[Edaily Reporter Minji Son ] From July 6 to 10, the pharmaceutical and biotech industry was abuzz with news of the controversy surrounding Peptron, Inc.(087010)’s joint research with Eli Lilly and HLB INC.(028300)’s failure to secure U.S. approval for a new liver cancer drug. Investor sentiment at Peptron, Inc. plummeted after it was reported that the subject of its joint research with Lilly was not terzepatide, as the market had anticipated. HLB INC.’s stock price plummeted after the company received its third Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the combination therapy of riboceranib and camrelizumab for first-line treatment of liver cancer.

Cracks in Expectations for Peptron, Inc.’s “Once-a-Month Mounjaro”

Peptron, Inc. drew investors’ attention as market expectations surrounding its joint research with Eli Lilly began to waver. The catalyst was a statement by Choi Ho-il, CEO of Peptron, Inc. As his remarks were interpreted to mean that turzepatide was not included in the scope of the joint research with Lilly, the issue of whether there was a discrepancy between the expectations the market had held for over a year and the actual scope of the research came to the forefront.

Tirzepatide is the active ingredient in Lilly’s diabetes and obesity treatments “Mounjaro” and “Zepbound.” Until then, the market had anticipated that Peptron, Inc.’s long-acting drug delivery platform, “SmartDepo,” could be applied to Lilly’s tirzepatide. This was because, when Peptron, Inc. announced in October 2024 that it had signed a Material Transfer Agreement (MTA) with Lilly, some interpreted the agreement as being related to the development of a “once-monthly Mounjaro.”

These expectations persisted even after Lilly signed a collaboration agreement with Sweden’s Kamurus in June of last year regarding a long-acting drug delivery platform. At the time, Peptron, Inc. stated, “The technical evaluation with Lilly for the development of a long-acting obesity treatment remains solid and is proceeding smoothly.”

However, the controversy intensified when CEO Choi stated at the “Shinhan Bio Forum in Daejeon 2026,” held on the 9th at the Intercity Hotel in Yuseong-gu, Daejeon, “We are jointly developing an entirely different peptide formulation with Company L, and Tuzepatide is not included,” adding, “That agreement was likely made with Kamurus.”

In response, Peptron, Inc. issued a statement the previous day to clarify the matter, but the controversy shows no signs of subsiding. The company stated, “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 currently proceeding normally according to plan.”

HLB INC. Receives Third CRL… Approval of New Liver Cancer Drug Hit Another Snag

HLB INC., which received its third Complete Response Letter (CRL), was also one of the biggest topics in the biotech industry this week. HLB INC. announced the previous day that its U.S. partner, Eleva Therapeutics, had received a CRL from the U.S. Food and Drug Administration (FDA) regarding the combination therapy of riboceranib and camrelizumab for first-line treatment of liver cancer.

The combination therapy of riboceranib and camrelizumab is a first-line treatment for liver cancer that HLB INC.’s U.S. subsidiary, Eleva, is seeking approval for in the United States. Riboceranib is a targeted anticancer drug for which HLB INC. holds the rights, while camrelizumab is an immunotherapy developed by China’s Hengrui Pharmaceuticals. HLB INC. has been seeking to enter the U.S. market for first-line liver cancer treatments with this combination therapy.

It has been reported that the FDA recently identified deficiencies during a Current Good Manufacturing Practice (cGMP) inspection of DaihanPharmaceutical’s manufacturing facility and issued a Form 483 (a document notifying the company of findings identified during the inspection).

HLB INC. stated, “The FDA explained that while the findings identified during this inspection may not pertain directly to the NDA for Riboceranib itself, since the manufacturing site in question is listed in the NDA, we must work with the facility to resolve the issues in a timely manner.”

They continued, “The FDA stated that it cannot approve the Riboceranib NDA until the issues at the facility in question are resolved and compliance with cGMP standards is confirmed,” adding, “The CRL also noted that even after the cGMP-related issues are resolved, the FDA may conduct a Pre-Approval Inspection (PAI) at the facility if necessary, and that new drug approval is only possible after satisfactory results are obtained from both the cGMP inspection and the PAI.”

HLB INC. had previously received its first CRL in May 2024, followed by another CRL in March of last year. With this latest setback—marking the third time the approval process has been halted—the timeline for Riboceranib’s commercialization in the U.S. has once again become uncertain.

HLB INC. plans to address the issues raised by the FDA and, in consultation with Hangzhou Pharmaceutical, announce a response plan for resubmitting the marketing authorization application.

Kim Dong-geon, CEO of Eleva, said, “We have not identified any specific concerns regarding clinical efficacy or safety data, nor any requests for additional clinical trials in this CRL,” adding, “Since the main requests for additional information relate to the cGMP inspection of the manufacturing facility, we will consult closely with the FDA to confirm the necessary procedures and proceed with a resubmission as soon as possible.”

However, given that this is the third CRL, market fatigue is bound to grow. This is because the longer the approval delay continues, the greater the burden of being a late entrant and the higher the costs of additional corrective actions may become.