Kolon TissueGene Escapes Fourth Limit-Down; Peptron Jumps After Hours[K-Bio Pulse]

[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 executives prepare to answer questions during a press conference held at Kolon One&Only Tower in Gangseo-gu, Seoul, on July 21. (Photo by Kim Sae-mi, Edaily)

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 straight limit-down finish. It had remained locked at the lower limit throughout the previous three sessions.

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

Recent share-price trend of Kolon TissueGene. (Source: KG Zeroin MP DOCTOR)

The sell-off reflects the company’s heavy dependence 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. TG-C-treated patients showed improvements in pain and physical function, but the trial failed both co-primary endpoints because the differences versus placebo were not statistically significant. None of the four secondary endpoints showed a significant benefit.

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

“These figures are difficult to describe as a near miss,” a biotech industry official said. “Expectations for the twin study are inevitably declining as well.”



Syntekabio, DuChemBio and NGeneBio Hit Limit-Up

Syntekabio, DuChemBio and NGeneBio all reached the daily upper limit on company-specific developments.

Syntekabio rose 30.0 percent after saying 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 prediction, not laboratory measurements.

DuChemBio climbed 29.8 percent after completing a U.S. Food and Drug Administration drug master file registration for the active ingredient used in 18F-FP-CIT, a PET radiopharmaceutical for Parkinson’s disease diagnosis.

The FDA assigned the ingredient DMF number MF044308. DuChemBio said the registration provides a foundation for U.S. ingredient supply and North American technology-transfer partnerships.

A DMF contains manufacturing and quality-control information that may be referenced during drug review. 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 hospital network 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 2.5-Fold

Peptron’s headquarters in Daejeon. (Source=Peptron)

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.

The expansion, however, has added uncertainty to Peptron’s target of beginning construction in September. The amended permit remains 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. After delays, it extended the investment period to June 2027 and recently set a new September 2026 groundbreaking target.

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