TAIPEI, Feb.4, 2021
TAIPEI, Feb.4, 2021 /PRNewswire/ -- Golden Biotechnology Corp.(TPEx:4132)("GoldenBiotech"), a leading Taiwanese biopharmaceutical company, announced that it has made two achievements for its Covid-19 new drug candidate Antroquinonol® (HOCENA®): receiving positive response after DMC review in Phase 2 clinical trial and signed first agreement in global licensing progress. GoldenBiotech receives in Jan. the "Positive Response" from DMC , an FDA approved independent Data Monitoring Committee for its Phase 2 Covid-19 trial in the USA . The trial data of the first set of patients were unblinded and reviewed by the DMC and got "positive response" without modification on the trial and can proceed the following recruitment. According to the FDA 's guidance, the DMC advises the sponsor regarding the continuing safety of trial subjects as well as the continuing validity and scientific merit of the trial.
GoldenBiotech will be applying for the US Emergency Use Authorization (EUA) once the clinical trial exhibits significant clinical results. It has expanded the multi-national centers of trial to the US, Peru and Argentina that will be completed the fastest in the Q 2 of this year. This Covid-19 drug candidate has been granted ODD (Orphan drug designation) approval by the US FDA for treating AML(Leukemia) , HCC(Liver Cancer) and Pancreatic Cancer and by European EMA for treating Pancreatic Cancer.
GoldenBiotech has started the global licensing plan of Antroquinonol® for Covid-19 treatment. The first signed licensing agreement in Jan. with BNC Korea Co., Ltd, a leading South Korean company in medical fields is for developing and commercialization of Antroquinonol® to treat Covid-19 in S. Korea, Russia, Ukraine and Turkey. GoldenBiotech will receive totally up to USD 18 million payments including an upfront fee of USD 4 million and milestone fee of up to USD 14 million. GoldenBiotech will receive 25% royalty payment of sales when the drug is granted EUA by the US FDA or clears the new drug application and selling in the market.
The Phase 2 clinical trial is for mild to moderate COVID-19 hospitalized patients. The primary outcome measure is the proportion of patients alive and free of respiratory failure on Day 14. This is the first and only Taiwanese new drug approved by the USA, Peru and Argentina for the Covid-19 trial. Antroquinonol has shown anti-viral, anti-inflammatory and anti-fibrotic characteristics in past animal studies, suggesting high likelihood in becoming successful treatment option for Covid-19. Other indications of clinical trials and research for Antroquinonol® are pancreatic cancer, NSCLC , AML, Hyperlipidemia, Atopic dermatitis, Hepatitis B and Alzheimer's Disease etc..
Currently there is no drug for Covid-19 that can effectively improve the severe inflammatory response induced by the virus or the overall survival rate. The characteristic of multiple effects makes Antroquinonol more advantageous than other antiviral and/or anti-inflammatory drugs.
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