[Edaily Reporter Minji Son ] On July 15, South Korean pharmaceutical and biotech stocks rallied, led by a broad surge in HLB affiliates, while Curiosis and Peptron posted double-digit gains.

Investor sentiment was boosted by renewed optimism that HLB’s liver cancer therapy could resume the U.S. Food and Drug Administration (FDA) approval process, Curiosis’ global supply agreement with Germany’s Merck KGaA, and insider share purchases by Peptron’s chief executive following last week’s controversy over its collaboration with Eli Lilly and Company.

HLB Group Hits Limit-Up on Renewed FDA Approval Hopes

According to KG Zeroin’s MP Doctor platform, HLB jumped 29.96% to close at 34,700 won.

The rally extended across the group. HLB Innovation, HLB Panagene, HLB Pharmaceutical, and HLB Therapeutics all gained 30%, while HLB Pep, HLB Genex, HLB BioStep, and HLB Life Science also closed at or near the daily upper limit. On the KOSPI, HLB Global rose 29.99%.

The gains followed news that one of the key manufacturing issues underlying the FDA’s Complete Response Letter (CRL) for HLB’s liver cancer therapy appeared to have been substantially resolved.

Last week, HLB disclosed that its U.S. partner, Elevar Therapeutics, had received a CRL from the FDA for the combination of rivoceranib and camrelizumab as a first-line treatment for hepatocellular carcinoma.

On Tuesday, however, HLB announced that Elevar had received notification from its Chinese partner, Jiangsu Hengrui Pharmaceuticals, that the FDA had completed its cGMP inspection of the active pharmaceutical ingredient manufacturing facility.

The inspection was classified as “Voluntary Action Indicated” (VAI), meaning the FDA found the facility to be generally compliant with current Good Manufacturing Practice (cGMP) standards while recommending only minor corrective actions. A VAI classification is considered less severe than “Official Action Indicated” (OAI) and typically does not trigger enforcement measures.

HLB noted that the API manufacturing site had been specifically cited in the CRL, making the VAI classification an important step toward resolving one of the key regulatory hurdles.

Elevar also plans to submit additional questions to the FDA in conjunction with a previously scheduled Type A meeting in an effort to clarify the agency’s position as quickly as possible.

The company noted, however, that follow-up procedures for the drug product manufacturing facility remain pending. Hengrui plans to submit its response and corrective and preventive action (CAPA) plan for the facility’s Form 483 observations by July 24.

“The original review process concluded with the issuance of the CRL, so Elevar will need to resubmit the application before the FDA determines the next regulatory steps,” an HLB official said.

“The uncertainty regarding how long it would take to resolve the manufacturing issue had weighed on investors. The VAI classification appears to have alleviated that concern.”

Curiosis Shares Surge on Merck Global Supply Agreement

Curiosis rose 20.66% to 15,420 won after announcing a global supply agreement with Merck for an automated live-cell imaging product.

The five-year agreement, signed on July 12 and effective as of July 7, will automatically renew in one-year increments unless terminated.

The product is based on Curiosis’ Celloger Mini Plus live-cell imaging system, customized with software and specifications requested by Merck.

The instrument automatically monitors and analyzes cultured cells in real time. Merck plans to distribute the product globally through its U.S. life sciences division, EMD Millipore.

Curiosis will continue to sell products based on the same intellectual property under its own brand while adding Merck’s global distribution network to its existing sales channels.

Commercial shipments are expected to begin in the second half of this year and contribute to revenue.

“Initially, shipments will mainly consist of demonstration units rather than full commercial volumes,” a company official said. “The first deliveries could begin as early as the third quarter.”

Samsung Securities analyst Jeong Dong-hee said the deal represents “an important reference case” as Curiosis seeks to become a global original development manufacturer (ODM) for laboratory equipment.

He added that the company’s next targets include expanding regional supply agreements for Colony Picker and Celloger Pro, as well as commercializing the large-scale Celloger Stack-H culture system.

Peptron Rebounds After CEO Buys Shares

Peptron rose 18.18% to close at 130,000 won, recovering some of the sharp losses triggered by last week’s comments from CEO Choi Ho-il regarding the company’s collaboration with Eli Lilly.

The rebound came after Peptron disclosed that Choi had purchased 10,000 shares on the open market.

Following the purchase, his holdings increased to 1.68 million shares, raising his ownership stake to 7.19%.

"The purchase reflects management's commitment to responsible leadership and long-term growth alongside shareholders," the company said.

"We fully recognize investors’ concerns following recent market volatility."

Last week, Choi stated at the Shinhan Bio Forum in Daejeon that Peptron was developing “a completely different peptide formulation” with “Company L” and that tirzepatide was not included in the collaboration.

Investors interpreted these remarks to mean that Lilly’s blockbuster obesity drug ingredient was not part of the joint research program, triggering concerns about the strategic value of the partnership. Peptron subsequently hit the daily lower limit in after-hours trading.

The company later clarified that its collaboration with Lilly extends beyond a single candidate and continues to include multiple next-generation obesity, diabetes, and central nervous system (CNS) drug candidates under the original development plan.

Still, some uncertainty remains.

"Investors had high expectations regarding the possibility of applying Peptron’s long-acting platform to tirzepatide," said one securities industry official. "Future stock performance will depend on how clearly the company demonstrates the actual scope and progress of the joint research program."