[Edaily Reporter Kim Jinsoo ] On the 21st, shares in the pharmaceutical and biotech sector plummeted to the daily limit-down following news of the clinical failure of “TG-C” (formerly Invossa), a cell-gene therapy for osteoarthritis currently under development by Kolon TissueGene, Inc. Subsequently, KOLON LIFE SCIENCE Inc.(102940), which holds the commercialization rights to TG-C, also hit the daily limit-down, while KOLON CORPORATION(002020), Kolon TissueGene, Inc.’s largest shareholder, closed slightly higher after trading at the limit-down for most of the session.

NGeneBio Co., Ltd.(354200)recorded a price limit up, driven by improved supply and demand following the resolution of uncertainties related to a rights offering and the establishment of a stable business structure.

Failure to Prove TG-C’s Efficacy… KOLON CORPORATION in Turmoil

According to KG Zeroin’s MP Doctor (formerly Marketpoint), Kolon TissueGene, Inc.’s stock price plummeted to the daily lower limit right at the market open and closed at 42,900 won. The decline in Kolon TissueGene, Inc.’s stock price is attributed to the failure of its cell-gene therapy for osteoarthritis, “TG-C,” to demonstrate statistical significance in its U.S. Phase 3 clinical trial.

After the market closed on the 20th, Kolon TissueGene, Inc. announced the results of TG-C’s U.S. Phase 3 clinical trial. According to the results, neither the 12-month pain index (VAS) nor the total score for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)—both of which were co-primary endpoints—demonstrated statistical significance compared to the placebo.

Specifically, the change in VAS was -38.7 in the TG-C group and -39.2 in the placebo group, with the placebo group showing a 0.5-point greater improvement. Similarly, for the WOMAC total score, the TG-C group recorded -27.61 and the placebo group -26.54, showing that the TG-C group improved by 1.07 points more. However, with a p-value of 0.5701, the results did not demonstrate a clear statistical superiority.

At a press conference on the 21st, Jeon Seung-ho, Co-CEO of Kolon TissueGene, Inc., stated, “Within the TG-C treatment group itself, the efficacy was equivalent to or exceeded that of previous clinical trials,” adding, “Although we were unable to demonstrate a difference compared to the placebo group, we plan to conduct a detailed and comprehensive analysis, including the raw data, to determine why these results occurred.”

According to Kolon TissueGene, Inc., analysis suggests that factors in the placebo group—such as analgesic use, high baseline pain scores, and variations across trial sites or evaluators—may have amplified the placebo response. Accordingly, Kolon TissueGene, Inc. plans to begin analyzing the causes within the next few days.

The company also expressed optimism regarding the second U.S. Phase 3 clinical trial, scheduled for announcement this October. While the second trial shares the same protocol and design as the first, it features different trial sites, principal investigators, and patient cohorts. Kolon TissueGene, Inc. maintains that, as this is a separate and independent clinical trial, it is too early to predict the results. The company plans to engage in discussions with the U.S. Food and Drug Administration (FDA) if statistical significance is confirmed in the second trial.

Meanwhile, following the failure of the TG-C clinical trial, the stock prices of KOLON CORPORATION and KOLON LIFE SCIENCE Inc.—both of which are involved—hit their daily trading limits. KOLON CORPORATION’s stock price fell to 23,600 won, down 28.27% from the previous day. On that day, KOLON CORPORATION also hit a new 52-week low. KOLON LIFE SCIENCE Inc.’s stock price hit its daily trading limit at the market open and fell to 21,100 won.

KOLON CORPORATION is the largest shareholder of Kolon TissueGene, Inc., holding a 39.26% stake. KOLON CORPORATION has also been consistently injecting funds into Kolon TissueGene, Inc. Specifically, over the past five years, KOLON CORPORATION has participated five times in Kolon TissueGene, Inc.’s third-party private placements, investing a total of 206.2 billion won.

KOLON LIFE SCIENCE Inc. holds the rights to develop and commercialize TG-C in Asia. As KOLON LIFE SCIENCE Inc. had been seeking development and commercialization opportunities in major Asian markets, including Greater China, based on these rights, it is believed that the company was affected by this clinical trial failure.

Business Stabilization Drives NGeneBio Co., Ltd. to ‘Daily Price Limit’

On that day

, NGeneBio Co.,

Ltd.’s stock price hit

the daily price limit

early in the session and closed at 1,825 won. The rise in NGeneBio Co., Ltd.’s stock price is attributed to improved supply and demand following the resolution of uncertainties related to the rights offering, as well as the establishment of a stable business structure.

Following the finalization of its rights offering on the 17th, NGeneBio Co., Ltd.’s ex-rights date was implemented on the 21st. Consequently, the burden of participating in the subscription was lifted for new investors, and demand from those who had previously been on the sidelines is believed to have flowed in.

Furthermore, securing a stable revenue base through recent consecutive business achievements appears to have had a positive impact on investor sentiment. On the 13th of this month, NGeneBio Co., Ltd. signed a long-term supply contract for next-generation sequencing (NGS) total solutions with Soonchunhyang Bucheon Hospital. On the same day, the company began supplying its “HimAcuteTest” precision diagnostic panel for blood cancers to Seoul National University Bundang Hospital, thereby expanding its clinical application scope primarily among major tertiary general hospitals in Korea.

NGeneBio Co., Ltd.’s blood cancer panel business has maintained an average annual growth rate of 36% over the past five years. In the first quarter of this year, sales grew sharply, rising 38% domestically and 102% overseas compared to the same period last year. In particular, the pace of overseas sales growth has accelerated, establishing the blood cancer panel business as one of NGeneBio Co., Ltd.’s core growth drivers.

Additionally, in mid-month, the company signed a strategic channel partnership agreement with Illumina, a global leader in DNA sequencing and array-based technologies, to distribute Illumina’s NGS products and array-based technologies. Through this partnership, NGeneBio Co., Ltd. has expanded its business scope from its existing focus on diagnostic products and analysis software to include the supply of testing equipment, thereby completing a full-stack NGS business model that encompasses testing equipment, diagnostic panels, and AI-based analysis software.

A NGeneBio Co., Ltd. official stated, “The agreement with Illumina also opens up potential for future OEM and ODM collaboration,” adding, “It appears that the stock price has risen due to expectations of continued business achievements and earnings growth.”