[E-Daily Reporter KIM SAE-MI ] On the 10th, in the biotech sector, Peptron, Inc.(087010)and #HLB INC. all hit their daily price limits due to individual negative factors. Nevertheless, buying momentum spread across the KOSDAQ market as a whole, bringing a tailwind to other biotech stocks.

CEO Choi Ho-il Backtracked on His Remarks, but… Peptron, Inc. Falls

According to KG Zeroin MP Doctor (MP DOCTOR) on that day, Peptron, Inc. closed at 111,600 won, down 47,700 won (29.94%) from the previous day.

Previously, Peptron, Inc.’s stock price had plummeted to the daily limit-down in after-hours trading following CEO Choi Ho-il’s remarks the previous day at the “Shinhan Bio Forum in Daejeon 2026,” where he stated, “We are jointly developing a peptide formulation that is completely different from Lilly’s, and it does not include 터제파타이데.”

To address the controversy, Peptron, Inc. issued a statement at 8:00 a.m. that day, stating, “Joint research on multiple compounds—including next-generation obesity and diabetes treatment candidates held by a global pharmaceutical company, as well as compounds targeting the central nervous system (CNS)—is proceeding normally according to plan.”

The company also emphasized that the joint research had not been suspended and that research in the obesity and diabetes fields had not been terminated, stating, “The joint research is not limited to a single specific commercial product.” This statement could be interpreted to mean that the company is researching multiple compounds, including 터제파타이드, or that it is researching next-generation compounds other than 터제파타이드.

Consequently, the market interpreted this to mean that Tuzepatide was not the subject of the joint research, and Peptron, Inc.’s stock price hit the daily lower price limit starting at 10:18 a.m.

In response, the company revised its statement around noon on the same day, announcing, “The joint research is not limited to the single product mentioned at the forum; joint research is currently underway on multiple compounds, including the mentioned product, as well as next-generation obesity and diabetes treatment candidates and CNS-related compounds.”

There is a strong likelihood that the phrase “the product mentioned at the forum” refers to turzepatide. Consequently, while Peptron, Inc.’s stock price temporarily recovered from the daily price limit at 12:24 p.m., it fell back to the limit at 1:41 p.m.

Peptron, Inc. issued a revised announcement that was interpreted as effectively retracting CEO Choi’s statement that “Tuzepatide is not included.” However, within the company, it is understood that CEO Choi’s remarks were intended to clarify that while Tuzepatide was previously the subject of a Material Transfer Agreement (MTA) with Lilly, it is not currently included in the scope of the joint research.

An official from an investment firm stated, “Although the company has attempted to defuse the situation through statements and other measures, it will be difficult for market anxiety to subside easily given that the remarks were made at an investor relations event attended by the CEO in person,” adding, “Amid the recent sharp correction in biotech stocks, trust issues at individual companies could lead to risk-averse sentiment across the entire sector.”

Another official from an investment firm predicted, “With investor confidence already weakened by controversies such as the extension of the technology evaluation period and delays in the groundbreaking for the Osong Plant No. 2, these remarks have dealt the final blow,” adding, “Given the company’s confidentiality obligations, it will be difficult for them to provide a detailed explanation, making it challenging to dispel the market’s misunderstandings.”

Third CRL… CMC Risk Shakes HLB INC

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At 7:44 a.m. that day, HLB INC. announced in a regulatory filing that it had received its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the marketing authorization for the combination therapy of “Riboceranib” and “Camrelizumab” as a first-line treatment for liver cancer. The reason for the CRL was the failure of HanmiPharm’s manufacturing facility to meet current Good Manufacturing Practice (cGMP) standards, and the FDA notified HLB that a re-inspection could be conducted if necessary.

Following this news, not only HLB INC. but also most of the HLB Group’s listed companies hit their daily price limit down.

On that day, HLB INC.’s stock price plummeted by 15,600 won (29.89%) compared to the previous day, and the following HLB Group listed companies also fell to their daily price limit: HLB PHARMACEUTICAL(047920)(-29.98%), HLB Life Science(067630)(-29.87%), HLB Therapeutics(115450)(-29.82%), HLB innoVation(024850)(-29.82%), and HLBbioStep(278650)(-29.72%). HLB PANAGENE(046210)(-25.05%), GenoFocus, Inc.(187420)(-23.17%), and ANYGEN CO., LTD.(196300)(-14.32%) avoided hitting the lower price limit but could not escape sharp declines.

Concerns had been mounting in the market regarding the approval of Hantong Pharmaceutical’s new drug, as there had been no news of an on-site inspection until recently. Although HLB INC. issued four separate announcements on its official blog that day to clarify the situation, these efforts were insufficient to restore investor confidence, compounded by allegations of inadequate information sharing.

HLB INC. explained that this inspection was not a Pre-Approval Inspection (PAI) for new drug approval, but rather a routine cGMP inspection or surveillance inspection of DaihanPharmaceutical’s Drug Substance (DS) and Drug Product (DP) facilities. Based on the company’s explanation, the FDA inspected the DS facility in April and the DP facility in July, identifying areas for improvement. Following the DS facility inspection, Hangseo Pharmaceutical received a Form 483 detailing on-site findings and submitted corrective documentation; the company was also preparing a response regarding the findings from the DP facility inspection.

The company believes that since products related to Riboceranib are also manufactured at these facilities, even if Riboceranib itself was not the direct subject of the inspection, the FDA could not have granted new drug approval unless the facilities’ cGMP compliance had been confirmed. HLB INC. emphasized, “This CRL contained no additional findings regarding clinical data, efficacy, safety, or the submitted CMC data,” adding, “There were also no separate requests for corrective actions regarding the production processes for riboceranib and camrelizumab themselves.”

Another key issue in this matter is the problem of information sharing between Hangzhou Pharmaceutical and Eleva. According to HLB INC.’s explanation, Hangzhou Pharmaceutical viewed this inspection as a general cGMP audit not directly related to the Riboceranib NDA and therefore did not share this information with Eleva in advance. As a result, Eleva learned of the inspection and the issuance of Form 483 only after the fact. This means that regulatory risks were not shared in a timely manner, even though the key product is manufactured at the same facility.

From an enterprise value perspective, the damage to trust is likely to pose a greater burden than the approval delay itself. A significant portion of the HLB Group’s enterprise value was based on expectations for the U.S. approval and commercialization of Riboceranib. In particular, HLB PHARMACEUTICAL, which is currently pursuing a large-scale rights offering, is expected to find it difficult to avoid the impact of dampened investor sentiment.

Buying Momentum Picks Up on KOSDAQ… Bio Sector Sees “Upturn” Despite Individual Setbacks

Despite the negative news surrounding Peptron, Inc. and HLB INC., the biotech sector as a whole saw a positive trend. Some stocks, such as SyntekaBio,Inc.(226330)(30%) and ANTEROGEN CO., LTD.(065660)(29.94%), hit their daily price limits, while others, including ToolGen Incorporated(199800)(25.11%) and PROTEINA CO., LTD. (13.46%), also showed strong gains. Alteogen Inc.(196170), a large-cap stock, also rose 24,000 won (8%) from the previous day to close at 324,000 won.

Analysts attribute this to buying momentum flowing into biotech stocks as market demand—which had recently been concentrated on certain large-cap stocks due to a decline in trading volume by retail investors—spread across the KOSDAQ market as a whole. On this day, the buy-side circuit breaker was triggered in the KOSDAQ market, and investor sentiment improved rapidly, with the index recovering to above the 800-point mark.

An official from the financial investment industry analyzed, “As the positive supply-and-demand momentum extended to the KOSDAQ, many stocks surged,” adding, “Large-cap stocks showed strength, with the exception of individual stocks facing negative news, such as Peptron, Inc. and HLB INC.”