gaining in popularity among consumers in China, Southeast Asia, South Korea and Japan. Commonly grown in greenhouses, the plant is a daily ingredient at dinner tables in Guangdong province.One businessman, however, is finding success in producing the plant by eschewing commonly used methods. Rather than using greenhouses, Yang Shaowen is utilizing the natural habitat of longan forests near Zhangzhou, Fujian province, to grow the precious plant.Yang is president of Zhangpu Yankee Biotech Co, a company that specializes in growing herbal flowers, including the dendrobium officinale. Born in Zhangzhou, Yang has been working in the TCM industry for more than 20 years.Over the past three years, the wholesale price for dendrobium officinale has soared from 800 yuan ($128; 96 euros) per kilogram to 1,200 yuan. With more and more home cooks using the plant in soups and porridges and as a medicine to treat the flu, the price is climbing.Yang is not the first to grow the herb on a large scale. In recent years, Fujian's neighboring province of Zhejiang has used greenhouses to grow it. Zhejiang is now a major base for cultivating and processing herbs in China.In its natural environment, dendrobium officinale grows on rotting leaves and moss; if grown in soil, their roots are easily affected by bacteria. Replicating this delicate environment in a greenhouse costs millions of yuan.But Yang has a big advantage in Zhangzhou. The average temperature here is higher compared to Zhejiang and its winters are less harsh. The city's other distinct advantage is its thick longan forests, 35 hectares of which Yang has turned into his farm to cultivate 100,000 sprouts annually.In his natural farm, he mixes pine sawdust with soil and places the sprouts in a basket. He then hangs the baskets on branches, where the lush leaves shade the plants from sunlight. Tiered in layers of branches, this method saves space as compared to conventional flat greenhouses.Under these conditions, a tree can generate an annual output of 30,000 yuan and every hectare of longan forest can yield plants with a total value of 4.5 million yuan, Yang says."By using the forest, we can save from investing on expensive equipment. We can also roll out this business pattern to the local farmers."Yang says a listed company in Hong Kong has been negotiating with him to invest in another 30 hectares of what he calls "forest plantation".Yang says one issue is that the supply of dendrobium officinale isn't meeting market demand, so he is telling local farmers to grow the plant under their own longan trees with the promise that he will buy their mature plants at a decent price.He says health products made with dendrobium officinale are already popular in major cities. In five-star hotels in Fujian province, a cup of tea made from the plant's flower charges for 168 yuan.With popularity high, he says many plantations have begun to grow the herbs using his method. "We have to be efficient because many places have turned eyes to these plants," Yang says.To make their products more competitive, Yang is extending its industry chain to product processing and development. "Compared with our competitors in Zhejiang province, we lag behind in processing and marketing."Yan Jianhong, deputy general manager of Zhangpu Yankee Biotech, says they are exploring the medicinal value of the herbal plants by working with pharmaceutical companies."In the next two to three years, we will focus on health food development," Yang says. "But in the long term, we plan to develop new medicines. By extending the industry chain, we gain a better position in the competition landscape so our company can escape the low-level price competition."(China Daily 02/22/2013 page12)

 

Capital crunch: Life science startups look to new sources of funding

Updated Feb. 22, 2013 at 12:26 p.m.By ED MATHERS, Partner, NEADURHAM, N.C. —It's no secret that the flow of capital into the life sciences industry has slowed to a trickle over the last several years. The number of funds being raised continues to decline, with only a handful of firms raising fresh funds in the past two years (including NEA), leaving venture capitalists with a shortage of dry powder and an ever-dwindling appetite for risk. In 2012, the sector saw a 10 percent drop in total dollars invested and a six percent decrease in the number of deals. First-time financings were hardest hit, with the lowest number of deals since 1995.Coupled with an unstable economic environment and a widespread aversion to capital-intensive projects, the hurdles to bringing new treatments and therapies to patients seem higher than ever, and the threat of an innovation bottleneck (with grave consequences for human health) looms large. Clearly the industry must redirect the flow or find new sources of capital to survive.This transformation underway in life sciences is a core focus of the upcoming CED Life Science Conference, where we'll discuss the broader funding landscape, dynamics within the venture capital industry, and emerging opportunities to pursue less traditional sources of capital. The flow of capital will certainly be a key topic for discussion at CED and throughout 2013, and we can expect several key shifts to emerge or become more firmly rooted during the course of the year.

New Role for Big Pharma What has begun to unfold in the life sciences industry is a massive paradigm shift of the role "big pharma" plays in the startup ecosystem. As more and more VCs pull away from the early-stage biotechnology and medical device sectors, many big pharmaceutical and biotech companies have stepped in and supplied an influx of much-needed corporate cash. Why now?Historically, big pharma has honed in on products as they enter late-stage development, seeking low-risk opportunities to close the gap on existing pipelines. Previously, the corporate venture groups participated in financings—fast forward to now, and we see more pharma-led financings. Ironically, at the same time, pharma is also cutting back on R&D budgets, and exiting certain therapeutic areas.This crisis has delivered a wake-up call for big pharma in recognizing the importance of platform-oriented companies, which are focused on creating new, disruptive, and broadly-applicable technologies rather than a specific therapeutic product. Structured to foster innovation, these types of companies are uniquely positioned to make technical and scientific advancements that will fuel the next generation of therapeutics. Large pharmaceutical and biotech companies depend upon a thriving life sciences ecosystem, and platform-focused companies are an increasingly important factor in that equation.

Corporate R&D "Going to Where the Science Is" Corporate R&D, equally important to the ecosystem, has increasingly made "going to where the science is" central to its strategy. Large corporations are increasingly collaborative, partnership-focused, and are cultivating hubs for innovation.For example, Johnson & Johnson recently announced the launch of four research centers in prominent life sciences communities, including Boston, California, China and London. Merck established the California Institute for Biomedical Research in San Diego to conduct early-stage drug research. Bayer partnered with the University of California, San Francisco, to establish an innovation center focused on helping basic research discoveries progress to the drug development stage. Pfizer has also announced several academic relationships, all with a goal of early access to cutting edge technology and relationships with academic leaders in their fields. We can expect to see more of this in 2013.

Casting a Wider Net Clearly, reviving the flow of capital to life sciences cannot (and should not) be fueled by big pharma alone, and there is still considerable room for growth in developing new strategies for funding. A successful future for the life sciences industry will require medical startups to think outside of the box to bring in fresh capital, and they have already begun to do so.During the last few years, the concept of alternate funding sources appears to be gaining traction in life sciences. Liquidia Technologies received a $10 million equity investment from the Bill & Melinda Gates Foundation in support of their development and commercialization of safe and more effective vaccines. Hedge funds in Boston and San Francisco are the latest backers of Intarcia Therapeutics, which is developing a potential treatment for type-2 diabetes.Pharma-backed VC funds companies are also beginning to flow significantly more money into deals, proving their willingness to elevate their role from simply strategic investor to financing leader in this space. As life sciences startups lay the bricks for alternate roads to funding, we're likely to see increased momentum when it comes to finding new sources of capital and, longer-term, a much more diverse life sciences ecosystem.

The Seeds Are Planted Although the life sciences sector is struggling right now, it appears that the seed has been planted for new survival strategies. As the VC capital channels to life sciences continue to shrink, the industry must become much more flexible and innovative in their fundraising process through big pharma's increased support of platform and product-oriented companies as well as medical startups' exploration of new avenues to fresh capital. The evolution of the psyche of the life sciences investment ecosystem only stands to continue in 2013 and, for the sake of all of our health, let's hope it does.

 

 

Vitro Biopharma Appoints Established Life Science Sales Executive to Its Board of DirectorsGOLDEN, Colo.

 Feb 20, 2013 (GLOBE NEWSWIRE via COMTEX) -- Vitro Diagnostics, Inc. (otcqb:VODG), dba Vitro Biopharma, simultaneously accepted the resignation of Mr. Erik Van Horn from its Board of Directors and appointed Pete Shuster, the CEO of Neuromics, Inc. to its Board of Directors. Mr. Shuster is a seasoned and experienced sales executive. He is the current owner of Neuromics, Inc., a privately held and profitable business focused on sales of numerous (>2500) specialty life science products including stem cell products manufactured by Vitro Biopharma. Neuromics, Inc. sales have grown over 5.5-fold since inception in 2003. Shuster has extensive prior experience in managing sales of computer software and related products for companies including Caterpillar, Baxter Healthcare and Harley-Davidson.Mr. Erik Van Horn has also resigned from Vitro Biopharma's Board of Directors due to the request of his present employer. Vitro Biopharma is presently engaged in expansion of sales of its stem cell products and is executing a marketing and distribution strategy based on strategic expansion of its product lines together with accelerated sales activity. Thus, while the Board regrets the loss of Mr. Van Horn's management expertise and technical acumen, its present business development activities are considerably strengthened through the addition of Mr. Shuster to its Board of Directors.Dr. Jim Musick, Vitro Biopharma's President & CEO, said, "I am very pleased to have been associated with Mr. Erik Van Horn throughout his tenure with Vitro Biopharma. Erik joined Vitro Biopharma in 1991 as an employee and was instrumental in the establishment of the diagnostic antigen business unit that was later sold to Venaxis,Inc., formerly Aspen Biopharma, Inc. (Nasdaq, APPY). He subsequently contributed to the technical development of our present stem cell product line while providing critical business guidance throughout his role as a director of the company. On behalf of all Vitro Biopharma shareholders, stakeholders and other associates, I congratulate Erik on his contributions and service to the Company. I am also very pleased to announce the addition of Mr. Pete Shuster to the Board of Directors. His strong background in sales of similar products to those that we manufacture represents a significant addition to our team. I greatly look forward to working more directly with Mr. Shuster to advance our business plan focused on expansion of sales of existing products and strategic addition of new high-value products to enhance drug discovery and development through use of well-characterized cell-based assay systems derived from stem cell technology and through the introduction of novel products targeting select opportunities within the field of regenerative medicine.""Jim Musick and his team have developed an innovative platform for generating umbilical cord blood and induced pluripotent derived stem cells", said Shuster. "They are well positioned to provide both off the shelf and engineered cells to align with the unique needs of pharmaceutical and biotech companies in discovering new therapies for autoimmune and degenerative diseases as well as certain forms of cancer. I look forward working closely with Jim to generate profitable revenue from his current and future stem cell based assay solutions."There are currently no commitments or understandings regarding Mr. Shuster's compensation as a director, although it is expected he will be offered some form of equity package consisting of stock options, stock grants or a combination. No decision has been made with respect to Mr. Shuster's service on one or more standing committees of the Board.

About Mr. Pete ShusterHe received a Bachelor's Degree in Biology from Lawrence University in Wisconsin during 1981 and performed graduate studies in biochemistry at the University of Minnesota. He was in Sales and Sales Management with Teltech from 1985 to 1994 where he was a top producer. He was a sales representative at Connect, Inc from 1994 to 1995 where he sold systems integration solutions. He was a Major Account manager at SDRC from 1995 to 1999 and Senior Account Manager at EAI for sales of Product Visualization Software. At both of these firms, he achieved significant sales success including completion of several large transactions. In 1998, he was recognized as the #1 sales person worldwide for total sales of Metaphase Product Data Management solutions with multi-million dollar sales to Harley Davidson, Baxter Healthcare and Sauer Sundstrand. From 1996 to 2002, he was the founder and owner of Kingdom2.com, an online reseller of re-manufactured satellite systems. From 2000 to 2002 he was Large Account Sales Director of PTC, a company that sold product data management and CAD software, where he lead teams that sold to heavy equipment manufacturers, including Caterpillar, John Deere and Case. The team achieved sales > $15,000,000 in FY2001.In 2003, he founded Neuromics, Inc, his present business that is a web-based marketer of reagents to accelerate discovery in Neuroscience, Diabetes/Obesity and Cancer offering products including antibodies, proteins, transfection reagents, stem cell and primary cell lines, cell culture media and apoptosis measurement kits. He maintains a strong presence in various social media and is responsible for several blogs related to life science products. He has considerable expertise and experience in strategic selling.

About Vitro BiopharmaVitro Diagnostics, Inc. dba Vitro Biopharma (otcqb:VODG) (http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending US patent for generation of pluripotent stem cells and an additional pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, the MSC-Gro(TM) Brand of optimized media for MSC self-renewal and lineage-specific differentiation. In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships including an alliance with Neuromics, Inc. (www.neuromics.com). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems We jointly manufacture stem cell assay systems with HemoGenix(R), Inc. (http://www.hemogenix.com/), known as the LUMENESC(TM) quantitative assay for determination of MSC quality, potency and response to toxic agents. Vitro Biopharma has an agreement with Stemgenesis, Inc. (http://www.stemgenesisinc.com) for distribution of its stem cell products into select Chinese provinces. Also, Vitro Biopharma's CEO is a consultant on an NSF grant at the City College of New York to advise Dr. Lane Gilcrest, Professor of Materials Science and Engineering, and his colleagues regarding the development of novel extracellular materials for use in self-renewal and differentiation of mesenchymal stem cells.

 

中國生物仿製藥 外企佈局策略

默沙东与三星合作 共同开发生物仿制药2013年02月26日09:04 来源：米内网T|T【慧聪制药工业网】 跨国药企巨头默沙东（在美国和加拿大被称为默克）近日宣布，与三星旗下生物制药公司三星Bioepis已达成协议，共同开发和商业化多个生物仿制药。根据协议，三星Bioepis将负责临床前和临床研究、过程开发和制造、临床试验和注册，而默沙东将负责商业化。默沙东全球官方网站上的信息已经证实了上述合作，但默沙东中国并没有对以上信息发表评论。记者了解到，未来几年，数十个品牌生物药将失去专利保护，从而让出市场独占权，不少企业瞄准了市场机遇，纷纷涉足生物仿制药领域，甚至不少非制药企业也参与进来。

牵手三星Bioepis记者从默沙东全球官网获知，三星Bioepis将收到默沙东公司的预付款、产品供应收入。但是，进一步的财务条款尚未披露。早在2008年，默沙东就成立了生物投资业务部（Merck Bio Ventures），开启了默沙东进军生物仿制药市场竞争的新战略。在中国市场，默沙东与国内知名民营企业先声药业在去年成立合资公司。双方将整合资源，开展在产品研发、注册、制造和销售等方面的合作，先期将以心血管与代谢性疾病领域的领先品牌专利药和非专利药合作开发为重点，但暂不涉及国际市场。在业内看来，先声药业联手默沙东，海正药业牵手辉瑞，以及复星医药与龙沙集团 (Lonza) 联姻，都是国内企业拓展生物仿制药的代表。默沙东最新财报显示，2012年公司全球销售收入为473亿美元，四季度全球销售收入为117亿美元。中国市场2012年四季度销售增长35%，继续成为推动增长的主要市场。资料显示，三星Bioepis是三星旗下三星生物（Samsung Biologics）与全球生物技术产业巨擘百健艾迪（Biogen Idec）成立的合资公司，致力于生物仿制药的发展。在生物制药领域，三星去年与昆泰（Quintiles Transnational Corp.）2.6亿美元合资建厂进军生物制药业，将生产的药品拓展至类似美罗华（Rituxan）等生物制剂领域。

生物仿制药机遇将至默沙东和三星在生物制药方面展开合作，与近年来该市场的增长不无关系。工业研究总院副院长俞雄曾在第二届生物仿制药高峰论坛期间接受记者采访表示，生物技术药物销售收入连续多年保持15%以上的增速，是全部药品销售收入增速的两倍以上。"2010年世界前20位畅销药中，生物技术药物占到7席，预计到2020年，生物技术药物占全部药品销售收入的比重将超过三分之一。"与此同时，品牌生物药专利到期也给仿制药的上市销售提供了巨大空间。英国知名行业分析公司Datamonitor的研究显示，2011年到2015年期间，将有30多个品牌生物药失去专利保护，从而让出市场独占权，这些产品目前的市场销售额约500亿至600亿美元。预计到2015年，生物仿制药的全球市场规模将由2010年的2.43亿美元增长到37亿美元。在此背景下，诺华、默沙东、礼来、辉瑞、葛兰素史克、拜耳等跨国制药巨头都在积极备战生物仿制药。诺华2003年整合其所有的仿制药进入山德士，山德士成为了仿制药的龙头，后又逐步成为了生物仿制药的龙头企业；礼来2008年10月收购Imclone大举扩张生物制药产品线；辉瑞2009年12月宣布进军生物仿制药领域……此外，生物仿制药行业的美好前景还吸引制药业之外的参与者。2012年3月，数码科技巨头富士与日本协和发酵麒麟公司成立了开发、制造、销售生物仿制药的合资公司——协和麒麟富士胶片生物制剂公司。

 

潔適康「水針不織布」

不織布 是一種布料種類的統稱，與「針織布」相對。一般針織布需透過機器實體操作「經、緯線」編織而成，日常生活中會使用到的布料均屬此類。而「不織布」則不需透過實體的經緯線編織，故稱作「不織」布。 不織布通常可做為以下的用途：鞋材：例如 鞋內襯、後鞋套、底部的加強。包裝袋：例如 不織布袋、禮品內袋。防火設備：例如 防火衣、防火毯、防火手套。醫療設備：例如 床褥墊、藥膏貼布、口罩。生產工業：例如 過濾布、土木工程用布。不織布因其生產的過程不同，又可分成「水針(水刺)、熱風、熱軋、無塵」四種不同的布質。因生產過程的不同，所產生出來的材質、觸感、密度都不相同。以下特別針對「水針布」及「無塵布(無塵紙)」做說明。 水針布 水針布( Spunlace Nonwoven ) 又稱『水織布』、『水刺布』或『水針不織布』，為一種新型的『不織布( Nonwoven ) 』生產技術，由美國杜邦公司發明，1978 年開始工業化生產。

生產過程 利用高壓水( 40-120kg/cm2 ) 所產生如針一般的極細水柱( 0.1mm )，直接噴射向由纖維所混合成的棉網，由於水的反彈作用，使纖維和纖維間糾纏結成織布。利用高壓水針纏結天然纖維原料，不藉任何化學物質所製成的不織布，是一種環保產品使用時柔軟、舒適，不會沾黏鬍鬚，韌性夠、耐擦。 產品特性

水針法( Spunlace ) 所生產之不織布( Nonwoven ) 不同於其他方式生產的不織布，水針不織布( Spunlace Nonwoven ) 不需用化學樹脂黏合，且具備高柔軟性和懸垂性，和具有吸水性強、透氣性佳的特性。另外可添加防火或抗菌處理，高堅韌度使其易加工縫合或洗滌，不含福馬林或螢光劑，所以能兼顧環保而不會產生二次污染，因而可以利用於諸多不同的領域。具有便宜、抗菌、方便、衛生、環保、透氣…等諸多特點。

無塵紙 將破壞過後的纖維，加上化纖及乳酸(為了使布料結合成形)鋪製而成，不耐溫，超過攝氏50度即會釋出有害的化學物質。一般餐廳使用的包裝濕紙巾大多是用無塵紙製造，若不添加任何化學物質，會散發出製程中所添加的乳酸的酸味，所以一般包裝濕紙巾通常需要加入香精以抑制其酸味。現在市面上9成以上的護理巾都是用無塵紙製造而成，但因無塵紙不耐高溫，遇熱所釋放出來的化學物質堪慮。

市售濕紙巾內含的化學添加物對人體有哪些傷害？在溼熱的氣候中，有許多人習慣以濕紙巾擦拭黏膩的身體，也有許多父母使用濕紙巾，來呵護小寶貝嬌嫩的肌膚，但沒想到強調衛生殺菌的濕紙巾，卻含有潛在危險。單單是螢光劑一樣，經台師大化學系教授吳家誠指出，就可分八大類，有三百五十九種化合物，輕者產生過敏，重者恐導致肝腎病變、甚至致癌。在美國，每當有新螢光劑上市，美國食物及藥物管理局（FDA），都會公開宣布該螢光劑成分、實驗結果、容許添加量及對人體影響等。反觀國內商品檢驗局、標準檢驗局等檢驗單位，頂多檢出商品有無含螢光劑，無法測得螢光劑實際含量，加上市面上濕紙巾包裝上大多未列出實際的添加物成分，等於讓「消費者自己繳錢當白老鼠」，尤其過敏性及嬰兒的皮膚很敏感，拿含螢光劑的濕紙巾擦拭，很可能擦出問題。而甲醛具有使細胞蛋白質凝固的作用，會抑制細胞功能，可作為殺菌消毒劑，但也對細胞具有毒性，因此世界衛生組織(WHO)已將甲醛列為可能致癌物，且行政院環境保護署也將其列為毒性化學物質。消基會秘書長吳家誠指出，皮膚長期接受甲醛易產生對黏膜組織的傷害，並引發血液、淋巴、呼吸系統、肺部等致癌病變。

一般市售的濕紙巾內含哪些化學添加物？一般市售的濕紙巾經檢測出多樣添加物，如清潔劑、介面活性劑、螢光增白劑、防腐劑、保濕劑、抑菌劑、丙二醇、棕櫚酸脂、乙二稀酸鉀、安息香酸、人工香精、酒精等…簡直是族繁不及備載。

一般包裝濕紙巾加酒精有兩大因素

一. 除味：因為國內的濕紙巾絕大部分是採用價格低廉的無塵紙，為使其看起來有質感並增加其視覺上的厚度，就必須讓無塵紙發泡，發泡的過程必須加入乳酸劑，因此產生一種腐敗似的酸味，而酒精或香精就是要去除或壓過那令人無法忍受的酸味

二.殺菌：酒精雖有較佳的殺菌效果，但具揮發性，清潔過後會使肌膚表面水分流失，感覺緊繃乾澀，造成肌膚的不適。其他添加成分愈複雜，對肌膚會造成愈大的負擔，甚至會有過敏的現象，即便是不惜成本，添加了食品級的化學添加劑，一樣是有其使用上限，在毫無規範的使用下，僅考慮到用愈多越不會壞的防止出事機制，其實是有疑義的！

※建議消費者購買濕紙巾時，一定要挑選材質優良且無任何化學添加成分的濕紙巾，以保護肌膚，更避免造成身體的傷害。

(Source: 潔適康http://www.iclean.com.tw/info/view.asp?id=263)

 

南六將上市 (水針不織布技術)

南六、鑫禾上市案過關！最快4月陸續掛牌交易鉅亨網記者張旭宏 台北2013-02-26 17:25:09　 國內最大水針不織布製造商南六企業(6504-TW)及可成(2474-TW)轉投資全球前3大筆電樞紐製造商鑫禾科技(4999-TW)，今(26)日同步通過證交所上市董事會，預計最快4月起陸續掛牌交易。鑫禾為可成轉投資，資本額6.12億元，可成持股27.23％。目前主要從事樞紐零組件製造及銷售，產品包含筆電、AIO、POS機、實物投影機及車用樞紐零組件等。鑫禾NB樞紐全球市占率約2成，主要銷售客戶為廣達(2382-TW)與仁寶(2324-TW)等大廠。鑫禾2011年稅後淨利為1.95億元，每股盈餘為5.29元；2012年營收19.91億元，年增31.71%，前三季稅後淨利達2.72億元，每股盈餘4.45元，法人估計去年仍會賺超過半個股本。南六企業為國內最大水針不織布製造商，目前已成功跨足面膜、濕巾等生技保養品，濕巾為國內最大代工廠，面膜產品亦於台灣及大陸皆創下接單新高紀錄，目前台灣及大陸水針產能皆屬於滿載，大陸平湖投資設立全球最新、最大6.2米幅寬水針不織布生產線將於第二季正式投產，產能將大幅提升，營收獲利將再衝新高。南六去年在大陸公司獲利挹注下，合併營收達37億元，稅後淨利1.96億元，每股盈餘3.19元，營收獲利均創下歷史新高。

寶齡 新藥Zerenex已送日本上市許可(by Torii Pharmaceutical in Japan)

寶齡富錦(1760) 補充說明本公司與Keryx授權合約內容。發言時間 102/02/2611:56:28 發言人 江宗明 發言人職稱 總經理 發言人電話 02-26558218 主旨 : 補充說明本公司與Keryx授權合約內容。 符合條款第40款 事實發生日102/02/26 說明 1.事實發生日:102/02/26 2.公司名稱:寶齡富錦生技股份有限公司 3.與公司關係(請輸入本公司或聯屬公司):本公司 4.相互持股比例(若前項為本公司，請填不適用):不適用。 5.發生緣由: 補充說明本公司與Keryx之授權合約內容: 本公司2005年將腎病新藥之歐、美 、日市場授權予Keryx(其產品名稱為Zerenex)，2007年經由Keryx再授權 JT/Torii進行日本市場開發。依本公司與Keryx授權合約內容，Keryx將依產品 開發進度支付本公司里程金、產品銷售權利金，謹補充說明如下。 (1)銷售權利金(Royalty)： 被授權人(Keryx)應支付或使其再授權之被授權人支付權利金予授權人(寶齡)， 權利金依其各自市場之淨銷售額乘與一定比率計算之。 淨銷售額之定義：授權產品之銷售總額(亦即發票金額，但不含公司內部間專 屬移轉或買賣)，減去合理之銷售扣除額 (包含產品毀損、折扣、運費、服務 費、保險…..等) (2)進度達成里程金(Milestone Payment)： 依合約約定里程金之支付時程及目前開發進度如下： A.授權產品向美國FDA進行第一次申請新藥上市(NDA)後120天內支付：尚未達成 (目前尚未送件申請新藥上市) B.授權產品取得美國FDA第一次上市許可(marketing approval)後120天內支 付：尚未達成(目前尚未送件申請新藥上市，亦未取得上市許可) C.授權產品取得歐洲任一國家第一次上市許可(marketing approval)後120天 內支付：尚未達成(目前尚未送件申請新藥上市，亦未取得上市許可) D.授權產品取得日本第一次上市許可(marketing approval) 後120天內支 付：已於102/1/7送件申請新藥上市，但尚未取得上市許可 (已送件申請新藥上市，但尚未取得上市許可) 6.因應措施:無。 7.其他應敘明事項:依目前國外授權伙伴之開發進度(Keryx還未向美國FDA、 歐洲EMA送件申請新藥上市，日本雖已送件但未取得上市許可)尚未達到約 定之支付里程金及銷售權利金時程，故對本公司財務尚無影響。 以上資料均由各公司依發言當時所屬市場別之規定申報後，由本系統對外公佈，資料如有虛偽不實，均由該公司負責.

Zerenex (ferric citrate) is an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has completed a U.S.-based Phase 3 clinical program for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. The submission of an NDA with the FDA and a MAA with the EMA is pending. Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease. Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has filed its New Drug Application for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease.

(Source:  Keryx Biopharmaceuticals, Inc.)

 

百度 攜手 SFDA 佈局醫藥產業

China Corporate News: Baidu Gains Access to Official Drug Database; Sinopec Buys Chesapeake Limestone Oil Assets

Baidu Gains Access to Official Drug Database Baidu Inc (Nasdaq: BIDU) signed a deal with China's State Food and Drug Administration, where the nation's dominant search engine will have access to information about more than 200,000 medicines. The SFDA hopes the partnership will produce legal and safe search results of medicines. Illegal search results are rampant in China relating to buying advanced medicines overseas at 1/10 the prices of the same imports. Qihoo 360 Technology Co (NYSE: QIHU), the developer of China's most used antivirus software, was reportedly in talks last week with state-run search engine Jike.com for cooperation to challenge Baidu, which is relatively weak in the medicine search market. Qihoo's So.com search engine also has a deal with the SFDA for online search service based on its medicine information.

Sinopec Buys Chesapeake Limestone Oil Assets Sinopec Group, the parent of Sinopec Corp (NYSE: SNP, HKG: 0386, SHA: 600028), said one of its subsidiaries signed a deal to buy US oil assets as the company steps up overseas acquisition. Sinopec International Petroleum Exploration and Production Corp will spend $1.02 billion purchasing 50% of limestone oil assets in Oklahoma from Chesapeake Energy Corp (NYSE: CHK) and have access to half of its 850,000-acre asset that produced 46,000 barrels of oil a day in 2012. The oil block is estimated to hold reserves equivalent to 490 million barrels of oil. Sinopec Group previously said it planned to roll out the equivalent of 50 million tons oil overseas per year – or half of its total output – by the end of 2014. The number was 15.7 million tons in 2011.

CNOOC Finalizes Nexen Takeover CNOOC Ltd (NYSE: CEO, HKG: 0883), China's largest offshore energy explorer, said it has completed its acquisition of Nexen Inc (NYSE: NXY) as its largest offshore takeover. CNOOC made the $15.1 billion bid for the Calgary-based developer of oil sands resources in July 2012. The deal had been repeatedly extended for regulatory review. CNOOC chairman Wang Yilin said the company will benefit from the Nexen deal in the long run, especially in international operations.

Taubman Centers Sets Up Second JV with Wangfujing Taubman Centers Inc (NYSE: TCO), a US mall operator, has set up a second joint venture with Beijing Wangfujing Department Store Group Co (SHA: 600859) to open a shopping mall in Zhengzhou, Henan province probably in 2H 2015, the China Daily reported. Taubman will invest $35.5 million for a major stake in the project and offer its know-how in mall design, development and management. Taubman and Wangfujing set up their first joint venture in August 2012, planning to open a shopping center in Xi'an, Shaanxi province in Q3 2015.

Hainan Airlines Eyes Expansion in Xinjiang Hainan Airlines Co (SHA: 600221), China's fourth biggest carrier, said it signed a deal with the government of Urumqi, the capital of Xinjiang, to found a local airline and cooperate in the tourism and hospitality and a string of other industries. Hainan Airlines is the second largest player in Xinjiang's air travel market, after China Southern Airlines Ltd (NYSE: ZNH, HKG: 1055, SHA: 600029), the nation's biggest carrier by passenger traffic.

Tencent Builds US Office to Market Weixin Tencent Holdings Ltd (HKG: 0700) is building an office in the US to popularize Weixin, its free text and voice messaging and photo sharing app also known as WeChat. Tencent said Weixin accounts went beyond 300 million by the end of January 2013 as it tries to edge Sina Weibo, China's most popular microblogging service that has registered over 500 million accounts. Weixin began expanding last year in Taiwan and Hong Kong as well as overseas such as Southeast Asian nations.

Semir Earnings Dive 38% on Lower Prices and Increased Spending Zhejiang Semir Garment Co (SHE: 002563), China's largest clothing retailer by market value, said its net profits slipped 38.2% to ¥756 million last year after it lowered prices to clear inventory. The company also ramped up investment in R&D, online marketing and logistics, dragging down its earnings. Revenue fell 9.3% to ¥7.04 billion in 2012.

CCB Said to Bid $300m for Rabobank Unit China Construction Bank Corp (HKG: 0939, SHA: 601939), the nation's biggest mortgage lender, offered $300 million for Rabobank's Indonesian unit, Bloomberg reported, citing a person with knowledge of the matter said. CCB has submitted a non-binding offer in the first round of bidding for the assets, said the person.

搶醫藥搜索富礦，百度牽手SFDA 2013-02-27 07:46  來源：南方都市報  2013年才剛開了個頭，互聯網搜索市場已經劍拔弩張，這一次大家的槍口一致對準「醫藥」市場。日前，百度與國家食品藥品監督管理局(S F D A )簽署戰略合作，國家藥監局的三大藥品數據庫，總計20餘萬個權威藥品信息全面入駐百度。今後在百度搜索藥品或藥店，經國家藥監局備案的會以醒目的認證標志顯示。無獨有偶，去年9月人民搜索旗下的「即刻搜索」獨家獲得藥監局的權威數據和信息，而不到一周前，奇虎360公司宣布與「即刻搜索」展開戰略合作，全面接入藥監局的藥品查詢數據。

藥品數據入駐搜索 此次國家藥監局向百度開放的三大數據庫包括：藥品數據庫，包括18餘萬種國產和進口藥品信息；藥品說明書範本數據庫，包括近6000餘種非處方藥(O T C)化學藥品說明書範本及中藥說明書範本；經過認證的可向個人售藥的網站的數據庫信息。用戶在百度搜索藥品，可以通過對通俗的商品名、專業的藥品名、批準文號等多個途徑，得到權威準確的藥監局認證藥品數據。相比此前網絡上魚龍混雜未經認證的藥品搜索結果，相當於每種藥品獲得了一個「身份證」。百度副總裁朱光表示，網民在進行醫藥信息搜索時，可認準藥監局認證的權威信息標志，一旦發現虛假醫藥信息，可通過每個搜索結果頁下方提供的舉報通道進行舉報。而奇虎360則「借道」即刻搜索，全面接入國家食品藥品監督管理局的藥品查詢數據，聯合運營網絡曝光台以及食品安全欄目，相關功能將於近期上線。據了解，即刻搜索「藥品類網頁搜索」收錄了國家藥監局2008年以來所有網絡藥店認證信息和18 .8萬餘條藥品信息，雙方展開合作後數據將會引入到360搜索的結果頁面當中。

爭奪醫療搜索市場 南都記者嚐試在百度搜索中輸入藥品名「開瑞坦」，搜索結果頁第一項即顯示「開瑞坦」的2種同類產品的具體信息，提供包括商品名稱、產品名稱、批準文號、生產企業的信息，並標明由「國家食品藥品監督局批準藥品信息」。而奇虎360搜索只顯示商品名稱、批準文號，搜索結果出現「即刻醫藥」的標志。此外，經國家藥監局備案的網絡藥店認證信息也入駐百度。當網民在百度搜索「藥品名+網上藥店」，或直接搜索某藥店名稱時，可通過「認證」標識進入藥監局權威認證的正規藥店。而這項功能，奇虎360搜索並未具備。有搜索行業的人士透露，百度在一年前已經開始與藥監局商談合作。此次各家搜索企業爭相與國家藥監局合作，聯手嚴打虛假醫藥信息，意在爭奪醫療搜索市場的版圖，防止對手入侵。（南都記者 謝睿 高淩雲）

 

 

(佈局中國醫美) 雙美: 膠原蛋白製造商 取得"玻尿酸"代理權

每CC萬元人民幣...雙美代理玻尿酸搭膠原蛋白 攻陸金字塔頂市場！2013/02/26 19:35 記者胡薏文 台北 雙美生技今天與歐洲知名藥廠CROMA-PHARMA GmbH舉行簽約儀式，獲得玻尿酸醫學美容植入劑總代理權。雙美董事長王進富表示，雙美去年底也取得第2張膠原蛋白執照長效劑型執照，未來2項產品將進行搭配，搶攻大陸金字塔頂級市場，包括眼科、牙科及骨科等領域產品也將共同開發及行銷。雙美透露，長效型膠原蛋白的定價，每CC達1.3萬元人民幣。CROMA-PHARMA GmbH成立於1976年，致力眼科、骨科、醫學美容領域等專科醫療產品研發與行銷，總部位於奧地利，版圖擴及歐美國家，產品行銷全球62個國家，王進富表示，CROMA-PHARMA GmbH是全球數一數二的玻尿酸醫療產品專業製造廠，看重雙美在大中華地區醫學美容通路的經營經驗，決定將玻尿酸醫學美容植入劑產品總代理權交給雙美。王進富指出，雙美獲得大陸玻尿酸醫學美容植入劑代理權，未來獲得認證後將納入港澳地區，而亞洲代理權將是下一階段目標。雙美預定將玻尿酸搭配長效劑型膠原蛋白，搶攻大陸金字塔頂市場，每CC提高定價為人民幣1.3萬元，包括醫師施打費用等，新策略包括選定與中國大陸各省業績前5大的醫美診所合作，並提供培訓醫生與醫生、諮詢服務，目前已與中國大陸醫美四大家族之一洽談合作，未來並將推出「雙美卡」，年費人民幣30萬元，提供套裝服務。

雙美 代理奧地利玻尿酸【聯合晚報╱記者徐睦鈞/台北報導】2013.02.26 02:52 pm 膠原蛋白廠雙美生技(4728)今天上午與奧地利知名藥廠CROMA-PHARMA GmbH簽署大中華區總代理權合約，未來CROMA將把其玻尿酸醫美植入劑產品總代理權交給雙美，雙美也將因此成為大中華區同時擁有膠原蛋白及玻尿酸兩類產品的醫美廠商。雙美董事長王進富表示，雙方未來也將在眼科、牙科及骨科產品進行共同開發及市場行銷合作。雙美去年底取得大陸第二張膠原蛋白執照－長效劑型，王進富表示，該產品將發展雙美的自有品牌，鎖定高端市場，每CC售價將提高為人民幣1.3萬元，初步規劃在每個省選定業績前五名的診所合作，今年效益將逐步顯現。【2013/02/26 聯合晚報】@

雙美已取得陸長效劑型膠原蛋白執照【聯合晚報╱記者徐睦鈞／即時報導】2013.02.26 01:00 pm 膠原蛋白製造商雙美生技 (4728)去年底取得大陸第二張膠原蛋白執照－長效劑型，董事長王進富今表示，該產品將發展雙美的自有品牌，鎖定高端市場，每CC售價將提高為人民幣1.3萬元，初步規劃在每個省選定業績前五名的診所合作，同步提供產品、醫生服務，並結盟大陸四大家族的第一大家族，今年效益將逐步顯現。王進富表示，長效型針劑屬奢侈品，一年僅需施打一次，奢侈品就該以奢侈品的價格銷售，鎮定金字塔頂端的客戶。目前雙美正在組織經營團隊，也已經和大陸四大家族的第一大家族談定合作。【2013/02/26 聯合晚報】

 

 

台灣1000元生技股 歷史紀錄誰將搶頭香 ?!!

商業周刊／生技股　將是下個千元股王？文●王毓雯繼宏達電、大立光之後，台股下一檔能登上千元高價的股王，最可能出現在哪個類股？答案是2012年紅透半邊天的生技類股。四五．五八％，這是去年台股上櫃生技類的漲幅，漲幅之大，高居上市櫃所有類股之冠，更遠勝加權指數的八．八七％。去年投資報酬率高約三成的德盛全球生技大壩基金經理人傅子平認為，今年三大條件齊備，包括政府政策、美國食品暨藥物管理局(FDA)審查進度、專利藥到期數量增加等，其中美國總統歐巴馬(Barack Obama)注重醫療生技產業，FDA過去兩年均核准三十個以上的新藥，比前五年的平均二十五個明顯增加。傅子平強調，專利藥到期數預估在2015年再創小高峰，因此這一波多頭走勢將延續到明年底，而生技製藥業的進入門檻高、受專利保護，「我認為不會像太陽能、LED一樣一閃即逝，」他並認為，今年焦點仍將是新藥開發公司。新藥取得藥證之前，須經過三階段的臨床實驗，越接近後期(第三期)的評價越高，如果順利取得藥證，「賺兩、三個資本額都有可能。」德信投顧研究員楊人穆認為。以嬌生(J&J)旗下的卵巢癌藥為例，一年全球銷售額曾達六億美元，就算只拿三成的市占率、毛利率僅估五成，對一家資本額十億元(台灣新藥公司多為此規模)的公司而言，一年就可大賺超過兩個資本額，而這僅僅是一個產品的貢獻度。就是在這樣的本夢比支撐下，永豐餘集團轉投資的基亞生物科技，去年漲幅高達二九一．四一％，是台股約一千四百檔股票中漲幅最大；去年十二月底掛牌的台灣微脂體，短短兩個月內最大漲幅就逾一．五倍。新藥與類新藥也因此成為風險投資者的天堂，但高額報酬率伴隨高風險，以台微體、安成聯手開發中的卵巢癌學名藥為例，二月四日被印度公司Sun Pharma捷足先登、取得第一張學名藥證後，台微體股價短短兩個交易日就下跌逾一成。傅子平強調，每一個階段的臨床實驗成敗與否，到最後取得藥證與否，「就是決定藥廠股價上天堂、還是下地獄的關鍵。」新藥開發公司中，最好避開下列類型的公司：太過早期、尚未進入臨床實驗，市場過小、目標只有台灣市場，而單壓一支新藥的則是風險過高。另外，植物新藥不易被歐美市場認同，即使進入臨床第三期，往往價值也不高。最保守穩健的生技股投資方式，則是鎖定營收、獲利均達一定規模的個股，例如台灣東洋與台灣原料藥龍頭神隆等，相比起多數的電子股，這類公司的成長力道仍強，例如台灣東洋正與嬌生洽談代工合作事宜，將是台灣少數與國際一線大廠接軌的藥品製造廠。去年是台灣生技產業開花結果的第一年，這一波多頭趨勢仍將延續兩年，投資人可多留意代表全球投資生技類股資金的風向球，美國NBI指數的走勢，搭上這一波全球生技財。

(宣昶有) 何謂價值30億台幣的技術 ! Anti-CD3膠原蛋白支架抗體

膠原蛋白支架複合物之醫療應用技術

1.技術研發目標 隨著醫學研究發展，面對愈來愈複雜的疾病，小分子化學合成藥物發展技術面臨瓶頸，繼而帶動生物技術的發展，因此技術門檻較高的蛋白質藥漸成為製藥界主流。近年來，更逐漸發展人源化(Humanized)之抗體，而人源化抗體技術是把鼠源抗體的大部分轉換為人類抗體的結構，使之接近於人體自身的抗體，從而消除或降低人體免疫系統對異源性蛋白的排斥反應。一般傳統的小分子藥物治療如同「轟炸機的炸彈」，範圍以內的區域都會遭殃，正常細胞也會受到波及。由於單株抗體可以在人體內辨識出特定抗原，針對目標進行「導彈」攻擊，因此在治療癌症或免疫性疾病時，可藉由殺死特定細胞並減少對其他細胞的傷害來降低副作用。抗體藥物治療時兩大關鍵為專一性(Specificity)與結合強度(Affinity)，此攸關藥物能否找到特定癌細胞，並將其抓緊、抑制其生長。專一性是指藥物對癌細胞表面過度表現標靶辨認的準確度，而結合強度則是指藥物對該標靶的結合緊密度。本技術利用人類第21型膠原蛋白所研發的膠原蛋白支架，其構造為三股螺旋體的形狀(三價型)，較目前採用的抗體結構Y字體(二價型)還多了一隻手(價數，Arm)，抓力更強，不容易與癌細胞脫落，讓藥效可以充分發揮。另外，這款膠原蛋白支架的前後兩端，都可與癌細胞結合，同時具有針對兩種不同標靶進行結合的優勢地位。與目前廣泛被使用的Y 字型抗體二價結構相較，三價型膠原蛋白支架抗體(CSA, Collagen Scaffold Antibody)已被證明可增加抗體與標靶結合的強度達數倍至數十倍之多。膠原蛋白支架技術平台除了可被運用於單株抗體藥物製造外，也可與任何具生物結合作用之蛋白分子進行融合(如配體、酵素及細胞激素)而成為新穎複合體，因此應用範圍相當廣泛。膠原蛋白支架與蛋白藥物融合，可加強藥物專一性進而減少用藥劑量且降低藥物可能引起之副作用。當膠原蛋白支架應用於分子影像時，則可融合具螢光或泠光之蛋白分子或外接具放射性之蛋白分子、奈米分子與核種。膠原蛋白支架也可應用於體外檢驗試劑，利用其多價特性，可大幅提升抗體與抗原之親和力，進而減少抗體使用量，並增加偵測靈敏度。膠原蛋白支架為台灣自主研發之專屬(Proprietary)技術平台，已申請美國、澳洲、台灣、歐盟等多國專利在案，擁有註冊商標，並發表論文於國際期刊。在發展技術平台初期，即先針對市售商品進行專利分析，確認其專利空間，選定具有市場競爭力、但仍具改善空間之抗體進行技術及產品開發。目前選定多發性硬化症(Multiple Sclerosis)、類風濕性關節炎(Rheumatoid Arthritis)與惡性腫瘤(Malignant Tumor)為治療標的，依序開發候選藥物。

2.技術發展藍圖 由於膠原蛋白支架平台之應用性相當廣泛，第一項開發策略為選擇將此支架與目前臨床使用或經臨床驗證之蛋白質藥物進行融合，同時進行生產高產率、高純度之新穎基因重組膠原蛋白支架生物製劑，期望能利用此技術開發出在藥效或副作用上優於市售抗體藥物之生物製劑。該選擇什麼樣的分子與本技術平台進行融合，也是一個重要的關鍵，抗體分子的恆定區片段(Fc, Fragment of Constant Region)會決定此抗體在血液中的半衰期，進而影響到療效或是用藥頻率。膠原蛋白支架型抗體不含抗體IgG分子之恆定區片段，導致其在生物體血液中之半衰期較抗體IgG 分子短，因此在分析標的藥物之作用機轉後，優先挑選治療機制與半衰期較無關之疾病(如免疫調節相關之疾病)作為膠原蛋白支架候選產品。對於一些需要長時間維持有效劑量之疾病標靶分子，則會利用結構生物學技術與分子生物學技術，改變膠原蛋白支架複合物之結構，除達到延長半衰期之效果外，同時具有高專一性及強結合力等優勢。以下將分別說明三項候選藥物之技術發展。

多發性硬化症 為此新穎技術之第一個治療模式，候選藥物之結構為利用膠原蛋白支架融合CD3分子，形成抗-CD3膠原蛋白支架抗體(Anti-CD3 CSA)。目前已完成抗體細胞株開發與種細胞庫建置、建立純度可達99.2%之純化步驟、建立生物活性分析方法學確認其活性優於同源 IgG 分子、完成體外(in vitro)安全性評估確認不具免疫性、不會刺激T細胞活化、不會造成血小板活化或凝集之發生、不會誘發產生發炎反應細胞激素(Pro-inflammatory Cytokine)。建立抗體藥物量產標準作業流程，在非藥物良好作業規範環境下(non-GMP)可生產純化得到2 gm之蛋白質。在小鼠單一與重複劑量毒理實驗中，確認藥物之安全性，同時也證實低劑量即能達藥物療效且無細胞素風暴(Cytokine Storm)副作用。在小鼠動物模式進行對多發性硬化症有效性之評估，結果顯示連續 5 天投予 anti-CD3 膠原蛋白支架抗體藥物治療之小鼠，其病徵程度(以分數評量)明顯較未投藥或投予市售藥(IFN-β)輕微，證明 anti-CD3 膠原蛋白支架抗體藥物具治療效果，且較現有之市售藥物顯著有效。在黑猩猩劑量提升試驗安全性實驗中顯示，低劑量(0.1~1.0 mg/Kg)給藥，黑猩猩並無不良反應，證明藥物之安全性及具藥效(Primary PD)。預計第一個膠原蛋白支架複合物候選產品將於 2013 年提出新藥臨床試驗(IND, Investigational New Drug)。

治療類風濕性關節炎之藥物為第二項欲開發之候選藥物，其原理為將膠原蛋白支架與對腫瘤壞死因子(TNFα)具專一性之標靶分子進行融合。由於治療類風濕性關節炎的藥物需要在生物體內保持較長之時間，以維持其功效，因此在開發此候選藥物時，必須重視如何增加其血液半衰期與避免引發免疫反應。在半衰期方面，利用TNFα膠原蛋白支架融合蛋白與市售抗TNFα抗體藥物-恩博(Enbrel® )進行一個同步試驗比較，結果顯示，TNFα膠原蛋白支架融合蛋白在小鼠血液中之半衰期約為 10 小時以上，與Enbrel® 相差無幾，證明TNFα膠原蛋白支架在結構上進行修飾後，確實可以延長在血液中的半衰期。在動物實驗方面，則是利用關節炎小鼠進行評估，並與Enbrel® 做一個同步試驗比較，結果顯示，TNFα膠原蛋白支架拮抗劑明顯抑制小鼠發病的病徵，且治療效果顯著性地比Enbrel®組佳(P < 0.05)。因此可以確定TNFα膠原蛋白支架拮抗劑具療效，而且療效比Enbrel® 佳。未來將持續進行TNFα膠原蛋白支架拮抗劑的藥效、藥動及毒性試驗。惡性腫瘤之治療藥物為第三個開發之候選藥物，利用膠原蛋白支架的前後兩端具結合能力，且可與不同的標靶結合之特性，開發雙特異性膠原蛋白支架抗體，藉由其三價體之特性強化 T 細胞與腫瘤細胞間的結合穩定性，進而有效地誘導 T 細胞的活化，並促進毒殺功能。目前尚在標靶治療(Targeted Therapy)機制研發階段，已完成細胞株及純化步驟之建立，在小鼠療效實驗中則顯示候選藥物對於腫瘤治療、預防腫瘤產生皆有效果，後續此一候選藥物也將依循標靶治療之機制進行蛋白質鑑定分析、動物試驗及蛋白質量產純化等程序申請IND，也將與國內外廠商接洽，期能強化國內廠商投入意願、吸引國際大廠關注，藉此形成策略聯盟，以分擔國內廠商風險，開創新藥研發的合作模式。相關技術標示見圖2-4-3-2-2。

3.產業效益 面對人口高齡化、腫瘤及自體免疫疾病的醫療需求及新興市場的崛起，為單株抗體藥物帶來很龐大商機。根據Evaluate Pharma 的分析預估，2014年全球前百大藥品中，生技藥品將超過半數，且其中前十大藥品中前三名都是單株抗體藥物，成為藥品市場中的主力。由於膠原蛋白支架複合物技術平台具高度專一性、低副作用等優勢，因此其治療標的將著重於常見之慢性自體免疫疾病之治療，如多發性硬化症。全球約有250萬多發性硬化症的患者，美國則約有35萬病例，而每年約有1萬個新增病例，依據2011年 Visiongain 的報告中預測，緩和多發性硬化症用治療藥物於2015年將達到158億美元之規模。未來 anti-CD3 膠原蛋白支架抗體藥物上市後，將提供醫生與患者用藥新選擇。抗類風濕關節炎之藥物是獲利高且成長快速的市場，根據 Infiniti Research Limited 公司在 2012 年 3 月出版的市場報告指出，全球類風濕性關節炎藥物市場於2011~2015 年期間預計將有 12.1%的成長。2015 年類風濕性關節炎全球藥物市場將達 270 億美元，其中最大宗的抗體藥物包括 Johnson & Johnson 的 Remicade®、Amgen的 Enbrel®、Abbott的Humira®。另一方面若TNFα膠原蛋白支架拮抗劑開發成功後，預計將可達全球市場占有率的20%。癌症除了以手術切除、放射療法外，大多以小分子藥物進行化學治療。但小分子藥物有專一性差、副作用大及腫瘤細胞產生抗藥性之缺點。全球癌症市場用藥 2008年規模約483億美元，2013 年預估增至807億美元，年複合成長率為19%，成長主要來自生物製劑，而生物製劑又以單株抗體為大宗。預期雙特異性膠原蛋白支架抗體擁有多重用途治療級抗體之架構，並可提升療效，降低使用量，因此將可與同質性產品區隔，提高其市場競爭性。

(Source: 2012 產業白皮書)

電子業重量級人士 看好宣捷生技 !!

加捷好熱(樂) !! 宣捷 (宣昶有) 佈局 蛋白質新藥 …