HLB's Subsidiary Syringe 'Sofject' Approved by US FDA... Used for Vaccinations Across the United States

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 24th that its subsidiary Hwajin Medical's syringe "Sofjec" recently received fast track approval from the US FDA. Hwajin Medical is a syringe specialist company wholly owned by HL Biopharma.

On the 23rd (local time), following the first official approval of the Pfizer vaccine, vaccination is expected to become mandatory mainly for school staff and military personnel, and booster shot administration is also expected to accelerate. As a result, the demand for disposable syringes for vaccination is expected to continue increasing. In this situation, Hwajin Medical's syringe "Sofjec," equipped with LDS (Low Dead Space) functionality, can vaccinate more people without wasting vaccines, and is expected to be highly preferred across the United States.

Following this approval, Hwajin Medical will be able to supply syringes to the US federal government through AMTC, a US medical device distribution specialist. Separately from this approval, Hwajin plans to promote direct distribution of "Sofjec" and also pursue separate approval for supplying a new digital syringe product, the "Digital Infusion Pen," which enables precise remote injections.

With this FDA approval, "Sofjec" is expected to be rapidly approved in other countries such as Europe. Currently, export inquiries are surging from European and Middle Eastern countries including Poland, Oman, Qatar, Spain, and Saudi Arabia.

Hwajin Medical also plans to expand its production facilities soon following the FDA approval. Currently, Hwajin produces about 15 million syringes per month through GMP (Good Manufacturing Practice) certified production facilities.

Lee Woo-jun, CEO of Hwajin Medical, said, "Through this FDA approval, our products, which have focused on the domestic market, are expected to be exported worldwide including the US, leading to a significant long-term increase in sales." He added, "Hwajin is a member of the HL Biopharma bio-ecosystem, HBS (HLB Bio eco-System), and we expect the growth momentum to accelerate further as 'Sofjec' is likely to be used for administering 'Nanocovax,' the COVID-19 vaccine for which HL Biopharma has secured global rights."