為什麼一個科羅拉多州的小縣可以讓所有居民做新冠肺炎篩檢?

發文時間: 2020/03/27 文 / 李家同. 新竹

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一位美國朋友寄給我的文章,《The Atlantic》是美國精英份子愛看的雜誌,我請一位清大電機系博士生將重要的地方翻譯了。為什麼一個科羅拉多州的小縣可以讓所有居民做新冠肺炎篩檢?

科羅拉多州的聖米格爾縣是一個很小的縣,居民人數只有8000人,縣裡沒有醫院,公共衛生部門只有3位職員。在縣內有一個小鎮叫做特柳賴德鎮,這個小鎮雖然小,卻是一個旅遊勝地,經常有來來往往的旅客,因此使得居民暴露在新冠肺炎傳染的風險中。

聯合生物醫學公司(United Biomedical)的執行長及共同創辦人Mei Mei Hu和Lou Reese夫婦居住在特柳賴德鎮,當他們夫婦得知小鎮醫療資源不足後,就答應捐贈新冠肺炎篩檢的套件,讓聖米格爾縣的所有居民都能接受篩檢。

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Why a Tiny Colorado County Can Offer COVID-19 Tests to Every Resident

There are advantages to having biotech executives as neighbors.

MARCH 23, 2020

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San Miguel County in Colorado has, in ordinary times, fewer than three full-time employees in its public-health department. It has no hospital. Its total population is only 8,000. And yet last week, the county became the first in the United States to announce that it would be offering all its residents a new kind of test for COVID-19.

The tests are being donated by United Biomedical, a multinational biotech company whose executives, a married couple, happen to live part of the year in Telluride, the resort town that is also San Miguel’s county seat.

“It’s a small community,” Mei Mei Hu of United Biomedical told me on the phone from Colorado this weekend. “Very small,” her husband, Lou Reese, added. “Whether it’s just getting a donut or walking by on the street or on the ski hill with the ski patrol,” he said, “we know and have met or interacted with almost every member of the medical or emergency community here throughout the course of our lives.”

Hu and Reese—along with Hu’s mother, Chang Yi Wang, who is United Biomedical’s chairwoman—are the founders of the company’s new COVID-19–focused subsidiary, c19. United Biomedical has facilities in New York, China, and Taiwan, and it develops animal vaccines as well as diagnostic kits for human diseases. So when the novel coronavirus first appeared in China, the company started working on testing, and when cases started showing up closer to home, Hu and Reese thought of their community in Telluride. They floated the idea of testing the county to an old family friend, who also happens to be the area’s chief paramedic. Like they said, it’s a small community.

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數字台灣HD297 疫情蔓延下的新科技投資! 謝金河 劉文雄

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聯生藥抗體新藥UB-221獲中國NMPA核准進行臨床I期試驗

聯合生物製藥(股)公司(聯生藥)今日宣佈,中國國家藥品監督管理局(National Medical Products Administration,NMPA)已核准其開發中抗體新藥UB-221之I 期臨床試驗的申請。此試驗將在健康受試者中評估單劑量UB-221的安全性、耐受性、藥物動力學與藥理學。

目前,另有一項UB-221在人體首次I期臨床試驗正在台灣進行中,目的在於評估單劑量UB-221作為慢性自發性蕁麻疹(Chronic Spontaneous Urticaria,CSU)患者的附加療法的安全性、耐受性、藥物動力學與藥理學(ClinicalTrials.gov Identifier: NCT03632291)。

UB-221是一株第三代人源化抗IgE 單克隆抗體,第一項作用機制是中和游離性IgE,從而阻止IgE與肥大細胞和嗜鹼性細粒細胞上的FcεRI(高親和力IgE受體)結合,進而抑制後續系列反應引發產生的各種過敏症狀。第二項作用機制是與CD23結合的IgE結合,通過穩定B淋巴細胞上膜結合CD23(FcεRII,低親和力IgE受體)進而抑制IgE合成。臨床前研究數據已充分證明UB-221具有比目前市售的抗IgE單克隆抗體更佳的藥理學特徵,包括較高的人類IgE的親和力 (8倍)、降低IgE合成的能力(2-5倍)。UB-221在猴子動物實驗中靜脈注射與皮下注射給藥的平均半衰期分別為10.7 與 11.4天。

通過控制人體內的IgE水平或IgE合成的抗IgE治療已經被確認為過敏性疾病的新型治療選擇。UB-221可開發的適應症包括慢性蕁麻疹、重度氣喘、過敏性鼻炎、嚴重食物過敏和異位性皮膚炎等。

關於 UB-221

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United BioPharma Received Approval from China NMPA for a Phase 1 Trial with UB-221 in Healthy Volunteers

Taipei, Taiwan – Mar. 20 2020 –United BioPharma (UBP) announced approval of an Investigational New Drug (IND) application from China National Medical Products Administration (NMPA) to conduct a phase 1 clinical trial with the company’s anti-IgE UB-221 monoclonal antibody (mAb).

The phase 1 trial is an open label, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of UB-221 in 15~30 healthy volunteers. Another phase I trial of UB-221 in patients with moderate to severe chronic spontaneous urticaria (CSU) is currently underway in Taiwan. (ClinicalTrials.gov Identifier: NCT03632291). A similar clinical trial protocol with UB-221 has also been approved by the US FDA in November 2019.

UB-221 is a humanized, anti-IgE antibody with unique properties not only to neutralize serum free IgE but also inhibit the IgE synthesis by B cells. UB-221 binds free IgE and blocks its binding to the high-affinity receptor FcεRI on mast cells and basophiles, so as to inhibit the release of allergic factors such as histamines, proteases, and inflammatory cytokines. UB-221 can also inhibit the production of new IgE by binding to the IgE already bound on the low-affinity receptor CD23 (FcεRII), a unique IgE binding nature not shared by Xolair® (Omalizumab), the only anti-IgE mAb approved for clinical use. 

In the preclinical, UB-221 exhibits a 3- to 8-fold higher activity in regard to IgE binding, neutralization of IgE binding to the receptor FcεRI, reduction of new IgE synthesis, and suppression of de-granulation from allergic basophils, as compared to Xolair®. A PK study in cynomolgus monkeys demonstrated UB-221 has a longer serum half-life (~11 days with SC administration) than Xolair®.  

Anti-IgE therapy by controlling IgE levels in the body has been identified as a new treatment option for allergic diseases. Potential indications of UB-221 include IgE-mediated allergies such as chronic spontaneous urticaria, allergic asthma, allergic rhinitis, food allergies, and atopic dermatitis.

About UB-221

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新冠肺炎延燒 陳建仁:疫情緩和至少還需兩個月

00:262020/03/24 中時 崔慈悌

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取自陳建仁臉書

新冠肺炎全球延燒,副總統陳建仁深夜發文認為,肺炎肆虐的緩和,至少還需要兩個月的時間。面對外界呼籲全台普檢聲浪,他說,絕大多數病例無法追溯感染源的國家,才有必要採取普檢。臺灣加強密切接觸者及高風險族群的病毒檢驗,「是合宜的、有效的、而且符合成本效益的!」

有抗sars經驗的陳建仁在臉書發文表示,新冠肺炎全球大流行,帶給全人類相當大的恐慌與憂慮,以及生活上的限制與不便。很多人都盼望能夠早日脫離瘟疫的死蔭幽谷,恢復正常、平安、喜樂的生活!

目前各國疫情仍處在上升的階段,他認為,肺炎肆虐的緩和,至少還需要兩個月的時間。目前各國都努力利用病毒檢驗,來加強發現確診病例,予以適切的隔離治療。只是各國病毒檢驗的對象並不相同,有的進行普遍檢驗,有的加強檢驗密切接觸者和高風險族群!

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《#老謝看世界》2020.03.21 不堪「疫」擊 全球展開救市行動 謝金河 李淳 吳孟道

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What is the Corona/ Covid-19 Virus Really Teaching us?

I’m a strong believer that there is a spiritual purpose behind everything that happens, whether that is what we perceive as being good or being bad.

As I meditate upon this, I want to share with you what I feel the Corona/ Covid-19 virus is really doing to us:

- It is reminding us that we are all equal, regardless of our culture, religion, occupation, financial situation or how famous we are. This disease treats us all equally, perhaps we should to. If you don’t believe me, just ask Tom Hanks.

- It is reminding us that we are all connected and something that affects one person has an effect on another. It is reminding us that the false borders that we have put up have little value as this virus does not need a passport. It is reminding us, by oppressing us for a short time, of those in this world whose whole life is spent in oppression.

- It is reminding us of how precious our health is and how we have moved to neglect it through eating nutrient poor manufactured food and drinking water that is contaminated with chemicals upon chemicals. If we don’t look after our health, we will, of course, get sick.

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无需等临床结果,东京大学刚刚宣布已找到能有效阻止新冠病毒的入侵的特效药

Original 指北酱の工作室 留日指北

东京大学医学科学研究所亚洲传染病研究中心的井上淳一郎及其团队与3月18日下午对外公布公布,原用作治疗胰腺炎的药品萘莫司他(nafamostat)在浓度低至1-10 nM时能明显阻止新冠肺炎病毒侵入人体。

东京大学医学科学研究所亚洲传染病研究中心的井上淳一郎教授和山本瑞雄助教授表示,新型冠状病毒感染的致病病毒SARS-CoV-2(COVID-19)是首先进入细胞的,若保证安全定量的膜融合测定系统,使用丝氨酸蛋白酶抑制剂萘莫司他(nafamostat)的话,浓度将为之前使用的融合抑制剂的浓度的十分之一。

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微信視頻 : 新冠病毒隨之而來的反省

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A third of coronavirus cases may be ‘silent carriers’, classified Chinese data suggests

  • More than 43,000 people in China had tested positive without immediate symptoms by the end of February and were quarantined
  • It is still unclear what role asymptomatic transmission is playing in the global pandemic

Josephine Ma, Linda Lew and Lee Jeong-ho
Published: 6:00pm, 22 Mar, 2020

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Scientists have been unable to agree on what role asymptomatic transmission plays in spreading Covid-19. Illustration: Perry Tse

The number of “silent carriers” – people who are infected by the new coronavirus but show delayed or no symptoms – could be as high as one-third of those who test positive, according to classified Chinese government data seen by the South China Morning Post.

That could further complicate the strategies being used by countries to contain the virus, which has infected more than 280,000 people and killed nearly 13,000 globally.

More than 43,000 people in China had tested positive for Covid-19 by the end of February but had no immediate symptoms, a condition typically known as asymptomatic, according to the data. They were placed in quarantine and monitored but were not included in the official tally of confirmed cases, which stood at about 80,000 at the time.

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德國新冠肺炎死亡率低 原因曝光

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德國已實施關閉學校、公共設施、餐館酒吧等嚴格的防疫措施。圖為慕尼黑的地鐵站空蕩蕩。(路透)

德國新冠肺炎確診死亡率維持在低水準。德國專家認為,這要歸功於德國強大的疫情監控體系、檢測能力和重症醫療能力,但能否繼續保持低病亡率,取決於能否控制疫情快速蔓延。

據德國媒體NTV21日報道的最新數據,德國新冠肺炎累計確診病例已超過2萬例,據德國疾控機構羅伯特·科赫研究所20日公佈的數據,目前德國新冠肺炎死亡病例共31例,病亡率遠不到1%。

德國亥姆霍茲傳染研究中心流行病學科負責人克勞澤認為,目前病亡率較低有幾個原因。

新華社報導,首先,德國很早得到預警,德國科研團隊1月初便開發出快速檢測試劑,羅伯特·科赫研究所也公佈了詳盡的病例定義等指導文件。

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LIVING A SURRENDERED LIFE


Is there something God is asking you to relinquish to Him? In military terms, surrender means defeat, but as followers of Jesus, it means victory over whatever is hindering our Christian life. In this message, Dr. Stanley explores what it means to ask the Lord for His will to be done in our lives and encourages us to let go of anything that God says is not for our best. We lose nothing when we yield everything to Him.

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聖經鳥瞰21 但以理書 (王生台弟兄)

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聯亞生技四路並進 攻堅新冠肺炎病毒帶來的災難

聯亞生技集團於3月19日受新竹科學園區管理局之邀請參加記者會,於記者會由聯亞藥業研發營運長彭文君博士代表集團發表有關COVID-19檢測試劑、疫苗及治療藥物之近期開發進度。

新冠肺炎(COVID-19)疫情自2019年底爆發至今,情勢愈益嚴峻,疫情仍正加速在全球升溫,為了這場與新冠肺炎病毒的超級戰役,UBI集團董事長暨科學長王長怡博士與團隊投入對2019-nCoV病毒的抗體診斷試劑及對抗COVID-19的疫苗與治療藥物之設計,運用其在功能性抗原學逾30年的研究與商業化經驗,以及在重組蛋白藥物領域的20年產業經驗,展開一系列的產品開發計畫,包括:

1. 以合成肽為抗原的病毒抗體診斷試劑:
UBI集團的「合成肽病毒抗體檢測試劑」技術平台發展完善且驗證良好,過去已成功開發出全球獨佔的HIV、HCV、HTLV及FMDV血液抗體檢測試劑,這種原理的檢測試劑精確度高,且因檢測容易並可透過高通大量使用,所以可以與分子檢測試劑RT—PCR互補達到更佳的檢測與診斷效果。在2003年SARS爆發之際,也曾運用此技術平台在短短4個月內設計出可以診斷SARS病毒感染的抗體檢測試劑,並與台大醫學院高全良、薛博仁、李君男等教授及中研院何美鄉研究員合作驗證、結果顯示具100%專一性及高靈敏度。成果於2004年9月發表於美國CDC之Emerging Infectious Disease 期刊。團隊此次快速設計出的新冠病毒(SARS-CoV2)抗體血液檢測試劑已與國際合作夥伴進行大規模測試、驗證其高專一性,於3月16日向美國FDA提交緊急使用前授權申請案(Pre-Emergency Use Authorization),並將在台灣與大陸多城市作流行病調研的各種測試。

2. 高精準設計型疫苗(high precision designer vaccine):
UBI集團全球獨家的專利技術平台UBITh® 也可應用在合成肽疫苗的設計。UBI團隊設計出標靶在S蛋白RBD "尖端"的新冠肺炎疫苗,三月中起即可陸續取得免疫血清,進行與新冠病毒的中和(Neutralization)測試。此精準設計(包括B細胞表位、毒殺T細胞表位及輔助T細胞表位)的疫苗開發計畫正準備與相關病毒學實驗室進行測試。待時機成熟便立即申請I / II期臨床試驗。UBI集團的高精準設計型疫苗平台過去曾成功開發豬口蹄疫合成肽疫苗(於2004年取得中國農業部頒發第一類新獸藥證並且已經在豬隻保健產品市場全球最大中國累計銷售40億劑)、公豬免疫去勢疫苗(2014年在台灣取得許可證已行銷十多國),並就人用疫苗展開各臨床試驗,包括阿茲海默症疫苗UB-311(已完成第二期臨床試驗,即將進入第三期臨床試驗)、帕金森氏症疫苗UB-312(已完成第一期人體臨床試驗且即將在病人受試者進入二期臨床試驗)以及過敏疫苗UB-211(第一期臨床試驗IND已獲准,即將開始執行)等。

3. 亞單位疫苗(subunit vaccine):
聯生藥(台灣)和聯亞藥(上海和揚州)由彭文君博士(總經理)與王長怡博士主導帶領的團隊亦正開發以CHO 細胞來表達2019-nCoV S 蛋白RBD-scFc 融合蛋白作為亞單位疫苗(subunit vaccine)之備用疫苗。

4. 治療2019-nCoV 病毒的蛋白質藥物:
聯生藥(台灣)和聯亞藥(上海和揚州)彭文君博士團隊亦進行以CHO 細胞來表達長效型ACE2-scFc 蛋白,以作為新冠肺炎之抗病毒療法,替代取自感染後康復的患者體內之中和性抗體療法。新冠病毒乃是透過結合ACE2 受體進入宿主細胞內。UBI 集團團隊開發的ACE2-scFc 蛋白可競爭性抑制新冠病毒進入宿主細胞。該產品的最大優點是,儘管病毒發生突變,亦不影響該蛋白質對於病毒的阻礙進入作用,對於受病毒感染病患之療效將比中和性抗體好且半衰期長。
由王博士帶領的UBI團隊已在兩月中完成以SARS-CoV2病毒與其受體ACE2有關的生物資訊為主而設計的抗體診斷試劑、疫苗及治療藥物系列產品與其製造程序細節之廣泛專利申請。回顧過往在HIV、HCV、FMDV、SARS等緊急流行病爆發危機下,王博士都帶領團隊盡力參與貢獻,目前集團資源比以前深厚,將會更快速整合可支配的資源,帶領團隊積極達成抗疫目標!

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