[비즈한국] HLB028300 has made its third attempt to gain approval from the U.S. Food and Drug Administration (FDA) for the combination therapy of 'Rivoceranib' and 'Camrelizumab,' which is being developed as a first-line treatment for liver cancer. While manufacturing and drug quality risks, rather than efficacy or safety, have been the hurdles to approval, the outcome will depend on whether this re-submission has effectively addressed those variables.
HLB announced on the 23rd that its U.S. drug development subsidiary, Elevar Therapeutics, had submitted the re-approval application documents for the Rivoceranib and Camrelizumab combination therapy to the FDA. This comes approximately 10 months after receiving a second Complete Response Letter (CRL) in March 2025.
Since failing to obtain approval in May 2024 and receiving its first CRL, HLB has faced criticisms regarding the CMC (Chemistry, Manufacturing, and Controls) of the Camrelizumab production facilities run by its partner, China's Hengrui Pharma. The company is now expressing confidence that these issues have been resolved. Depending on the track the FDA assigns to this application, a final decision on the approval of the Rivoceranib and Camrelizumab combination could be reached as early as two months (Class 1) or, at the latest, six months (Class 2).
Some in the industry remain cautious, expressing concern that the FDA might apply more stringent standards when re-inspecting facilities that have previously been flagged for quality issues. In this regard, Jang-Ik Lee, a professor at Seoul National University's College of Pharmacy who previously served as an FDA clinical pharmacology reviewer and team lead, analyzed, "While regulatory standards can be strengthened as science and technology advance, it doesn't mean arbitrary rules are applied. The key is how well Hengrui Pharma has addressed the CMC issues."
There are many cases of companies eventually crossing the FDA threshold after facing multiple setbacks due to quality issues. Hugel145020 received FDA approval for its botulinum toxin product 'Letybo' after receiving two CRLs. GC Biopharma006280 also successfully entered the U.S. market after gaining approval for its intravenous immunoglobulin (IVIG) product 'Alyglo' on its fourth attempt. It is common for global pharmaceutical giants like Pfizer, Sanofi, and Eli Lilly to secure FDA approval only after multiple attempts.
Having deeply felt the importance of quality control alongside efficacy and safety during this process, HLB has significantly strengthened its risk management capabilities. A prime example is the appointment of Kim Tae-han, the former CEO who led the founding and growth of Samsung Biologics, as the Chairman of the Bio Division of HLB Group on the 1st. This is interpreted as a move to elevate the company's entire quality system, from global regulatory compliance to post-commercialization standards, rather than just focusing on the approval of the Rivoceranib and Camrelizumab combination.
HLB also plans to proceed with the FDA new drug approval process for its second-line cholangiocarcinoma treatment, 'Rivabrutinib,' in the near future. At the 2026 ASCO Gastrointestinal Cancers Symposium held from the 8th to the 10th, the company revealed excellent Phase 2 clinical data, including an Objective Response Rate (ORR) of 46.5%, a Disease Control Rate (DCR) of 96.5%, and a median Duration of Response (mDOR) of 11.8 months. There is also anticipation that it will be eligible for 'Priority Review,' which shortens the review period, as it received Breakthrough Therapy Designation (BTD) from the FDA in 2023.
An HLB official stated, "We have faithfully addressed the points raised during the previous review process and re-submitted the application after re-checking and refining all submitted materials. We will carefully review and respond to the overall review process and engage earnestly in communication with the FDA to ensure the best possible outcome for the company."