HLB affiliate gets USFDA approval for low dead space syringes

By Baek Byung-yeul

Hwajin Medical, an affiliate of local biotech firm HLB, has won an approval from the U.S. Food and Drug Administration (FDA) for its low dead space (LDS) syringe Sofjec, raising expectations that the local syringe company can make inroads into the lucrative U.S. market.

With the FDA approval, Hwajin said it is now able to supply the Sofjec syringes to the U.S. federal government through AMTC, a medical device distribution company there.

The importance of LDS syringes has been highlighted as the product helps minimize wasted vaccine doses by reducing space between the needle and the plunger.

With the spread of the COVID-19 Delta variants, the number of positive COVID-19 cases in the U.S. surpass 150,000 a day, and the shortage of syringes has long been an urgent issue for the treatment of patients.

After Pfizer received FDA approval for its COVID-19 vaccine, vaccination will be mandatory for educators and soldiers, and booster shots will also be increased in the U.S., which will continue to increase demand for disposable syringes for vaccination.

Hwajin said its Sofjec is expected to “be highly preferred throughout the U.S. as it is equipped with an LDS function to vaccinate more people without wasting vaccines.”

Hwajin added it plans to expand its production facilities in the near future. Currently the company produces 15 million syringes a month.

"With the FDA's approval, our products, which focused on the domestic market, will be exported to the world including the U.S. in the long term. As Hwajin's Sofjec is also expected to be used for the COVID19 vaccine 'Nanocovax,' which HLB has recently gained global rights to, its growth is likely to continue,” Lee Woo-jun, president of Hwajin said.