Oct.30, 2020

Company Introduction

Golden Biotechnology Corporation (GoldenBiotech)(4132.TWO), founded in 2002, is a Taiwanese based leading pharmaceutical company which dedicates to discovering new compounds and developing innovative therapeutics against serious and rare diseases in hopes to improve and promote a lasting quality of life, health and longevity. GoldenBiotech also develops evidence-based health supplement products.

The current focus of GoldenBiotech targets on the development of Antroquinonol®.
Antroquinonol® was discovered in 2006 and its compound structure, preparation methods and applicable indications have been protected with patents worldwide. As of today, there are a total of more than 140 patents in over 40 countries/regions.
After many years of dedicated development, GoldenBiotech has set up not only PIC/S GMP certified facilities, but also chemical synthesis plant. Now GoldenBiotech has been well prepared for further clinical development as well as future global market demands,welcoming all possible collaborations with open arms.
The current pipeline of Antroquinonol® includes clinical developments in COVID-19,non-small cell lung cancer, pancreatic cancer, acute myeloid leukemia, hepatocellular carcinomas, breast cancer, ovarian cancer, Alzheimer’s disease, hypercholesterolemia and hyperlipidemia, atopic dermatitis,and hepatitis.

Covid-19

US FDA has approved Antroquinonol for its investigational new drug (IND) application to proceed a phase 2 clinical trial to assess the efficacy and safety of therapy in hospitalized, mild to moderate Covid-19 patients in USA. This is the first and only Taiwanese new drug approved by FDA for the Phase 2 clinical trial in Covid-19.If the results of all trials exhibit significant effects, they will help GoldenBiotech to submit emergency use authorization (EUA) request to the FDA.

Antroquinonol has shown anti-viral, anti-inflammatory and anti-fibrotic characteristics in past animal studies, suggesting high likelihood in becoming successful treatment option for coronavirus-induced pneumonia.The multiple action characteristics of Antroquinonol has gained favor and was selected as the final 25 among 300+ contestants in one COVID-19 roadshow hosted by MyBioGate. Future development includes applying for NIH public –private partnership.

Oncology

Received ODD(Orphan drug designation) approval by US FDA: AML , HCC and Pancreatic Cancer. ODD Approval by European EMA: Pancreatic Cancer.

Acute Myeloid Leukemia (AML)

The ongoing Phase II study in relapsed or refractory AML patients who are restricted from intensive therapy showed positive results.
Adult patients treated with Antroquinonol have achieved complete remission or that with incomplete hematologic recovery (CR/CRi) are better than other drugs.
Future development includes planning for Phase II study in pediatric patients, negotiating collaborations with US institutions such as Leukemia & Lymphoma Society, etc., and seeking out-licensing and/or investment opportunities.

Non-small cell lung cancer (NSCLC)

Antroquinonol monotherapy study in Stage IV NSCLC patients who have failed at least two lines of anti-cancer therapy has shown longer progression free survival (PFS) with the median of 11.9 weeks and overall survival (OS) with the median of 47.3 weeks. Golden Biotechnology Corp. presents brilliant results in 2019 ASCO Meeting Abstract for its Antroquinonol in Phase 2 NSCLC clinical study.
With its observable well tolerance, GoldenBiotech is planning to combine Antroquinonol with Paclitaxel and Platinum-based chemotherapy for the first-line treatment in advanced NCSLC patients.
Future development includes testing on efficacy of the combination between Antroquinonol and immunotherapies with aims to help convert non-responders into responders.

Pancreatic cancer

A Phase I/II study is currently ongoing in process to evaluate the treatment efficacy of combining Antroquinonol with Nab-paclitaxel and Gemcitabine for the first-line treatment for stage IV metastatic pancreatic cancer patients.
The purpose of this combination is to delay chemo resistance and to increase chemo cycles. Estimated completion of this trial will be by mid-2021.

Neurodegenerative disease Alzheimer’s disease

GoldenBiotech collaborated with J&J in testing the therapeutic efficacy and pharmacokinetics of Antroquinonol in AD mice under the Australian Queensland government funding scheme.Preclinical study has shown Antroquinonol’s crossing of blood-brain barrier (BBB),improvement in spatial learning and memory, alleviation of the amyloid pathology in mouse brain, characteristics of neuroprotection, as well as reduction of oxidative stress and inflammatory cytokines.
Detailed descriptions of the preclinical study findings were published in Nature- Scientific Report 2015.
GoldenBiotech is planning to carry out a Phase II clinical trial in mild-to-moderate AD patients and we welcome any form of collaborations.

Cardio-metabolic syndromes

Non-alcoholic steatohepatitis (NASH)

Antroquinonol is also evident for its potential in treating excessive fat build-up in the liver such as Non-alcoholic fatty liver disease (NAFLD) and NAFL, and the significant decrease in AST and ALT, the two most common markers used to diagnose the liver injury. GoldenBiotech and Stelic Institute & Co. in Japan jointly conducted study on NASH rat model which showed the significant improvement on fatty liver.
Moreover, Antroquinonol could reduce triglycerides and LDL cholesterol levels as well as improving blood vessel elasticity in mouse models. Suppression of fibrosis could also be observed after Antroquinonol treatment.
Blood Triglyceride(TG) is strongly associated with nonalcoholic fatty liver disease among markers of hyperlipidemia and diabetes. GoldenBiotech’s double-blind human phase II clinical trial aimed at hypercholesterolemia and hyperlipidemia patients for Identification of the efficacy in triglyceride, lipid-lowering and fatty liver. The study was completed in 2018, and the results showed the significant reduction of triglycerides in the blood of patients, and a significant reduction in arteriosclerosis indicators, fatty liver parameter changes, and low-density lipoprotein cholesterol (LDL-C) levels.

Overview

Overall, Antroquinonol has shown characteristics of high efficacy, low side effects, carrying additional side benefits, lower drug resistance as well as high patient compliance in comparison with current approved and investigating monotherapies and combination of chemotherapies and immunotherapies.
With such exceptional advantages, along with our wide-ranged application, we believe that Antroquinonol would be the best choice for quality treatment experience. Hence, GoldenBiotech is proud to say that Antroquinonol is not only a breakthrough in ideal medicines, but also an ideal medicine all the patients desires.
In order to achieve our mission of improving and promoting lasting quality of life, health and longevity for as many patients as possible, GoldenBiotech welcomes all opportunities with strategic partners in out-licensing, co-development and investment.