[Stephen Kim, Edaily Reporter] Korean small-cap pharma, biotech, and healthcare stocks 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: Warning Letter to U.S. Partner Brings Regulatory Clearance into 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 on 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, regarding the APLICOR 3D bioprinting system. Tides Medical had classified the product as a Class I liquid medication dispenser, a category exempt from premarket notification. In practice, however, the company 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 halt 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 reassess 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 fell after the U.S. subsidiary, Rokit America, withdrew its Nasdaq listing application in July. First-half revenue rose 67.6% to 16.28 billion won, but the operating loss reached approximately 15.8 billion won. The decline in the stock price also pushed the conversion price of the 62.5 billion won in redeemable convertible preferred shares (RCPS), issued in March, down to its floor of 48,401 won. This increased the number of convertible shares to 1,291,283, adding to concerns about overhang.

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 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 perform 17 tests from 70 microliters of blood in under 10 minutes. It targets independent U.S. veterinary clinics seeking to reduce outsourced lab costs and wait times.

On the human diagnostics front, U.S. subsidiary Nano-Ditech is seeing 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 use in clinics and recurring cartridge orders.

“We plan to supply a cumulative total of 130 units by year-end,” CEO Kim Han-shin said in a recent interview with Edaily, adding, “As the number of installed analyzers increases, our cartridge sales will grow in tandem.”

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

Genolution rose 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 October 5. The products utilize peptide design technology from the U.S. AI biotech firm BGT.

The company’s core RNA green-biotech business is also making progress. Co-CEO Kim Min-yi presented strategies for the mass production and commercialization of double-stranded RNA (dsRNA) at an OECD-supported international symposium held on October 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 technology to control pine wilt disease. Repurchase rates and profitability will determine the value of the cosmetics business, while commercial supply results will do the same for the RNA business.

“Despite this being our first-ever broadcast launch, 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.