SR-100進入三期臨床,德英轉機就在明年2011-07-25 【時報】生技展再傳佳音!植物新藥廠德英(4911)SR-T100凝膠通過衛生署核准,將進入3期人體臨床試驗。董事長郭國華表示,將乘勝追擊在8月申請美國FDA第二期人體臨床試驗許可,另外,肝病用藥Hepanamin外銷許可,最快7月底有機會拿到,不過營運轉機應該在明年。德英去年每股稅後虧損0.22元,今年首季每股稅後虧0.04元,雖然今年植物新藥研發進度頗有進展,但要正式轉虧為盈,還是有點困難。郭國華表示,SR-T100主要是在治療麟狀細胞原位癌(日光性角化症),該癌症目前兩種治療法為液化氮及軟膏,其中軟膏光是美國市場2008年總值就達3 .09億美元,過去5年複合成長率約26%,全球總值4.75億美元,目前全球慣用軟膏僅有5-Fu、Lmiquimod及Diclofenac,國內僅進口5-Fu、 Lmiquimod,市占率約35%及52%,因此,SR-T100的市場潛力看好,郭國華表示,目前洽談的4家藥廠中,以一家全球前10大的歐洲跨國藥廠最積極。至於原預計4月可外銷的Hepanamin,因簽約的cGMP藥廠查廠影響進度落後,第3季才會比較明朗,該藥品預計將銷往日本、加拿大及東南亞國家。
Sunday, July 24, 2011
德英治療HPV病毒疣新藥!
德英治癌新藥 將赴美臨床試驗 2011/07/21 經濟日報【台南訊】德英生技(4911)治療鱗狀細胞原位癌的新藥 SR-T100第三期已送衛生署申請,為台灣本土首件癌症治療 用藥申請第三期人體臨床試驗,另外近期內將向美國FDA( 食品暨藥物管理局)送件申請第二期臨床;肝病用藥 Hepanamin預計今年底前可取得外銷藥證。德英生技董事長郭國華表示,該公司是植物新藥廠,目前進 行中的新藥除SR-T100凝膠、Hepanamin外,還包括肺癌新藥Apocin、婦癌與頭頸癌注射劑Solarise、治療外陰部癌前 病變及皮膚疾病的藥膏SR- T200等。日前並提出青少年常發病的扁平疣、或藉由接觸傳染的皮膚尖疣(菜花)等人類乳突狀病毒疣(HPV)的治療病毒疣用藥、治療和預防發炎與皮膚光損害及光防護皮膚用藥等二件 專利申請,其中皮膚尖疣新藥已在成大醫學中心開始執行先導性人體臨床試驗。同時郭董事長受邀請在2011臺北生技大 師圓桌論壇做植物新藥研發、發展新模式等議題的演講,研 發能量備受肯定。郭國華表示,治療鱗狀細胞原位癌的SR-T100,已委託專業 CRO公司向美國FDA送件申請二期臨床;而國內三期臨床已向 衛生署申請中,最快7月可得到通知,啟動三期臨床,屆時 將申請經濟部科專補助。至於肝病用藥Hepanamin,郭國華表示,預計年底前取得外 銷許可,明年取得國內藥證,預估國內肝藥市場規模上看2 億元,全球市場上看100億元,未來上市後可望對營收產生 顯著貢獻。
口服5-FU 縮短大腸癌患者治療時間!
化療口服劑型可替代靜脈注射5-FU 增加病患生活品質 2011/07/23 經濟日報【台北訊】以往大腸癌患者接受化療,必須帶著俗稱「化療奶瓶」的注射裝置在身上,注射完畢還是得回醫院拆卸注射針頭。目前已有口服劑型可替代靜脈注射的5-FU,患者可直接在家服藥,只需每兩週回診一次打2個小時的鉑類藥物即可,不但節省許多往返醫院的時間,還可以像正常人一樣下水享受夏日樂趣。三總血液腫瘤科主任高偉堯表示,大部分第二、三期大腸癌的治療以手術搭配輔助性化療為主,而目前用於大腸癌的輔助性化療組合,以5-氟尿嘧啶(簡稱5-FU)為基礎,有靜脈注射或口服劑型,兩者皆須搭配注射草酸鉑類(Oxaliplatin)。以往患者使用靜脈注射的5-FU時,病患需每兩週住院至少48小時打點滴,雖然後來發展出化療奶瓶,可以讓病患揹著注射裝置走動,但注射完畢還是需要回醫院拆卸注射針頭。但近年來化療方式出現極大的變革,最新的口服劑型可替代靜脈注射的5-FU,患者可直接在家服藥,只需每兩週回診一次打2個小時的鉑類藥物即可。更不必像靜脈注射得裝入人工血管,病友能夠穿著像是細肩帶或背心的休閒服飾,不必怕旁人異樣的眼光,且能較自在地活動,不用害怕人工血管會破裂,大幅提升患者的生活品質。此外,臨床數據顯示,口服化療藥物之治療效果與靜脈注射的療法相當,安全性更佳,高偉堯呼籲所有腸癌病友,千萬別因過去的刻板印象而拒絕接受化療,延誤病情。
施巴(Sebamed) 品牌 延伸女性醫美應用
施巴護潔露 專業醫美研發2011-07-22 【中央網路報】悶熱的夏季,女性常想擺脫惱人的肌膚黏膩不適,單用一瓶沐浴乳不足以滿足身體各部位需求,尤其是細緻的私密處酸鹼值更與一般肌膚不同,德國施巴潔護膚產品以一貫溫和特性,推出最符合女性私密處酸鹼值的<施巴護潔露pH3.8>,讓不同年齡層女性,皆能獲得私密潔淨保護,建立正確的私密清潔觀念,同時邀請台灣最美麗醫師娘-佩甄和施巴一起,守護女性最私密的心事。 7月21日施巴護潔露pH3.8產品發表記者會現場,透過施巴女伶實際演譯女性私密處困擾生活情境,以貼近女人心事展現施巴護潔露p H3.8產品優點。施巴保養品業務處張果為處長表示「德國施巴向來以專業醫美角度出發,針對人體肌膚的pH值作為研發,延續施巴一貫主軸,希望能建立女性正確的私密清潔觀念,擁有第二瓶保養品,獲得最親密的保護。」產品發表記者會特別邀請台灣最美麗的醫師娘-佩甄,以女性私密潔淨守護者身分,從自身生活困擾經驗出發,輕鬆有趣演譯典型的忙碌都會女性,表現在滿滿的通告中又要兼顧家庭小孩,壓力大時突然之間私密處乾癢不舒服的困擾情境。並談到自己過去錯誤的私密處保養觀念,因為穿著過緊牛仔褲感到不舒服甚至感染搔癢時,誤以為只要用一般沐浴用品加強洗淨就能改善,反而越洗越糟,沒想到其實是因該用更適合私密肌膚的產品,在用對正確的施巴護潔露pH3.8後得到解脫舒緩,才認知私密保養是需要的重視的!並且在專業泌尿科醫師老公知識提供中,得到正確的對私密處養護的觀念。佩甄將私密處比喻成身體第二張臉,認為是身體十分重要的部分,私密保養就像是安太歲,有保養就有平安,定時安心的養護,勝過感染後不知所措。他也提到選擇使用私密潔淨pH3.8的經驗,強調選擇施巴產品是為德國原裝進口,產品健康品質值得信賴,其中的洋甘菊舒緩和蘆薈保溼的成分,使用起來十分舒適,更能天天使用保養自己,更以醫師娘的身分呼籲女性,應該要擁有正確的私密清潔觀念,強調<施巴護潔露pH3.8>是不可或缺的女性第二瓶沐浴乳! 德國施巴團隊更與佩甄一同為了守護女性私密肌膚共同努力,共同啟動象徵<施巴護潔露pH3.8>最呵護女性私密潔淨的決心!
專屬女人德國施巴潔護膚pH3.8,天天使用守護潔淨 德國施巴潔護膚pH3.8符合不同年齡在育齡當中的身體私密處酸鹼值概念,德國原裝進口的專業的品質保證,受到7成專業護理人員使用肯定,量身打造專屬女性私密肌膚的護潔露pH3.8,以符合女性獨特的弱酸生理環境,可以天天使用,期望能讓所有女性都得到呵護!
Skin care and treatment device!
Taiwan researchers invent 'cosmetic chip' to detect skin problems 2011/07/23 22:17:48 Taipei, July 23 (CNA) Researchers from the National Chiao Tung University have developed a "cosmetic chip" device that can detect skin problems and gauge the effects of skin care products. The device, which utilizes light-based photoplethysmography (PPG) technology, helps determine skin conditions through the use of an infrared light, said Huang Sheng-chieh, head of the research team. It measures the amount of light that is reflected from small blood vessels in the skin to a light sensor, he said. The sensor, pressed against the user's skin, records the amplitude of the reflected light wave, which is then transmitted to a computer database for analysis. The smaller the variations in the amplitude of the light wave, the better and healthier the skin, as it means that nutrients are spread more evenly across the small blood vessels under the skin, Huang said. As the chip allows people to measure the changes on their skin, it would, therefore, allow them to gauge the effects of their skin care products and whether a certain product is suitable for them, the professor said. Huang and researchers from the biomedical system-on-chip research laboratory under the university's electrical engineering department worked with dermatologist over a period of six years to develop the device. He said more than 20,000 people have already used the device to test their skin conditions. He told CNA on Saturday that the inspiration for the invention came from his 87 year-old grandmother who cared little about her body pains, but made great efforts to keep her skin in good repair. He said his grandmother helped him realize the importance of skin care, regardless of age. It also motivated him to think about how integrated circuit technology can be used to develop devices that are "closely related to people's everyday lives" and can point to a new path for Taiwan's IC industry, he said. The current goal of the team is to make the chip device smaller and more refined so that it can fit into popular and portable devices such as mobile phones and MP3 players, the professor said. The ultimate goal is to make the chip available to everyone at a low cost, he added. Huang said that his team, which comprises doctors specializing in Chinese medicine, is also expanding its database so that Chinese medical views about the body and its circulatory system can also be provided to skin patients through the device. "It is like taking the pulse in Chinese medicine, just that instead of having one's pulse taken by doctors who depend on their experience, it will be done through a standardized chip," Huang said. The professor also said that his team is working to improve the therapeutic functions of the chip. He said the device is equipped with light emitting diodes (LEDs) that can emit red, blue and other lights that have been found to have a therapeutic effect on the skin. "Hopefully in the future people will be able to maintain their skin while talking on the phone," he said. Huang said his team has chosen light therapy over other forms of skin treatment such as laser, intense pulsed light and mesotherapy, because of its is non-invasive, painless and easily accessible.