[Edaily Reporter Minji Son ] On the 15th, in the domestic pharmaceutical and biotech stock market, while shares of the HLB INC.(028300) group all hit their daily price limits, #Curiosis Inc. and Peptron, Inc.(087010)showed strong performance with sharp gains. Investor sentiment was boosted by expectations that HLB INC. would resume its bid for U.S. Food and Drug Administration (FDA) approval for a new liver cancer drug, and by Curiosis Inc.’s global supply agreement with Merck KGaA of Germany, respectively. Peptron, Inc., which had plummeted recently due to controversy over management statements, saw investor sentiment recover somewhat following the CEO’s purchase of company stock.

HLB INC. Group Stocks Hit ‘Daily Price Limit’ en Masse… Expectations for Resumption of U.S. Approval Process for New Liver Cancer Drug

According to KG Zeroin MP Doctor (formerly Marketpoint), HLB INC., a company developing new anti-cancer drugs, closed at 34,700 won on the KOSDAQ market today, up 29.96% (8,000 won) from the previous trading day.

During the same period, HLB innoVation(024850), HLB PANAGENE(046210), HLB PHARMACEUTICAL(047920), and HLB Therapeutics(115450)each rose 30.00%, while ANYGEN CO., LTD.(196300)(29.97%), GenoFocus, Inc.(187420)(29.96%), HLBbioStep(278650)(29.86%), and HLB Life Science(067630)(29.82%) also closed at their daily price limits. On the Korea Composite Stock Price Index (KOSPI) market, HLB GLOBAL Co., Ltd. also hit its daily price limit, rising 29.99%.

This is interpreted as the result of market optimism that HLB INC. has largely resolved the manufacturing facility issues that had led to the U.S. FDA’s hold on approval for its new liver cancer drug, “Riboceranib.” Last week, HLB INC. announced that its U.S. partner, Eleva Therapeutics, had received a Complete Response Letter (CRL) from the U.S. FDA regarding the combination therapy of Riboceranib and Camrelizumab for first-line treatment of liver cancer.

However, HLB Therapeutics announced today that on the 14th (local time), its Chinese partner, Hangzhou Pharmaceutical, confirmed the completion of the U.S. FDA’s Current Good Manufacturing Practice (cGMP) inspection of the Riboceranib active pharmaceutical ingredient (API) manufacturing facility.

It is reported that the FDA determined the facility to be generally compliant with current cGMP standards and ultimately classified the cGMP inspection results as a “Voluntary Action Recommendation” (VAI). A VAI is a classification assigned when the FDA determines that, while some improvements are needed based on the inspection, the issues do not constitute serious violations warranting mandatory regulatory action. It is considered a lower classification than “Official Action Required” (OAI), which could directly impact the approval review process.

HLB maintains that, since the FDA had previously cited the general cGMP inspection results of Hanso Pharmaceutical’s Jinqiao API manufacturing facility as the specific reason for the CRL regarding the new liver cancer drug, the conclusion of this VAI has resolved one of the major obstacles to approval. Eleva Therapeutics also plans to submit additional inquiries to confirm the FDA’s position as quickly as possible, separate from the scheduled Type A meeting.

However, follow-up measures regarding the finished drug product (DP) manufacturing facility remain. According to HLB INC., the Form 483 issued to that facility contained findings similar in nature to those at the API manufacturing site. Accordingly, Hangzhou Pharmaceutical plans to submit a response and a Corrective and Preventive Action (CAPA) plan to the FDA by the 24th.

HLB INC. officials stated, “With the issuance of the CRL, the existing approval review process has been concluded,” adding, “Eleva must resubmit its application before the FDA can decide on subsequent procedures.”

The official added, “While it was a concern that we couldn’t predict how long the process might be if the cGMP issues weren’t resolved, the fact that the case has now been closed as a VAI seems to have been received positively not only internally but also by the market.”

Curiosis Inc. Shares ‘Soar’ 21% on Supply Agreement with Germany’s Merck

Curiosis Inc. closed trading at 15,420 won, up 20.66% (2,640 won) from the previous trading day.

The rise in the stock price is believed to have been driven by news that the company signed a global supply agreement with German life sciences firm Merck for automated cell imaging products.

The previous day, Curiosis Inc. announced that it had signed the supply agreement with Merck on the 12th. The contract is valid for five years starting on the 7th and will be automatically renewed on an annual basis thereafter.

The products to be supplied are based on Curiosis Inc.’s live-cell imaging system, the “Celloger Mini Plus.” They are a modified version of the Celloger Mini Plus that Curiosis Inc. has been selling, incorporating the software and certain specifications requested by Merck.

The Celloger Mini Plus is a device capable of automatically observing and analyzing cell conditions in real time during the cell culture process.

Merck plans to sell this product worldwide through its U.S.-based life sciences subsidiary, EMD Millipore. While supplying products to Merck, Curiosis Inc. will be able to continue selling products based on the same intellectual property (IP) under its own brand, thereby adding Merck’s global distribution network to its existing sales channels.

Full-scale supply is set to begin in the second half of this year and is likely to be reflected in the company’s financial results. A Curiosis Inc. official stated, “Initially, supplies are expected to consist mainly of demonstration units rather than full-scale sales volumes,” adding, “We are cautiously projecting that the first shipment will take place as early as the third quarter of this year.”

On the same day, Jeong Dong-hee, an analyst at SamsungSecurities, said, “This contract is viewed as a key step toward establishing Curiosys as a global Original Design Manufacturer (ODM) in the laboratory equipment sector,” adding, “The pipeline for future contracts includes expanding the supply regions for the Colony Picker and Cellogger Pro, as well as the Cellogger Stack-H, a large multi-layer culture vessel.”

Peptron, Inc.: Investor Sentiment Recovers as CEO Buys Company Stock

Peptron, Inc., a peptide-based new drug development company, closed at 130,000 won today, up 18.18% (20,000 won) from the previous trading day.

Amid a recent sharp drop in the stock price due to controversy surrounding remarks made by Peptron, Inc. CEO Choi Ho-il regarding an obesity treatment, investor sentiment appears to have partially recovered after CEO Choi purchased the company’s shares on the open market.

The previous day, Peptron, Inc. announced that CEO Choi had acquired a total of 10,000 shares through on-market purchases. As a result of this purchase, the number of shares held by CEO Choi increased to 1,676,662, and his ownership stake rose by 0.04 percentage points (p) to 7.19%.

Regarding this, a Peptron, Inc. spokesperson stated, “This share purchase was a decision made to demonstrate management’s commitment to strengthening responsible management and growing together with our shareholders,” adding, “We take very seriously the concerns many investors are feeling due to recent market conditions and stock price fluctuations.”

Earlier, on the 9th, at the “Shinhan Bio Forum in Daejeon 2026” held at the Intercity Hotel in Yuseong-gu, Daejeon, CEO Choi stated, “In our joint research with Company L, we are developing an entirely different peptide formulation together, and Tuzepatide is not included,” adding, “That agreement was likely made with Kamurus.”

These remarks sparked controversy as they were interpreted to mean that Turze, which the market had anticipated would be included in the joint research between Peptron, Inc. and Eli Lilly, was not part of the agreement. Consequently, concerns grew regarding the value of the joint research and the prospects for a future master agreement, causing Peptron, Inc.’s stock price to hit the daily lower limit in after-hours trading on the day of the remarks. Tuzepatide is the active ingredient in Eli Lilly’s diabetes and obesity treatments “Mounjaro” and “Zepbound.”

As the controversy spread, Peptron, Inc. clarified that the joint research was not limited to a single specific product. The company explained, “The joint research we are currently conducting is not limited to the single product mentioned at the forum,” adding, “Joint research on multiple compounds—including the mentioned product, next-generation obesity and diabetes treatment candidates held by global pharmaceutical companies, and compounds targeting the central nervous system (CNS)—is proceeding normally according to plan.”

However, the fact that differences in interpretation remain regarding CEO Choi’s remarks and the company’s clarification is a variable. A securities industry official said, “Given that the market has placed considerable expectations on the potential application of terzepatide, the future direction of the stock price may depend on how specifically the actual targets of the joint research and the progress of the research are confirmed.”