分類彙整：公司新聞

聯合生物製藥(股)公司(聯生藥)今日宣布，抗皰疹病毒單株抗體藥物UB-621已獲得美國FDA批准在由HSV-2感染所引起之復發型生殖器皰疹 (Recurrent Genital)患者族群上進行臨床第2期試驗: “A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 in Adults with Recurrent Genital HSV-2 Infection”。UB-621可透過和病毒(HSV-1和HSV-2) 外表包膜上gD 蛋白之靶點作高親和力結合的機制1，阻止病毒侵入宿主而抑制感染。 繼續閱讀 →

Taipei, Taiwan, June 10th , 2019 — United BioPharma (UBP) announced the receipt of Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 2 clinical trial with UB-621 monoclonal antibody for recurrent genital infection caused by Herpes Simplex Virus, type II (HSV-2). UB-621 works to inhibit the infection through high-affinity binding to the same epitope on viral surface envelope gD protein on both type I (HSV-1) and type II (HSV-2) viruses.1 繼續閱讀 →

Taipei, Taiwan, May 21, 2019 — United BioPharma (UBP) announced today that the company has obtained U,S. FDA’s permission to conduct a clinical trial with UB-421 in the USA, under the protocol entitled “A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination with Optimized Background Therapy (OBT) Regimen in Patients with Multi-Drug Resistant (MDR) HIV-1 Infection.” 繼續閱讀 →

聯合生物製藥(股)公司(聯生藥)今日宣布，其治療愛滋病單株抗體新藥UB-421規劃在台灣、泰國與中國三個地區執行之多國多中心臨床3期試驗，已於5月10日獲中國國家藥品監督管理局(National Medical Products Administration， NMPA)核准執行。此臨床試驗計劃先前已分別獲台灣衛生福利部食品藥物管理署 (TFDA)與泰國食品藥品管理局(Thailand FDA) 核准。 繼續閱讀 →

Taipei, Taiwan, May 13, 2019 — United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a multi-nation, multi-center phase 3 clinical trial with UB-421 substitution monotherapy for HIV-infected adults who are on a stable treatment course of antiretroviral therapy (ART). The INDs of this trial had been approved earlier by Taiwan and Thailand regulatory agencies. 繼續閱讀 →

Administration of a single broadly neutralizing human immunodeficiency virus (HIV)–specific antibody to HIV-infected persons leads to the development of antibody-resistant virus in the absence of antiretroviral therapy (ART). It is possible that monotherapy with UB-421, an antibody that blocks the virus-binding site on human CD4+ T cells, could induce sustained virologic suppression without induction of resistance in HIV-infected persons after analytic treatment interruption. 繼續閱讀 →

HIV treatment has come a long way since the early days of the epidemic. Patients can now take various combinations of dozens of medications keep the virus under control and halt their disease from decimating their immune systems and leading to more serious, often fatal outcomes.

But harnessing HIV requires daily vigilance. Missing doses of the pills can give the virus the chance to develop resistance to the drugs and lead to a surge in new copies of HIV that flood the body.

In a new study published in the New England Journal of Medicine, researchers at Taiwan-based United BioPharma report encouraging results with a single injection that seems to stymie HIV as well as daily pill regimens. The results add to a growing number of studies suggesting that patients may be able to take pill holidays without putting their health at risk. 繼續閱讀 →

Regular infusions of an antibody that blocks the HIV binding site on human immune cells may have suppressed levels of HIV for up to four months in people undergoing a short-term pause in their antiretroviral therapy (ART) regimens, according to a report published online today in The New England Journal of Medicine. Results of the Phase 2, open-label study indicate the antibody, known as UB-421, was safe and did not induce the production of antibody-resistant HIV. The study was supported in part by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, and United Biopharma, Inc. 繼續閱讀 →

United BioPharma Announces Publication of Breakthrough HIV Clinical

Trial Data in the New England Journal of Medicine 繼續閱讀 →

聯合生物製藥(股)公司(聯生藥)今日宣布,其治療 HIV 感染之抗體新藥 UB-421
之臨床 II 期試驗結果以「Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound
after Treatment Interruption」為題的原創論文,榮獲刊登於最新一期的新英格
蘭醫學期刊(The New England Journal of Medicine, NEJM)。 繼續閱讀 →

UB-421 Q & A 繼續閱讀 →

For two decades, biotech companies trying to tackle Alzheimer’s disease have had little success. While vaccines have often shown promise for certain patients, they’ve come with devastating side effects for others—brain swelling, for example—because researchers haven’t been able to reliably keep patients’ immune systems from kicking into overdrive when exposed to the vaccines. Now, a four-year old Dublin startup believes it may be on to something. 繼續閱讀 →

2018 維也納聖誕音樂會 繼續閱讀 →

愛因斯坦曾富哲理地說過：「有時候『重要的』無法計算，能計算的又不重要。」知識，正具有無法量化的重要性。 繼續閱讀 →

Watch This CEO Discuss A Potentially Ground-Breaking Vaccine for Alzheimers 繼續閱讀 →