中華大學生資系努力研究 開台灣靈芝神奇面紗 中央社訊息服務 (中央社訊息服務20150728 15:47:49)靈芝(Ganoderma lucidum)是著名的珍稀傳統中藥材，已有千年以上的應用歷史。中華大學生物資訊學系長久以來致力於靈芝基因體解碼，日前首度完成台灣靈芝的全基因體遺傳序列解碼。中華大學生物資訊學系主任劉志俊教授利用目前最新的「新世代高通量定序」(Next Generation Sequencing)生物科技技術，結合該系之基因體分析生物資訊技術，成功地解開台灣靈芝的基因體遺傳序列。劉教授表示，靈芝的主要活性成分如靈芝多醣與靈芝三的合成基因目前所知甚少，解開台灣靈芝的全基因體序列，有助於加速瞭解這些主要活性成分的合成機制，並可透過比較基因體分析，研究台灣的原生靈芝品種與中國、日本、韓國等地的靈芝品種的差異，對於台灣本土優良原生靈芝品種的選育，以及最佳靈芝培養與採收條件的建立有極大助益。劉志俊指出，目前國內與國外對真菌基因體的解碼，均是透過大型研究團隊運用大量研究資源方得以達成，而該校日前完成之台灣靈芝的全基因體遺傳序列定序，不論是經費與技術皆是由中華大學獨立資助與開發進行，使得此項研究成果更顯得難能可貴。靈芝是珍貴的藥用真菌，主要分布在台灣、中國、日本等東亞國家，在傳統中醫藥方面已有2000年以上的應用歷史，而在亞洲國家亦被廣泛作為養身與長壽的健康食品。傳統中醫藥典《神農本草經》中將靈芝歸類為上品，強調其無毒的上等藥材特性。集我國古代本草學知識之大成的經典著作李時珍所著《本草綱目》中，記載赤芝「氣味苦、平、無毒、主治胸中結、益心氣。補中、增智慧、不忘、久食輕身不老、延年神仙」。近三十年來靈芝免疫調節與抗癌功效受到國際學術界的高度重視，靈芝對身體保健的神奇功效也隨著現代嚴謹的科學實驗與研究論文的發表而得到證實。靈芝具有極高的藥用價值，有免疫調節、抗癌、保肝、以及抗老化等多樣化的保健功能，除了作為珍貴的傳統中藥材之外，近年亦有許多獲得衛福部健康食品標章的靈芝保健產品的問世。在靈芝研究方面，目前雖有超過1500篇的國際學術論文發表，但靈芝確切的活性成分合成基因與其作用機轉仍有許多地方尚待釐清。訊息來源：中華大學
Thursday, July 30, 2015
國鼎口服Hocena /GHPANC (Antroquinonol) 獲孤兒藥資格 (肝癌/胰臟癌/血癌) !!
國鼎新藥破紀錄 連獲美國3項孤兒藥資格 鉅亨網記者張旭宏 台北 2015-07-2908:49興櫃新藥廠國鼎生技(4132-TW)新藥研發再下一城！研發中抗肝癌新藥GHHCC日接獲美國藥物暨食品管理局(FDA)罕見藥物發展發展部(OOPD)認證信函的通知，獲准通過用於治療肝癌的孤兒藥認證。國鼎指出，經美國FDA認定為「孤兒藥」的藥品，除可獲得美國研究經費補助外，藥物主管機關更給予行政協助及市場專賣保護期等優惠措施。未來新藥獲得上市許可後，將有7年的美國市場專賣獨占權，擁有專利保護以外更具價值的市場專屬保護。 國鼎近期在新藥研發的成果上屢獲美國FDA的肯定，今年元月美國FDA核准通過國鼎GHPANC用於治療胰臟癌的孤兒藥資格認證；5月獲得通過GHAML用於治療急性骨髓性白血病(AML血癌)的孤兒藥資格認證；7月底，又獲得通過GHHCC用於治療肝癌的孤兒藥資格認證，2015年將是國鼎生技自2002年成立以來，新藥研發獲得最重大進展的一年，目前於美國FDA與台灣FDA申請新藥臨床試驗並執行中的非小細胞肺癌臨床二期試驗，病患收案順利，相信非小細胞肺癌臨床二期試驗的期中報告的產出，可以拭目以待。肝癌是全球癌症致死率高的癌種之一，專家預測在2019年時，美國肝癌的藥品約有15億美金左右的市場。由於生活飲食習慣與病毒性肝炎的影響，全球近9成的肝癌患者出現在亞洲區，台灣衛福部公佈肝癌發生人數排名在101年度為第3名，近幾年雖然有大藥廠積極研發抗肝癌新藥，但對肝癌治療的整體有效性尚未有突出的效果，病患仍有治療藥物匱乏與新藥研發急迫性的需求。孤兒藥治療的對象為罕見疾病的病患族群，所以孤兒藥的臨床實驗設計與一般藥物的臨床實驗設計不同而具有優勢，孤兒藥的臨床試驗，僅需在相對少量的病患數身上看到藥物的有效性，即有機會以特殊的審查通道拿到藥物的銷售許可，特殊的審查通道包括快速審批(Fast Track)、優先審查(Priority Review)、加速核准(Accelerated Approval)以及突破性治療(Breakthrough Therapy)等。國鼎生技目前正積極策劃抗肝癌新藥GHHCC人體臨床試驗，由於臨床一期的安全性已證實與患者高度的相容性與服用安全性，臨床二期試驗預計將與國際知名的醫藥研發外包公司CRO合作，於近期內展開全球肝癌臨床二期試驗，以2-3年內完成臨床試驗並申請肝癌孤兒藥銷售許可的目標邁進。
澄清新聞媒體報導 本資料由 (興櫃公司) 國鼎生技 公司提供 發言日期104/07/23發言時間11:50:52發言人 林哲吉 發言人職稱 財務長 發言人電話0228086006符合條款 第 26 款 事實發生日104/07/23說明1.傳播媒體名稱:經濟日報生技專刊D12版新聞 2.報導日期:104/07/23 3.報導內容:『經媒體刊登 「國鼎營收創新高 新藥大突破」，在美國進行的非小細胞 肺癌臨床二期，也預期今年第4季會有期中報告產出。國鼎Antroquinonol的多適應證 的開發策略，是台灣原研藥的突破性發展。 陳志銘指出，此份期中報告另外一方面，亦可做為申請非小細胞肺癌ras基因突變患者 在治療上的孤兒藥認證。4.投資人提供訊息概要:無 5.公司對該等報導或提供訊息之說明: 針對媒體報導本公司非小細胞肺癌新藥之臨床試驗進度，予以說明如下：(1)研發新藥代號或名稱：Hocena(Antroquinonol) 和 GHPANC(Antroquinonol) (2)用途：一種治療非小細胞肺癌、胰臟癌小分子新藥。 (3)預計進行之所有研發階段：口服劑型：二、三期臨床試驗(需與美國食品藥物管理 局協商確認)、FDA新藥查驗登記審查。(4)目前進行中之研發階段： (一)提出申請/通過核准/不通過核准：本公司已獲得美國食品藥物管理局及台灣行政院衛生福利部同意，本公司在 美國及台灣執行非小型細胞肺癌新藥Hocena的第二期人體臨床試驗。本公司已獲得美國食品藥物管理局認證治療 「胰臟癌孤兒藥(#14-4608) 」；和「血液腫瘤類之急性骨髓性白血病孤兒藥資格認定(#15-4763)」(二)未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用。(三)已通過目的事業主管許可者，未來經營方向：本公司將依原先年度計畫，繼續研發完成臨床二期試驗，如獲得突破性新藥資格 將適用美國的法令申請新藥上市許可。(四)已投入之累積研發費用：已完成臨床前之相關試驗與一期臨床試驗。 (5)將再進行之下一研發階段： A.預計完成時間：口服劑型臨床後續(三期)試驗規劃及範圍，需依據與美國食品藥物管理局討論 審核結果而定。"突破性新藥"為美國食品藥物管理局於2013年通過之最新法案，對於具有特殊癌症生物指標的族群有顯著性療效證明，即可於美國申請藥證並 上市銷售。 B.預計應負擔之義務： 該小分子新藥係國鼎生技獨立研發,擁有100%專利權, 僅須完成相關臨床試驗。 6.因應措施:有關本公司財務業務及新藥研發進度等相關事宜， 請依本公司於公開資訊觀測站揭露之資訊為準。 7.其他應敘明事項:新藥開發時程長、投入經費高且並未保證能一定成功，此等可能使 投資面臨風險，投資人應審慎判斷謹慎投資。
生達 布局API (生泰/生展) 與 奶粉與藥妝通路(勝霖藥品)
生達下半年營運估優上半年，全年EPS拚續揚 2015/07/30 11:05 MoneyDJ新聞 2015-07-30 11:05:53 記者 蕭燕翔 報導 製劑廠生達(1720)第二季營收季減2.8%，法人估計，因未分配盈餘加徵所得稅，單季每股稅後盈餘約0.4元。而該公司今年上半年相較去年微降1.3%，法人預期，下半年隨該公司攜手日本大藥廠切入的精神科新藥，有望取得國內藥證，及轉投資的原料藥廠生展獲利增長，題材面相對上半年豐富，全年營收估增個位數，每股盈餘也力拚優於去年的2.09元。生達是國內三大學名藥廠之一，近年在整合上下游資源與橫向拓展產品線上，表現積極。除目前集團已各有有機合成及發酵為主的原料藥廠生泰(1777)與生展外，也透過併購參股，跨足奶粉與藥妝通路事業，去年獲利創下新高，每股稅後盈餘2.09元。不過，因生達今年上半年內、外銷沒有重量級藥證到手，登陸銷售的奶粉挹注也僅穩定增長，營收較去年同期微降1.3%，第二季營收則因季節性因素，較前季下滑2.8%。法人估計，因生達去年盈餘未全數配發，第二季恐有未分配盈餘加徵所得的稅負支出，單季獲利降幅將略高於營收，每股稅後盈餘約0.4元，上半年每股稅後盈餘0.98-1元。展望下半年，生達除傳統營運將優於上半年外，題材面也會較上半年為多。首先，在與日商大日本住友會社合作的精神科新藥，歐美上市銷售優於預期，生達將其引進國內，並加速臨床與藥證申請，今年下半年有望取證，明年正式銷售，未來雙方在精神科系列用藥，可望加強合作，拓展生達產品線。而生達轉投資的兩家原料藥廠，今年營運仍朝正面發展，其中生泰因深耕日本市場有成，獲利可望續揚創高，雖生達將生泰的轉投資部位，列入備供出售項，僅有市價變動影響股東權益，對當期損益表影響不大，但雙方長期仍有加強合作可期。至於持股過半的生展，去年11月登錄興櫃，生達以權益法認列該公司當期損益，隨生展今年獲利可望優於去年，且年底前逐步啟動送件申請上櫃計畫，生達今年認列來自生展的投資收益也會同步成長。法人預估，生達今年營收將年增個位數，外銷佔比持穩，全年獲利有機會較去年小幅成長，全年每股稅後盈餘力拚優於去年的2.09元，再創近年高。
美國核准雙下巴消脂針(Kybella, deoxycholic acid) 台灣還早!!
FDA approves treatment for fat below the chin Source: FDA April 29, 2015 The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended. Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin."Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment," said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area." Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds. The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo. Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area. Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area. Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product. Consumers and health care professionals are encouraged to report adverse reactions from the use of Kybella to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-FDA-1088. Kybella is manufactured by Kythera Biopharmaceuticals Inc. based in Westlake Village, California. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
KYTHERA Biopharmaceuticals Announces US Availability of KYBELLA™ – First FDA-Approved Injectable Treatment for "Double Chin" – Through KYBELLA™ Trained Physicians June 19, 2015 Westlake Village, Calif., June 19, 2015 — KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced the U.S. availability of KYBELLA™ (deoxycholic acid) injection, the first and only FDA-approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition also known as "double chin." KYBELLA™ was approved in April by the U.S. Food and Drug Administration (FDA), and can now be purchased by physicians who have been trained on the safe use of KYBELLA™ and its approved indication. Training began earlier this month for KYBELLA™ physician trainers, with broader KYBELLA™ physician training programs to begin in late summer. Only physicians who have participated in a training program will be able to purchase KYBELLA™ and treat patients. KYBELLA™ will be available to trained physicians in a pack of four, 2 mL, single-patient use vials at a cost of $1,200 per pack or $300 per vial."Many people complain that a double chin makes them feel older and heavier than they actually are," said Frederick C. Beddingfield, III, M.D., Ph.D., Chief Medical Officer, KYTHERA. "With KYBELLA™, for the first time, people have access to a non-surgical solution to address this long-standing but common aesthetic complaint. KYBELLA™ causes the destruction of fat cells, so once the aesthetic response is achieved, retreatment is not expected." KYBELLA™ is administered by injections into the fat under the chin, tailored to the treatment goals of the patient and their physician. In clinical trials, many patients experienced visible results in two to four treatments,[i] though up to six treatments may be administered. The average dose was 2-3 vials per treatment session (which equates to 4-6 mL). KYBELLA™ treatment resulted in high patient satisfaction during clinical trials. In fact, 79 percent of KYBELLA™-treated patients reported satisfaction with their appearance in association with their face and chin. Patients also reported improvement in the visual and emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat. Health care practitioners and consumers can visit www.MyKYBELLA.com for further product and prescribing information, and to find physicians who have been trained on the use of KYBELLA™. KYBELLA™ is supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™.[ii] The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema and formation of areas of hardness in the treatment area. The percentage of adverse reactions reported as mild were 81 percent, moderate 17.4 percent, and severe 1.6 percent. In clinical trials, the incidence and severity of most side effects decreased with subsequent KYBELLA™ treatments. KYBELLA™ can cause serious side effects, including trouble swallowing (2% of clinical trial patients) and nerve injury in the jaw that can cause an uneven smile or facial muscle weakness (4% of clinical trial patients). Adverse reactions resulted in study discontinuation in 1.6 percent of subjects.
About Submental Fullness Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance[iii] – leading to an older and heavier look.[iv] Submental fullness can affect adults – both women and men – of all ages, weight and gender. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise. According to a survey by the American Society for Dermatologic Surgery (ASDS), nearly as many consumers are bothered by submental fullness (68%) as by lines and wrinkles around the eyes (71%).[v]
About KYBELLA™ KYBELLA™ is the first and only approved injectable drug for contouring moderate to severe submental fullness, a condition that is commonly referred to as a double chin. KYBELLA™ is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.[vi] When injected into subcutaneous fat, KYBELLA™ causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.[vii] KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safe and effective use of KYBELLA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
Important Safety Information KYBELLA™ should only be administered by a trained healthcare professional. KYBELLA™ is contraindicated in the presence of infection at the injection sites. Avoid injecting in proximity to vulnerable anatomic structures due to the increased risk of tissue damage. Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported during clinical trials. To avoid the potential for nerve injury, KYBELLA™ should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days). Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of KYBELLA™ in these patients as current or prior history of dysphagia may exacerbate the condition. In clinical trials, 72% of subjects treated with KYBELLA™ experienced injection site hematoma/bruising. KYBELLA™ should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur. To avoid the potential of tissue damage, KYBELLA™ should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles. The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
About KYTHERA® KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. In addition to its lead product KYBELLA™, KYTHERA also licensed the worldwide rights to setipiprant (KYTH-105), an early-stage potential treatment for hair loss. KYTHERA's longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. KYTHERA has submitted regulatory filings for ATX-101 in Canada, Switzerland and Australia. Find more information at www.kythera.com.
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