Huons gets FDA approval for vial anesthetic med, raising hope for record sales

Kosdaq-listed Huons said on Sunday it has scored an FDA nod for its 1% lidocaine hydrochloride injection 5mL vial in the United States, marking the first time that it has obtained a vial standard license in the world¡¯s largest pharmaceutical market.

The company had previously received FDA approval for three ampoule injections: saline solution injection in 2017, lidocaine injection in 2018 and bupivacaine injection in 2019. Its share closed 3.2 percent higher at 51,400 won ($42).

The company said the latest approval will facilitate its FDA applications of marketing approval for other injectable meds to be produced from its vial line in the future, and the four lidocaine injections are basic meds that once suffered from a chronic supply shortage in the U.S. Now the company has a monopolistic position in the supply of the products.

Huons has strengthened its position as a company specializing in injectable meds in the U.S. as rivals withdrew themselves from the market of low-margin generic injections. Exports to ex-U.S. markets are also expected to gain momentum.

With the approval of Huons lidocaine injections in ampoule and vial formulations, the company is now able to tap further into the U.S. market, said Seo Geun-hee, a Samsung Securities analyst, adding the company¡¯s U.S. business is poised for further growth as it is waiting for FDA approval for one additional anesthetic product.

A regulatory ban on a botulinum toxin product from Medytox is also expected to benefit Huons as its license partner CKD launched Wondertox, a new botox product from Huons Group, this month.

Samsung Securities said Huons will reap record revenue and operating profit this year, estimating 404 billion won and 51 billion won, respectively. Still, mounting COVID-19 infections in the U.S. are worrisome as patients avoid an injection at hospitals due to infection fears, affecting sales of injectable solutions and other hospital-administered medicines.

[¨Ï Maeil Business Newspaper & mk.co.kr, All rights reserved]