[비즈한국] Kim Tae-han, the Bio Division Chairman who joined HLB Group028300 unexpectedly early this year, expressed confidence in the U.S. Food and Drug Administration (FDA) approval of HLB's liver cancer drug combo therapy, Rivoceranib and Camrelizumab.
At the HLB Group integrated shareholders' meeting held at the KBIZ Hall of the Korea Federation of SMEs in Yeongdeungpo-gu, Seoul, on the 9th, Chairman Kim stated, "Since joining HLB Group, I have reviewed all materials exchanged with the FDA over the past 2-3 months, as well as documents from Elevar Therapeutics and Hengrui Pharma." He added, "Together with experts from our U.S. new drug development subsidiary, Elevar, I personally visited the production plant of China's Hengrui Pharma to inspect every corner and share our know-how in responding to the FDA."
Having served as the CEO of Samsung Biologics for over a decade, where he experienced various instances of client drugs navigating the FDA's rigorous standards, he explained that the situation facing HLB's liver cancer drug combination of Rivoceranib and Camrelizumab is a common hurdle. Chairman Kim said, "I view the second Complete Response Letter (CRL) received by Hengrui Pharma as being on the boundary between approval and supplement." He added, "Everyone is doing their best, and with the final decision imminent in July, I would like to wait and see along with our shareholders."
Previously, HLB applied for FDA approval for the Rivoceranib-Camrelizumab combination therapy, but received CRLs twice, in May 2024 and March 2025. Both instances pointed to Chemistry, Manufacturing, and Controls (CMC) issues at the Camrelizumab production facilities of their partner, China's Hengrui Pharma.
Jin Yang-gon, Chairman of the HLB Board of Directors, praised Chairman Kim's joining as a significant source of strength. Chairman Jin said, "Previously, even after internal discussions and reaching a decision, we lacked the experience and network to be sure if it was the right path. However, since Chairman Kim joined, our concerns fall within his scope of experience, allowing us to reach clear conclusions, and I am feeling very much at ease."
Chairman Kim worked at the Samsung Group for over 40 years, including leading the first 10 years of Samsung Biologics, considered a leader in K-Bio. He is credited with laying the foundation for Samsung Biologics to leap into a global CDMO (Contract Development and Manufacturing Organization) company.
Chairman Kim revealed that his motivation for joining HLB Group was to fulfill his dream of developing new drugs. He said, "During my time at Samsung Biologics, I had three dreams: to become a global CMO (Contract Manufacturing Organization) company, to succeed in the biosimilar business, and to start developing novel bio-drugs." He added, "As you all know, our achievements in the CMO and biosimilar businesses far exceeded expectations, reaching global top-tier status, but I could not embark on novel drug development before my term ended."
He continued, "I was drawn to HLB Group because it possesses excellent new drug candidates and has a well-established ecosystem for developing them." He expressed his ambition, stating, "I will apply the know-how accumulated over decades at Samsung to contribute to HLB's growth into a global competitive new drug development company."
HLB is awaiting FDA approval decisions for the Rivoceranib-Camrelizumab combination therapy in July and the bile duct cancer treatment, Lirafugratinib, in September. Chairman Jin emphasized, "As we have prepared every moment with a desperate heart, I believe we will become the first and second cases of Korean bio companies that have independently developed and received approval for global anticancer drugs."