東生華總座陳俊良：年底取得降血脂藥證 搶食50億元商機2012/4/12 鉅亨網 東生華(8432)今(12)日召開上櫃前法人說明會，總經理陳俊良表示，今年年底將取得降血脂組合藥物藥證，搶攻國內降血脂藥物約有50億台幣的市場商機，同時維持維持每兩年1個新產品上市的速度，預計民國105年新成分、複方、劑型藥比重提高至8成，強化獲利動能。 陳俊良進一步指出，公司未來發展將走向「微笑曲線」，創造研發及行銷的差異化，持續專精於差異化慢性病(CV、GI、Auto Immune Disease)藥物及Specialty Drug(劑型、配方改良、me- better)開發，研發以組合劑型、長效劑型為主，未來搶攻的市場將鎖定心血管疾病和自體免疫疾病，目前手邊已有多款研發中新藥，每2年都會有一個新藥上市。目前進度較快為1個降血脂組 合藥物，包含降低低密度膽固醇同時提高高密度膽固醇，有機會今年年底前取得藥證。目前國內降血脂藥物約有40-50億台幣的市場規模，預期未來藥品上市後將有機會帶動東生華營運明顯成 長，挹注新成長動能。 陳俊良表示，國內去年健保給付藥品規模約1,270億元，近年平均複合成長3.8%，而其中醫療院所占比80%，該公司的策略是透過劑型及設計改良，切入新劑型/新複方/特殊藥等利基領域，也 就是從「Me too」到「Me better」，公司核心能力除疾病類別管理外，特別鑽研長效劑型及組合劑型，以降低健保局及病人自付成本。 陳俊良強調，公司10年來逐步聚焦慢性疾病，發展心血管、腸胃道及自體免疫等三大領域，目前在醫療院所通路中，19家醫學中心都已涵蓋，300多家地區型醫院占有也近半，而從醫療院所發 展核心通路對於次級的開業診所及藥局也會有「蝴蝶效應」，幫助公司藥品向下普及。同時在藥品發展定位在二、三棒，也就是從人體臨床試驗開始承接，再到推動藥品上市，因選擇 領域多屬新成分、新複方及新劑型新藥，受健保調整的衝擊較少，使得營收維持5-10%左右成長的。去年來自新成分比重37%、新複方22%及新劑型藥5%，2016年新藥比例將提高至82%。 陳俊良樂觀表示，年底將有一個降血脂的藥品N11上市，去年底也與永昕(4726)合作，發展類風溼性關節炎的蛋白質藥，預計民國107年新成分新藥及生物製劑上市。另外，中國也有1張藥證申請及2張專利等待獲准，其中1張藥證為高血管領域，2張專利則可望在年底獲准後啟動臨床，估計2年後中國將有明顯營收挹注。
Thursday, April 12, 2012
醫療人員 恢復正常工時 真能來臨嗎?
盛弘 新通路(瑪科隆) 仍需時間整合!!
KKR Invests in China Cord Blood
Dangers of Chinese Medicine Brought to Light by DNA Studies
by Kai Kupferschmidt on 12 April 2012 Traditional Chinese Medicine (TCM) is enjoying increasing popularity all over the world. But two molecular genetics studies published this week show that the trendy treatments can be harmful, as well. The papers focus attention on the fact that not all of their ingredients are listed, or even legal, and that some can cause cancer. "These two studies show very clearly how dangerous the products of TCM can be," says Fritz Sörgel, the head of the Institute for Biomedical and Pharmaceutical Research in Nuremberg, Germany, who was not involved in the work. "The public needs to be better informed about these dangers." Hundreds of millions of dollars are spent on TCM products each year—a growing portion of it on the Internet—and some scientists are looking at these preparations hoping to discover new pharmacological substances. Many would like to emulate the success of Tu Youyou, the Chinese scientist who isolated artemisinin, now the world's most important malaria drug, from an ancient Chinese medicine. Tu won a Lasker award last year and is rumored to be a Nobel candidate. But critics have long warned that some mixtures can also contain naturally occurring toxins, contaminants like heavy metals, added substances such as steroids that make them appear more effective, and traces of animals that are endangered and trade-restricted. Now, researchers at Murdoch University in Australia have investigated the problem using modern sequencing technology. The team, based at the university's Australian Wildlife Forensic Services and Ancient DNA Laboratory in Perth, analyzed 15 samples of traditional Chinese medicine seized by Australian border officials. "We took these traditional preparations, smashed them to pieces, and extracted the DNA from the powder", explains molecular geneticist Michael Bunce. The scientists then fished out copies of two specific genes, trnL, a chloroplast gene common to all plants, and 16srRNA, conserved among plants and animals, and multiplied and sequenced them. By comparing the sequences to genetic databases, they could pinpoint the animals and plants used to make the medicine. "Sometimes we really struggled to assign a particular DNA to a particular species," Bunce says. But as genetic databases expand, this should become easier. Some products contained material from animals classified as vulnerable or critically endangered, such as the Asiatic black bear and the Saiga antelope—just as the producers claimed. But often, the medicine also harbored ingredients not mentioned on the packaging, the team reports online today in PLoS Genetics. "For example, a product labeled 100 percent Saiga antelope contained considerable quantities of goat and sheep DNA," Bunce writes. "Using DNA to identify the animal species and thus prove illegal trading is very elegant," says Dietmar Lieckfeldt, who works in molecular forensics at the Leibniz Institute for Zoo and Wildlife Research in Berlin, Germany. Identifying animals by their DNA has been possible for a while, he says, but the next--generation sequencing technology makes it possible to nail different species in a mixture very quickly. In the herbal preparations, Bunce and his colleagues found 68 different plant families, among them plants of the genera Ephedra and Asarum. Both can contain toxic chemicals such as aristolochic acid, a compound banned in many countries because it causes kidney disease and cancer of the upper urinary tract (UUC). While detecting DNA from a certain species does not mean that a toxin produced by that plant is present, chemical analysis of one of the four samples containing Asarum DNA did turn up aristolochic acid. The threat posed by aristolochic acid is also highlighted in a paper published in the Proceedings of the National Academy of Sciences on Monday. The researchers, led by pharmacologist Arthur Grollman of Stony Brook University, focused on Taiwan, the country with the highest rate of UUC in the world. A previous analysis had shown that roughly one-third of the Taiwanese population consumed herbs likely to contain aristolochic acid. The scientists sequenced the tumors of 151 patients with UUC. Among patients with characteristic mutations in the important tumor-suppressor gene TP53—which make people more vulnerable to cancer—84% also showed a known molecular signature of exposure to aristolochic acid, they found. The study provides compelling evidence that aristolochic acid is a primary cause of UUC in Taiwan, the authors argue. Bunce and his colleagues also found DNA from plant families known to contain medicinally important species that could pose risks when used in combination with other drugs, as well as DNA from soybean and plants of the cashew family, which can contain allergens. "This just shows that the ingredients in these preparations aren't accurately declared," Bunce argues. Indeed, says Sörgel, the studies show that partaking in traditional Chinese herbal medicine is a gamble. "We just don't know enough about it."
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