[Edaily Reporter Kim Seung-kwon ] On the 22nd, while large-cap semiconductor stocks were weak on the domestic stock market, small- and mid-cap pharmaceutical, biotech, and healthcare stocks showed mixed performance.

Among the top decliners on the KOSDAQ that day, ROKIT HEALTHCARE Inc. saw the sharpest drop. In contrast, in vitro diagnostics company Precision Biosensor Inc.(335810)and green biotech company GENOLUTION INC.(225220)each posted slight gains. In particular, #ROKIT HEALTHCARE Inc. is raising market concerns as its stock price fell below its 52-week low without any separate disclosure.

ROKIT HEALTHCARE Inc.: U.S. Partner’s Warning Letter Highlights Approval and Sales Requirements

According to KG Zeroin MP Doctor (formerly Marketpoint) today, ROKIT HEALTHCARE Inc. closed at 18,020 won, down 4,380 won (19.55%) from the previous trading day. This is significantly below the 52-week low of 19,800 won recorded on the 20th.

On the 6th of this month, the FDA issued a warning letter to Tizes Medical, a U.S. distribution partner, regarding the 3D bioprinting system “APLICOR 3D.” Tizes Medical had described the product as a Class I liquid drug dispensing device, which is exempt from premarket notification. However, the system was actually introduced as a device that creates customized grafts from the patient’s own adipose tissue for the treatment of diabetic foot ulcers, pressure ulcers, and burns. The FDA determined that this intended use falls outside the scope of that classification. Consequently, it demanded a halt to commercial distribution and the correction of the violation, and required the company to submit, in writing, corrective actions and a plan to prevent recurrence within 15 business days.

The crux of the warning letter is not product quality, but whether the company meets the regulatory requirements to market the product for “wound treatment.” Observers point out that even if the company changes partners, it must re-examine its approval pathway if it intends to continue marketing the product for the same purpose.

Market confidence has already been weakened. The stock price rose to 142,000 won on April 3 but has continued to decline since July, following the withdrawal of the Nasdaq listing application by its U.S. subsidiary, Rokit America. Revenue for the first half of the year rose 67.6% to 16.275 billion won, but the operating loss for the same period was approximately 15.8 billion won. Due to the decline in the stock price, the conversion price of the 62.5 billion won worth of RCPS issued in March fell to the minimum limit of 48,401 won, and the number of convertible shares increased to 1,291,283. This has effectively increased the potential supply pressure.

ROKIT HEALTHCARE Inc. issued a statement announcing that it is currently proceeding with the termination of its contract with Tizes Medical and is also pursuing a new contract with a major U.S. hospital chain. A company official stated, “This contract termination was not a sudden decision related to the FDA warning letter, but rather an issue that had been under discussion for some time as we pursued new business partnerships with other companies,” adding, “This warning letter does not pertain to quality defects in our products.”

Precision Biosensor Inc., up about 9%… Beyond the deployment of testing devices, cartridge reorders are key

Precision Biosensor Inc. closed at 1,600 won, up about 9%. The company is a subsidiary of KwangdongPharmaceutical that supplies point-of-care diagnostic equipment and consumables. This year, it signed a contract with U.S.-based Zomedica to supply veterinary clinical chemistry analyzers and cartridges to the U.S. and Canada for a 10-year period from 2026 to 2035. It shipped 60 units by August and will supply an additional 70 units in the fourth quarter.

The product uses a dry-chemistry cartridge system that tests 17 parameters within 10 minutes using just 70 μL of blood. It is targeted at independent veterinary clinics in the U.S. seeking to reduce outsourcing costs and waiting times for results.

In human diagnostics, the company’s U.S. subsidiary, NanoDetec, is increasing sales with respiratory diagnostic products. The company expects North American sales this year to reach 8.4 billion won, comprising 7 billion won from respiratory diagnostics and 1.4 billion won from veterinary diagnostics. However, this is merely the company’s forecast. The key factor will be whether these units lead to actual hospital adoption and repeat orders for cartridges, rather than simply the number of units shipped.

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

GENOLUTION INC. Up About 7.4%… “Two-Track” Strategy with AI Peptide Cosmetics and RNA

GENOLUTION INC. closed at 1,608 won, up about 7.4%. Its subsidiary, Bianbl Biotech, unveiled two new products from its skincare brand “Guham” on LOTTE SHOPPING CO., LTD. on the 5th of this month. These products incorporate peptide design technology from U.S. AI biotech firm BGT.

Progress is also being made in its core RNA green biotech business. Co-CEO Kim Min-yi presented strategies for the mass production and commercialization of dsRNA at an OECD-sponsored international symposium held on the 13th and 14th. dsRNA is a key raw material for RNAi-based crop protection agents. The company is also expanding its pipeline with “HoneyGuard-R,” a gene therapy for honeybees, and technology for controlling the pine wood nematode. The company’s future enterprise value is expected to hinge on the repurchase rate and profitability of its cosmetics business, as well as its track record of commercial supply in the RNA business.

A company official stated, “Despite this being our first home shopping broadcast for a new product launch, we achieved a successful entry into the home shopping market thanks to consumer response that exceeded initial expectations,” adding, “We will expand our customer reach through more major home shopping channels and online and offline distribution networks.” However, specific sales figures were not disclosed.