Korea BNC Signs Exclusive Manufacturing Agreement with Golden Biotech for COVID-19 Treatment Candidates in 4 Countries

[Asia Economy Reporter Hyungsoo Park] Korea BNC announced on the 4th that it has signed a production-related contract for the COVID-19 treatment candidate substance Antroquinonol (product name: Hocena) with Taiwan's Golden Biotech.

The company introduced that it has signed an exclusive contract for marketing, promotion, distribution, sales, and manufacturing in Russia, Turkey, Ukraine, and Korea. Negotiations were conducted for about five months after signing a strategic agreement on August 6 last year. The commercialization contract period is 10 years after the licensing contract is signed, with an additional 5 years extension agreed upon through further consultation.

In July last year, the clinical trial plan was approved by the US FDA, and Phase 2 clinical trials began on October 8. Currently, subject registration and administration are underway at clinical trial hospitals in Indiana, Kansas, New Jersey, and other locations in the United States.

The target number of subjects is 174, and Phase 2 clinical trials are being conducted as a randomized, placebo-controlled, double-blind efficacy and safety confirmation test targeting patients hospitalized with mild to moderate pneumonia caused by the COVID-19 virus. If the clinical trial results confirm the efficacy and safety of Antroquinonol, an emergency use authorization will be applied for with the US FDA. It is expected that receiving emergency use authorization in the US will positively influence emergency use authorizations in other countries.

The cumulative number of COVID-19 patients in Russia has exceeded 3.1 million. It ranks fourth in the world in the number of patients, following the United States, India, and Brazil. It is expected that supply and sales will rapidly increase in the respective countries once the treatment is approved.

A Korea BNC official explained, "Antroquinonol, which has already proven safety in clinical trials such as anticancer drugs and confirmed antiviral, anti-inflammatory, and anti-pulmonary fibrosis effects, is undergoing clinical trials in the US, and we expect to successfully obtain emergency use authorization as planned."

He added, "Once PIC/S GMP approval is obtained at the Korea BNC GMP factory in Sejong City, which has completed construction, we plan to manufacture Antroquinonol at Korea BNC's manufacturing facility in consultation with Golden Biotech."

Antroquinonol is a single component extracted from mushrooms native only to Taiwan. So far, in cell and animal tests, it has reduced hepatitis B virus E antigen and S antigen levels by 50% and 40%, respectively. It has been confirmed to reduce hepatitis C virus RNA levels by up to 95%. Regarding the cytokine storm, which is problematic in COVID-19 infection, it is expected to potentially lower inflammation levels. Golden Biotech explained through provided materials that it also expects a protective effect against pulmonary fibrosis caused by infection.

This content was produced with the assistance of AI translation services.