AntroQ Singapore

10/10/2023

Dear all,

It is with much sadness that I have to inform you all the passing of one of our directors, Mr Chaw. He has made an enormous contribution to the development of the business. He will be greatly missed by all of us.

Ms Yvonne Koo will ensure continuity of the business and services to you. Please contact Ms Koo at 0124871006 directly with all matters or enquiries relating to products.

Yours sincerely,
AntroQ Biotechnology Sdn Bhd

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.

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

07/01/2022

🔊🔊🔊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.

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 (...

17/09/2021

COVID-19 Scoop: Epoch-Making GoldenBiotech's Oral COVID-19 New Drug Trial Got Green Light from the FDA to Extend Recruiting COVID-19 Patients

TAIPEI, Sept.16, 2021 /PRNewswire/ -- Golden Biotechnology Corp.(TPEx:4132) ("GoldenBiotech", GBC), a leading Taiwanese biopharmaceutical company, announces that its oral investigational new drug Antroquinonol (HOCENA®) has made headway with COVID-19 treatment development in more broaden clinical trial patients permitted in inclusion severity as well as future marketing expansion by signing a new international MOU for cooperation and development of the new drugs in 23 European countries.

On Aug. 30, 2021, pursuant to clinical trial protocol amended following the recommendation of the approved second interim DMC (Data Monitoring Committee) review, GoldenBiotech was noticed by CRO that the Food and Drug Administration(FDA) agreed that its ongoing phase 2 trial of Antroquinonol for treating COVID-19 patients can be extended recruiting from the mild or moderate hospitalized patients to the severe hospitalized COVID-19 patients who need non-invasive oxygen support. The total trial subjects will remain the same, 174 patients in total.

The trial recruiting is expedited in full swing covering the USA, Peru and Argentina where the new upheaval pandemic is rampant with highly transmitted SARS-CoV2 variants. "So far, there is no oral drug approved or receives the EUA from the FDA for COVID-19 treatment. Our recent progress will help shorten the completion time of our phase 2 clinical trial and time to apply with the US FDA emergency use authorization (EUA) when the significant trial results are achieved," quoted by Alex Liu, the Chairman of Golden Biotechnology Corp.

Currently, Golden Biotechnology Corp. is the only Taiwanese company that undergoes the formal clinical trial for COVID-19 treatment in multi-national centers and follows the FDA guidance for COVID-19 trials to set the trial as randomized, double-blinded and placebo-controlled study.

Antroquinonol is a new small molecule drug (NCE) with convenient oral administration design and distinguished from other emerging oral treatment drugs for COVID-19 by its multi-functional effects on anti-viral, anti-inflammation and anti-fibrosis characteristics revealed by studies. The new permitted extensive enrollment from mild, moderate to severe patients in the trial will assess the efficacy of recovery rate and prevent the milder COVID-19 patients becoming more severe conditions which will ease the heavy loading of the medical systems.

Antoquinonl stands out from current many anti-viral drugs with its ingenious capability of anti-inflammation and liver protection effects which it recruits the COVID-19 confirmed patients consistent with pneumonia from their chest X-ray or computerized tomography (CT) scan. The sign of viral pneumonia indicates the inflammation and the tendency of severity which is lack of effective cure and with poor prognosis. People with liver disease are the vulnerable group to COVID-19 infection even the lower and slower antibody protection will produce after their receiving vaccination acc. to the recent studies.

GoldenBiotech signs MOU on Aug. 24 with Sanova Pharma GesmbH for cooperation and development of Antroquinonol in the 23 European countries including Austria, UK, Italy, Norway, Denmark and Switzerland. Sanova Pharma is a leading healthcare products and logistics provider in Austria and Europe with over 70 years of history in the healthcare sector. As integrated into the Herba Group in Austria and part of global McKesson group, Sanova Pharma benefits from the knowledge and experience of the major local and global pharmaceutical wholesalers. "The MOU with Sanova Pharma will help boost the cooperation and expansion of the development for Antroquinonol in Europe," said Dr. Today Su, CEO of GoldenBiotech.

On Jan. 22, 2021, GoldenBiotech signed the licensing agreement with BNC Korea Co., Ltd, a leading South Korean company in medical device, biologicals and pharmaceuticals, for its COVID-19 new drug candidate Antroquinonol. BNC Korea is authorized for developing and commercialization of Antroquinonol for the treatment of COVID-19 in the territories of S. Korea, Russia, Ukraine and Turkey.

ClinicalTrials.gov Identifier: NCT04523181
https://www.clinicaltrials.gov/ct2/show/NCT04523181

About Antroquinonol (HOCENA®)

Antroquinonol®, a novel small molecule that was discovered in 2006 by Golden Biotechnology Corp. Its compound structure, preparation methods and applicable indications have been protected with patents worldwide. Embraced by its safety and multi-functional bioactive advantages, it has been applied in several clinical trials or research in oncology, coronavirus, liver metabolism symptoms, cardio-vascular, auto-immune and neuro-degenerative diseases. Other indications of clinical trials for Antroquinonol (HOCENA®) are pancreatic cancer, NSCLC (Lung cancer), AML(Leukemia), Hyperlipidemia, Atopic dermatitis and Hepatitis B etc. It has been granted the Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of Pancreatic Cancer, Acute Myeloid Leukemia (AML) and HCC (Liver Cancer) in 2015. It also received the ODD for the treatment of Pancreatic Cancer from European EMA in 2017.

About Golden Biotechnology Corp. ("GoldenBiotech", GBC)

Golden Biotechnology Corporation, founded in 2002, is a Taiwanese based leading pharmaceutical company which dedicates to discovering novel compounds (NCE) and developing cutting-edge innovative therapeutics with breakthrough advantage against serious and rare diseases in hopes to improve and promote a lasting quality of life, health and longevity.

https://www.prnewswire.com/news-releases/covid-19-scoop-epoch-making-goldenbiotechs-oral-covid-19-new-drug-trial-got-green-light-from-the-fda-to-extend-recruiting-severe-covid-19-patients-301378463.html

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

22/07/2021

-19: to address the speech at Bio Asia Taiwan 2021 Conference for its New Drug

Congrat! GoldenBiotech was invited to address the speech at the Bio Asia Taiwan 2021 Conference for its investigational new drug Antroquinonol for Covid-19 treatment.

The clinical trial of Covid-19 of Antroquinonol currently is conducting in the USA, Peru and Argentina and has passed two DMC reviews with positive response. DMC recommends the trial can be extended to recruit hospitalized severe patients ( without invasive oxugen support or high flow ventilation).

Bio Asia Taiwan 2021
Conference
Session 6 – Pandemic Control after Vaccination (B)
Date: 22 July (Thursday)
Time: 10:40 – 12:10 (GMT+8)

11:35 – 11:45
Acquiring Triple A Resilience with Antroquinonol

Today Su, CEO,
Golden Biotechnology Corp.

https://expo.bioasiataiwan.com/en/visitorExNewsDetail.asp?id=7645&fbclid=IwAR09WZ2ojnmZfFLYY_9PiCuJnefuKQ3OMKH18bipEJWhJ-Jy1ZQnEeYTyug

November. 4 - 7, 2021 - Asia’s leading event for biotech industry. Find out unexpected business opportunities at Bio Asia-Taiwan Exhibition.

21/07/2021

Will oral treatments become a game-changer in Covid-19 endemic era?

As Covid-19 prolongs, experts emphasize the importance of oral therapeutics because the novel coronavirus is increasingly likely to become an endemic that occurs periodically rather than a one-off pandemic.

BNC Korea owns the domestic sales rights and manufacturing rights for , an oral Covid-19 treatment candidate.

Golden Biotech, a Taiwanese company that developed , recently received emergency use approval for treating 100 mild to moderate Covid-19 patients from the Taiwan drug regulators on June 30.

The company also received approval to conduct a phase 2 clinical trial for the drug from the U.S. Food and Drug Administration in July last year and plans to apply for emergency use approval after obtaining the results.

"After confirming the results of phase 2 clinical trial for in the third quarter, if it is positive, we plan to apply for emergency use approval to the FDA," Golden Biotech said.

출처 : KBR(http://www.koreabiomed.com)

http://www.koreabiomed.com/news/articleView.html?idxno=11695

As Covid-19 prolongs, experts emphasize the importance of oral therapeutics because the novel coronavirus is increasingly likely to become an endemic that occurs periodically rather than a one-off ...

16/07/2021

Doses, Distance, and Data : The Road to Safe Travel

Although vaccines reduce the infectiousness and fatality rate of the coronavirus, new viral variants are more transmissible and could be resistant to current vaccines. Furthermore, vaccinated travelers could still spread the virus and circulate new strains of COVID-19.

Taiwanese biopharmaceutical company Golden Biotechnology Corp. is highly aware of the importance of providing innovative solutions for coronavirus treatment. The company has approached completion of its Phase II clinical trials in the U.S., Peru, and Argentina for COVID-19 treatment using the drug Antroquinonol (Hocena®).

Golden Biotech purifies Antroquinonol from Antrodia camphorata, a mushroom used as a traditional Chinese herbal medicine. Antony Lee, Golden Biotech’s corporate development manager, notes that according to current findings, Antroquinonol has anti-virus, anti-inflammatory, and antibiotic features, producing several possible positive effects against coronavirus strains. The company expects that the drug will alleviate coronavirus symptoms and minimize the potential side effects of the treatment process.

“As of now, there is no single drug on the market that can simultaneously fight the COVID-19 virus as well as the symptoms,” says Lee. “When you combine several drugs, you also put patients at higher risk of adverse effects. Antroquinonol exhibits positive efficacy with low toxicity and has so far shown few adverse effects, which means that we expect it to be safer to use – particularly for older patients and those who already take other medications.”

The Phase II clinical trials for Antroquinonol involves 174 patients. The trial is a randomized, double-blinded, and placebo-controlled study of the safety and efficacy for hospitalized patients with mild to moderate symptoms. Initial results of the trials have received a positive response from the Data Monitoring Committee (DMC), an independent body approved by the U.S. Food and Drug Administration (FDA). DMC also suggested that the study be expanded to severely ill hospitalized COVID-19 patients on non-invasive ventilation or high-flow oxygen.

Despite rigorous border control and strict measures, COVID-19 has made its way into Taiwan. Now businesses, researchers, and government are working on

11/07/2021

Pandemic Control after Vaccination :
Acquiring Triple A Resilience with Antroquinonol

Bio Asia Taiwan 2021
Conference
Session 6 – Pandemic Control after Vaccination (😎
Date: 22 July (Thursday)
Time: 10:40 – 12:10 (GMT+8)

11:35 – 11:45
Acquiring Triple A Resilience with Antroquinonol

Today Su, CEO,
Golden Biotechnology Corp.

COVID-19 pandemic is not only a health crisis but also an inescapable restructuring of the old standard value. Although pioneering therapeutics such as mRNA-based vaccines fights SARS-CoV-2, therapeutic challenges have emerged due to the increased SARS-CoV-2 variants and the lack of safe and effective medicines simultaneously targeting distinct phases of COVID-19. Responding to the pandemic management after vaccination, Golden Biotech will provide a high level of Adaptability to fit fast-changing circumstances, easy Accessibility and Affordability of safe and effective medicines.

Golden Biotech has a phase II clinical trial of Antroquinonol for fighting COVID-19 pandemic. This phase II trial is a randomized, double blind and placebo controlled study to evaluate the safety and efficacy of Antroquinonol in mild-moderate COVID-19 hospitalized patients. Initial and interim results received a positive response from the Data Monitoring Committee (DMC), an independent group approved by the U.S. FDA, which also suggested that the Antroquinonol study be expanded to severe COVID-19 hospitalized patients on non-invasive ventilation or high-flow oxygen. Antroquinonol exhibited anti-viral, anti-inflammatory and anti-fibrotic characteristics in previous preclinical studies, which suggests effective abilities to treat patients at distinct phases of COVID-19. Based on previous clinical studies, demonstrated safety profile with low risks of adverse effects, and high efficacy carrying additional side benefits make Antroquinonol a safe medicine. Additionally, oral Antroquinonol formulation can fight COVID-19 early and enable the widespread.

Navigating to effective pandemic management after vaccination, Golden Biotech contributes to the global effort to relieve the burden of COVID-19 pandemic. Future development in making Antroquinonol a new formulation, such as nasal spray or inhalation, is being planned to protect an individual or prevent further spread of SARS-CoV-2. Economical and scalable synthesis of Antroquinonol currently enables a wider range of affordable real-world applications. Together, Golden Biotech will provide the triple A Antroquinonol in the post-vaccination era.

BIO Asia–Taiwan,亞洲生技大會,生技月,台灣生技月

04/06/2021

💥CORONAVIRUS/Taiwan-developed drug ® to be tested on COVID-19 cases in U.S.

Taipei, June 4 (CNA) A drug candidate developed by a Taiwanese company for the treatment of COVID-19 will be administered to seriously ill patients in its Phase II clinical trials in the United States, pending authorization by the relevant authorities, according to the developer Golden Biotechnology Corp.

The drug Antroquinonol (HOCENA) is already in Phase II clinical trials in the United States, Peru and Argentina, where a total of 174 hospitalized patients with mild to moderate COVID-19 symptoms are enrolled in a double-blind placebo study, the company said in statement released late Wednesday.

After a review in the U.S., the Phase II trials there received a positive response from the Data Monitoring Committee (DMC), an independent body approved by the U.S. Food and Drug Administration (FDA), GoldenBiotech said.

The DMC also suggested that the HOCENA study be expanded to severely ill hospitalized COVID-19 patients on non-invasive ventilation or high-flow oxygen, according to GoldenBiotech, one of Taiwan's leading biopharmaceutical companies.

GoldenBiotech CEO Today Su (蘇經天) said the company will present the DMC's recommendation to the U.S. FDA and seek approval to proceed with the inclusion of severely ill patients.

If all goes well, Su said, GoldenBiotech will complete the Phase II clinical trials for the drug in the third quarter of the year and will seek Emergency Use Authorization (EUA) from the U.S. FDA.

Su said the drug was independently developed by his company, which owns 100 percent of its patent rights, therefore it can apply for market licenses after all phases of the trials are completed.

In 2015, HOCENA was granted orphan drug designation (ODD) approval by the U.S. FDA for the treatment of leukemia and liver and pancreatic cancer. Two years later, it obtained ODD approval from the European Medicines Agency for the treatment of pancreatic cancer.

Last October, GoldenBiotech received the U.S. FDA's approval to conduct Phase II clinical trials of the drug on COVID-19 patients in the U.S.

(By Han Ting-ting and Elizabeth Hsu)

Enditem/pc

Taipei, June 4 (CNA) A drug candidate developed by a Taiwanese company for the treatment of COVID-19 will be administered to seriously ill patients in its Phase II clinical trials in the United States, pending authorization by the relevant authorities, according to the developer Golden Biotechnology...

07/01/2021