[Edaily Reporter KIM SAE-MI ] Jin Yang-gon, Chairman of HLB INC., who had shown strong confidence ahead of the U.S. Food and Drug Administration’s (FDA) approval of a new liver cancer drug, has received a third Complete Response Letter (CRL). Chairman Jin had raised expectations for the new drug’s approval by purchasing shares in affiliate companies 45 times since the start of this year, personally attending major investor relations (IR) events, and even taking on the role of CEO of HLB innoVation; however, the U.S. approval of Riboceranib has been delayed once again.

Chairman Jin is the figure who transformed HLB INC.—which had previously operated in the shipping industry—into a bio-focused corporate group. Through mergers and acquisitions, he expanded the group’s business scope into the bio, healthcare, diagnostics, and materials sectors, and cultivated the targeted anticancer drug Riboceranib as the group’s core growth engine. He is also well known for communicating directly with shareholders via YouTube videos, investor relations (IR) sessions, and shareholder meetings whenever major management issues or clinical trial and approval results are announced.

Riboceranib is a compound developed by the U.S.-based Advancen Research Institute, and its Chinese rights were transferred to China’s Hangzhou Pharmaceutical in 2004. Subsequently, LSK Bio Partners—the predecessor to Eleva—secured global rights (excluding China) in 2007. Counting from 2009, when Chairman Jin acquired HLB INC. and began full-scale development, this year marks approximately the 17th year of the project. If we trace the compound’s history back to its early development stages, this new drug development effort has been ongoing for over 20 years.

Chairman Jin’s actions this year were interpreted as a sign of confidence regarding the approval of Riboceranib. On the 25th of last month, he purchased 20,000 shares of HLB Therapeutics(115450) and 27,000 shares of GenoFocus, Inc.(187420) on the open market. Including these transactions, he has purchased shares in affiliated companies—such as HLB innoVation(024850), HLB PANAGENE(046210), HLB Therapeutics(115450), GenoFocus, Inc.(187420), and HLBbioStep(278650) —a total of 45 times this year.

At the HLB INC. Integrated Shareholders’ Meeting held on April 9, he attended alongside the CEOs of the 10 listed companies and personally answered shareholders’ questions. Kim Tae-han, the former CEO of SAMSUNG BIOLOGICS who joined the HLB INC. Group earlier this year as Chairman of Bio Operations, also addressed the meeting to reassure shareholders. The appointment of Chairman Kim—who, as the first CEO of SAMSUNG BIOLOGICS, established a global pharmaceutical manufacturing and quality control (CMC) system—was viewed as a decisive move to resolve recurring CMC risks.

On the 1st, Chairman Jin assumed the role of co-CEO of HLB innoVation. This move was interpreted as an effort to oversee the recovery of the semiconductor business’s performance while personally managing the development costs, fundraising, and business development strategy for the chimeric antigen receptor T-cell (CAR-T) program at the U.S. subsidiary, Verismo Therapeutics. The combination of the purchase of shares in affiliated companies, the recruitment of Chairman Kim, and his direct involvement in management was interpreted by the market as a sign of confidence in securing new drug approval.

However, the FDA’s decision fell short of shareholders’ expectations. HLB INC.’s U.S. subsidiary, Eleva Therapeutics, received its third Complete Response Letter (CRL) from the FDA on the 9th (local time) regarding the New Drug Application (NDA) for riboceranib. Eleva had been pursuing approval for the combination therapy of riboceranib and Kamrelizumab—an immunotherapy developed by China’s Hengrui Pharmaceuticals—as a first-line treatment for liver cancer.

The immediate cause of this CRL was the FDA’s Current Good Manufacturing Practice (cGMP) inspection of DaihanPharmaceutical’s manufacturing facility. Last April, the FDA conducted a routine inspection of the active pharmaceutical ingredient (API) manufacturing facility for riboceranib and issued a “Form 483” listing the findings. Although this inspection was a general inspection targeting other drugs—not a pre-approval inspection for riboceranib—the facility was listed in the riboceranib New Drug Application (NDA), so the findings were reflected in the review.

HLB INC. emphasized that this CRL, too, did not stem from issues with the clinical efficacy or safety of riboceranib or camrelizumab themselves. The company explained that no additional clinical trials were required and that the main points for correction related to the cGMP inspection of the Hangzhou Pharmaceutical manufacturing facility.

However, criticism in the market regarding HLB INC.’s ability to manage its partners has intensified. This is because, following the first and second CRLs—which also pointed out issues with Hangzhou Pharmaceutical’s manufacturing and quality control of camrelizumab—Hangzhou Pharmaceutical’s manufacturing facilities once again proved to be a stumbling block in the third review. In particular, the explanation that Hangzhou Pharmaceutical failed to promptly share with HLB PHARMACEUTICAL and Eleva the details of the API facility inspection and the issuance of Form 483 has fueled controversy over whether the information-sharing and regulatory risk management systems between the two companies were functioning properly.

It is also noteworthy that, unlike previously—when Chairman Jin personally explained the situation via YouTube immediately after receiving the CRL—he did not host a separate YouTube broadcast this time. This decision was reportedly made in consideration of shareholder demands.

Five days after receiving the CRL, a glimmer of hope emerged. On the 14th, the FDA concluded its inspection of the active pharmaceutical ingredient (API) manufacturing facility for riboceranib with a “Voluntary Action Item” (VAI), a voluntary improvement recommendation. A VAI classification indicates that while there are observations, they do not warrant administrative or regulatory action, and voluntary corrective action by the manufacturer is required. HLB INC. views the direct cause of the third CRL as having been largely resolved and plans to formally inquire with the FDA regarding the resumption of the approval process and the procedure for resubmission.

However, uncertainty remains, as a Form 483 has also been issued for the finished drug product manufacturing facility for riboceranib. Hangzhou Pharmaceutical plans to submit a response and a corrective and preventive action plan to the FDA by the 24th. HLB INC. plans to formally inquire with the FDA regarding the impact of the VAI closure at the active pharmaceutical ingredient (API) manufacturing facility on the grounds for this CRL, while also discussing the resumption of the approval process and the timing and method of resubmission based on the progress of corrective actions at the finished drug product manufacturing facility. Ultimately, the results of the corrective actions at the finished drug product manufacturing facility and the FDA’s assessment of them are expected to determine the future resubmission schedule and the pace of the approval process.

A biotech industry official stated, “Given that the company has received three CRLs, it is difficult to be purely optimistic about the prospects for future approval,” adding, “Even if the new drug is approved, the market for first-line liver cancer treatments is already fiercely competitive due to combination immunotherapy treatments from global pharmaceutical companies, so it is unlikely that approval itself will immediately lead to commercial success.”

However, he added, “The movement of HLB INC.’s stock price is difficult to explain solely based on the intrinsic value of the new drug,” noting, “There have been several instances in the past where the stock price rebounded as expectations were rebuilt following negative news, so it is difficult to predict with certainty how the stock price will move going forward.”

◇Profile of Jin Yang-gon, Chairman of the Board of HLB INC.
△Born in Busan Metropolitan City in 1966
△Graduated from Wonkwang University with a degree in Law in 1990
△1993: Master’s degree in Economics, Yonsei University Graduate School
△Worked at Busan Bank from 1991 to 1994
△Worked at Pyeonghwa Bank, 1994–1998
△2004: CEO of Golden Light
△2006: Chairman of Hyundai Life Boat
△2008: Acquired HiCell and became Chairman
△2013: Acquired HLB INC.
△2017–2025: CEO of HLB INC.
△2025–Present: Chairman of the Board, HLB INC.