Coronavirus: The Hammer and the Dance

What the Next 18 Months Can Look Like, if Leaders Buy Us Time

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This article follows Coronavirus: Why You Must Act Now, with over 40 million views and 30 translations. If you agree with this article, consider signing the corresponding White House petition. Translations available in 29 languages at the bottom. Running list of endorsements here. 9 million views so far.

Summary of the article: Strong coronavirus measures today should only last a few weeks, there shouldn’t be a big peak of infections afterwards, and it can all be done for a reasonable cost to society, saving millions of lives along the way. If we don’t take these measures, tens of millions will be infected, many will die, along with anybody else that requires intensive care, because the healthcare system will have collapsed.

Within a week, countries around the world have gone from: “This coronavirus thing is not a big deal” to declaring the state of emergency. Yet many countries are still not doing much. Why?

Every country is asking the same question: How should we respond? The answer is not obvious to them.

Some countries, like France, Spain or Philippines, have since ordered heavy lockdowns. Others, like the US, UK, or Switzerland, have dragged their feet, hesitantly venturing into social distancing measures.

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Why coronavirus antibody testing in one Colorado town could provide a way forward

Testing in the ski town Telluride could allow for fewer restrictions nationwide.
By Dr. Mark Abdelmalek,Eden David and Josh Margolin 29 March 2020

While it might be impossible to figure out who is going to become sick with novel coronavirus, some public health experts believe the more critical question may be who has already been exposed.

In Telluride, Colorado, last week, one biotech company put that idea to work.

United Biomedical is now working with San Miguel County, which includes the famous Rocky Mountain ski destination, to test all 8,000 residents for COVID-19 antibodies — making it the first community in the country to do widespread antibody testing. The idea, officials said, is to learn from an individual’s blood whether there is evidence the person has already been exposed. With that information, officials can then make decisions about whether quarantines and restrictions would need to continue and whether they need to be as widespread as they are in states and cities across the country right now.

“The goal of this is to show you can predictably get an entire county back to its new normal as quickly as possible by using testing," said Lou Reese, co-CEO of United Biomedical and its COVAXX subsidiary.

Reese stressed that, if successful, the testing program could be expanded, “starting at the hot-spot areas right now to solve this problem, stop the panic and get people to their lives and back to work."

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「我們的任務是在這個非我所願的複雜混沌的時刻,展示自己最好的品格和行為。願我們與智慧和風度同行。」– Lawrence Bacow, President of Harvard University

For Immediate Release
Contacts: Diane Murphy (diane.aquariusgroup.net; +1.310.658.8756)
Susan Lilly (SusanL@SanMiguel Sheriff.org)

MEDIA ALERT

UNITED BIOMEDICAL GROUP’S C19 COMPANY PARTNERS WITH SAN MIGUEL COUNTY, COLORADO TO BE FIRST IN NATION TO TEST AN ENTIRE COUNTY FOR COVID-19 WITH NEW ANTIBODY DIAGNOSTIC TEST

Telluride, CO (March 19, 2020) –United Biomedical, Inc. (UBI) and its subsidiary c19 are taking on the COVID-19 pandemic by partnering with San Miguel County, Colorado, to be the first in the United States to test an entire county with their COVID-19 antibody test for the SARS-CoV-2 virus. The testing is being offered free of charge by UBI and c19 and will be administered by the Public Health Department of San Miguel County, with the goal of detecting and containing community spread, and providing a more accurate assessment of disease prevalence.

 “We are thankful for UBI/c19 for taking the leadership to offer these accurate blood tests to our entire county, free of charge, which can be instrumental in saving lives,” said Sharon Grundy, Public Health Medical Officer for San Miguel County and Medical Director of Primary Care at the Telluride Medical Center. “When we reported this in our county meeting, yesterday, the entire team cried.” 

UBI is a leading international biopharmaceutical group that has successfully developed diagnostics and vaccines for chronic and infectious diseases for more than 30 years. The company has developed an antibody blood screening test for COVID-19 and, at the same time, is progressing a vaccine for COVID-19, which is currently in animal testing. The company is leveraging its prior work with SARS and its extensive collaborations in China, Taiwan and the world, to validate and commercialize this antibody diagnostic test and vaccine through existing manufacturing infrastructure. Through its c19 subsidiary, the company will be one of the first in the nation to offer these antibody tests. 

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Frequently asked questions about UBI SARS-CoV2 ELISA

Who is the UBI Group? 

UBI Group was founded in 1985 and currently has over 5 operating entities and 950 employees globally. We have facilities in China, Taiwan, Ireland and the US. For the past three decades, we have developed, manufactured and sold HIV, HCV, HTLV and FMDV blood diagnostic kits worldwide through various distribution partners including Organon Teknika and BioMerieux. We have also developed, manufactured and sold over 4.5 billion vaccines and ~500 million doses annually through partners. Dr. Chang Yi Wang, our Chief Scientific Officer, is inventor and author of over 100 patents and peer-reviewed publications. She has, together with the UBI team, pioneered the employment of antigenic peptides in the development of  4 blood screening test kits for detection of antibodies to HIV, HCV, HTLV I/II and FMDV for identification and differentiation of viral infections and 2 licensed synthetic peptide based vaccines (FMDV and LHRH) which are globally distributed. She has been awarded Inventor of the Year Award (NYPLA), Pioneer in Technology Award (BMSF), and recipient of funding from Gates Foundation, MOEA and multiple NIH grants over $20M, including for SARS antibody screening diagnostic work. She is currently collaborating with Dr. Anthony Fauci/NIAID and colleagues on HIV functional cure program, and discussed extensively with Dr. Redfield in this area, both leaders in the coronavirus response today.

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全面檢測新冠肺炎的方法:14天內兩次檢測抗體 — 丘福隆博士 撰作

檢測新型冠狀病毒可知:(1)病人是否為新冠肺炎患者。(2)新冠肺炎的傳播疫情。(3)採取何種有效防疫手段方不致崩解醫療體系。

大量且全面的篩檢能夠防止外方患者的進入以及處理內方患者的適切隔疫,從而掌控疫情。若不然,必須採取類似武漢封城的激進手段才能有效制止疫情擴大。

新冠肺炎的核酸診斷試劑採取檢測病毒核酸片段的方法。其專一性、技術要求與價格均甚高。將其測試結果與臨床數據配合使用時,有助於病情的診斷。但是,由於採樣困難及其他不明原因,這種試劑的檢出率不高。

此外,大部分確診患者竟然是從無症狀患者得到感染。確實,因感染症狀經常在5天或更長時間後才顯示症狀(長潛伏期),而已感染的年青人則往往因抗體濃度甚高而呈無症狀狀態,造成無症狀下散播疾病的諸多病例。

顯然,臨床診斷(看症狀)與核酸檢測(測新冠病毒)無法應付「無症狀感染」的挑戰。

當身體被病毒侵入時免疫系統會產生抗體。IgM抗體會在7天後達到定量,而IgG抗體會在14天後達到高量。這些抗體有兩種作用:直接接上病毒把它糾纏至死,或接上病毒後再呼喚免疫細胞前來將病毒殺死。

因此,一旦檢測出抗體便表示患者曾經受到感染,不論有無症狀。

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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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檢測試劑來了!美FDA授權開賣

[台灣之光]聯亞生技集團(UBI)旗下聯合生物製藥(聯生藥)展現研發能量,已開發出新冠病毒抗體血液檢測試劑,與國際合作夥伴大規模測試後,準確率達100%。該公司3月18日已獲美國食品藥物管理局(FDA)通過緊急使用授權申請,將開始上市銷售。

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United BioPharma Received Approval from China NMPA for a Phase 2 Trial to Evaluate the Reduction Effect of UB-421 mAb on Latent HIV Reservoirs in ART-stabilized HIV Patients

Taipei, Taiwan – March 17, 2020 – United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a Phase 2 clinical trial to evaluate UB-421’s efficacy on reduction of latent HIV reservoirs in Antiretroviral Therapy (ART)-stabilized HIV patients. 

This is a proof-of-concept (POC) study for functional cure of HIV infection. A similar study protocol has been approved by the Taiwan FDA, with  a clinical trial in progress since September 2019.

The trial in China will enroll 40 ART-stabilized patients whose plasma HIV viral load is maintained at a level below 50 copies/mL. During the 48-week treatment period, study participants will receive 25 mg/kg  of UB-421 either bi-weekly or monthly in addition to ART. At the end of the study, several key parameters, including the level of total HIV DNA, will be analyzed.  

ART alone cannot cure HIV infection due to permanent persistence of latent HIV reservoirs.  Patients must adhere to ART for lifebecause plasma HIV viral load will rebound shortly upon ART interruption.  The latently infected cells can reactivate and begin to produce HIV when the suppressive effect of ART is removed.  

Researchers around the world have been diligently seeking therapy for cure of HIV infection. A “functional cure of HIV infection” represents that an HIV infected individual has healthy immune function and the ability to maintain the viral load at an undetectable level in the absence of ART, so as to prevent disease progression and transmission.

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中國NMPA核准聯生藥治療愛滋病抗體新藥UB-421 之一項評估減少病患HIV病毒儲存庫的臨床II期試驗申請

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)核准其治療HIV-1感染抗體新藥UB-421之II 期功能性治癒概念驗證臨床試驗的申請。此試驗將在穩定接受抗逆轉錄病毒治療 (Anti-retroviral Therapy,ART)的 HIV-1感染患者中,研究UB-421與ART 聯合使用對於降低病患體內 HIV 病毒儲存庫 (HIV reservoir)的效果, 類似之方案目前也正在台灣進行臨床試驗中。

自1996年開始使用於控制HIV-1感染者的抗逆轉錄病毒藥物療法 (ART)已經使愛滋病成為一種可控制的慢性病,多數患者也可維持良好生活品質,但患者必須終生服用抗逆轉病毒藥物,若終止藥物治療一段時間,血液中被壓制的HIV載量立即會反彈回升 (HIV rebound),因此,ART療法仍無法治癒愛滋病。

愛滋病患體內的HIV病毒無法被ART藥物根除之原因在於當HIV感染宿主細胞 (CD4+ T細胞)後,HIV RNA反轉錄(reverse transcription)的HIV DNA會嵌入至宿主細胞DNA中成為”HIV 前病毒(HIV provius)”,部分HIV 前病毒不會馬上複製,而是進入不活動的狀態。這些帶有前病毒的免疫細胞即所謂潛伏性HIV儲存庫( latent HIV reservoir)。“前病毒”可隨時被重新激活並進入複製週期產生新HIV病毒,但休眠的HIV 儲存庫則無法被體內免疫系統辨識與消滅。而潛伏性HIV儲存庫的長期存在是導致愛滋病無法被目前藥物治癒的主要原因。

許多研究人員一直在努力尋找治癒HIV-1感染的藥物與療法。HIV 功能性治癒 (HIV functional cure)意指已治療的愛滋病患者在停止藥物治療的狀況下,體內的HIV載量仍可維持在偵測不到之水平,且患者保有正常的免疫功能、無愛滋病症狀、也不會傳播HIV。

功能性治癒HIV-1感染的策略之一是「Shock、Kill and Block」,將休眠的前HIV病毒激活(Shock)而表現HIV抗原於細胞表面、從而使免疫細胞辨識到HIV抗原而將該潛伏感染的細胞殺死 (Kill),並且保護未受感染之健康細胞不受HIV感染(Block)。先前前臨床與臨床實驗數據顯示,標靶在CD4 受體蛋白的UB-421 具有抑制非細胞接觸型傳播(cell-free HIV transmission)與細胞接觸型傳播(cell-to-cell HIV transmission )的作用可阻止HIV進入宿主細胞內感染,臨床II期試驗結果發現UB-421單藥使用(monotherapy)可有效降低HIV感染病患的病毒載量,16週的施打期間無受試者出現病毒反彈現象,且能降低HIV前病毒DNA含量約2倍(亦即使HIV病毒儲存庫減少) ,此外,UB-421也被觀察到有免疫調節功能,包括使HIV專一性的CD8+ T 細胞數目增加,抑制調節性CD4+T細胞 (Treg)百分比減少。基於上述特性,聯生藥設計UB-421併用ART聯合療法為期48週臨床方案,藉以評估此療法的安全性與降低HIV 儲存庫的效果,作為進一步設計功能性治癒HIV感染治療方案的基礎。

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騰訊新聞:新型冠狀病毒肺炎疫情實時追蹤

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Coronavirus Dashboard

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预防 2019 年新型冠状病毒 (2019-nCoV) 传播给家庭和社区中其他人的暂行指南

本暂行指南基于目前已知的有关 2019 年新型冠状病毒 (2019-nCoV) 和其他病毒的呼吸道感染传播情况。美国疾病控制与预防中心 (CDC) 将根据需要并在获得更多信息时,更新此暂行指南。

冠状病毒是一大类病毒,其中一些会导致人类患病,而另一些会在动物(包括骆驼、猫和蝙蝠)之间传播。在罕见情况下,动物冠状病毒能进化并感染人类,然后在人群中传播,例如在中东呼吸综合症 (MERS) 和严重急性呼吸道症候群 (SARS) 中所见到的情况。2019-nCoV 的人传人可能性尚不明确。以下暂行指南可能有助于预防这种病毒在家庭和社区的人群中传播。

此暂行指南适用于以下情况:
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The Next Pandemic

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《文茜世界周報》人類對新冠病毒了解有限 面對疫情如蒙眼打怪

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31 questions and answers about COVID-19

My thoughts on what to do now and other topics.
By Bill Gates| March 19, 2020

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Yesterday I did a Reddit Ask Me Anything session on COVID-19. As usual, Redditors asked a lot of smart questions, and it was a great opportunity to have a fact-based discussion about this pandemic and what we can do to prevent the next one. (And as I mentioned in this exchange, it’s nice to have so many positive interactions in such an uncertain time.)

Below is a transcript of all the questions I could get to (lightly edited for length), along with my answers. I’ll be sharing more about COVID-19 here on the Gates Notes and on my social channels. In the meantime, stay healthy and keep washing your hands!

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The Tip of the Iceberg: Virologist David Ho (BS ’74) Speaks About COVID-19

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As of March 20, more than 8,700 people worldwide had died of COVID-19, the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Caltech trustee David Ho (BS ’74) of the Aaron Diamond AIDS Research Center, Columbia University, says that this is just the tip of the iceberg. Ho, an expert on viral epidemics, has spent decades researching HIV/AIDS, having begun his career in Los Angeles, “ground zero" of the first outbreak, in the early 1980s. On March 18, Ho sat down with members of the Caltech community to discuss the novel coronavirus and the future of our society in the light of this global pandemic.

Walk us through the spread of the virus in the United States. What does the country look like right now?

Let me just give you a picture of what I see here in New York. About two weeks ago, we had our initial case, and now in New York City newly diagnosed confirmed cases are tripling every two days. In our New York Presbyterian Hospital, approximately 25 percent of the swab samples that are submitted for testing are positive. In the suburban communities outside of New York, approximately 10 percent of the swabs submitted are positive. So, the virus is everywhere. And in New York, we know that we are in the exponential growth phase of the epidemic.

Looking back at what has transpired throughout the world, we saw the first wave hit China; the second wave hit South Korea, Italy, and Iran; and then, trailed by only about a week or so, France, Germany, Spain, and the U.S. We all know that China went through a period of great devastation. It has over 80,000 cases. Italy is rapidly catching up, with over 31,000 cases. We suspect that in the U.S. this will rapidly sweep from the coastal regions and it will hit middle America. It is already there, but we will see exponential growth very, very soon. Then of course we are all worried about what would happen when this epidemic strikes places like Africa and India where the health care system is less developed.

Can you tell us about the pathology of the disease?

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《文茜世界周報》韓國防疫套裝三個 T : 追蹤 篩檢 治療分流

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《#老謝看世界》2020.03.28 全球「疫」相引爆經濟熔斷潮 百工百業生存戰 謝金河 龔明鑫

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THE SEVEN HABITS OF A GODLY LIFE


Brushing teeth, drinking a cup of coffee, scrolling through social media—habits like these streamline the rhythm of our daily lives. But not all habits are equal, or even beneficial. In this message, Dr. Stanley details the seven habits that undergird a healthy spiritual life. He encourages us to dedicate ourselves to practices like prayer, generosity, and forgiveness. Make pursuing godliness a habit—you won’t regret it!

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聖經鳥瞰22 小申言者書 (王生台弟兄)

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微信視頻:在全民因新冠病毒在家自我管理之時、看看軽鬆的人生一面

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野火.空汙與防疫 催生澳洲第一個口罩生產廠!用時尚設計打破西方文化口罩迷思【消失的國界】

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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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