[Kim Sae-mi, Edaily Reporter] South Korea’s biotech sector showed sharp divergence on July 24. Kolon TissueGene narrowly avoided a fourth consecutive limit-down close, while Peptron surged in after-hours trading on expectations for a major expansion of its second manufacturing plant.

Kolon TissueGene Loses 85% in a Month

According to MP Doctor, operated by KG Zeroin, Kolon TissueGene closed at 15,000 won, down 28.7 percent from the previous session.

The stock hit the daily lower limit in the afternoon but recovered slightly before the close, narrowly avoiding a fourth consecutive limit-down close. It had remained locked at the lower limit throughout the previous three trading sessions.

Kolon TissueGene disclosed topline results from U.S. Phase 3 Study 15302 of its osteoarthritis cell and gene therapy TG-C after the market closed on July 20. Since then, its share price has plummeted 75.5 percent from 61,200 won over four trading days and 85.2 percent from 101,100 won a month earlier.

The sell-off reflects the company’s heavy reliance on TG-C. Other programs targeting hip osteoarthritis, spinal disc disease, and veterinary indications remain mostly in early clinical or preclinical development.

Study 15302 also left little room for an optimistic interpretation. While patients treated with TG-C showed improvements in pain and physical function, the trial failed to meet both co-primary endpoints because the differences compared to the placebo were not statistically significant. None of the four secondary endpoints demonstrated a significant benefit.

This clear failure has also dampened expectations for Study 15301, a parallel Phase 3 trial with a nearly identical design.

“It’s hard to describe these results as a near miss,” said a biotech industry official. “Expectations for the twin study are inevitably declining as well.”

Syntekabio, DuChemBio, and NGeneBio Hit

Daily

Price Limit-Up

Syntekabio, DuChemBio, and NGeneBio all reached the daily price limit-up on the back of company-specific developments.

Syntekabio rose 30.0 percent after announcing that its AI-based antibody design platform had identified biobetter candidates with predicted solubility five to 20 times higher than existing blockbuster antibodies, including Keytruda.

The company redesigned antibodies targeting 10 marketed antigens using high-solubility framework regions. However, the five- to 20-fold improvement was based on AI predictions, not laboratory measurements.

DuChemBio climbed 29.8 percent after completing a U.S. Food and Drug Administration (FDA) Drug Master File (DMF) registration for the active ingredient used in 18F-FP-CIT, a PET radiopharmaceutical for the diagnosis of Parkinson’s disease.

The FDA assigned the ingredient the DMF number MF044308. DuChemBio stated that the registration lays the groundwork for the supply of the ingredient in the U.S. and for technology transfer partnerships in North America.

A DMF contains manufacturing and quality control information that may be referenced during the drug review process. The registration itself does not constitute FDA approval of either the ingredient or a finished product.

NGeneBio also hit the upper limit after doing so on July 21 and 22. Investor interest continued following news that the company had added Seoul National University Bundang Hospital to the network of hospitals using its hematologic cancer diagnostics panel.

Its small market capitalization of about 23.1 billion won likely amplified the rally. NGeneBio is also conducting a rights offering of 7.15 million shares, equivalent to 80 percent of its existing shares. Expected proceeds have fallen from 22.4 billion won to about 7.7 billion won.

Peptron Expands Plant Plan by 2.5 Times

Peptron surged 14.8 percent in after-hours trading to 124,900 won after announcing that it had applied to amend the building permit for its second Osong plant.

The revised design would expand the plant’s gross floor area from about 12,000 square meters to 30,000 square meters, reflecting larger production and support facilities.

However, the expansion has cast doubt on Peptron’s goal of beginning construction in September. The amended permit is still under review, further design work may be required, and a contractor has yet to be selected.

Peptron initially planned to begin construction in the first half of 2025 and complete the plant by June 2026. Following delays, it extended the investment period to June 2027 and recently set a new groundbreaking target for September 2026.

The larger design may also lead to further increases in construction, equipment, and financing costs. The planned investment has already risen from 65 billion won to 89 billion won, though the company has not disclosed whether the latest expansion will require additional funding.