Rokit Healthcare Plunges 20% on FDA Warning Letter to U.S. Partner[K-bio Pulse]

[Stephen Kim, Edaily Reporter] Korean pharma, biotech and healthcare small caps moved in opposite directions on Oct. 22, as large-cap chipmakers weakened. Rokit Healthcare posted the steepest decline on the KOSDAQ, while in-vitro diagnostics firm Precision Biosensor and green-biotech company Genolution advanced. Rokit fell below its previous 52-week low after an FDA warning letter to its U.S. distribution partner came to light.

Rokit Healthcare (Naver Stock Trend)

Rokit Healthcare, U.S. partner’s warning letter puts regulatory clearance in focus



Rokit Healthcare closed down 4,380 won, or 19.55%, at 18,020 won, according to KG Zeroin’s MP Doctor. That is well below the 52-week low of 19,800 won recorded as of Oct. 20.

On Oct. 6, the U.S. Food and Drug Administration (FDA) sent a warning letter to Tides Medical, Rokit’s U.S. distributor, over the APLICOR 3D bioprinting system. Tides Medical had described the product as a Class I liquid medication dispenser, a category exempt from premarket notification. In practice, however, it promoted the system for creating personalized grafts from a patient’s own fat tissue to treat diabetic foot ulcers, pressure ulcers and burns. The FDA concluded that this intended use fell outside the exempt classification. It ordered the company to stop commercial distribution for that use and submit corrective and preventive actions in writing within 15 business days.

The core issue is not product quality but whether the system meets regulatory requirements for wound-care use. Even with a new partner, Rokit may need to revisit its U.S. clearance pathway to market the system for the same indication.

Investor confidence had already eroded. Shares peaked at 142,000 won on April 3, then slid after U.S. subsidiary Rokit America withdrew its Nasdaq listing application in July. First-half revenue rose 67.6% to 16.28 billion won, but operating loss reached about 15.8 billion won. The share decline also pushed the conversion price of 62.5 billion won in redeemable convertible preferred shares (RCPS), issued in March, to its 48,401-won floor. That raised the number of convertible shares to 1,291,283, adding to overhang concerns.

In a statement, Rokit said it is terminating its contract with Tides Medical and pursuing a new agreement with a major U.S. hospital chain. “The termination was not a sudden decision tied to the FDA warning letter, but a matter we had been discussing while pursuing a new business partnership,” a company official said. “The warning letter does not concern any quality defect in our products.”

Precision Bio Stock trend

Precision Bio sensor up 9%...cartridge reorders, not just installations, are key



Precision Biosensor rose about 9% to 1,600 won. The point-of-care diagnostics company, an affiliate of Kwangdong Pharmaceutical, signed a 10-year deal this year with U.S.-based Zomedica to supply veterinary clinical chemistry analyzers and cartridges to the U.S. and Canada from 2026 to 2035. It shipped 60 analyzers through August and plans to ship 70 more in the fourth quarter.

The system uses dry cartridges to run 17 tests from 70 microliters of blood in under 10 minutes. It targets independent U.S. veterinary clinics seeking to cut outsourced lab costs and wait times.

On the human diagnostics side, U.S. subsidiary Nano-Ditech is growing sales of respiratory tests. The company projects North American revenue of 8.4 billion won this year, including 7 billion won from respiratory diagnostics and 1.4 billion won from veterinary products. These are company estimates, however. The real test is whether shipments translate into active clinic use and recurring cartridge orders.

“We plan to supply a cumulative 130 units by year-end,” CEO Kim Han-shin said in a recent interview with Edaily, adding, “As installed analyzers increase, our cartridge sales will grow alongside them.”



Genolution up 7.4%...two tracks in AI peptide cosmetics and RNA



Genolution climbed about 7.4% to 1,608 won. Its subsidiary Bienvle Biotech launched two products under the KU:HAM skincare brand on Lotte Home Shopping on Oct. 5. The products use peptide design technology from U.S. AI biotech firm BGT.

The company’s core RNA green-biotech business is also advancing. Co-CEO Kim Min-yi presented strategies for mass production and commercialization of double-stranded RNA (dsRNA) at an OECD-supported international symposium on Oct. 13-14. dsRNA is a key ingredient in RNAi-based crop protection products. Genolution is also expanding its pipeline with Honeyguard-R, a gene therapy for honeybees, and pine wilt disease control technology. Repurchase rates and profitability will determine the cosmetics business’s value, while commercial supply results will do the same for RNA.

“Despite being our first launch broadcast, we achieved a successful home shopping debut thanks to consumer response that exceeded expectations,” a company official said. “We will expand customer touchpoints through more major home shopping channels and online and offline distribution.” The company did not disclose specific sales figures.