膠原蛋白廠 搶進海外市場2011-08-01 工商時報 在知名旅美醫材專家張有德的TMF創投可望成軍，國內高階再生醫材膠原蛋白廠乘勝追擊，積極布建海外市場，和康生技與美國Nasdaq上市公司NuVasive策盟，而雙美則與大陸普瑞森、五洲集團聯手進軍中國，而柏登的生物眼角膜明年進入人體臨床，亦將躋身國際競技場。和康生技董事長張立言表示，國際醫材廠近年重新大洗牌，美國保健暨消費品巨擘嬌生集團（Johnson ＆ Johnson）以213億美元的價碼，併購瑞士醫療設備製造商Synthes，穩穩坐擁龍頭寶座，另外，Stryker也以3.16億美元買下Orthovita，醫材廠的競爭白熱化，也將導致廠商的結盟將成趨勢。目前和康是與全球市佔率居第五的NuVasive策盟搶攻美國市場。張立言表示，NuVasive專注於骨科及脊椎微創醫材產品的開發與行銷公司，2009年投資入股和康，約持有10％股權，目前雙方的合作初期鎖定是骨科材料，未來則將延伸至牙科和眼科等材質。另外，為了創造公司的營收，和康近年也積極主打碧芙蕾詩（BIOFLASH）系列、黛諾（Dr.Neo）等自有品牌，開發醫學美容保養品，已開始打進康是美、屈臣氏等通路，並將為國內頂級觀光旅遊景點設計系列美容保養產品。除了和康搶攻美國市場，柏登開發以膠原蛋白為材質的組織修復產品則專攻歐美市場。柏登董事長賴弘基表示，該公司主打的ologen自有品牌，已開發出世界第一個眼組織修復產品，目前全球已累積超過16,000例自費手術使用，該產品去年並得到捷克及瑞典的健保給付，預計明年有機會取得美國及德國的保險給付許可。賴弘基認為，柏登未來最大的利基在於研發中的生物眼角膜，在荷蘭及中國的動物試驗已經成功下，明年將進入人體試驗，未來的商機十分可觀。國內投入膠原蛋白廠商已漸成氣候，除了和康、柏登和雙美已有產品上市外，已於2009年8月併入海昌國際的生立生技，也是投入眼科生醫材料，目前正藉由海昌通路，拓展至國際市場。另外，目前是國內最大的膠原蛋白原料後加工廠的大江生醫，其產品廣泛用於保養品、保健食品及機能性飲料，一年進口量超過90公噸，約占台灣總量的三分之二。大江副董事長關淑君表示，在看好膠原蛋白前景，大江已規劃設立自己的膠原蛋白生產基地，並就近從屏東獲得最高等級的黑鮪魚中，萃取膠原蛋白，預計年底開始動工，該產品將用於美容保養品。不同於大江生醫的膠原蛋白是以黑鮪魚為主，和康的原料是牛筋，而雙美則是自己開發S.P.F（無特定病源感染）等級的豬體皮，是全球唯一用豬皮生產膠原蛋白的廠商。雙美已於2009年取得中國第一張SFDA膠原蛋白皮膚植入劑上市許可證照，並拿下普瑞森四年23億元膠原蛋白訂單，去年因為被中國課徵消費稅，導致業績受到衝擊，不過，今年在與代理商協調後，營運已回復常軌，雙美董事長王進富表示，該公司今年上半年已獲利，正式擺脫虧損命運。目前雙美除了和普瑞森集團合作搶進大陸市場外，也將和中國知名的五洲集團聯手進軍醫美領域，初期會先以植牙及牙腔美容等領域為主，未來再延伸至眼科、骨科等事業。
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Sunday, July 31, 2011
國光生技疫苗充填問題將徹底解決!!
土銀主辦國光生技40億授信2011-08-01 工商時報 土地銀行主辦國光生物科技股份有限公司新臺幣40億元聯貸案，已成功完成募集，於日前舉行聯貸簽約儀式，由土地銀行王耀興董事長代表銀行團與國光生物科技股份有限公司詹啟賢董事長簽訂聯合授信合約。該聯貸案資金用途為國光生物科技股份有限公司為償還銀行借款、建置廠房附屬設施、購置機器設備暨其附屬設備、充實營運週轉金所需，募集15年期總金額35億元聯貸案，經參貸銀行超額認購，總金額達新臺幣41億元，最終以40億元結案。國光生物科技股份有限公司設立於民國54年，從事疫苗及檢驗試劑之研發製造銷售，主要產品為日本腦炎疫苗、結核菌素純化蛋白衍生物、破傷風類毒素疫苗、流行性感冒疫苗等，為國內唯一、全球少數具有量產新型流感（H1N1）疫苗能力之公司，位居國內疫苗產業龍頭地位，所生產之流行性感冒疫苗、日本腦炎疫苗、破傷風類毒素等，其品質受到衛生署的肯定。國光生技為拓展外銷業務，將以本案資金興建符合美國食品藥物管理局（FDA）規格之充填線，預計今年內可以完工、明年上線生產，將有助於該公司進軍國際市場。國光生技在董事長詹啟賢先生的領導下，一步一腳印的全力打造全球頂尖的疫苗王國，未來營運成長力道可期。
廣達 生產醫療電子和器材GMP廠
林百里：看好ICT產業 進軍醫療電子 【2011/07/28 聯合晚報】 時代基金會今日舉辦資訊科技、創新醫療高峰論壇暨技術展，邀請多位麻省理工學院(MIT)學者專家來台演講。時代基金會董事長林百里於致詞時表示，看好台灣ICT產業發展成功，具備進軍醫療電子的優勢，相信在和MIT等產官學界的合作之下，能夠朝高價值的電子醫療裝置發展，加速台灣電子產業升級。時代基金會是由麻省理工學院院長梭羅(Lester C.Thurow)和台灣企業大老共同成立，以「推動知識經濟的橋梁」自期，為台灣經濟發展尋找利基。其中，醫療產業也是台灣高科技產業升級的一大重點。林百里最近多次強調，廣達(2382)正從技術密集產業，升級為知識密集產業，因此持續加速布局雲端、醫療相關領域。在雲端業務上，廣達已有明顯展獲，而醫療領域的成果則還需要等待，可望在這幾年會推出相關產品。廣達布局醫療電子領域多年，廣達的醫療電子團隊2008年獲得經濟部通過「醫療級骨科診斷裝置技術開發計畫」，在ICT大廠中位居領先群。2009年廣達更取得衛生署GMP認證，具備生產醫療電子和器材產品的資格。2010年，廣達再投資英國的醫療用無線通訊科技廠商Toumaz Technology，取得該公司超過1%的股權，加強在醫療性電子產業的佈局。
皇將靠生產製藥設備獲利 還需等嗎?
Polaris begins phase III HCC trial
Polaris Group Doses First Patient in Pivotal Phase 3 Clinical Trial of Lead Therapeutic Candidate ADI-PEG 20 for the Treatment of Hepatocellular Carcinoma Company Advances Into Late-Stage Development a Biologic That Systemically Depletes Circulating Arginine Needed by Certain Cancer Cells to Survive SAN DIEGO, July 28, 2011 /PRNewswire/ -- Polaris Group (Polaris) today announced that it has dosed the first patient in a pivotal Phase 3 clinical trial evaluating its lead cancer therapeutic, pegylated arginine deiminase (ADI-PEG 20), in hepatocellular carcinoma (HCC) patients. Over 600 patients who have failed prior systemic therapy will be enrolled in the randomized, double-blind, placebo-controlled study at sites in China, Taiwan, the United States, Italy and the U.K.. Patients will receive weekly intramuscular injections of ADI-PEG 20 until disease progression. The primary endpoint of the study is overall survival, and secondary endpoints will include progression-free survival and time to progression. "Based on our recently approved Special Protocol Assessment from the FDA, this pivotal Phase 3 study is significant as it will hopefully serve as the basis for approval in the U.S.," said John Bomalaski, M.D., executive vice president, medical affairs, of Polaris. "We believe ADI-PEG 20 is a promising cancer therapeutic not only for HCC, but also other arginine-dependent cancers such as leukemia, lymphoma, sarcoma and prostate cancer. We look forward to continuing clinical development in all of these areas to understand the full potential for this therapeutic."Ghassan Abou-Alfa, M.D., of Memorial Sloan-Kettering Cancer Center in New York, the principal investigator of the study, said, "We are delighted to be involved in a pivotal study for ADI-PEG 20, which has the potential to become a much needed treatment option for HCC patients. There is no currently approved therapeutic for HCC patients who have failed first line therapy. Thus there is a significant unmet need in this patient population."Additional information about the trial can be found online at www.clinicaltrials.gov/ct2/show/NCT01287585?term=polaris+group&rank=1 .
About Hepatocellular Carcinoma Hepatocellular carcinoma (primary liver cancer) is one of the most common cancers worldwide, resulting in approximately 700,000 deaths annually. Infection with hepatitis B or C and alcohol consumption are highly associated with the development of hepatocellular carcinoma. The prognosis for patients with this disease is poor because chemotherapy often does not result in prolonged survival, and liver transplantation only increases the survival of selected patients. Despite all forms of current treatment, life expectancy for most patients is less than one year post-diagnosis.
About ADI-PEG 20 ADI-PEG 20 is a biologic being developed by Polaris to treat cancers carrying a major metabolic defect that renders them, unlike normal cells, unable to make arginine internally. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 works by systemically depleting the external supply of arginine, which causes these arginine-dependent cancer cells to die while leaving the normal cells unharmed.Multiple cancers have been reported to have a high degree of arginine-dependency. Phase 2 clinical trials of ADI-PEG 20 have yielded positive results in patients with hepatocellular carcinoma or metastatic melanoma, and Phase 2 trials for small cell lung cancer and mesothelioma are currently ongoing. Polaris also plans to initiate clinical studies in prostate cancer, pancreatic cancer, leukemia, lymphoma and sarcoma this year.
About Polaris Group Polaris Group is a privately held multinational biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company's lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris is also investigating ADI-PEG 20 as a treatment for other arginine-dependent cancers, such as melanoma, prostate cancer, leukemia, lymphoma, sarcoma and pancreatic cancer. In addition to the ADI-PEG 20 project, Polaris is researching and developing other biotherapeutic agents and has a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.
Wong Chi-huey: “at least 60 new drugs developed by Taiwanese companies are undergoing clinical testing”….!!!
Academia Sinica paves the way for Taiwan's biotech industry Wong Chi-huey, head of Academia Sinica, expects research and development efforts backed by the institution to help upgrade Taiwan's biotechnology industry. 07/29/2011 Source： Taiwan Today Academia Sinica, Taiwan's top research institution, has maintained a reputation as a powerhouse in the production of leading scholars and cutting-edge research for over 80 years. In the 21st century, however, its president sees the institution's mission as broader than ever before, with direct participation in practical applications. "Research generates the greatest benefit for humanity when it is transformed into products that common people can use," Wong Chi-huey told Taiwan Today July 11. A specialist in synthetic chemistry and biocatalysis, Wong speaks from experience. He has created several important vaccines, including the world's first breast cancer vaccine developed with glycoprotein technology. The drug, currently in the final stages of clinical trials in Hong Kong, Singapore and Taiwan, is expected to be ready for the market within two to three years. "The practical benefits of a study are more important than any accolades it may receive," said Wong, who has been directing Academia Sinica, Taiwan's top research institution, since 2006. The institute has been an incubator for advanced studies in areas ranging from stem cells, DNA sequencing and atomic sciences to history, literature and linguistics. It is in the vanguard of promoting Taiwan's biotechnology sector, named one of the six emerging industries by the government in 2009. A Cabinet-level action plan will boost biotech development through the establishment of the Taiwan Medtech Fund, an NT$60 billion (US$2.08 billion) joint public-private venture capital company; the Supra Incubation Center to provide patent consulting services and market analysis; and the Taiwan Food and Drug Administration (TFDA), which will bring the country's pharmaceutical sector in line with international standards. Wong believes the five-year program will serve as the desperately needed connection between research and production. "Taiwan's higher education and research institutions have exhibited stunning potential in biotech research, and the action plan aims to transform exciting discoveries into marketable products," he said. Pharmaceutical innovation could be the engine for the entire biotech sector, Wong stressed. As new drugs are developed, he explained, other aspects of the industry, such as instrument manufacturers, lab testing facilities and standardization developers will be mobilized as a result. "Once a brand-name drug becomes successful, the royalties collected worldwide can provide robust backing for drug developers, making them self-sustaining, provided that a strong support mechanism for researchers is in place."Chang Tse-wen, an antibody engineering expert at Academia Sinica's Genomics Research Center, presents a case in point with his anti-allergy drug Xolair, approved in the U.S. and EU in 2003 and 2005, respectively, for treating severe allergic asthma. The journey to such success is so long, however, that it will intimidate any research team without solid backing. "It took us 16 years to take the drug from a lab concept to a marketable product," Chang said. "But it was all worthwhile, as our brainchild is now actually helping patients." According to Wong, at least 60 new drugs developed by Taiwanese companies are undergoing clinical testing, with 30 complying with U.S. Food and Drug Administration standards. These efforts include an antibody for HIV by TaiMed Biologics Inc. and antibiotics targeting cancer by TaiGen Biotechnology Co. Ltd. Numerous new drugs coming from Taiwan should appear on the market in the next few years, he said. Wong believes such drug development efforts will enjoy better resources as the government moves to provide a more encouraging environment, a key part of which will be a biotech park proposed by Academia Sinica. To facilitate a cluster effect for drug development, which typically consists of drug discovery, preclinical research and clinical trials on humans, the new park adjacent to the institute in Taipei's Nangang District is set to become headquarters for key participants in drug discovery and testing. Sitting on a 25-hectare section of what used to be the No. 202 Munitions Works Plant, the park, slated to open in 2017, will be home to Taiwan's leading research in translational medicine—the process of converting pharmaceutical discoveries into products that actually cure patients or prevent diseases. Representative offices of the National Science Council, Ministry of Economic Affairs, National Laboratory Animal Center and TFDA, under the Department of Health, will provide on-site support for the NT$22.5 billion initiative, Wong said. "We are working to build a biotech park that harbors innovation and creativity, rather than a string of biotech factories that copy and produce the same generic drugs," he said. Given the biodiversity in the park and its surroundings, totaling over 180 hectares, preservation is another concern the institute values. "Office buildings will take up merely 9.6 hectares, and we plan to rehabilitate the entire area, which used to be wetlands," Wong said. "We seek to create the most benefits for humans and the natural environment." The plans to help drug companies will also lead to an environment more conducive to the cultivation of biotech talent. "People with key expertise are crucial to a knowledge-based industry such as biotechnology," Wong said. "Only when the industry chain is fully integrated and supported will the best brains have a stage to shine on," he said, stressing that people are the most important asset for building Taiwan's biotech future. (THN)
佳醫3千床銀髮照護 強化Aisa Best Healthcare（ABH）登興櫃!
佳醫登陸，攻銀髮、醫美市場2011-07-30工商時報 佳醫（4104）與大陸國藥合資的「御佳醫療」的第一家醫療通路最快年底前將在北京成立，加上合資成立的五官醫院納入醫保後也轉盈，雖然有亮麗的利多題材，但該股在大盤重挫中，卻出現貼息走勢。28日除息的佳醫，現金股息是2.5元，雖然填息勢不如預期，不過，自營商昨日買超150張。御佳醫療由佳醫與中國國藥合資成立，額定資本額為5億人民幣，目前實收資本額為2億人民幣，佳醫持股49％。第一家醫療通路將設在北京，已拿到公司許可，預計7月拿到各項營業執照，最快年底正 式開業，將設立醫美及眼、牙、皮膚科等。至於醫美部分則將結合曜亞（4138）的資源，共同搶進大陸龐大商機，未來雙方將陸續在上海、瀋陽、天津、杭州、福建、廣州等地開設據點，爭取醫改商機。另外，該公司搶攻的銀髮醫療照護商機的Aisa Best Healthcare（ABH），去年已開始獲利，今年目標達3千床，預計明年第1季底登錄興櫃，成為另一隻金雞母。
Thursday, July 28, 2011
中國“十二五” 單克隆抗體極力發展自主知識產權(IP)
竹北生醫園區進入招商 房產有機會!!
生醫園區招商 帶動購屋潮2011-07-28 中國時報 新竹縣房地產市場發展由高鐵通車前後六家站區，到縣治一、二期，及目前推動中的三期計畫，由於整體串聯度高，加上街廓、公設綠地、國中小學預定地完整開發，不論生活品質及推案水準都有目共睹。其中占地達38.1公頃的新竹生醫園區，目前更已進入招商階段，後續龐大購屋動能，預計可為地方帶來上萬居住需求。占地達38.1公頃的新竹生醫園區，開發之初就定位為生醫產業專業園區，除了將做為國內外相關領域高科技人才創新研發及產業育成基地，對提升台灣加值產業也有重要幫助。三大營運主體包括臨床醫學中心、產業及育成中心、生技與產品研發中心目前都已進入招商階段。由於生醫園區已展開招商設廠計畫，相關公共建設及景觀工程目前都由縣府發包完工，其中生技大樓主體工程也已正式開幕，生醫科技與產品研發中心，則以籌備處方式先行進駐生技大樓，五月中已掛牌營運。根據新竹縣政府官網資料指出，生醫園區目前共規劃三大發展主軸，包括新竹生醫園區醫院、生醫科技與產品研發中心、產業及育成中心等，縣府更已核准六家廠商進駐案，分別是分別是是百丹特、暐正、竟天生技、國璽幹細胞、紅電醫學以及聯合骨科器材，預計後續可提供卅家相關產業進駐。拜新竹縣政府推動各項重大政策利多之賜，造就地方推案後續增值潛力，特別是規劃中6.8公頃的世貿展演中心已進入土地規劃徵收階段，加上生醫園區、綠能產業園區等就業居住人口需求，預估未來購屋動能將衝破上萬戶。以高鐵六家車站做為開發中心的三園四所，則鄰近延伸生醫園區、科學園區及園區三期規劃案，加上台灣大學竹北分部、台灣科技大學竹北分部、交通大學竹北園區、清華大學第二園區，建構完整科技大學城。在這樣的規劃中，包括台大、台科大校區及生醫、園區三期都已步入開發階段，都造就房地產市場加值利多。
衛生署核准德英SR-T100三期試驗
德英植物新藥SR-T100進入三期臨床 【2011/07/28 聯合晚報】德英生技 (4911)今公告，該公司開發之植物新藥SR-T100凝膠治療皮膚癌，衛生署函文核准進入人體臨床第三期試驗，此次臨床試驗將委由國立成功大學附設醫院王德華醫師、高雄榮民總醫院洪千惠醫師、高雄醫學大學附設中和紀念醫院張中興醫師及奇美醫院賴峰傑醫師等共同主持。
佳醫評等調降!! 於中國短期獲利漸平緩
永豐投顧 調降佳醫評等 【2011/07/28 經濟日報】永豐投顧指出，考量佳醫中國市場效益要到2012年下半年後始有機會開始顯現，整體進度不如預期，短期獲利成長動能也趨於平緩，因此將其投資評等調降至中立，未來將再觀察中國相關業務發展狀況再重新評估。
合一轉投資上海中天生技…獲利優先!
中天旗下泉盛報喜 【2011/07/29 經濟日報】中天生技（4128）轉投資公司合一、泉盛昨（28）日雙雙報喜。合一將透過第三地轉投資上海中天生技共350萬美元，擴展生產動能；泉盛則是獲得中研院對抗c-Met蛋白之癌症抗體藥物授權。中天昨日股價收38.55，上漲0.25元；該公司今年首季稅後純益約3.8億元，每股稅後純益為1.7元。泉盛表示，此項授權案將引進領域的全世界開發權利，及抗體藥物傳輸系統之建立及驗證方法。此項授權案標的，是對抗c-Met之人類單株抗體片段（scFv），此項合約將由泉盛生技，支付給中央研究院授權金及里程金共4,300萬元。此外，中天也將透過第三地轉投資上海中天，上海中天資本額為1,300萬元，將增加到1,400萬美元。上海中天目前主要從事中藥、新藥的研發、開發等，主要是以保健食品的製造為主，也負責新藥開發。
五鼎於中國建廠 布局醫改醫材商機
Wednesday, July 27, 2011
中國跨國藥廠合資策略的轉變!!!
跨國藥企在華掀合資潮 默沙東牽手先聲藥業 2011年07月28日南方都市報 日前，跨國藥企默沙東與先聲藥業集團正式簽署框架合作協定，雙方將在中國成立合資企業。儘管雙方未宣佈該合資企業的具體合作細節及資金規模，但這已不是當下關注的關鍵。今年6月初，全球最大的制藥公司輝瑞和海正藥業(40.10,0.23,0.58%)也達成了合作協定，計畫投資2.95億美元共同設立合資公司。有業內人士分析認為，跨國藥企競相與國內領先的制藥公司成立合資公司，顯示外資在醫藥領域的"中國策"正在加速演變，同時釋放了跨國藥企越來越本土化並加速滲透中國醫藥(27.52,0.20,0.73%)市場的信號。
默沙東欲走"平民"路線 先聲藥業方面昨日在接受記者採訪時稱，成立合資公司這一合作方式，將彙聚合作雙方的研發、銷售經驗和資源，以達成雙方建立戰略性合作夥伴關係的目標。據瞭解，該合作將包含雙方的產品研發、註冊、製造和銷售等多方面內容。此外，在合作初期將以心血管與代謝性疾病領域的領先品牌藥為重點。但由於目前具體合作細節尚有待雙方敲定，該合資企業的資金規模最快要等到8月份方能對外披露。根據協定，雙方將拿出各自的精選品牌和非專利藥組合交由合資企業經營，力求在心血管和糖尿病用藥市場實現較大突破。按規劃，默沙東將開展一系列合作、收購、兼併舉措，改善其原有市場銷售管道不暢的窘境。公開資料顯示，儘管默沙東進入中國已經有20個年頭，但其發展步伐平緩，而阻礙其發展的除了藥價過高問題，另一個重要原因便是其銷售管道不夠理想。為改變這種狀況，默沙東在去年曾主動將一款治療心血管疾病的藥物"舒降之"降價52%，使之成為首個進入國家基本藥物目錄的外資原研藥。而據南都記者瞭解，默沙東與先聲藥業此次醞釀成立的合資企業，合作經營的品種就有"舒降之"。默沙東公司全球人類健康部總裁石亞敦將此次與先聲藥業的合作視為默沙東在中國擴大業務戰略的重要一步。公開資料顯示，先聲藥業是一家從事創新藥和率先上市非專利藥研發的中國藥企，現為美國紐交所上市公司，目前在中國擁有800多人的銷售團隊，100多家戰略合作夥伴，以及1500多家經銷商，其產品行銷到4000多家醫院以及70000家藥店。業內人士表示，先聲藥業龐大的銷售網路對於此前在中國市場急缺管道的默沙東來說，具有很大的吸引。而默沙東在創新藥物研發和非專利藥率先仿製方面則可為先聲提供智力和資金支援。(南方都市報www.nddaily.com SouthernMetropolisDailyMark 南都網)值得一提的是，今年3月就任先聲藥業C E O的張業鴻此前曾任職于默沙東，張業鴻於2007年到2008年間在默沙東擔任中國區總裁。此次雙方合資，也被業界普遍認視為"張業鴻曲線回歸默沙東"。
跨國藥企改變"中國策"隨著多家跨國藥企相繼牽手國內領先的制藥公司，跨國藥企為何在華興起合資潮已經成為業界關注的重點。有分析人士表示，當前跨國藥企正面臨專利到期與原研藥降價兩大危機，在此情況下，通過收購或聯手優質本土藥企來獲得市場擴張正在成為他們在華新的策略。 "默沙東與先聲的合資，輝瑞與海正的合資，這一波合資潮與西安楊森1985年與漢江制藥廠的合資不同。西安楊森與漢江制藥廠的合資，更多的是取得一個'牌照'，便捷、合法地開發中國醫藥市場。而當前的兩例合資案例，則是要深度拓展中國醫藥市場。"一位在北京的業內資深人士如是說。據瞭解，當前跨國藥企在中國業務的擴張，最大的挑戰有兩個：一是政策變幻所帶來的不確定性。第二是跨國制藥企業的人力成本較高所帶來的向市場底部滲透力度不夠的問題。而合資公司的設立則在保證產品品質的前提下，有利於解決生產成本、分銷管道以及國內基層市場的拓展。
中國 肝素（Heparin）供應商 另一黑馬: 千紅制藥
千紅制藥肝素鈉原料藥獲FDA認可海普瑞 唯一性 遭遇挑戰 證券時報 2011-07-26 近日，近日，千紅制藥(002550)肝素事業部接到客戶山德士公司的通知，美國食品和藥物管理局（FDA）於2011年6月8日批準了山德士肝素鈉注射液在美國上市，這也意味著千紅制藥向美國FDA遞交的注射級肝素鈉原料藥的所有資料得到了FDA的認可。對於A股的投資者而言，"肝素鈉與FDA之間的關系"曾引起過市場的軒然大波。海普瑞和千紅制藥被稱為肝素鈉雙雄，2010年5月海普瑞登陸中小板時，發行價達到令人咋舌的148元，一時榮膺"股王"桂冠。當時，海普瑞最大賣點在於其宣稱自己是"國內唯一同時取得美國FDA和歐盟CEP（歐洲藥典適應性認證證書）認證的肝素鈉原料藥生產企業，且是壟斷供應"。但是，較昔日肝素鈉演繹的瘋狂，千紅制藥對於公司肝素鈉獲FDA認可的影響顯得較為謹慎。千紅制藥稱，公司向山德士銷售符合美國藥典標準的注射級肝素鈉原料藥，有利於公司外銷產品結構的優化和調整；有利於公司肝素系列產品經營業績的提升；但是公司能否實現經營業績的提升，還要根據未來產品供需關系變化、客戶市場開拓情況、國內原料價格變化等實際情況而定，存在一定不確定性。據悉，2008年初，百特公司生產的肝素鈉產品在美國引發多人死亡的嚴重不良反應，為其提供原料的常州SPL公司隨即被禁止向美出口。國內其他肝素鈉企業也受到重大沖擊，而只有海普瑞零缺陷通過了當年FDA的重新認證，並獨家向美國出口，海普瑞的壟斷概念由此而來，但海普瑞這一"壟斷身份"曾備受懷疑。雖說質疑不斷，但"FDA認證"卻是海普瑞的一塊金字招牌，該公司肝素鈉原料藥始終處於供不應求局面，公司產能無法滿足全部客戶需求。2010年，中國前四家肝素產品出口企業的出口額，約占中國肝素鈉產品出口總額的97.67%，而海普瑞2010年出口額約占中國肝素產品出口總額的51%。2010年年報顯示，海普瑞FDA等級肝素鈉原料藥(產品）實現營業收入4.79億元、營業利潤1.94億元，毛利率為40.57%。 2009年7月，千紅制藥通過山德士加拿大公司向美國FDA遞交肝素鈉原料藥的注冊申請，根據新的肝素鈉質量標準進行DMF文件（藥品主文件）的更新工作。在2010年年報中，千紅制藥曾表示，公司生產的可作為依諾肝素原料的肝素產品已通過美國FDA的現場檢查；肝素鈉原料藥現正在申請進行美國FDA的認證工作。今日公告則意味著千紅制藥向美國FDA遞交的注射級肝素鈉原料藥的所有資料得到了FDA的認可。目前，千紅制藥已開始向山德士銷售符合美國藥典標準的注射級肝素鈉原料藥。