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Wednesday, April 15, 2020

(康友) 大輸液 六安華源製藥 占率大陸第六/ 印尼帝斯生技 拚 禽類疫苗全藥證廠

康友子公司帝斯與中國派斯德合作 估下半年效益展現 2020-04-07 17:14 經濟日報 / 記者陳書璿/即時報導 疫苗、輸液廠康友-KY6452)今(7)日公告3月營收4.09億元,較2月營收3.74億元,月增9.35%,雖受制於換匯利差擴大至6.58%,仍比去年同期成長0.48%,若以人民幣計價,3月營收年增率達7.55%。康友表示,受到COVID-19(新冠肺炎)疫情嚴峻影響,大陸各大醫藥經銷商搶補大輸液庫存所致。康友第1季營收10.9億元,在2月只有20個工作天之下,若以人民幣計價,第1季營收年增率達3.84%,然受到當季匯差拉大到歷史高點5.59%,若用新台幣計價,第一季營收年減1.97%。今年以來,全球受到疫情影響,子公司六安華源製藥,佔85%營收的大輸液穩定向上,佔15%營收原料藥亦保持過往水準。康友指出,六安華源市占率已是中國大陸第六,未來除了有重大資本支出,將受惠於小廠退出而穩健成長,雖過去一年受制於人民幣貶值,營收成長有限,但毛利率還是一直穩定慢慢向上,這個趨勢短期內還是不會改變。至於印尼帝斯生技,受到全球染疫影響,印尼亦進入封國,遞延三張二價疫苗及一張三價疫苗藥證挹注營收時程,然因應印尼封國,帝斯生技已備妥庫存,只是物流、人流管制下,45月營收仍將有所影響。康友表示,展望第2季,扣除匯兌因素,有機會維持與去年同期表現相當,以期印尼帝斯生技在藥證豐富下大幅挹注營收,進而推升營運成長動能。惟藥證豐富時間可能還要半年,禽流感、二價三價疫苗可望先行取得外,後續有關多張活毒及其他禽類疫苗,跟BESTAR(中國派斯德股份有限公司)合作授權下,約在半年後陸續取得,屆時的帝斯就是印尼唯一擁有禽類全藥證之疫苗廠,整個綜效也可明顯發揮。康友指出,此次疫情,可明顯發現,生技產業不僅須擁有研發生產能力,更須要通路實力,進而發揮綜效。帝斯在印尼為一全新公司,二年來就是架構研發生產及通路,此一綜效,在藥證陸續完備下,可望提升整體營運成長動能。

Baricitinib 用於圓禿與新冠狀病毒潛力

尋抗疫解方 美藥廠啟動巴瑞替尼臨床試驗 路透社 中文新聞 2020411日(路透印第安納波利斯10日電)美國跨國藥廠禮來公司(Eli Lilly & Co)表示,將針對2019冠狀病毒疾病(COVID-19),展開藥物「巴瑞替尼」(baricitinib)療法的臨床試驗。禮來公司表示,已與美國國家過敏與傳染病研究院(NIAID)達成協議,將研究巴瑞替尼,審視這種藥物若用於治療2019冠狀病毒疾病住院患者,藥效和安全性如何。禮來公司先前曾試驗巴瑞替尼能否作為異位性皮膚炎的療法之一。禮來公司在聲明中表示,這項研究本月先在美國展開,之後擴及歐洲和亞洲其他地點,研究結果預計2個月內揭曉。中央社(翻譯)

Arguing the Case for Clinical Testing of Baricitinib for COVID-19 APR 10, 2020 | KENNETH BENDER, PHARMD, MA The likelihood that therapeutic agents against SARS-CoV-2 can be identified quicker by repurposing currently available products has impelled medical sleuths across the globe to sift through an array of medications for actions that could be directed at recently elucidated vulnerabilities of the virus.  Justin Stebbing, MD, PhD, and colleagues at BenevolentAI, London UK  described finding baricitinib, an agent approved for rheumatoid arthritis, by using artificial intelligence (AI) to search for candidates that might offer both antiviral and anti-inflammatory actions against SARS-CoV-2.  The investigators sought agents in particular that inhibited AP2-associated protein kinase 1 (AAK1), a regulator of the endocytosis through which viruses can enter cells. "Disruption of AAK1 might, in turn, interrupt the passage of the virus into cells and also the intracellular assembly of virus particles," Stebbing and colleagues explained.  Of 378 products that they found inhibited AAK1, 47 were approved for medical use and 6 of these inhibited AAK1 with high affinity. Among the candidates were oncology drugs that the investigators considered too dangerous to suggest for this application.  Baricitinib, 1 of the 6 with high AAK1 binding, is a janus kinase (JAK) inhibitor that also binds the cyclin G-associated kinase, another regulator of endocytosis. This agent, the investigators noted, inhibits AAK1 within its approved therapeutic plasma concentrations. "We suggest it could be trialed, using an appropriate patient population with (COVID-19) acute respiratory disease, to reduce both the viral entry and the inflammation in patients," they indicated. The proposition drew a critical response from 1 group of rheumatologists, who were not only familiar with use of the agent for rheumatoid arthritis but also practiced in Lombardy, Italy, within the first European epicenter of coronavirus disease 2019 (COVID-19). Favalli and colleagues expressed concern about potential adverse effects, including interfering with the action of interferon, if it is employed to prevent viral replication. "The described mechanism affecting viral endocytosis mediated by 2 members of the numb-associated kinase family is one of the many unfamiliar effects of a relatively recent drug class, the real safety profile of which still remains to be definitively clarified," remarked Ennio Favalli, MD, Division of Clinical Rheumatology, ASST Gaetano Pini-CTO Institute, Milan, Italy, and colleagues.  In response to their concern, Stebbing and colleagues pointed out that pegylated interferon is unlikely to be used for COVID-19. In addition, they clarified that they anticipate the timing of administering baricitinib would avoid early stages of the disease not requiring hospitalization, during which the virus is often cleared spontaneously. They suggest that with increased severity requiring hospitalization, "JAK-STAT pathway inhibition might be a potential strategy." In a subsequent correspondence in The Lancet Infectious Diseases, Stebbing and colleagues addressed a concern with the drug, identified in the US Food and Drug Administration stipulated black-box warning, about potential for serious infection, including with pulmonary pathogens. "The most significant side-effect seen over 4214 patient-years in the clinical trial programs used for European Medicines Agency registration was a small increase in upper respiratory tract infections," they indicated.  They argued, further, that baricitinib would be a good agent to use in combination therapy with an antiviral such as remdesivir--currently nearing control trial results for COVID-19—as it has minimal interaction with the drug metabolizing cytochrome-P450 enzymes.  Stebbing and colleagues close their case by claiming, "combinations of baricitinib with these direct-acting antivirals could reduce viral infectivity, viral replication, and the aberrant host inflammatory response."

Olumiant (baricitinib) granted Breakthrough Therapy designation by FDA Baricitinib has been granted Breakthrough Therapy as a treatment for alopecia areata, an autoimmune condition with no FDA-approved therapies. Man with alopecia areata - three bold spots on the side of his scalp/head. The developers of Olumiant (baricitinib) tablets, Eli Lilly and Company, have announced that the US Food and Drug Administration (FDA) has granted the drug Breakthrough Therapy designation for the treatment of alopecia areata (AA), an autoimmune condition that results in unpredictable hair loss.  Breakthrough Therapy designation is designed to expedite the development and review of drugs intended to treat a serious condition when pre-clinical or clinical evidence suggests it may offer benefits over currently available therapies. "Patients with AA currently do not have any FDA-approved treatment options available to them," said Dr Lotus Mallbris, vice president of immunology development at Lilly. "AA not only causes hair loss but also may be a psychosocial burden for people living with this disease. At Lilly, we aspire to create new medicines that can give hope to patients. We look forward to working with the FDA to further explore baricitinib's potential to become the first approved treatment option for these individuals." The designation was based on the Phase II results of the adaptive Phase II/III study BRAVE-AA1. The adaptive study evaluated baricitinib against placebo in adult patients with AA. In the Phase II portion no adverse events were reported and the most common side effects were upper respiratory tract infections, nasopharyngitis and acne. The Phase II and Phase III trial results and an additional Phase II double-blind study (BRAVE-AA2), are currently being used to assess the efficacy and safety of the 2mg and 4mg doses of baricitinib relative to placebo. "There are millions of people around the world affected by and living with AA," said Dory Kranz, president and Chief Executive Officer of the National Alopecia Areata Foundation. "We're encouraged by baricitinib's potential to be one of the first FDA-approved medicines to treat AA."  Baricitinib 2mg doses are currently approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).   

臺灣癌症發生率 全球第十名: 每十萬人口296.7

抽血就能驗淋巴癌、血癌! 北醫跨國研究團隊找到關鍵 健康醫療網/記者林怡亭報導 2020330 【健康醫療網/記者林怡亭報導】根據經濟合作暨發展組織(OECD)最新公布的全球癌症發生率,臺灣癌症發生率每十萬人口296.7,已名列全球癌症發生率第十名;衛生福利部的死因統計也顯示,國人每年死於癌症的人數已逼近5萬人,因此,如何有效防治癌症,已成當前重要課題。不過,癌症篩檢又有新發展!由臺北醫學大學主導的跨國研究團隊利用AI人工智慧,透過一般健檢的抽血數據,就可發現未來可能罹患癌症的高風險族群。

AI人工智慧新突破 抽血篩檢惡性血液腫瘤 臺北醫學大學醫學資訊研究所副教授雪必兒(Shabbir Syed Abdul)指出,這項研究主要透過AI人工智慧進行,透過機器學習演算法,以細胞群落數據(Cell Population Data, CPD)篩檢惡性血液腫瘤。研究團隊蒐集韓國首爾Konkuk大學附設醫學中心共882個血液腫瘤案例,其中457例為惡性,425例非惡性。接著以SGDSVMANN、線性模型、邏輯迴歸等七種模型進行人工智慧(AI)學習,再讓AI針對這些血液腫瘤案例的抽血數據進行判讀,結果發現ANN的診斷率最高,達93.5%

新篩檢方式可內常規健檢 及早發現降低癌死亡率 這項研究有韓國、斯洛維尼亞及沙烏地阿拉伯等國共同參與。雪必兒副教授表示,由於血癌不如其他癌症容易診斷,通常需要配合血液抹片以及骨髓抹片檢查,許多患者發現時往往都已是中末期,錯過最佳治療時期,而這種新的篩檢方法則可以在常規健檢中,從抽血檢查就能即早發現風險,及早因應。雪必兒副教授說明,該研究結果只要透過現行抽血數據加上AI的輔助分析,就能發現未來罹患淋巴癌、血癌等惡性血液腫瘤的風險高低,且不需再做額外的檢驗,既可節省醫護人力,減少醫療用及時間等成本,也可收早期發現,早期治療,並減緩癌症死亡率。