(Breast metastasis) Circulating tumor cells appear earlier than lymph nodes !!!!!

Test May Predict Spread of Early Breast Cancer   Rare Tumor Cells Found in Blood May Predict Aggressive Disease, Even When Breast Cancer Is Caught Early   By Brenda Goodman, MA WebMD Health NewsReviewed by Louise Chang, MD June 5, 2012 -- A new study shows that some breast cancers try to spread much earlier than doctors once believed, and a blood test may one day be the way to find out.The study, of 302 patients with early-stage breast cancer, found that about 1 in 4 patients whose tumors had not yet apparently spread beyond the breast or lymph nodes already had cancer cells circulating in their blood. These rare cells, which are shed by tumors, are thought to be cancer seeds that can take root elsewhere in the body.What's more, the study showed that patients who had these cells in their blood were also the ones that had the poorest outcomes."If they have them they had roughly four times the risk of either [the cancer] recurring or dying than those who don't have the cells," says researcher Anthony Lucci, MD, a surgical oncologist at the University of Texas M.D. Anderson Cancer Center in Houston.Overall, 15% of patients who tested positive for circulating tumor cells (CTCs) relapsed and 10% died during the study, compared to 3% and 2%, respectively, of patients who did not test positive for CTCs.The odds that breast cancer would progress or turn fatal rose with each CTC that was detected.Patients with two or more CTCs, for example, were more than five times likelier to see their cancer progress and eight times more likely to die than patients with no CTCs. Those with three or more CTCs were nearly seven times more likely to see their cancer progress and nearly 12 times more likely to die over the three years, on average, they were followed for the study.The study, which is published in The Lancet Oncology, may help to explain why about 25% of patients who catch their cancer early will see it return, even after successful surgery to remove their tumors.The study also suggests that a blood test may one day help doctors better identify and treat patients who have fast-spreading cancers.

 A Useful Tool for the Future" This study is pretty compelling evidence that this might be a good tool for oncologists to say, 'OK, because these patients have cells in circulation, their prognosis is worse,'" says Carmen Gomez-Fernandez, MD, professor of pathology and director of breast pathology services at the University of Miami's Miller School of Medicine. Gomez-Fernandez reviewed the study for WebMD but was not involved in the research.

Other experts agree. "What it means is that we can identify those individuals quite early on who might have a decreased survival based on a simple blood test," says Justin Stebbing, MD, PhD, a surgical oncologist at Imperial College London in England. Stebbing wrote a commentary on the study but was not involved in the research. The test used in the study is called CellSearch. Doctors use it to judge how well patients with late-stage colorectal, breast, or prostate cancers are doing on their treatments.It costs $500 to $600 each time it's performed, and it isn't always covered by health insurance."Circulating tumor cell tests are not cheap, but they give us a lot of information about the future," Stebbing says.What's less clear, he says, is how to use the test in patients who are in earlier stages of disease."What that information doesn't tell us is what to do. Do we treat these patients more aggressively? Do we turn to targeted therapies that focus on the circulating tumor cell pool? We don't yet know," Stebbing says. "We don't know if eradicating [circulating tumor cells] kills cancer."Lucci agrees that it's too early to recommend the test for early-stage patients."We don't know if treating patients with additional therapies or different therapies will change the outcome," he says. "That's the next step."

看腰圍(女性) 知糖尿病風險!!

Waist Size Alone May Predict Diabetes Risk   Study Finds Waist Size Strongly Linked to Diabetes Risk, Especially in Women    By Kathleen Doheny WebMD Health NewsReviewed by Louise Chang, MD June 5, 2012 -- Waist size can predict your diabetes risk, even if you are not obese, according to a new study.  Diabetes experts have long used both body mass index (BMI), a measure of weight related to height, and waist size to predict risk.  Obese people, with a BMI of 30 or more, and non-obese individuals with large waists are considered at higher risk.Now, the new research finds that waist size alone predicts risk of diabetes, especially in women.Some overweight men and women with very large waists have the same risk of diabetes as obese people, says researcher Claudia Langenberg, MD, PhD, of the Institute of Metabolic Science, Addenbrooke's Hospital, in Cambridge, England. In BMI terminology, "overweight" is a step below "obese."More doctors might consider using their tape measures, she tells WebMD."Our results now provide clear evidence that a simple measurement of waist circumference can identify overweight individuals (BMI 25-[29.9]) with a large waist, whose risk of future diabetes is equivalent to that of obese people," Langenberg tells WebMD.A large waist is 35 inches or more in a woman and 40 inches or more in a man.The findings are published in PLoS Medicine.

Waist Size, BMI, and Diabetes Risk  About 19 million Americans have diagnosed diabetes, according to the American Diabetes Association.Most have type 2. The body does not make enough of the hormone insulin or the cells don't use it effectively.Langenberg's team, the InterAct Consortium, re-evaluated data on more than 28,500 people.They lived in eight European countries. They were in the EPIC (European Prospective Investigation into Cancer and Nutrition) study. It looked at lifestyle and other factors, and chronic disease.Langenberg compared about 12,400 people with type 2 diabetes with about 16,100 people without.They looked at their waist and BMI data.

Among the findings: Overweight women with a large waist (35-plus) and overweight men with a large waist (40-plus) had a 10-year incidence of diabetes similar to that of obese people. Higher waist size and higher BMI were each linked with higher diabetes risk. High waist size was a stronger risk factor for women than for men. Obese men with a large waist (40-plus) were 22 times more likely to develop diabetes than men with a low-normal BMI (18.5-22.4) and a smaller waist (less than 37 inches). Obese women with a large waist (35-plus) were nearly 32 times as likely to get diabetes than women of low-normal weight and a smaller waist (less than 31 inches)."BMI measures overall adiposity and gives no information about fat distribution," Langenberg says.Adiposity is a term used to represent fatness. Waist size reflects belly fat and fat around the internal organs, she says. That fat is strongly linked with type 2 diabetes. The new research is ''basically fine-tuning what we have known for years," says Steven Edelman, MD, a diabetes expert and professor of medicine at the University of California, San Diego. He reviewed the findings.While taking a patient's waist measurement ''wouldn't be a bad idea," doctors have many other ways to assess risk, he says.They can take a good history, order lab tests, and simply eyeball the patient, he says.It can be difficult to measure the waist exactly the same way each time, says James T. Lane, MD, the Harold Hamm chair in clinical diabetes research at the Harold Hamm Diabetes Center at the University of Oklahoma.''It's helpful for measuring progress, but it's another statistic that should be used with caution by doctors because of the possibility for irregularity and inconsistency," Lane says."This further confirms that it is important to avoid carrying extra fat, particularly so around the abdominal region," Lane says. Fat hampers the body's ability to respond to insulin.Edelman serves as a speaker, consultant, or advisory board member for Medtronic, Novo Nordisk, Lilly, Abbott, and other companies.Lane has received grants or research support from Novo Nordisk, Boehringer Ingelheim, Merck, Pfizer, and other companies.

富硒灵芝宝????

國家工商總局叫停古漢養生酒等15個嚴重違法廣告 2012年05月28日 11:40:26  來源： 北京青年報 昨天，記者從國家工商總局獲悉，古漢養生酒、富硒靈芝寶等15個嚴重違法廣告存在利用消費者名義和形象做證明、誤導消費者的問題，現已被叫停。據悉，這些嚴重違法廣告均是今年3月對全國部分電視、報紙、廣播等媒體發布的醫療、藥品、保健食品、化粧品及美容服務類廣告進行監測抽查時發現的。國家工商總局認為，古漢養生酒食品廣告、富硒靈芝寶保健食品廣告、雷震子牌護康膠囊（北大護康膠囊）保健食品廣告中，出現與藥品相混淆的用語，宣傳食品的治療作用，利用專家、消費者的名義和形象做證明，誤導消費者。

 2012-06-05 08:47来源：南方日报一直以来，肿瘤都被视为是“不治之症”，尤其晚期肿瘤，人们更是谈其色变。形成此观念的原因是多方面的。首先是由于晚期肿瘤患者机体免疫力低下，快速增殖的肿瘤细胞在消耗大量营养后，会加剧肿瘤患者免疫功能下降的速度，形成恶性循环，导致患者出现高热、乏力、厌食、进行性消瘦等多种症状，以至卧床不起。经过多年的观察研究，肿瘤专家指出，肿瘤缩小必须着手于解决两大难题：一是直接抑制肿瘤细胞的快速增殖；二则是增强患者自身的抗肿瘤能力。为此，中国农业科学院的专家经过20余年的攻关研究，融汇东西方的抗肿瘤理论精髓，研制出了新型的中西结合抗肿瘤产品富硒灵芝宝。

“靶向”抗癌，迅速又安全  肿瘤患者在接受手术、放疗、化疗时，由于这些手术在杀灭肿瘤细胞的同时，不可避免的杀伤正常的组织细胞，而且在手术治疗后，往往会发生转移、复发，面对这些，肿瘤患者无可奈何。20世纪90年代，世界卫生组织宣布，硒是“抗肿瘤之王”，硒能“靶向”抑杀肿瘤细胞，不会损坏正常的组织和细胞，不会带来任何副作用。富硒灵芝宝含有一种高效、纯天然成分有机硒蛋白，利用硒对肿瘤细胞独特的“靶向性”，其经人体吸收后，在血液中形成稳定的血硒浓度，可以“靶向性”地准确捕捉并聚集在肿瘤细胞周围，通过破坏肿瘤细胞DNA的合成，阻止其分裂增殖，切断肿瘤细胞的能量供应，使其因能量枯竭而迅速萎缩、凋亡，从而有效控制和缩小肿瘤病灶。

构造一道坚固的免疫防线  许多肿瘤患者的身体免疫力都普遍低下，通常会出现一些并发症；而肿瘤患者接受手术放化疗后，更要遭受强烈的毒副作用，如恶心、呕吐、腹泻、疼痛、咯血等等，肿瘤患者苦不堪言。要解决这些并发症和毒副作用，就必须提高肿瘤患者的身体免疫力，让肿瘤患者拥有良好的身体素质对抗肿瘤。国内大量专家通过大量临床测验证实，灵芝具有提高身体免疫力的显著功效，富硒灵芝宝采用的破壁赤灵芝孢子粉具有强大的“扶正固本”功能，通过刺激免疫细胞大量增殖，活化T淋巴、巨噬细胞、NK细胞，迅速激活机体主动免疫功能，增强患者自身抗肿瘤能力，构造起一道坚固的免疫防线！

“带瘤生存”也能活得好“带瘤生存”就是在肿瘤治疗时，以病人高质量的生存为主要目的，允许病人带着肿瘤生存下去。病人坚持服用富硒灵芝宝，没有咳嗽、疼痛等症状，吃得好、睡得香，能像正常人一样生活，帮助肿瘤患者减轻痛苦，延长生命期。

卓越品牌，值得信赖  从1999年到2012年，富硒灵芝宝走过了辉煌的十三年，十三年的时间，从默默无闻成长为国内抗肿瘤领域的先锋，富硒灵芝宝凭借优秀的品质、良好的口碑、卓越的疗效，获得了社会的认可、患者的信赖。富硒灵芝宝的成功研制，为肿瘤患者找到了一条新的出路。经临床验证：富硒灵芝宝对于肺、胃、肠、肝、乳腺、子宫、肾、淋巴、脑、骨、膀胱、鼻咽等人体各部位肿瘤及白血病均效果显著。

杏輝 &日本DAITO 合作量產口服乳癌藥!

杏輝結盟日商 攻抗癌藥 【2012/06/06 經濟日報】 杏輝醫藥集團昨（5）日宣布，與日本DAITO公司再次攜手合作，簽訂抗癌藥物製造合約，及2項口服抗癌學名藥的合作開發契約，抗癌藥預定今年第4季陸續出貨至日本，該地區一年市場規模超過新台幣50億元。杏輝表示，本次簽訂的2項抗癌藥物開發案，其中之一用於乳癌、非小細胞肺癌、前列腺癌、頭頸癌及胃腺癌的臨床治療；此藥物2010年全球銷售金額高達30億美元以上，日本本地銷售金額則約1.86億美元。此外，另一項治療轉移性大腸直腸癌藥物，2010年全球銷售也在20億美元以上，總計該2 項藥物全球市場規模達到50億美元；而這個合作開發項目預計3年內取得日本銷售許可，未來的生產製造也將由杏輝負責。至於量產製造的抗乳癌口服錠劑契約，杏輝表示，是於2010年與日本DAITO公司簽定共同開發的項目，目前已經依進度順利進入量產，預定今年8月可通過日本厚生省查核取得藥證，年底正式在日本上市，預估未來年出貨量至少300萬粒。據了解，目前杏輝與DAITO共推動5項產品合作案，將陸續完成認證及量產，雙方更計畫推出新系列合作案，以配合日本市場的需要與發展。近期杏輝積極擴充軟硬體設施，完成所有符合國際PIC/S規範的製劑工廠擴建，製劑範圍也含蓋了注射及口服等劑型，除了日本的深度耕耘，也已大力開拓歐美市場，預期不久的將來應能看到成果。

友霖 ...涎漏抑制新藥OP014 FDA phase II completed (2012 Q4)

友霖月底登錄興櫃交易 授權進度加快 最快明年起獲利   鉅亨網記者張旭宏 台北　　2012-06-05 友華(4120-TW)旗下新藥廠友霖生技(4166-TW)將於6月底登錄興櫃交易，年底送件申請上櫃，並於下周二召開上興櫃前法說會。友霖所開發的藥物涎漏抑制新藥OP014，去年3月獲FDA核准進入美FDA二期臨床，預計下半年可以完成，因此公司目前積極尋求歐美日等地對外授權，近期可望傳出好消息，最快明年開始獲利。友霖生技成立2008年，專注於新藥及學名藥的開發、並擁有先進TFDA PIC/s認證產能，目前的研發除自行研發新藥外，積極與先進國家藥品公司或學界共同研發新產品，包括新劑型、新劑量、新複方、新適應症及新給藥途徑等新藥為主，主要開發藥物為OP014涎漏抑制新藥，去年3月獲美國FDA核准進行第二期臨床試驗，預計完成後將與國際廠商策略聯盟，收取權利金。 友霖生技另一個新藥為ORADUR長效性膠囊，預計於2年內上市。另外在學名藥部份，自行開發之「膀胱過動症」及「精神分裂症」兩項具有國際市場利基之長效劑型口服學名藥，已經經濟部核准通過「業界開發產業技術計畫」，取得政府補助款。由於目前仍屬於新藥研發階段，因此近幾年都沒有獲利，2011年稅後淨利虧損2.05億元，每股稅後純益虧損1.35元；今年首季虧損4千萬元，幅度明顯縮小，法人估計，今年恐仍呈虧損，但隨新藥完成二期臨床尋求對外授權後，最快明年將開始獲利。

Experts Eye mHealth Applications Market to Market Healthcare Services

June 05, 2012Frost & Sullivan, the Growth Partnership Company, which helps its clients face growth related challenges and opportunities, is now focusing its energies on the mobile health (mHealth) market. With the smartphone and the mobile operating software dominating the technology world, coupled with the unprecedented popularity of mobile apps, the last few years have resulted in the unparalleled growth in the mHeatlh market.However, while no one is denying the success of the mobile health (mHealth) market, industry experts are quick to point out its stagnancy, especially in terms of the saturation of mobile applications (apps). These mobile apps cover a wide gamut of segments, ranging from smoking cessation tools, regional allergy alerts and instant heart rate readings and so on.Thus, Frost & Sullivan senior industry analyst, Zachary Bujnoch's moderation of the panel, "What's Next for mHealth?" at the 9th Annual Healthcare Unbound Conference & Exhibition on July 19 to 20, will tackle this issue at the Hotel Kabuki in San Francisco, California. His proposal is based on the insight gained from past Frost & Sullivan's research; Analysis of the U.S. Broadband mHealth Applications Market."Today, we are seeing the tip of the iceberg in the U.S. mHealth market's potential," said Bujnoch."mHealth will continue on a steep growth curve as increasingly sophisticated mobile technologies and relationship-management tools disrupt the market."The focus will be on wireless technology and how crucial and relevant it is in today’s time. Health devices now come embedded with wireless technology and work in conjunction with apps like chronic care management, fitness tracking, medication compliance and diagnostic monitoring.The "What's Next for mHealth?" panel will also highlight the advantages of wireless technology and how consumers have benefitted from it, in regard to wireless health. The panel will also discuss the advantages of wireless technology and highlight the fact that wireless networks, ranging from body area to wide area networks are all pervasive. This alone makes it the ideal platform to market healthcare products and services and hence the tens of thousands annual mHealth app purchases are no coincidence."mHealth is an important theme at our Healthcare Unbound Conference, which also covers innovative applications of remote monitoring, home telehealth, eHealth, social media and gaming," said The Center for Business Innovation managing director, Satish Kavirajan."These approaches help to manage diseases, promote wellness and facilitate accountable care."

立院三讀 理賠診斷書應寫中文

 【2012/06/06 聯合報】醫院診斷書上記載的病名，常與病人投保病名不符，以致保險公司拒絕賠償，糾紛不斷。立法院昨天三讀通過醫療法第七十六條條文修正案，明定申請理賠之診斷書應以中文記載，所記病名若與保險契約病名不一致時，則另行加註。過去曾發生投保癌症險的病患因肺癌致心肺衰竭死亡，但診斷書只記載「心肺衰竭」，未記載肺癌，導致病人家屬持「心肺衰竭」診斷書向保險公司申請理賠卻遭保險公司拒絕。國民黨立委蔡錦隆等人為減少醫院、病患、保險公司三方對立及紛爭，因而提出修法。壽險業者指出，現行實務上，保險公司在審核理賠案時，除了醫生診斷書外，還會調閱病歷，或是請保戶提供相關檢驗報告；也就是說，不會只以診斷書做為唯一依據。至於修法後，能否有效降低保險理賠糾紛？壽險業者表示，恐怕得再觀察。因為醫院醫師有時候會應病人或家屬要求，將保單條款內容照抄上去，結果發生診斷書記載和病歷資料不符的現象，因此保險公司不會就此決定理賠。

Great potential...olfactory stem cells !!!!

The potential impact of olfactory stem cells as therapy reported    June 5, 2012 in Medical research  A study characterizing the multipotency and transplantation value of olfactory stem cells, as well as the ease in obtaining them, has been published in a recent issue of Cell Transplantation (20:11/12), now freely available on-line."There is worldwide enthusiasm for cell transplantation therapy to repair failing organs," said study lead author Dr. Andrew Wetzig of the King Faisal Specialist Hospital and Research Centre in Riyadh, Saudi Arabia. "The olfactory mucosa of a patient's nose can provide cells that are potentially significant candidates for human tissue repair."According to the study authors, olfactory neural stem cells can be derived from a patient's own cells, they are readily available by a minimally invasive biopsy technique, and they can be expanded in vitro. The cells are plentiful because the olfactory epithelium undergoes neurogenesis and continual replacement of sensory neurons throughout adult life."Using the rat as our animal model source, we examined the basic aspects of olfactory neural stem cell biology and its potential for self-renewal and phenotypic expression in various circumstances," said Dr. Wetzig. "Previously, we found that they have performed well in pre-clinical models of disease and transplantation and seem to emulate a wound healing process where the cells acquire the appropriate phenotype in an apparently orderly fashion over time."The researchers concluded that the olfactory neurospheres contain stem cells whose capacity for differentiation is triggered by signals from the immediate environmental niche."Stem cell numbers were shown to be enriched by our culture methods," explained Dr. Wetzig. "We also demonstrated that when adult olfactory stem cells are transplanted into an environmental niche different from that of their origin, they demonstrate multipotency by acquiring the phenotype of the resident cells.""This study highlights another potential source of stem cells that has shown some degree of promise in a number of studies" said Dr. John Sladek, professor of neurology and pediatrics at the University of Colorado School of Medicine. "Their relatively easy accessibility and multipotent properties are important factors that could rank these cells competitively with other stem cells thus giving them a potential impact as an excellent source for cell therapy".More information: Wetzig, A.; Mackay-Sim, A,; Murrell, W. Characterization of olfactory stem cells. Cell Transplant. 20 (11/12):1673-1691; 2011.

監察院水果泡雙氧水??

監院切片水果不變色… 泡雙氧水 【2012/06/06 聯合報】監察院昨天開全院談話會，監委程仁宏日前意外發現，監院提供的切片水果，擺了兩天竟不變色，送實驗室檢驗，驗出有過氧化氫殘留，也就是俗稱的雙氧水，昨天公布送檢結果，與會監委很驚訝，不排除調查切片水果衛生問題。程仁宏「熱心主動」送檢，得到重大發現，有人私下封程仁宏是「監院版」的「雞婆送檢員」。程仁宏表示，日前秘書處提供裝有西瓜、蘋果、芭樂的切片水果，他放了兩天竟然都不會變色，一時起疑，送兩盒到實驗室檢驗，驗出有過氧化氫殘留。消基會董事長出身的程仁宏剛上任，就曾主動送驗兩次，都無過氧化氫殘留，第三次驗出殘留。有監委認為，每種食物都有風險，如果遇到風險就不吃，是鴕鳥心態，吃水果是小事，不必太認真。一名監委說，監委討論吃不吃水果，傳出去會被笑，「最好不要見報」。

吊大筒 ! 解疲勞?!

獨家／退燒、醒酒、解疲有效？　吊大筒還不如一碗稀飯  陳鈞凱 2012年6月5日 11:35 迷信「吊大筒」可解疲勞、補充營養，不只台灣人買單，連中國大陸都有考生集體打點滴補習。記者陳鈞凱／台北報導台灣人就醫有不少奇怪的堅持，尤其，迷信「吊大筒」的速效，相信挨一針才好的快，造就不少人疲勞、發燒、不舒服時，都會主動要求打點滴，認為有助於補充體力、退燒，甚至還可以醒酒，但醫師戳破迷思，認為除非必要，多數人其實並不需要打點滴，否則可能花錢又傷身，且一般點滴營養價值還不如一碗稀飯。台灣人有多愛打點滴，連健保局都看不下去，特別在健保局自己出版的「全民健康保險雙月刊」中，刊登專文破解迷思，指出多數人「打點滴」觀念是錯的！一般人口中的「吊大筒」，正式名稱應該叫做「大量點滴注射」，是指經由靜脈注射瓶裝的生理食鹽水、林格兒氏液、Rock液、果糖液或血液代用劑、葡萄糖液等液體，一瓶容量大多為500CC。感覺疲勞時，打點滴可以補充體力或營養？是最常見的迷思之一，但健保局進一步分析，大部分點滴液的成分，不外是生理食鹽水、葡萄糖液、果糖液等，頂多再加些維他命，營養價值比一瓶運動飲料還低。以濃度5%的葡萄糖液為例，換算下來，一瓶500CC的點滴液，只含有25公克的葡萄糖，其營養價值還不如一碗稀飯；台北書田診所家醫科主任醫師何一成表示，打點滴以後會覺得比較有精神，主要是因為躺在床上休息的緣故，並非點滴的功效。何一成說，打點滴可以退燒、醒酒？也是一般人常見的迷思，事實上，打點滴並不能改善上述現象，也沒有任何特別的效果，打點滴頂多幫助補充流失的水份，暫時性地使人覺得比較舒服、比較有精神，因而誤認為打點滴對自己的症狀緩解大有助益。 想藉打點滴來解酒、提神，何一成指出，酒精大部分必須經過肝臟代謝才能排出體外，打點滴增加水分，雖可能加速酒精排泄，但效果不是很大，他舉例來說，如果一瓶啤酒要等上90分鐘才會退酒，打了點滴，不過僅僅提早10分鐘而已。哪些人需要打點滴，健保局指出，除非暫時無法進食或不宜進食、必須經由點滴注射抗生素、化學治療等藥物，或治療脫水狀態、電解質不平衡或極度低血糖、昏迷與休克等急救時，否則一般人不應該打點滴。健保局也提出警告，不需要的時候打點滴，不但無效還會延誤病情，更造成金錢跟醫療資源的浪費，增加腎臟排尿的負擔，部分病患如心肌炎、心肌梗塞等，打點滴還可能造成心臟衰竭惡化的危險。

台大外科暑期選修 找嘸學生

 2012-06-06 中國時報 張睿纖／台北報導　台大醫院創傷醫學部主任、台大醫學院外科教授柯文哲昨天指出，本來以為內、外、婦、兒科「四大皆空」現象離自己很遠，但卻發現今年只有三名學生報名暑期選修課「基礎外科重症醫學」，開設九年的課程首次未達開課標準。他自嘲，應該跟上年代，研究明年開新課程「外科醫美」。 　柯文哲說，選修課和市場很有關係 現在學生明顯沒有人要走外科重症，反而外科醫美市場蓬勃發展。他自嘲，應該研究明年開新課程「外科醫美」，或是「來看書了，跟上時代進步改開外科醫美」。今天他將回覆系辦是否仍要繼續開課。

U.S. on track to approve more cancer drugs in 2012

Monday, June 4, 2012MedlinePlus By Deena BeasleyCHICAGO (Reuters) - Cancer drug applications at the U.S. Food and Drug Administration are rising, with 20 submissions expected this year, as a better understanding of the molecular makeup of the disease leads to new treatments.Some of the novel techniques that are proving to be successful include targeting specific gene mutations in tumors and harnessing the body's own immune system to seek out and kill cancer cells."There are a large number of drugs being developed in oncology," said Dr. Richard Pazdur, head of the FDA's office of oncology products. "There is greater understanding of some of the disease processes."Last year, 10 out of 30 new drugs approved by the FDA were for treatment of cancer."This year we expect over 20 oncology applications will be filed," Pazdur said in an interview at a meeting of the American Society of Clinical Oncology in Chicago.In terms of approvals, he said some will have decision deadlines that fall into next year or could take longer than expected to review due to issues such as manufacturing, while some may not be approved at all.So far this year, cancer drugs approved by the FDA include Roche's Erivedge for basal cell carcinoma; Pfizer's Inlyta for kidney cancer; GlaxoSmithKline's Votrient for soft tissue sarcoma; and Leo Pharma's Picato for actinic keratosis.The agency is slated to decide by Friday on Roche's application for pertuzumab, an antibody designed for use in the 25 percent or so of breast cancer patients whose tumors generate a protein called HER-2, which can fuel cancer growth.Over the past year, the FDA has cleared several cancer drugs ahead of its legislated deadline."It is much easier to approve drugs that have greater efficacy," Pazdur said. "Our staff is interested getting the drugs out earlier ... it has to be drug that we really think is important."

BETTER SURVIVALOncology drugs are unique in that the regulatory emphasis is on effectiveness rather than safety because patients are often so gravely ill."In oncology, the greatest difficulty has been the efficacy issue," Pazdur said. "We are starting to see new drugs with important survival advantages."That does not mean, however, that every cancer drug to go before the FDA is a slam-dunk if a clinical trial demonstrates a statistically significant benefit for patients.The issue is particularly sensitive for drug trials designed to show an improvement in "progression-free survival," defined as the length of time a patient lives without their cancer getting worse. Cancer drug trials with PFS as their goal are usually much shorter than studies looking at the rate of overall survival for patients treated with an experimental drug."It isn't just statistical significance. That gets you in the door," Pazdur said. "You could overpower the trial -- and we have seen it -- to have a trivial improvement in PFS."The FDA last year revoked its conditional approval of Roche's Avastin as a treatment for breast cancer because, although there was evidence that it slowed progression of the disease, there was no conclusive data showing that it extended the lives of breast cancer patients. The drug is still approved for glioblastoma, colorectal, lung and kidney cancers.Pazdur said the FDA is chiefly focused on the magnitude of improvement demonstrated in a clinical trial."There is a big difference between a 10 percent improvement in PFS and a 60 percent improvement," Pazdur said.He also said there is now more emphasis at the FDA on meeting with drug developers earlier and more frequently."When we are seeing drugs with a high degree of efficacy -- so-called 'breakthrough' drugs -- it requires a different interaction with the companies," Pazdur said. "We may change the registration strategy or the size of the trial."(Reporting By Deena Beasley; Editing by Michele Gershberg and Maureen Bavdek)Reuters Health

 'Uncertainty' Remains Over Supply of Key Cancer DrugsWhile shortage of generics has eased, more must be done to prevent future shortfalls, experts sayMonday, June 4, 2012Cancer Chemotherapy MedicinesMONDAY, June 4 (HealthDay News) -- John Mahan, a 58-year-old Nashville firefighter battling a gastrointestinal cancer, couldn't believe what he was hearing last July.His doctor had just told him that his clinic had run out of injectable fluorouracil (5-FU), the generic chemotherapy Mahan needed to keep his tumor at bay."My initial reaction was, 'you've got to be kidding, right?'" he said.Unfortunately, the news was all too real. Mahan was switched to another drug, capecitabine. Taken in pill form, it had the same anti-cancer effectiveness as 5-FU but with more onerous side effects."It made me feel bad, weak," Mahan said, "just run down, feeling tired all of the time, loss of appetite."At a Monday news briefing at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Mahan spoke on behalf of the thousands of cancer patients who have been hit hard by the recent nationwide shortages of generic, injectable cancer drugs.The crisis peaked earlier this year when children with a leading form of childhood cancer, acute lymphoblastic leukemia (ALL), were faced with a looming shortage of a lifesaving drug, methotrexate. Quick action on the part of the U.S. Food and Drug Administration, the pharmaceutical industry and others averted that shortage, but deficits in this and other cancer medicines are still possible, experts warn."The good news has been that the frequency of the drug shortages has begun to decline for a variety of reasons," Dr. Richard Schilsky, chair of ASCO's government relations committee, told reporters. "But there is still an unpredictable availability of many drugs and we are never sure exactly when a generic drug is suddenly going to go out of supply. That creates a tremendous amount of uncertainty -- anxiety for our patients and great difficulty in planning if you're a physician."Overall, 22 crucial oncology therapies have recently been in short supply, noted ASCO President Dr. Michael Link. Of most concern right now, he said, are shortages of a handful of medicines:

•Methotrexate -- while there is currently an adequate supply of methotrexate for ALL and other cancers, there is now a shortage of a compound needed for patients who require high-dose infusions of the drug, Link said.

•5-FU -- gaps in supply remain for this mainstay generic medicine, used to fight cancers of the colon, pancreas, head-and-neck and other sites.

•Nitrogen mustard -- one of the earliest anti-cancer therapies developed, it remains essential to care of lymphomas and Hodgkin's disease. "It has been unavailable for some time," Link said, and there are no really good substitutes.

•Paclitaxel (Taxol) -- periods of short supply continue for this key treatment for breast cancer and other malignancies."Hearing from our members, we are learning that the shortages are most acute among community practices where the majority of adult patients are cared for," Link added. Smaller centers may not have the buying clout that larger, academic medical centers might have, leaving them more vulnerable to shortages, he explained.These drug shortages typically occur among sterile injectable cancer medications that have gone to cheaper, generic status. The experts gathered at the meeting noted that the world's supply of generic medications is now concentrated in only about six companies that may produce dozens or hundreds of drugs."So, for example if one company makes 30 products and they have a problem, suddenly 30 products are at risk of a shortage," explained Dr. Sandra Kweder, deputy director of the Office of New Drugs at the FDA. Producing highly sophisticated, sterile injectables is a particularly complicated process, she said, and quality issues can arise that cause plants to be temporarily shut down while the issue is resolved.In many cases, these safety issues are not minor ones, Kweder noted, and can include "particles of glass or metal shavings" found in vials that, of course, pose safety issues for patients.But, why the shortages now? According to Kweder, it's not that new, tougher quality-control rules have come into place recently. Instead, a host of popular drugs have recently gone off-patent and "what we've seen is great growth in the generic world," she said. As more generics get produced at more production facilities, "we are just seeing more in terms of problems in that manufacturing," Kweder said. Many companies are now modernizing their production facilities, she said, but that will take time.According to Kweder, the FDA, in close consultation with drug companies, has already prevented about 150 drug shortages since October of last year, when President Barack Obama signed a special Executive Order demanding action on the issue. As companies gave FDA early warning of looming problems, the agency and the pharmaceutical industry worked together to find alternate sources of supply, including imports from abroad, Kweder said.Methotrexate, the drug needed by children with leukemia, "continues to be very carefully monitored," Kweder said. "We expect the [shortage of] the injectable that has been difficult for some practices to obtain to be resolved within the next month completely."Progress is taking place at the Congressional level as well, the experts said, as a bill makes its way through the House and Senate that would mandate that generic drug makers give the FDA six months advance notice of any possible production problems.The bill, which has the full support of ASCO, also includes a provision that generics makers would pay the FDA a user fee, aimed at speeding oversight and approval for new generics.All of this gives some comfort to Mahan, whose cancer has progressed but is being held in check by a new course of therapy. Still, he worries about other patients who may be facing the same dilemmas he did."Until this impacts you personally," he said, "most people aren't even aware that there's even a shortage going on."SOURCES: June 4, 2012, press briefing, annual meeting of the American Society of Clinical Oncology (ASCO), Chicago, with: John Mahan, Nashville; Richard Schilsky, M.D., chair, government relations committee, ASCO, and chief, hematology/oncology, University of Chicago School of Medicine; Michael Link, M.D., president, ASCO, Stanford University School of Medicine and Lucile Packard Children's Hospital, Stanford, Calif.; Rear Admiral Sandra Kweder, M.D., deputy director, Office of New Drugs, U.S. Food and Drug Administration

FDA foresees jump in apps for cancer drugs

 June 5, 2012 | By Ryan McBride U.S. regulators expect to review lots of cancer drugs this year. With developers finding ways to get early readouts on efficacy, companies are expediting programs to set the stage for rapid development and speedy approvals of new anti-cancer therapies. In an interview with Reuters, FDA oncology chief Dr. Richard Pazdur predicts that the agency will receive 20 submissions for cancer drugs in 2012.It's too early to tell whether that will lead to an increase in approvals this year, but the number says a lot about intense participation in cancer drug research around the biopharma industry. The FDA has only fueled activity in oncology with its growing track record of green-lighting cancer drugs in short order when the treatments show evidence of benefiting patients with life-threatening malignancies. A recent example was the agency's approval last summer of Seattle Genetics' ($SGEN) lymphoma drug Adcetris based on small, single-arm studies with impressive results."It is much easier to approve drugs that have greater efficacy," Pazdur told Reuters. "Our staff is interested getting the drugs out earlier ... it has to be [a] drug that we really think is important."As Reuters notes, a third of the 30 new drugs approved last year in the U.S. were cancer treatments. What's behind the numbers? For one, researchers have drilled deeper into the biology of cancer, uncovering a wealth of disease-related gene targets that can be bull's-eyed with new drugs, and patients can be screened for the genes before they get the treatments. Developers have been able to move fast in the clinic with targeted cancer drugs and seek approvals earlier than they could for treatments against other diseases.Rather than the standard decade-long development timeline for drugs, companies have been able to jump from initial human studies to regulatory submissions for cancer meds in just a few years. Take GlaxoSmithKline's ($GSK) experimental melanoma drugs for patients with BRAF mutations. As FierceBiotech's John Carroll reported Monday, the London-based drug giant expects to file for U.S. and European approvals of the pair of targeted drugs later this year, little more than three years after kicking off early-stage studies of the treatments."It has been the fastest experience of my entire career," Paolo Paoletti, the president of GSK Oncology, said in the interview.Pazdur makes clear in his Reuters interview that the FDA pays special attention to game-changing therapies. And in recent weeks U.S. lawmakers have backed proposals to give the agency the flexibility to use a variety of tools to fast-track programs for drugs against serious and deadly diseases. In oncology, there are plenty such cases.

生策中心 ..台灣已無先驅優勢 (生技產業) !!!!

生技產業急起直追 系列論壇總體檢 【記者黃緒生台北報導】台灣生技產業逐漸起飛，但較亞洲鄰國仍有一段距離，為協助產業突破困境，生策會、生策中心將於6月22日起，分4面向舉辦生技醫療產業政策總體檢論壇。將參與本次論壇的包括財團法人生技醫療科技政策研究中心董事長王金平、社團法人國家生技醫療產業策進會會長陳維昭、行政院政務委員張善政、生技整合育成中心首席顧問蘇懷仁、中研院院長翁啟惠及產業界代表等多人。生策中心指出，政府倡議發展生醫產業20餘年，陸續推動加強生物技術產業推動方案、兩兆雙星、生技鑽石起飛行動方案等重大政策，台灣生技產業2011年總產值達新台幣2100億元，生技產業總家數1355家，其中上市上櫃公司從30家左右增長到60家，市值成長達4倍。但相較亞洲各國，如生技排名晉身全球10大的韓國、全球生技服務與學名藥產製重心的印度、已奠定國際研發及製造基地地位的新加坡、及每年以20%以上成長率快速發展的大陸，台灣生技產業已無先驅優勢，產業實力差距更待急起直追。為協助產業突破困境，生策會、生策中心將於6月22日、6月25日、6月27日、6月29日舉辦一系列政策總體檢論壇，從環境、體制、資源、法規4個面向進行討論。生策中心表示，希望能藉由生技產業論壇，切中生醫產業發展困滯環節，快速掌握關鍵議題與解決方案，未來4年生醫產業可望在行政體系貫徹執行下，逐項排除障礙，取得進入國際市場競爭契機。2012/6/4

中国生医政策松动开始燎原 !

 4条主线积极配置2012年06月05日14:30 |中国资本证券网-证券日报中国资本证券网-证券日报编者按：今日，生物医药板块走强，康芝药业（300086）涨停。机构认为，医药行业是非周期性行业，人口老龄化、疾病谱迁移、医药消费水平提高等多重因素支持行业的持续快速发展；从过往的经验看政策因素是导致行业波动的主要原因，而政策面由偏紧趋于缓和的阶段正是建仓医药股的良机。四条主线配置医药板块：板块指数安全、低估值是主力、向二线股转移、主题投资延续。

医药生物：政策松动开始燎原积极配置医药股行业动态：1、广东省医药采购平台发布《关于请部分生产企业确认基层采购价上浮10%的价格的通知》。要求各品种中标价格不高于国家和省价格主管部门公布的基本药物基层采购价上浮10%的价格，高于基本药物基层采购价格上浮10%的，将其中标价格调整为不高于基本药物基层采购价上浮10%的价格；2、中医药事业发展“十二五”规划发布，提出到2015年，力争100%的地市建有地市级中医医院，70%的县中医医院达到二级甲等中医医院水平，95%以上的社区卫生服务中心和90%乡镇卫生院设立中医科、中药房，70%以上的社区卫生服务站和65%以上的村卫生室能够提供中医药服务，每万人口中医床位数力争达到4.78张，每万人口卫生机构中医执业（助理）医师数力争达到2.4人。市场表现：对2012年年初到2012年6月1日的板块进行分析，医药板块绝对收益率6.6%，同期沪深300绝对收益率为15.0%，医药板块跑输大盘8.4个百分点。子行业中，表现排序分别为化学制剂>；；医药商业>；；生物制品>；；中药>；；化学原料药>；；医疗器械>；；医疗服务。以TTM整体法估值来计算，目前医药板块估值为30倍PE，低于历史平均水平36倍PE，随着政策面趋于缓和、行业利润增速回暖的验证，我们看好医药板块后续的表现。从医药子行业来看，所有的医药板块都低于历史平均水平，我们认为有核心竞争力并且高成长的个股在估值上应予以溢价。

行业最新投资策略  政策松动正呈现燎原之势：继甘肃对大输液执行新中标结果之后，广东省基药招标价格再次显示出松动迹象，表现为平均价确定为中标价、技术标权重占到70%、中标企业减少，政策松动正呈现燎原之势；我们重申在一季度业绩回顾报告《复苏成为主旋律》中看好医药板块的看法，在子板块上我们建议继续积极关注化学制剂，催化剂是政策缓慢转向过程中企业盈利预期正在改变（类似今年年初的房地产），其中集中度越高的品种弹性越大，建议积极关注大输液龙头科伦和双鹤。再次强调政策转向期是建仓医药股的最佳良机：医药行业是非周期性行业，人口老龄化、疾病谱迁移、医药消费水平提高等多重因素支持行业的持续快速发展；从过往的经验看政策因素是导致行业波动的主要原因，而政策面由偏紧趋于缓和的阶段正是建仓医药股的良机。　　

齐鲁医药行业投资组合  我们构建投资组合的选股思路保持4条主线：1、拥有优势业务组合，并且正处在成长加速阶段的公司，例如：复星医药（600196）；2、具有独特品种资源，并且营销在改善中的中药公司，例如：昆明制药（600422）和红日药业（300026）；3、受宏观政策影响较小的领域，包括涉足大健康产业的汤臣倍健（300146）、东阿阿胶（000423）、山大华特（000915），以及药用辅料领域的尔康制药（300267）；4、不断推出新产品，研发驱动型公司，例如：翰宇药业（300199）和双鹭药业（002038）。行业风险因素分析药品质量问题：持续保持警惕。继去年蜀中制药的“苹果皮”事件被曝光后，今年“毒胶囊”事件受到社会的广泛关注。药品的安全质量问题是我们在选择和跟踪上市公司的过程中，持续保持警惕的一项内容。流通环节整治：时间和力度都有不确定性。据媒体报道《药品流通环节价格管理暂行办法》或将在今年9月以后推出，细节可能和目前流传的征求意见稿将有所不同。（齐鲁证券）　　

医药行业：广东招标报喜政策指数向上  一周观点：广东招标报喜，政策指数向上。广东基药招标中部分优质独家品种和普药产品价格上调。有334个品规的普药产品价格约上浮10%，占全部品规的约10%。在医药实体运行层面，印证了我们对政策转向的判断，显示医药政策指数进一步向上。1-4月医药制造业收入同比增长21%，利润同比增长16%。4月单月医药行业收入、利润增速分别同比增长14.1%、19.8%，这是对行业3月份利润增速反弹趋势的延续。政策是重要的先导变量，政策指数向上将进一步兑现在行业利润增速和估值上。在未来各省非基药招标中，我们将看到广东基药招标转向的延续，行业利润增速有望持续回升，医药板块将由阶段性机会逐渐转为趋势性机会。建议关注转向预期+估值修复组合：华润双鹤（600062）、国药股份（600511）、国药一致（000028）；成长中坚：恒瑞医药（600276）、华东医药（000963）、天士力（600535）；无边界扩张行业整合者：康美药业（600518）、尔康制药。社会办医潮中关注：通策医疗（600763）、开元投资（000516）。市场回顾：本周医药板块上涨3.35%，跑赢大盘1.02个百分点。个股方面，ST金泰本周表现最好，累计上涨13.00%；东城生化跌幅最大，累计下跌4.90%。国泰君安医药细分行业指数：在9个细分行业和主题指数中，高端专科药、化学普药指数本周表现相对较好，分别上涨5.37%、5.13%；中药注射剂、医疗器械指数表现相对较差，分别上涨1.14%、2.00%。国内政策要闻：生物产业十二五规划即将印发，产值将达4万亿；中医药十二五规划出炉，培养1.5万临床骨干；取消以药养医，医院医疗卫生费用主要靠医保；儿童药安全引关注，审批将严格；卫生部将加强基层医疗机构监管，重查医疗安全；北京考虑将戒烟药物费用纳入医保引发热议。行业与公司动态：2012年一季度抗菌药物市场反弹；粤基药招标再探索，一成药中标价上浮10%；广药急推红罐鸿道推加多宝凉茶，两者胜算难测；上海医药（601607）管理层再洗牌；振东制药（300158）收购山西安特生物；华邦制药（002004）1.41亿元收购农药业务；修正3亿植物药用胶囊生产线开工；16个中医药养生保健项目落户陕西。海外重要信息：糖尿病药物市场将上演三国；国外制药巨头斥资2.85亿联手研发新抗生素；武田斥资16亿元收购巴西制药商；Mylan推出立普妥仿制药；罗氏诊断首席运营官DanielODay：诊断改变全球疾病管理方式；兰伯西推出抗疟新药。

医药行业：医药投资三维体系  构建医药投资的三维体系：1）政策面先导，基本面后验。政策已成为医药需求成长α之外重要的β变量，我们构建了国泰君安医药政策指数，发现从政策出台到基本面验证，表观数据上约有半年左右的窗口期；2）估值兑现基本面。基本面预期的改变是医药板块估值体系的决定性因素，我们的重点在于确定利润增长提速的窗口期。3）“相对美女”理论决定的资金面。除了政策面和基本面的作用，资金相对配置的好恶也成为关乎医药股阶段性表现的另一个重要变量。政策面：从顶层设计到转向预期。政策对行业直接影响无外乎“量”、“价”两个路径，其中医保和降价则是我们需要关注的核心变量。医保付费改革将是渐进过程，因此短期内，我们更关注“价”的变化。药品招标政策从“唯低价论”转向“质量优选，价格合理”的趋势，将在今年各省的非基药招标中逐渐兑现，政策环境有望逐渐趋于良性，我们构建的国泰君安医药政策指数将稳步回升。基本面：业绩提速态势有望重新确立。随着政策面的筑底反弹，从2010年下半年开始的利润增速下滑态势也将逐步改善，这在2012年一季度的行业数据已有所印证。从目前重点省份的药品招标情况看，我们判断2012年下半年行业对招标降价的整体承压有限，而抗限、新版GMP等负面政策对基本面影响正在边际改善，行业利润增速将呈逐渐回升态势。资金面：“相对美女”再现。医药目前2012年动态PE约22倍，处于历史底部，而医药板块超配比例为3.3%，较2011年的高位大幅回落，靠近历史中值。在宏观经济不明朗的背景下，若行业政策面趋好，基本面有向好态势，医药股极可能在中期成为资金配置的“相对美女”。资金可能在未来逐步加大对医药股的配置，成为主导医药阶段性行情的关键变量。选股策略：转向预期+成长中坚+无边界扩张。结合政策面以及基本面的判断，我们认为2012年下半年的医药行业将是一个政策面转向明朗、基本面反弹趋势确立的过程，若基本面数据超预期，行业阶段性机会有望转变为趋势性机会。我们建议首先关注转向预期+估值修复组合，推荐医药流通领域的国药股份、国药一致，同时，继续关注通过创新和国际化路线穿越政策迷雾的成长中坚：恒瑞医药、华东医药、莱美药业（300006）、天士力；无边界扩张行业的整合者：康美药业、尔康制药。社会办医潮中关注：通策医疗、开元投资。　　

医药生物：好转预期推动的行情会延续数据点评1-4月累计收入4930.3亿元，同比增长20.6%（1-2月21.33%、1-3月23.20%）；累计利润470.4亿元，同比增长15.75%（1-2月11.47%、1-3月14.39%）。利润增速的环比改善尤为重要：虽然这两年医药调整，但我们从来没有担心需求的增长，担心的只是毛利率下滑导致的利润增速放缓。今年以来行业数据见底回升，此时利润指标的意义更为重要。只要利润回升的势头延续，好转预期也就能延续。投资策略（短期）5月回顾：在5月1日的月报中我们提出，行业盈利的底部已经来临，未来会逐步改善。基于好转的预期，我们看好5月行情，乐观会持续到6月。5月组合大幅跑赢指数：云南白药（000538）（1.07%）、恩华药业（002262）（14.29%）、红日药业（11.08%）、中新药业（600329）（14.74%）、科伦药业（002422）（15.63%）。平均涨幅11.36%。6月展望：经过一个月的领涨，市场对医药行情有所犹豫，尤其是面对收入放缓的4月数据，但我们还是能延续的。原因是：（1）我们始终认为这轮上涨的逻辑是好转的预期，这种预期的重要性对短期策略而言，甚至重于基本面。（2）目前支持好转预期的因素依然存在，例如价格政策在好转、行业数据在好转、微观调研在好转等。（3）只要上述好转的迹象依然存在，医药板块的趋势就是向上的。6月投资建议：6月投资思路我们预计与5月类似：板块指数安全、低估值是主力、向二线股转移、主题投资延续。6月组合：中新药业（低估值业绩有弹性）、丽珠集团（000513）（低估值单抗主题）、莱美药业、恩华药业、云南白药（稳健）。　　

广州药业（600332）调研报告：打造“大南药”发展新平台广州药业600332医药生物研究机构：上海证券分析师：赵冰撰写日期：2012-04-13投资建议：未来六个月内，给予“大市同步”评级公司11年实现每股收益为0.35元，在不考虑重组与增发的条件下，预计公司12年实现每股收益为0.39元，以4月11日收盘价12.40元计算，静态、动态市盈率分别为34.98倍和31.52倍。由于公司业务横跨工业和商业，医药工业（中药）上市公司11年、12年平均市盈率分别为27.35倍、21.32倍；医药商业上市公司11年、12年平均市盈率分别为19.23倍、18.71倍。公司目前的估值水平稍高于行业平均水平。公司完成本次重组后，产能和收入规模显著扩大，医药产品结构进一步改善；有助于充分发挥协同效应，提高经济效益；消除同业竞争，减少关联交易。由于集团承诺未来还将把“王老吉”、广药研究院等注入上市公司，我们看好公司长期的发展前景，给予公司“大市同步”评级。　　

天方药业（600253）：收入平稳增长，大股东支持将是重要驱动因素天方药业600253医药生物研究机构：东海证券分析师：刘宇斌撰写日期：2011-10-25事件公司今日发布2011年3季报，1-9月份实现每股收益0.09元。评述公司1-9月份实现营业收入21.99亿元，同比增长5.87%；实现营业利润4287.55万元，同比增长12.84%；实现归属于母公司净利润3987.88万元，同比增长15.01%，实现每股收益0.09元。其中，7-9月份实现归属于母公司净利润1175.05万元，同比增长102.24%，每股收益为0.028元。营业收入保持平稳增长。报告期内公司营业收入同比增长5.87%，主要有两个原因：1）原料药出口方面，公司加快了国际市场注册认证步伐，积极开发新兴市场、新客户，扩大出口份额，其中上半年出口业务同比增长了31.62%；2）制剂方面，公司不断加大全国各省基本药物招投标的投入力度，公司的明星产品阿托伐他汀钙胶囊增长较快。毛利率小幅上升。1-9月份公司毛利率为13.12%，同比上升了1.73个百分点。公司是国内最大的林可霉素供应商之一，林可霉素也是公司主要的利润来源，2011年以来林可霉素一直保持在420-430元/BOU的水平，毛利率较去年同期提升了3个百分点；由于公司招标力度的加大，阿托伐他汀钙胶囊2011年增长较快.其毛利较高，带动制剂业务板块整理毛利率提升约5个百分点。集团大力支持公司发展将是长期趋势。2008年实际控制人通用技术集团进驻天方时，2010年增发和之前投入的5亿元现金，集团投入资金不足10亿元，预计通用技术集团仍将继续支持公司发展。通用技术集团旗下有中国医药（600056）、中国新兴集团等医药资产，天方作为集团内部最强的医药工业实体，为了增强医药产业整体实力，缩小差距，集团对天方投资不断加大将是长期趋势。盈利预测与评级：我们预计公司2011-2013年EPS为0.10元、0.13元、0.18元，以昨日收盘价6.25元计算对应的PE为64倍、49倍、35倍，我们认为林可霉素和硫酸氰红霉素价格仍有提升的空间，通用技术集团还将对公司进行支持，但公司目前盈利能力较差且估值较高，暂给予公司“中性”的投资评级。风险提示：原材料价格下跌的风险，阿托伐他汀钙推广的风险。　　翰宇药业（300199）：特利加压素着重学术推广，未来成长可期翰宇药业300199医药生物研究机构：广发证券分析师：贺菊颖撰写日期：2012-04-302012年特利加压素仍将是增长亮点2011年公司实现特利加压素销售收入为2166万元，同比增长102%，低于预期，主要原因为非基药招标时间延后，重点市场因打击商业贿赂影响新产品销售，销售策略有所偏差等，未来这些因素有望逐渐消除。目前特利加压素已进入10省医保，并在20多个省市中标，此外，公司计划在2012年通过两个四期临床试验研究在原有的适应症基础上增加抗感染休克，并推广在肝硬化手术中用药；在营销方式上，注重学术推广，加大与临床医生的合作。我们预计在四期临床试验研究完成后，特利加压素销售将快速增长，2012年特利加压素销售量将达20万支以上。传统产品增长较快，新产品进展顺利传统胸腺五肽在2011年实现40%以上的增长，预计2012年一季度有望实现50%左右的增长，全年考虑到招标价格下降因素，预计将有30%以上的增长。生长抑素竞争较为激烈，消化类药品调价对其影响不大，公司仍延续2011年终端下沉策略，0.75mg规格逐渐下沉基层，预计一季度销售量在50%以上增长，3mg规格主攻大医院，也实现较快增长。新产品爱啡肽有望今年下半年获批上市，卡贝缩宫素也将在明年年内获批。考虑到新产品推出后将经历1年左右的招标期，预计将在2014年实现较快增长。卡贝缩宫素推出后有望成为重磅级产品，新产品推出将支撑公司未来3-5年高成长性。香港子公司与国际接轨，未来公司产品线逐渐丰富公司于今年4月使用4000万超募资金和1000万自有资金成立香港子公司，并将引入糖尿病药物治疗药物溴麦角环肽。未来香港子公司将作为与国际接轨的平台，有望持续引进潜力较大的制剂产品或与国外药企进行原料药、制剂合作。公司具有较强的产品选择能力以及较好的质量控制能力，从产品线看，未来将逐渐集中在消化道，肿瘤，糖尿病，心血管等大病种领域。盈利预计及投资评级我们暂维持对公司2012-2014年EPS1.03/1.35/1.71元，同比增长28%，30%，27%，考虑到公司优秀的产品线以及质控能力，特利加压素逐渐进入轨道，新产品推出后持续支撑公司业绩，维持持有评级。风险提示1、新产品上市时间延期；2、药品降价风险；3、现有产品推广缓慢　　恒瑞医药：创新与国际化将启动增长第二季恒瑞医药600276医药生物研究机构：国泰君安证券分析师：李秋实撰写日期：2012-05-04投资建议：增持，目标价35元。创新和国际化引领公司穿越政策迷雾，加速发展，预计12~13年EPS为0.97元、1.18元，建议增持，目标价35元。　　华东医药：百令胶囊带来确定性增长华东医药000963医药生物研究机构：兴业证券（601377）分析师：王晞，项军撰写日期：2012-05-03盈利预测。我们维持此前的盈利预测，预估公司2012-2014年的EPS分别为：1.10、1.32和1.60元，目前估值合理，未来看点在于股改承诺问题能否得到有效解决，我们维持“增持”评级。　　

天士力：二线品种增长提速，新品成长潜力大天士力600535医药生物研究机构：德邦证券分析师：李项峰撰写日期：2012-05-02一季度工商业齐头并进，债券发行降低财务费用率：2011年，公司业绩低于市场预期，受四季度折旧、现金激励和产品试生产等因素影响。2012年一季度，实现销售收入21.29亿元，同比增长55.03%，归属于母公司的净利润1.48亿元，同比下降7.79%。扣除非经常性损益的净利润同比增长47.16%。2012年4月，公司分别完成短期融资券和一期债券的发行，短期融资券融资3亿元，利率为5.15%。公司债券第一期发行4亿元，发行利率为6%。短期融资券和债券的利率都低于银行贷款利率，将降低公司财务费用，提升盈利能力。复方丹参滴丸增长稳定，二线品种增长提速：在公司前瞻性布局基层医院市场和FDA临床II期通过的效应共同作用下，2011年丹滴的收入增长达20%以上，预计未来丹滴的增长保持稳定，增速为15%。二线品种养血清脑、水林佳等产品预计复合增速维持在30%以上，芪参益气滴丸将是今年重点推广的品种，预计增速达100%。丹参多酚酸注射液和重组人尿激酶原前景广阔：丹参多酚酸是恢复中药注射剂审批的第一个产品，类似的产品只有绿谷的丹参多酚酸盐。作为单组分丹参类注射液，未来取代多组分丹参注射液的空间很大。重组人尿激酶原是生物I类新药，属于第三代溶栓产品，优于尿激酶和链激酶，与tPA效果接近，未来有望替代tPA产品。流感亚单位疫苗市场空间大：亚单位疫苗是利用病毒表面抗原制成的不含病毒核酸的疫苗产品，抗原性较好，且安全性较高。是未来疫苗的趋势。相对裂解疫苗来说，流感亚单位疫苗国内生产厂家较少，竞争格局有利，市场空间巨大。2011年，国内仅有诺华疫苗与天士力金纳获得批签发。风险提示：1.新产品丹参多酚酸和重组人尿激酶原推广不顺利，进入医保时间低于预期；2.中药注射剂安全性的风险；3.丹滴FDA临床III期进展低于预期。盈利预测及估值分析：预计未来三年的营业收入分别为88.54，112.94和135.53亿元；归属于母公司净利润分别为7.23，9.28和11.56亿元；每股收益分别为1.40，1.80和2.24元。给予2012年30倍PE，目标价为42元，增持评级。　　

康美药业：业绩大幅超预期康美药业600518医药生物研究机构：东方证券分析师：江维娜，李淑花撰写日期：2012-04-27投资要点较低基数上的高增长，业绩超预期。一季度实现营业收入25.51亿元，同比增长83.46%，实现归属于上市公司的净利润4.05亿元，同比增长69.05%，实现扣非后每股收益0.183元，同比增长68.81%，实现较低基数上的高增长，业绩超预期。今年一季报所得税先征后返，处置部分存货，中药饮片增速快。一季度存货21.26亿，较公司年报存货19.06亿呈上升态势，但其中部分品种已经有所变化，可能与公司看跌部分药材价格，高位卖出部分药材有关，同时低位买入部分已跌价品种有关。去年所得税税率为25%，今年年报一季报都已经实现所得税先征后返，此外一季度单季度实现中药饮片销售收入4亿左右，增速较往年同期高10个百分点左右。处置部分存货、中药饮片增速快、所得税先征后返是业绩超预期的主要原因。业务多点开花，预计全年净利润增速40%。新开河红参2亿，12年将继续贯彻价值回归，3-5年内实现10亿左右收入规模。亳州药材市场销售收入有望在下半年进入应收账款。今年9月市场搬迁后，开票费、增值服务费等将提供另一可持续收入，随着新市场人气的提升，交易额的上升以及管理力度的加强，可持续性收入的规模将逐步增加。财务与估值我们预测公司12-14年EPS分别为0.68、0.90和1.22元。维持公司“买入”的投资评级，目标价18.2元。风险提示贸易增速下滑；高管减持；　　

尔康制药（300267）：主要产品快速增长，综合毛利率提高尔康制药300267医药生物研究机构：天相投资分析师：彭晓撰写日期：2012-04-262012年一季度，公司实现营业收入1.72亿元，同比增长24.24%；营业利润4025.12万元，同比增长112.99%；归属母公司所有者净利润3568.14万元，同比增长92.98%；基本每股收益0.19元/股。主要产品快速增长，综合毛利率提高。公司主要业务包括药用辅料及新型抗生素产品，是国内品种最全、规模最大的专业药用辅料生产企业之一，并且是国内少数几家拥有新型青霉素类抗生素—磺苄西林钠原料药和成品药注册批件的企业之一。目前国内药用辅料的管理仍不规范，尚未强制要求取得药品注册批件和GMP认证，但医用辅料的规范化管理是未来发展必然趋势。公司已率先将117种药用辅料进行了标准化生产，并获得了药用辅料注册批件，主要产品包括药用甘油、药用蔗糖、药用乙醇、药用丙二醇、药用氢氧化钠等。报告期内，公司业务快速增长，综合毛利率提高7.48个百分点至39.21%。公司在药用辅料领域具有核心技术优势，依托湖南省药用辅料工程技术研究中心，在药用辅料的产品研发、生产工艺、检测等方面均具有很强的竞争力，在产品质量、生产工艺和产品规模均处于行业领先地位。未来随着国家对药用辅料注册管理方面的加强，小的药用辅料企业将面临淘汰，行业集中度将不断提高，公司作为药用辅料标准的先行者，有望获得更大的市场份额。“十二五”规划促进药用辅料行业快速规范化发展。我国药用辅料品种较少，规格单一，标准体系不健全，新药用辅料的研究和应用落后，技术力量薄弱，这是制约我国制剂工艺发展的一个重要因素。目前我国已意识到药用辅料的重要性，开始加强药用辅料的管理工作。2012年1月，工信部医药工业“十二五”规划首次将药用辅料纳入五大重点发展领域，国务院在同期印发《国家药品安全“十二五”规划》中，明确提出将提高132个药用辅料标准，制订200个药用辅料标准的计划作为医药行业主要任务与重点项目。从长远来看，标准的提高有利于药用辅料行业快速健康发展，对我国的制剂工艺起到推动作用。盈利预测与评级。预计公司2012-2013年EPS分别为0.84元和1.06元，按最新收盘价计算，对应的动态市盈率分别为21倍和17倍，维持“增持”的投资评级。风险提示：1）辅料规范化进程低于预期；2）辅料销售不达预期；3）抗菌药新政影响公司产品销售。　　

华润双鹤（600062）：业绩符合预期资产注入预期强华润双鹤600062医药生物研究机构：联讯证券分析师：联讯证券研究所撰写日期：2012-05-021、成本上升，期间费用降低。由于原材料价格上涨以及经营规模扩大，公司成本较去年同期增加44%，高于收入增幅。同时，公司期间费用率则同比大幅下降，我们分析主要是源于公司内部改革的成效，包括营销团队和管理团队效率的提升。投资收益则来自于公司出售山西双鹤所致，约5200万元，同时由于公司计提了4000多万的资产减值，因此扣非后的净利润仍然同比增长12.75%。2、主打产品稳定增长。预计公司大输液销量增长速度超过30%，其中塑瓶与软袋的增速可能更大，预计超过50%。817软袋和三合一塑瓶是公司差异化营销产品，也是公司重点推出的输液产品，我们认为，随着公司高毛利三合一输液上市及817软袋的上量，公司输液龙头的地位将更加稳固。3、董事会换届在即资产注入预期更强。公司第五届董事会将于2012年5月任期届满，董事会换届在即。在公司董事会提名的11位董事与独立董事候选人中，5位华润高管现身。在此公司百亿工业收入目标的背景下，我们更有理由认为，控股股东将可能通过应用惯用的方式来实现双鹤的快速发展壮大。4、盈利预测。预计公司2012-2014年EPS分别为1.06/1.23/1.44元，目前股价对应12-14年PE为15/13/11。我们仍然看好公司持续增长的能力，尤其是华润控股后公司可能的资产注入预期，维持对公司的“增持”评级。

5、风险提示1）大输液降价与整合进度较慢2）系统性风险　　国药一致（000028）：抗生素业务、医药商业均出现好转，一季报超预期国药一致000028医药生物研究机构：中投证券分析师：周锐撰写日期：2012-04-23公司公告12年一季报，实现收入42.75亿，同比增长20.94%；净利润1.22元，同比增长39.71%，对应EPS0.42元，超过我们的预期，也超出市场预期。

投资要点：收入增速加快、净利润增速加快，管理费用率和销售费用率继续下降。12年实现营业收入42.75亿，同比增20.94%；利润总额1.55亿，同比增34.38%；净利润1.22亿，同比增39.71%；EPS0.42元。收入和净利润单季度增速均有所加快：预计商业增速超过20%，工业增速稳定接近10%。毛利率略有下降0.51个百分点，和商业、工业占比比重有关，预计是商业比重稍有增加导致。销售费用率、管理费用率有所下降带来净利润增速超预期，其中销售费用率下降0.64个百分点、管理费用率下降0.48个百分点。医药商业整体情况良好，资金面逐步宽松有利于商业环境：预计商业增速超过20%。超过公司的收入增速。公司布局两广地区、精耕细作的效应显现，未来还将继续加大对两个地区的布局。供应链管理加强，效率提高。深圳本地的基药配送也增加较多。多方因素促进商业的快速增长。随着今年资金面有所宽松，流通行业环境改善。医药工业稳定增长，抗生素业务出现好转，限抗政策执行半年后，50个品种内的抗生素品种出现反弹：医药工业收入增速不到10%，比较稳定，但抗生素业务开始出现好转，致君停产检修改造已经结束，基本不影响生产销售。预收账款增加50%，主要为致君销售态势良好。预计限抗政策最难过的日子过去，未来将会比较稳定。商业继续在两广地区扩张，龙头地位稳定；工业产品抗生素业务好转，加大新产品的开发和引进，逐步实现结构调整，保持稳定快速增长。我们预计公司12-14年EPS为1.4、1.71和2.08元，对应PE15、12、10倍，年复合增速超过20%，估值在医药板块严重偏低，有较大提升空间。　　

冠昊生物（300238）：细分领域龙头，后续品种给力冠昊生物300238医药生物研究机构：平安证券分析师：文献撰写日期：2012-03-20投资要点硬脑膜保持快速增长，生物膜今年增速有望提升公司硬脑膜市场占有率超过40%，2011年仍实现了25.8%的快速增长。升级型产品B型硬脑膜2011年底已获注册批件，有望助力脑膜未来继续保持较快增长。生物护创膜由于2010年基数较高且产能受限，导致2011年增速低于预期。预计今年上半年生物膜新生产线有望通过GMP认证，产能释放或带来2012年增速提高。

基层医院渐成增长主力，期待实现海外销售随着新医改对于基层医疗机构支持力度加大，基层医院将是未来硬脑膜市场的增长主力。公司与中国医师协会合作开展颅脑创伤救治及硬脑膜修补技术推广项目，且具有较强的基层医院配送能力，我们认为公司有望持续受益于该项目的实施。此外，预计2012年公司将积极开拓海外市场和代理产品销售，目标市场可能包括东南亚和欧洲，从而为公司业绩增长带来增量。

后续品种研发积极推进，市场空间巨大公司2011年研发投入占营业收入的比重高达15.7%，后续多个品种的研发正积极推进。其中处于临床试验阶段的组织补片、鼻梁假体等品种面向空间巨大的丰胸、隆鼻等医学整形美容市场，今年底明年初有望面市，将成为公司重要收入来源和新的利润增长点。首次给予“推荐”评级预计公司12-14年的EPS分别为0.85、1.09和1.40，对应3月19日收盘价53.93元的PE分别为63、49和39倍。公司作为再生型医学材料和植入器械细分领域龙头，研发实力雄厚，储备产品市场潜力巨大，虽然目前估值较高，但考虑到行业前景确定且标的具有稀缺性，首次给予“推荐”评级。　　

通策医疗：一季度或是利润增速低点通策医疗600763医药生物研究机构：东方证券分析师：庄琰撰写日期：2012-04-23根据公司季报，我们调整公司2012-2014年每股收益至0.57、0.75、0.96元，（原0.61，0.78，0.99元）公司估值一直相对较高，如果由于短期利润波动引起股价调整，或将提供较好的介入机会。仍看好长期发展，维持公司买入评级。来源中国资本证劵网)