分類彙整:生醫新知

陳時中率領防疫團隊視察UBI/聯亞集團,新冠疫苗研發生產一條龍,盼年底進入人體臨床試驗

今(19)日衛福部長陳時中率國家防疫團隊之政委吳政忠、台大副校長張上淳等人訪察聯合生物製藥(股份有限)公司(以下稱聯生藥),以了解UBI/聯亞集團所開發的新冠疫苗開發進度,及擬作為委託生產基地聯生藥的生產產能。 繼續閱讀

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News Feature: Avoiding pitfalls in the pursuit of a COVID-19 vaccine

As they race to devise a vaccine, researchers are trying to ensure that their candidates don’t spur a counterproductive, even dangerous, immune system reaction known as immune enhancement. 繼續閱讀

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联生药(扬州)生物医药有限公司通过药品生产许可证现场核查

2020年4月29日江苏药品监督管理局扬州直属分局徐剑秋局长带领专家组对联生药进行了为期两天的药品生产许可证现场核查。 繼續閱讀

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聯生藥抗體新藥UB-421用於多重抗藥性愛滋病患3期臨床試驗獲台灣FDA核准執行

聯合生物製藥(股)公司(聯生藥)今日宣佈,其抗體新藥UB-421應用於治療多重抗藥性(multi-drug resistant (MDR)HIV感染病患之3期臨床試驗已獲台灣FDA核准執行。這項研究是一個多國試驗,將包括台灣,中國和泰國。相同的臨床試驗方案將接續向中國和泰國的監管機構提交。 繼續閱讀

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United BioPharma Received Approval from TFDA for a Phase 3 Trial with UB-421 in Patients with Multi-Drug Resistance (MDR) HIV-1 infection

Taipei, Taiwan – Apr. 27, 2020 – United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from Taiwan FDA to conduct a Phase 3 clinical trial with UB-421, an anti-CD4 monoclonal antibody, in patients with multi-drug resistant (MDR) HIV-1 infection. The study is a multi-nation trial which will include Taiwan, China and Thailand; the same protocol will be submitted to the regulatory agencies in China and Thailand in the coming months. 繼續閱讀

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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. 繼續閱讀

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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

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. 繼續閱讀

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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.  繼續閱讀

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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?

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。 繼續閱讀

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

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. 繼續閱讀

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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。 繼續閱讀

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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). 繼續閱讀

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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: 繼續閱讀

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檢測試劑來了!美FDA授權開賣

檢測試劑來了! 美FDA授權開賣 繼續閱讀

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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. 繼續閱讀

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