Tuesday, July 20, 2021

微軟攜手台大開發血氧監測平台

MR助攻零接觸看診 盧佳柔 2021.07.13 歷經一年多的抗疫之戰,新冠病毒威力不減反增,不僅是一開始出現咳嗽、發燒案例需要注意,無形中出現的缺氧症狀(快樂缺氧,又稱寧靜缺氧),更可能成為隱形殺手,若無即時就醫處理,極有可能發生猝死的憾事。台大醫院智慧醫療中心副主任李建璋指出,發現缺氧症狀唯一的方法就是要提早偵測血氧,並且有效紀錄血氧數據。台灣多數的輕症病患採用的血氧機,主要是透過LINE上傳,無血氧日記規則紀錄,有時還會出現病人上傳紀錄疑似錯誤等問題,使醫生看診缺少可靠的數據作為參考依據。為解決上述問題,微軟攜手台大醫院推出血氧系統即時監測平台,能即時偵測病患的生命徵象,同時透過雲端平台的協助,能讓協助醫生遠端監控,並更精準掌握並精準掌握患者的身體變化。

血氧監測平台搭配MR裝置,打造零接觸醫療環境 微軟的Azure IoTAI平台,協同工研院的血氧數值AIoT量測專業、泰博科技及皇漢科技攜手開發血氧系統即時監測平台,可透過額溫槍、血氧計、血壓機等裝置,協助收集患者生命徵象。再搭配HoloLens混合實境(MR)頭戴式裝置,醫護人員能即時的觀看病房狀況,亦能與病患互相對話,形成一種雙向零接觸醫療的模式。一旦偵測到血氧濃度低於正常值95%,系統能即時發出預警、通知醫護介入處置,解決院前缺乏醫護人員隨時監控患者生命徵象的困境,也減少院內醫護人員需頻繁接觸確診患者的機會,保護醫護安全。目前,血氧系統即時監測平台與HoloLens已進駐部立桃園醫院,提供給集中檢疫所及微負壓隔離病房使用。衛生福利部桃園醫院院長徐永年表示,過去一周內,這套系統已給醫護人員明顯幫助,例如在負壓病房中,透過HoloLens進行遠端會診,醫生能在零距離接觸下診療病患,不僅減少醫護人員暴露在高風險傳染的環境,同時能保障病人有良好的看診品質。其實,市面上也有其他品牌推出血氧監測平台,不過系統及技術上有諸多差異。微軟強調,該公司血氧平台的最大價值就在於開放與延展性,因此,微軟一直持續致力於開放相關原始碼,廣納不同醫療領域的夥伴參與應用,讓資訊、數據與智慧化技術更能幫助相關產業效能。而這個平台中,搜集患者的生命徵象等數據後,持續累積後可以形成大數據,透過學習事件,可以幫助醫護人員及大眾推測未來什麼樣的人可能帶有疾病危險,甚至在危急情況之前先行預警,達到提醒的作用。再者,微軟最擅長的AI、資料分析與大數據,也會帶入此專案,期望持續透過產官學合作,將醫療數據化,讓智慧醫療更上一層樓。

建立防疫科學安全網,阻絕未來傳染病風險 「監測平台、混和實境病房、智慧監測是重要里程碑,且代表背後的重要意義,是多方力量的整合。」台大醫學院院長倪衍玄表示,每隔幾年就會有新興傳染病肆虐,2019年新冠病毒的崛起與猖獗問題,可預期將會逐步趨緩並獲得控制下來,但再過幾年相同問題將持續發生,因此防疫科學的建立是必要措施。防疫科學的重要概念是集合各界力量,如新冠疫情最一開始出現的台灣口罩國家隊,以及此次結合醫學、資訊與工業方面的人才,達成智慧監測的目標就是最好的案例,未來可望進一步擴展此概念,將社會科學、法律、倫理、教育、經濟等所有人才參與進來,並打造一套SOP標準因應未來的傳染病隱憂。

Monday, July 19, 2021

萊鎂醫: 居家COVID-19核酸檢驗 RT-LAMP: 1800元/劑


萊析樂™居家核酸快篩71日開賣 萊鎂醫營收成長性看俏  張秉鳳 2021.07.01萊鎂醫(6633)獲食藥署核准專案進口的居家快篩試劑-萊析樂™家用COVID-19核酸檢測組,71日起將小量在多家連鎖藥房及零售通路上架銷售,預計7月上中旬可望大量鋪貨到各家大型連鎖通路量販店;萊析樂™建議未稅售價每劑新台幣1800,部分通路同步採行預購方案,讓有意購買的民眾省下寶貴的詢問時間。萊鎂醫表示,萊析樂™採用分子增幅(RT-LAMP)技術,等於是一個微型COVID-19核酸檢測實驗室,能在11~30分鐘內得到PCR等級的檢測結果,較抗原快篩試劑更精準,也能糾出潛在感染者;為了讓有意的民眾得以進行居家COVID-19核酸檢驗,落實中央廣篩策略,在家用快篩指引出爐後公司就加速推進與通路方的合作,萊析樂™第一波優先鋪貨特定地區,包括全聯福利中心與大樹、丁丁等連鎖醫藥通路。萊鎂醫指出,此次先於國內同業引進核酸快篩,除了供居家快速採檢,對於不容停止運作的企業、工廠、金融、政府機關能起到快速精確的效果,在開始鋪貨藥局及通路之前,已經有10多家中大型企業採用萊析樂™核酸檢測產品,再加上新冠體外診斷器材(IVD)客製化開發製造業務,帶動1105月合併營收新台幣387萬元,年增503.11%,預期6月營收將受萊析樂™銷售貢獻,進一步推升公司後續幾季營業表現。萊鎂醫日前已與萊析樂™美國原廠Lucira Health, Inc.正式簽下產品台灣區經銷權,力求提供更穩定、完善的貨源與服務,為台灣地區防疫盡一份心。萊鎂醫特別提醒消費者,自行購買使用家用快篩的民眾,務必遵循衛福部家用快篩試劑指引之防疫規範內容。

博錸: 開發 新冠 檢測單次 判斷>10 個病毒 突變點


博錸開發病毒變異株試劑 獲日本官方認證 鉅亨網記者沈筱禎 台北2021/06/18醫材廠博錸 (6572-TE) 表示,與日本電化株式会社 (Denka) 共同研發的新冠變異株檢測試劑,已取得日本官方核准、上市,目前除已開始與當地大型檢測機構接洽外,也與台灣機場、各航空公司接觸。博錸指出,新冠變異株檢測試劑是透過旗下多元檢測平台 IntelliPlex,以及πCode MicroDisc 晶元磁片技術開發出來,單次可判斷超過 10 個病毒變異株突變位點,包括英國變種的 Alpha(B.1.1.7)、南非 Beta(B.1.351)Gamma(P1)、印度 Delta(B.1.617.2)、產業還在觀察的變異株 Epsilon(B1.427/B.1.429) 等。博錸表示,目前已上市的新冠疫苗,對部分新冠病毒變異株防護力仍不足,並有施打疫苗空窗期,加上快篩與 qPCR 核酸檢測無法立即判斷新冠變異病毒,需二次採檢才能確認,因此時間拉長下,除耗時,也可能讓確診者在等待報告時,錯失最佳治療時機。由於病毒變異株多為境外移入,博錸開發的新冠變異株檢測試劑,除了將在日本啟動銷售外,目前也積極在台灣推廣此產品,其中以機場出入境篩檢站為主,另外也會與各大航空公司、國際物流公司及台灣大型醫檢單位接洽。 博錸指出,未來若出現更多變異株,該產品可擴充探針檢測標的物數量,隨時因應檢測需求,且從檢測到取得報告時間約3小時,有望藉此診斷效率、降低成本。

大江 承諾$3.5 million (現金&股票) 換取 NewAge猶他廠; NewAge 擬併日本Aliven, Inc.


大江結盟NewAge 收購其猶他廠 作為大江美國總部 2021/07/12〔記者陳永吉/台北報導〕大江生醫(8436)今天宣布與納斯達克上市公司NewAge Inc.(股票代碼:NBEV)簽署意向書,擬收購NewAge位於猶他州的生產設施及代工銷售業務,並與NewAge展開長期合作之策略結盟。大江表示,NewAge總部位於美國科羅拉多州,為全渠道保健品及快銷品龍頭企業,行銷全球75國,掌握全球400,000 多個獨家經銷商和銷售網絡。大江生醫將取得NewAge位於美國佔地五萬平方公尺的工廠運營權,並接手該工廠既有代工業務,同時作為NewAge策略聯盟之製造夥伴。最快預計於今年第四季可由大江生醫正式啟用。近年來大江在美國營收占比逐漸攀高,此舉將縮短市場供應鏈,為更多美國品牌客戶即時反應服務,預計大江在美國營收將步入高速成長期。此交易為繼和康生技(1783)後,大江生醫集團化布局的最新進展,未來將持續加速國際擴張,為全球品牌客戶提供專業研發製造服務。大江生醫將以此為集團美國總部,於2023年前打造新台幣超過30億的生產規模,除建置高速自動化產線外,更將結合集團關係企業之高端檢測設備、醫材、專利原料、生活日用品等,作為布局世界級生物設計整合商社之產銷基地。大江生醫攜手NewAge,建立長期合作夥伴關係,雙方擬以現金及未來五年內業務合作為此次交易基礎。NewAge將透過大江生醫尖端科研及專業製造技術,降低其銷售商品之成本,並專注於其核心競爭力,充分利用其全球400,000多個獨家經銷商以及強勁的社交網絡,打造全球熱銷之保健品產品組合。大江生醫亦將受益於美國生產基地長期的額外營收貢獻。

Newage Inks Manufacturing Deal With Taiwan's TCI  Mon, July 12, 2021  Beverage company Newage Inc (NASDAQ: NBEV) has formed a manufacturing partnership with Taiwan-based TCI Co Ltd. In addition, Newage will sell its U.S. manufacturing operations and its office based in American Fork, Utah, to TCI. TCI will be providing a combination of $3.5 million in cash and a share of revenues over the next five years as consideration and will take over production over the next 90 days. NewAge will continue to produce its Tahitian Noni Juice extractions in its processing facility in Tahiti. NewAge expects to reduce the costs of goods sold by leveraging TCI's manufacturing expertise. NewAge also expects to benefit from significantly reduced headcount and SG&A expense that will directly impact its bottom line in 2021."TCI brings incredible technology and manufacturing expertise to the venture enabling NewAge to focus on leveraging its sales and marketing capabilities and global distribution network," said SVP of Operations, Phil Lewis. Price action: NBEV shares are trading lower by 1.86% at $2.11 in premarket on the last check Monday.

NewAge Announces Letter of Intent to Acquire Japan-Based Aliven, Inc. March 04, 2021 07:00 ET | Source: NewAge, Inc. DENVER, March 04, 2021 (GLOBE NEWSWIRE) -- NewAge, Inc. (Nasdaq: NBEV), the Colorado-based healthy products company intending to become the world's leading social selling and distribution company today announced that it has entered into an agreement to acquire Aliven Inc., a highly successful Japan-based direct selling company. Tokyo-based, Aliven is one of Japan's highly recognized and admired companies in the $16B e-commerce and direct selling industry. Aliven is anticipated to bring approximately $20 million in annualized net revenue and more than $3 million in annual EBITDA to the NewAge Group in Japan that comprises the Morinda organization, ARIIX, and the fast-growing entity ZENNOA. In addition to significant top and bottom-line contribution, Aliven has more than 100,000 customers and independent representatives to add to the group of talented and dedicated leaders at NewAge. Aliven was founded 15 years ago and is led by Yasuyuki Oi. Oi-san is a highly respected leader in the industry and brings outstanding relationships with the Japanese Government and industry officials given his reputation. Oi-san commented, "We are so excited to be joining the NewAge team, and are confident that our group will add a lot of value to the combined organization. We see NewAge as the new global leader and disrupter in social and direct sales, and all of our reps will benefit from the expanding portfolio and global reach." Established 15 years ago, Aliven Inc. is one of the Japan's most well-respected companies in the industry and sells a portfolio of differentiated healthy products including Skin Care infused with cultured stem cells, Nutritional Products, and their patented Far-Infrared technology products that are were demonstrated in human trails to stimulate nitric oxide production for increased blood flow and muscle recovery and reduction of localized pain. NewAge and Aliven have been evaluating a partnership over the past months that culminated in the signing of a letter of intent and an expected signing of a definitive agreement in the coming weeks. Consideration for the acquisition of Aliven is approximately 1 million shares of NewAge common stock. Completion of the proposed transaction is subject to negotiation and execution of a definitive agreement and the satisfaction of customary conditions to closing."We see this latest opportunity to expand our Japan market, but at an even faster pace," commented Joseph Wadsworth, NewAge President for Japan and North Asia. "We had good growth in Q4 2020 in Japan, NewAge's largest market. Now, with the addition of Aliven we believe we can accelerate our pace. We expect to fully integrate Aliven into NewAge, and envision imminent cross pollination of our products, including our NONI+CBD Shots where we have first mover advantage in Japan. Our vision for this union is large-scale and not only creates more opportunities for all our representatives, but furthers our expectation to become the leading social selling and distribution company in Japan."

About NewAge, Inc. NewAge is a purpose-driven firm intending to become the world's leading social selling and distribution company. Colorado-based NewAge commercializes a portfolio of organic and healthy products worldwide through primarily a direct route-to-market system. The company competes in three major category platforms including health and wellness, healthy appearance, and nutritional performance and leads a network of more than 400,000 exclusive independent distributors and brand partners around the world. The Company operates the websites NewAge.com, Noninewage.com, Ariix.com, Mavie.com, Thelimucompany.com, Zennoa.com and a number of other individual brand websites and a number of other individual brand websites.

NewAge, Inc.(股票代碼:NBEV)前身為New Age Beverages Corporation,原先公司業務主要經營健康功能的飲料,產品項目包含即飲茶、紅茶菌、能量飲料、瓶裝水等。20207月公司完成與ARIIX等其他四家電子商務與直銷公司合併案,跨足電子商務與直銷業務。

Sunday, July 18, 2021

(Denosumab骨鬆生物藥) 三菱瓦斯化學/台康/醣聯/Cultivecs 接續開發


醣聯攜手三菱瓦斯化學 啟動骨鬆生物相似藥臨床試驗 MoneyDJ新聞 2021-07-12台灣醣聯(4168)宣布,醣聯與日本三菱瓦斯化學(MITSUBISHI GAS CHEMICAL CO., INC.)已於近日簽訂骨質疏鬆症生物相似藥SPD合作協議,將共同進行該項藥物之臨床試驗。醣聯指出,生物相似藥SPD醣聯運用其獨特的技術平台,從基因定序、生產細胞株製備及產程開發、分析技術開發,一路到50公升試量產全程自行開發之生物相似藥。SPD與原廠藥具有極高的相似度,並已由日本三菱瓦斯化學確認1000公升之量產,其品質與醣聯製造之50公升產品一致,但由於去(2020)年以來,COVID-19疫情影響,醣聯在風險考量之下,決定委由台康生技(6589)生產臨床試驗用藥,以加速進入臨床試驗之時程,日本三菱瓦斯化學將來則將承接日本市場的藥品生產。醣聯表示,台康不僅是國內專業經驗非常值得信賴之CDMO,而且在生物相似藥開發的領域也有相當優異的成績,相信此次合作也能為這項產品帶來加分的作用。此產品不僅與原廠藥相似度極佳,醣聯所優化的精簡生產流程更能有效節省成本,使產品更具市場競爭力。醣聯並指出,醣聯與三菱瓦斯化學的合作,將由雙方共同出資,進行SPD後續之臨床試驗,以最快速度啟動該藥物於日本及全球主要市場之臨床試驗工作。醣聯與三菱瓦斯化學自2011年開始在抗體藥物製造上有長期的合作關係,這次的合作是十多年以來雙方規模最大的一次合作投資,這也象徵兩家公司的專業合作及信賴關係更趨穩固。醣聯也表示,調研機構GII研究報告指出,受人口老化影響,全球骨質疏鬆症治療藥市場20202025年的年複合成長率將達5.3%,預估超過2億人受骨質疏鬆症所苦,市場規模超過70億美金。有鑒於此龐大商機,雙方除積極推動SPD的臨床試驗進程,也同步持續拓展與其他國際大藥廠之合作商機,積極與具全球行銷通路之生技藥廠洽商SPD的共同開發及對外授權事宜,希望盡早以高品質的低價藥物,幫助到無法負擔高額藥物的病患。

Prolia (Denosumab) : 對人類RANKL(細胞核因子kappa-B配糖接受體活化因子)具有親和力及專一性的人類IgG2單株抗體,會與RANKL結合,RANKL是一種對蝕骨細胞(會產生骨蝕作用的細胞)之形成、功能與存活極為重要的穿膜蛋白或可溶性蛋白。Prolia可阻止RANKL活化其接受體,亦即蝕骨細胞及其前驅物表面上的RANK。遏阻RANKL/RANK間的交互作用可抑制蝕骨細胞的形成、功能與存活,因此可降低骨蝕作用(bone resorption),並提高皮質骨及小梁骨的骨量與強度。

Successful Mass-culture of Cells Producing Denosumab Biosimilar candidate  March 07, 2019 Mitsubishi Gas Chemical Company, Inc. (MGC; Head Office: Chiyoda-ku, Tokyo; President: Toshikiyo Kurai) has established the conditions that enable the mass-culture of cells producing a denosumab biosimilar candidate (referred to as "denosumab-producing cells" below), which is the antibody drug used to treat diseases such as osteoporosis and multiple myeloma. In order to mass-produce an antibody drug, it is necessary not only to improve the productivity of the cells that produce the antibody used as a drug substance, but also to mass-culture these cells. Maintaining antibody quality while mass-culturing the antibody-producing cells is a key requirement for successful commercial production. Using the denosumab-producing cells and the relevant manufacturing technology transferred from GlycoNex, an MGC partner, MGC had Cultivecs develop technology for mass-culturing those cells. The MGC subsidiary has now successfully identified the conditions for mass-culturing. With the establishment of the technology for mass-culturing denosumab-producing cells, MGC expects to be able to supply large quantities of a high-quality denosumab drug substance at a low cost. For possible joint development in the future, MGC will discuss this with a pharmaceutical company interested in commercializing the denosumab biosimilar. Leveraging the findings gained through developing the mass-culture technology, MGC will continue to develop various antibody drugs.

About denosumab Used for the treatment of diseases such as osteoporosis, multiple myelitis and giant cell tumor of bone, denosumab is the world's first antibody drug to target the RANK ligand, which is the protein required for developing and activating osteoclasts. Denosumab inhibits osteoclast activity.

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