[Edaily Reporter KIM SAE-MI ] On the 24th, in the biotech sector, Kolon TissueGene, Inc. narrowly avoided hitting the daily price limit down for the fourth consecutive trading day. Peptron, Inc. saw its stock price show strength in after-hours trading on expectations of an expansion of its second plant.

Kolon TissueGene, Inc. Avoids Hitting Daily Lower Limit for 4 Consecutive Days… Down 85% in One Month

According to KG Zeroin MP DOCTOR on that day, Kolon TissueGene, Inc. closed at 15,000 won, down 6,050 won (28.74%) from the previous day. Although the stock fell by 20% early in the session, it hit the daily price limit down in the afternoon but managed to narrowly avoid hitting the limit down for the fourth consecutive day as the limit was lifted toward the end of the session.

As a result, Kolon TissueGene, Inc. recorded its fourth consecutive day of hitting the daily price limit down following the release of topline results from the U.S. Phase 3 clinical trial (Study 15302) for its cell-gene therapy for osteoarthritis, “TG-C” (formerly Invossa). While the stock had remained at the daily price limit down for the entire trading session over the previous three days, there was a slight difference on this day in that the limit down was temporarily lifted during the early trading session.

Kolon TissueGene, Inc. announced the results of the TG-C Phase 3 clinical trial after the close of regular trading on the 20th. The company’s stock price, which stood at 61,200 won prior to the announcement (on the 20th), fell to 15,000 won that day. This represents a sharp plunge of 75.5% in just four trading days.

When viewed over a longer time frame, the rate of decline is even greater. Kolon TissueGene, Inc.’s stock price, which stood at 101,100 won on the 24th of last month, has fallen by 85.2% in just one month. Kolon TissueGene, Inc.’s stock price had been on a steep upward trajectory since last year, driven by expectations for the success of the TG-C Phase 3 clinical trial, and the rally continued through the first half of this year. On May 12, the stock briefly rose to 149,000 won during trading, marking its highest price in the past year.

The sharp decline in Kolon TissueGene, Inc.’s stock price is attributed to the fact that the company’s enterprise value is effectively concentrated solely on TG-C. Although Kolon TissueGene, Inc. has presented a pipeline of follow-up products—including treatments for hip osteoarthritis, herniated discs, and veterinary medicines—most of these are still in early clinical or preclinical stages.

The fact that the results of the 15302 trial were so disappointing that there was little room for a hopeful interpretation also dampened investor sentiment. Although the TG-C treatment group showed improvements in pain and function, the gap with the placebo group did not widen, resulting in the failure to meet all co-primary endpoints. None of the four secondary endpoints showed a statistically significant difference compared to the placebo either. In effect, the trial failed to demonstrate overall efficacy.

In particular, given that the results were so close to statistical significance that they can hardly be characterized as a “narrow miss,” expectations for Trial 15301—a virtually identical twin trial—are also declining. A biotech industry official stated, “It’s hard to view these numbers as anything but a clear failure,” adding, “Since this is a clear failure, expectations for Trial 15301, which is essentially a twin trial, are bound to drop as well.”

Synteca, DuChemBio Co., LTD, and NGeneBio Co., Ltd. Rise… What’s the Key Point?

On this day, SyntekaBio,Inc.(226330), DuChemBio Co.,LTD.(176750), and NGeneBio Co., Ltd.(354200)all hit their daily price limits due to individual news. According to KG Zeroin MP Doctor, SyntekaBio,Inc. closed at 1,835 won, up 423 won (29.96%) from the previous day, while DuChemBio Co, LTD closed at 7,310 won, up 1,680 won (29.84%) from the previous day. and NGeneBio Co., Ltd. closed at 2,585 won, up 595 won (29.90%) from the previous day.

SyntekaBio,Inc. announced this morning that, using its proprietary antibody design platform “Ab-ARS®,” it has secured an antibody biobetter candidate with higher solubility than blockbuster antibody drugs, including Keytruda (pembrolizumab).

According to the company, the study was conducted on 10 blockbuster antibodies targeting specific antigens that are currently on the market. SyntekaBio,Inc. redesigned existing antibodies by applying a framework (FR) with high solubility (150–200 mg/mL) and, based on analysis from its proprietary AI platform, identified candidates predicted to have solubility at least 5 to 20 times higher than that of existing antibodies.

Following this news, SyntekaBio,Inc.’s stock price began to surge, reaching the daily price limit at 9:42 a.m. and remaining there. However, it is important to note that the key figure driving the stock’s reaction—a “5- to 20-fold improvement in solubility”—is an AI prediction rather than an actual measurement.

DuChemBio Co, LTD posted a “spike” following news that it had completed the Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for the primary raw material of “18F-FP-CIT,” a positron emission tomography (PET) radiopharmaceutical used to diagnose Parkinson’s disease.

Following the registration process, the FDA assigned DMF number “MF044308” to the active ingredient. DuChemBio Co, LTD explained that this establishes a foundation for supplying the 18F-FP-CIT active ingredient in the U.S. and supporting the development and approval of finished pharmaceutical products there. Based on this registration, DuChemBio Co, LTD plans to expand technology exports and active ingredient supply partnerships in North America.

A DMF is a system for submitting and registering manufacturing process and quality control data for pharmaceutical active ingredients with the FDA. Developers of finished pharmaceutical products can refer to this data during the marketing authorization review process. However, the assignment of a DMF number does not in itself imply FDA marketing authorization for the active ingredient or the finished pharmaceutical product. For actual commercialization, follow-up procedures such as securing local partners and developing and obtaining approval for the finished pharmaceutical product are required.

NGeneBio Co., Ltd. hit the daily price limit not only today but also on the 21st and 22nd. It appears that the positive impact of the news on the 21st regarding the expanded supply of its precision diagnostic panel for blood cancers to Seoul National University Hospital is continuing. With a market capitalization of 23.1 billion won, the market is reacting sensitively to positive news.

Meanwhile, NGeneBio Co., Ltd. is currently conducting a rights offering to issue 7.15 million shares, equivalent to 80% of its existing shares. While the company initially planned to raise 22.4 billion won, the expected amount has shrunk to 7.7 billion won after the initial offering price was set at 1,074 won per share.

Peptron, Inc. to Expand Plant 2 by 2.5 Times… Will Construction Begin in September?

Peptron, Inc. showed strength in after-hours trading as news belatedly spread that the company had applied for a building permit amendment to expand the total floor area of its Osong Plant No. 2 by 2.5 times. As of 5:32 p.m. on the 24th, Peptron, Inc. was trading at 124,900 won, up 16,100 won (14.80%) from the previous day.

At 2:56 p.m. that day, Peptron, Inc. announced via a notice on its website that it had applied for a building modification permit to reflect design changes aimed at expanding the production and support facilities at its Osong Bio Park Plant No. 2.

According to the proposed changes, the total floor area of Plant No. 2 will be expanded by 2.5 times, from the current approximately 12,000 square meters to approximately 30,000 square meters. However, the company stated that it is difficult to disclose specific details regarding the design or facility configuration related to the building modification permit, as they constitute material non-public information pertaining to the company’s production technology and operational strategy.

With this significant design change, it has become even more uncertain whether the company will be able to meet its target of breaking ground this September. This is because the review of the building modification permit and the design revision process are still pending, and the construction contractor has not yet been finalized.

Previously, when Peptron, Inc. announced its investment plan for the new plant in August 2024, it had proposed beginning construction in the first half of 2025 and completing the project by June 2026. However, as the schedule faced delays, the company extended the investment completion date to June 2027 at the end of last year. Later this month, the company set a new target of breaking ground in September 2026, but this application for a change permit has introduced additional uncertainties to the schedule.

Since the total floor area has been expanded by 2.5 times—from approximately 12,000 square meters to 30,000 square meters—changes are likely to follow in construction costs, investment in production facilities, and the financing plan. Peptron, Inc.’s total planned investment has already increased from the initial 65 billion won to 89 billion won. Peptron, Inc. did not specify whether the total investment cost would change as a result of this design modification.