Antroquinonol Malaysia

29/01/2024

/PRNewswire/ -- Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, announces the release of...

08/05/2023

Targeting RAS: Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer

TAIPEI, May 5, 2023 /PRNewswire/ -- Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, announces the release of positive interim results from its Phase II clinical trial of Antroquinonol (HOCENA®) in combination with the standard of care (SOC) nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer. The median overall survival (mOS) was 12.6 months, which was 48% better than the 8.5 months mOS in the Phase III clinical study of the standard of care (nab-paclitaxel + gemcitabine). Compared to the current first-line treatments for this difficult to treat cancer, this study demonstrated that Antroquinonol in combination with SOC showed a significant survival advantage.

https://www.prnewswire.com/news-releases/targeting-ras-golden-biotech-announces-positive-results-with-longer-survival-compared-with-standard-treatments-from-interim-analysis-of-phase-2-trial-for-antroquinonol-as-1st-line-treatment-for-stage-4-metastatic-pancreatic-cance-301817006.html

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

/PRNewswire/ -- Golden Biotechnology Corp. (TPEX 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical drug development company, announces the release of...

25/07/2022

國鼎新冠新藥 Antroquinonol 美EUA獲書面受理 9月公布審查結果

國鼎 (4132-TW) 今 (25) 日公告，旗下新冠肺炎新藥的緊急使用授權前會議請求(Pre-EUA Meeting Request)，獲得美國 FDA 同意，除了將提出書面審查外，預計美國 9 月 9 日將會有審查結果。

國鼎開發的新冠新藥 Antroquinonol，是用來治療輕度至中度症狀的新冠肺炎住院病人，該新藥臨床試驗結果，委由 CRO 公司 (臨床試驗受託機構) 向美國 FDA 提出申請 Pre-EUA Meeting Request (緊急使用授權前會議請求)。

國鼎今日接獲 CRO 公司通知，美國 FDA 正式批准 Pre-EUA Meeting 會議請求，並通知會議時間及開會方式，會議將以書面審查方式進行，依照規定，開會審查整套文件需在美國時間 8 月 9 日前遞交完成。

國鼎表示，雖然文件送繳日期在 8 月，不過會儘速提供以利審查，此外，FDA 目前提供書面審查結果的答覆日期，暫定為美國時間 9 月 9 日，若時間有改變將另行通知。

國鼎開發中新冠新藥 Antroquinonol 二期臨床試驗於今年初完成，從試驗結果來看，主要評估指標康復率，病患在第 14 天用藥組的康復率是 100%，對照組的康復率是 96.0%。

國鼎 (4132-TW) 今 (25) 日公告，旗下新冠肺炎新藥的緊急使用授權前會議請求(Pre-EUA Meeting Request)，獲得美國 FDA 同意，除了將提出書面審查外，預計美國 9 月 9 日將會有審查結果。

18/04/2022

Taiwan國產新冠口服藥有譜？ 國鼎 Antroquinonol：實驗有效抑制Omicron

國內新冠口服藥到底夠不夠，指揮官陳時中回應，國內準備了百分之3人口的抗病毒藥物，超過70萬人份，目前是夠的。而國產新冠口服藥，國鼎生技則完成二期臨床試驗，國外實驗室報告，也證明能有效抑制Omicron病毒。訂閱【.....

18/04/2022

輝瑞、默克還不夠，加速解封國門還需哪些口服藥？

https://www.gvm.com.tw/article/87934

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

衛福部長陳時中一度表示，新型口服藥將是加速台灣解封的關鍵，此發言不禁讓人好奇，既有的口服藥市場，究竟還有哪些欠缺？台灣目前投入新冠口服藥的廠商，又看見了哪些潛在市場？

08/01/2022

💯% Covid-19 Recovery Rate - GoldenBiotech Announces Topline Results from Unblinded COVID-19 Trial for Oral New Drug in Hospitalized Mild, Moderate and Severe Patients.

Golden Biotechnology Corporation reported Wednesday on the preliminary results of its Phase II clinical trials for antroquinonol, its new COVID drug to be taken orally. The company''s representatives said they would apply for emergency use authorization from the U.S. FDA in March. Phase III trials will be conducted in Europe, South Korea and Singapore. Let''s hear from the company.

Today Su
Golden Biotechnology Corporation CEO
We will receive the clinical study report around April. We have asked them to see if we can get it in March, so we can discuss the matter with the FDA. If we get the green light, we will apply for emergency use authorization.

Alex Liu
Golden Biotechnology Corporation president
Phase III trials will be conducted in Europe, Singapore and South Korea. We will have more than 50 clinical trial centers, so that we can enlist subjects more quickly.

So far, Golden Biotech tested its drug on 124 hospitalized patients in the U.S. and South America. COVID recovery rate reached 97.9% by the 14th day after administering the drug. By the 28th day, the recovery rate reached 100%, with no deaths or respiratory failures reported. The treatment also shortened ICU stays to just 9.5 days.

08/01/2022

💯% Recovery - GoldenBiotech Announces Topline Results from Unblinded COVID-19 Trial for Oral New Drug in Hospitalized Mild, Moderate and Severe Patients

TAIPEI, Jan. 7, 2022 /PRNewswire/ -- Golden Biotechnology Corp.(TPEx:4132) ("GoldenBiotech", GBC), a leading Taiwanese biopharmaceutical company, announces that its Phase 2 COVID-19 trial for oral new drug Antroquinonol (HOCENA®) has achieved 100% recovery results of its primary outcome measure in hospitalized mild, moderate including ICU severe patients. In line with the plan, GoldenBiotech will submit the final clinical trial analysis report and related R&D documents to the US FDA to apply for emergency use authorization (EUA) for Antroquinonol (HOCENA®).

The clinical trial data revealed:

Primary Outcome Measure: recover ratio [Time Frame: 14 days]
The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non-invasive ventilation, high flow oxygen, or ECMO) on Day 14.
Result: In the Antroquinonol group, the recovery ratio was 97.9% at the day 14 visit. Furthermore, no death or respiratory failure was found in the Antroquinonol group at the day 28 visit with recovery ratio of 100%.

Secondary Outcome Measures:
(a) Duration of ICU Stay:
Result: The median duration of ICU stay in Antroquinonol group was 9.5 days shorter than that in the placebo group.
(b) Duration of hospitalization [ Time Frame: 28 days]: time for patient discharge.
Result: The median duration of hospitalization was 4 days in the Antroquinonol group.
(c) Time to 2-point improvement [ Time Frame: 28 days]: Clinical change score as measured by the "WHO COVID-19 Clinical Improvement Ordinal Scale".
Result: The median time to score of 0 in "WHO COVID-19 Clinical Improvement Ordinal Scale" was 29 days in the antroquinonol group.
(d) Time to virological clearance [ Time Frame: 28 days]: measured as study days from start of treatment to first negative SARS-CoV-2 PCR test.
Result: The median time to virological clearance was 14 days in the Antroquinonol group.

In safety evaluation, the data revealed that Antroquinonol showed good tolerability and safety results.

https://www.prnewswire.com/news-releases/100-recovery-goldenbiotech-announces-topline-results-from-unblinded-covid-19-trial-for-oral-new-drug-antroquinonol-in-hospitalized-mild-moderate-and-severe-patients-301456146.html

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

/PRNewswire/ -- Golden Biotechnology Corp.(TPEx:4132) ("GoldenBiotech", GBC), a leading Taiwanese biopharmaceutical company, announces that its Phase 2...

07/01/2022

Golden Biotechnology Corporation ( GBC ) seeks US authorization for oral COVID-19 drug - .

Golden Biotechnology Corp (GBC, 國鼎) plans to apply for emergency use authorization in the US for its experimental COVID-19 drug after positive results in its phase 2 clinical trials, the company said.

GBC on Wednesday announced some of the results from randomized, double-blind and placebo-controlled studies in phase 2 clinical trials of its COVID-19 oral drug antroquinonol, dubbed Hocena, for the treatment of people hospitalized with mild-to-moderate COVID-19 symptoms.

In the trials, 97.9 percent of people recovered by the 14th day after being given the drug and all participants recovered by the 28th day, GBC spokesman Alan Tseng (曾木增) said yesterday.

“Recovered” meant that participants did not have respiratory failure, and thus did not require ventilation, high-flow oxygen or extracorporeal membrane oxygenation, Tseng said.

The median length of hospitalization for those in the experimental group was four days, 20 percent shorter than for those in the control group, the company said.

Of the five participants in intensive care due to serious COVID-19 symptoms, the median length of treatment for those given the drug was 13.5 days, 9.5 days shorter than for those given the placebo, it said.

The median period in which those in the experimental group first tested negative for COVID-19 after receiving the drug was 14 days, the company said.

The full test results would be disclosed after GBC receives a report from Labcorp Drug Development, a US-based contract research organization that helped conduct the human trials, the company said.

The trials began in October 2020 and were conducted in Argentina, Peru and the US, it said.

https://www.taipeitimes.com/News/front/archives/2022/01/07/2003770898

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

Golden Biotechnology Corp (GBC, 國鼎) plans to apply for emergency use authorization in the US for its experimental COVID-19 drug after positive results in its phase 2 clinical trials, the company said. GBC on Wednesday announced some of the results from randomized, double-blind and placebo-contro...

06/01/2022

國鼎新冠新藥物Antroquinonol解盲成功！患者康復率達100%(包括ICU重症病患)！

研發對抗新冠病毒的藥物，台灣傳出好消息! 台灣國鼎生技旗下新藥，在美國阿根廷進行二期試驗，宣布解盲成功，將申請美國緊急使用授權EUA，根據二期試驗數據顯示，在ICU重症病人治療試驗結果，用藥組的治療時間縮短9.5天，到第28天完全無人死亡，也沒有呼吸衰竭，康復率達100%。

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

05/01/2022

🔊🔊🔊5 Jan 2022 Breaking News!

CORONAVIRUS/Taiwan-developed COVID drug (Antroquinonol) trial shows positive clinical results

Taipei, Jan. 5 (CNA) Taiwanese biopharmaceutical company Golden Biotechnology Corp. on Wednesday released positive interim unblinded data from the Phase 2 clinical trial of its oral investigational new drug for COVID-19 Antroquinonol, and announced it plans to apply for Emergency Use Authorization (EUA) in the United States in April 2022.

The overall patient recovery rate was 100 percent on the 28th day after drug exposure, while no deaths or respiratory failure cases reported, according to the company.

https://focustaiwan.tw/sci-tech/202201050019

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

Taipei, Jan. 5 (CNA) Taiwanese biopharmaceutical company Golden Biotechnology Corp. on Wednesday released positive interim unblinded data from the Phase 2 clinical trial of its oral investigational new drug for COVID-19 Antroquinonol, and announced it plans to apply for Emergency Use Authorization (...

05/01/2022

國鼎新冠新藥 Antroquinonol 可應對「不同變異株」　董座劉勝勇：有效抗發炎、纖維化

國鼎生技(4132)於今（5）日宣佈旗下口服新冠肺炎新藥Antroquinonol 解盲達標，董事長劉勝勇指出，將向美國FDA申請緊急授權EUA。針對不同的變異株方面，雖然這次臨床試驗本身沒有看各種變毒株的部分，不過這個藥效用為抗病毒、抗發炎、抗纖維化，不論是哪一種病毒，理論上都會有效，所以團隊沒有設定排除不同的病毒株，只要是肺炎都有收案。

https://finance.ettoday.net/news/2162209?redirect=1

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

國鼎生技(4132)於今（5）日宣佈旗下口服新冠肺炎新藥Antroquinonol 解盲達標，董事長劉勝勇指出，將向美國FDA申請緊急授權EUA。針對不同的變異株方面，雖然這次臨床試驗本身沒有看各種變毒株的部分，不過這個藥效用為抗病毒、...

05/01/2022

💥💥💥5 Jan 2022 突破性新闻!

美国FDA Covid-19 二期人体临床解盲成功！
100%！
国鼎向美国FDA申请 EUA (Emergency Use Authorization).

https://www.chinatimes.com/realtimenews/20220105003093-260410?ctrack=pc_money_headl_p01&chdtv

Antroquinonol Malaysia 🇲🇾 Contact ：+60380747008 ；+60192687008 ；+60124871006

國鼎生技今下午兩點公布新冠肺炎(COVID-19)研發新藥Antroquinonol二期臨床試驗分析數據，試驗採隨機、雙盲、安慰劑對照研究，用於因新冠肺炎而住院的輕度至中度患者的安全性和有效性的驗證研究；最新試驗結果顯示，