Hanmi Pharm Launches Independent Brand of COVID-19 Self-Test Kits... Nationwide Distribution Starting on the 10th

MFDS: 'Conditional Approval' Same as SD Biosensor Product

HANMI COVID-19 Home Test (Photo by Hanmi Pharmaceutical)

[Asia Economy Reporter Kim Ji-hee] Hanmi Pharmaceutical announced that it will launch SD Biosensor's COVID-19 self-test kit under its own brand and begin distribution nationwide at pharmacies starting from the 10th.

The newly launched "Hanmi COVID-19 Home Test" is the same product as SD Biosensor's self-test kit, which received conditional approval from the Ministry of Food and Drug Safety (MFDS). Hanmi Pharmaceutical recently obtained additional model approval from the MFDS.

This product allows users to collect a specimen directly from the nasal cavity and apply it to the kit, then visually check the presence of control line (C) and test line (T) within 15 to 30 minutes. If two red lines (control line C and test line T) appear simultaneously on the kit, it is suspected to be COVID-19 positive, and the user must visit a screening clinic operated by health authorities to undergo a nucleic acid amplification-based diagnostic test. If only one red line (control line C) appears, the result is negative.

A Hanmi Pharmaceutical representative stated, "Launching Hanmi's own brand product will further enhance Hanmi Pharmaceutical's competitiveness, which has strengths in distribution such as pharmacies," and added, "We expect to contribute to quarantine efforts through smooth distribution and expansion of the self-test kits."

Hanmi Pharmaceutical's self-test kits are medical devices that can be purchased at pharmacies without a prescription. They are distributed through Online Pharm, a specialized sales and marketing company for healthcare products. To accommodate consumers who need to purchase remotely due to the nature of the product, the kits are also available on the Pro-Calm website, Online Pharm's shopping mall site.

Meanwhile, Hanmi Pharmaceutical is also selling the self-test kits to domestic companies through SubOne, a company specializing in MRO (Maintenance, Repair, and Operations) purchasing solutions. In January, Hanmi Pharmaceutical and SubOne signed a corporate distribution contract for the medical professional rapid antigen diagnostic kit "Hanmi COVID-19 Quick TEST."

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