HLB Hits Limit-Up on FDA Optimism; Curiosis, Peptron Rebound Sharply [K-Bio Pulse]

[이데일리 손민지 기자] 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 buoyed by renewed optimism that HLB could resume the U.S. Food and Drug Administration approval process for its liver cancer treatment, Curiosis’ global supply agreement with a German company referred to as M, and Peptron CEO Choi Ho-il’s purchase of company shares following last week’s controversy surrounding its collaboration with Eli Lilly and Company.



HLB group hits limit-up on renewed FDA approval hopes

HLB stock trend.(Source=KG Zeroin MP DOCTOR)

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

The rally spread 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 finished 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 behind 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 said Elevar had received notification from 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 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 said 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 alongside 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 outstanding. 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 ended 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 over how long the manufacturing issue would take to resolve had weighed on investors. The VAI classification appears to have eased that concern."



Curiosis jumps on global supply agreement with German company M



Curiosis climbed 20.66% to 15,420 won after announcing a global supply agreement with German life sciences company M for an automated live-cell imaging system.

The five-year agreement was signed on July 12 and took effect on July 7. It will automatically renew for successive one-year terms unless either party terminates the contract.

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

The instrument automatically monitors and analyzes cultured cells in real time. M plans to distribute the product worldwide through its U.S.-based life sciences business.

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

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

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

Samsung Securities analyst Jeong Dong-hee described the deal as “an important reference case” for Curiosis as it seeks to establish itself as a global original development manufacturer, or ODM, of laboratory equipment.

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



Peptron rebounds after CEO buys shares

Peptron stock trend.(Source=KG Zeroin MP DOCTOR)

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

The rebound came after Peptron disclosed that Choi had purchased 10,000 shares in 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 said at the Shinhan Bio Forum in Daejeon that Peptron was developing "a completely different peptide formulation" with "L company" and that tirzepatide was not included in the collaboration.

The remarks were interpreted by investors as meaning Lilly's blockbuster obesity drug ingredient was not part of the joint research program, triggering concerns over 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 built high expectations around the possibility of applying Peptron's long-acting platform to tirzepatide," one securities industry official said. "Future share performance will depend on how clearly the company demonstrates the actual scope and progress of the joint research program."