HLB's liver cancer new drug has once again sought approval from the U.S. Food and Drug Administration (FDA), but on the 21st, it faced another request for 'supplementation', resulting in disappointment. Jinjang-gon, chairman of HLB Group, held an online press briefing that morning and noted, 'The issues raised by the FDA will be identified within 2 to 3 weeks,' and 'If we supplement this and reapply for approval, the result is expected to come out as early as July.'
The FDA has once again sent a request for supplementation (Complete Response Letter, CRL) regarding the combination therapy of HLB's riboceranib and China’s Antengene Corporation's camrelizumab, which were applied for new drug approval as a first-line treatment for liver cancer. The approval has not been granted.
Riboceranib is a targeted anticancer drug developed by Elevate under HLB Group. Camrelizumab is an immune checkpoint inhibitor from Antengene Corporation. Immune checkpoint inhibitors prevent cancer cells from evading immune cells by failing to bind to immune checkpoints necessary for disguising as normal cells.
The two corporations submitted their new drug application to the FDA in May 2023. The FDA issued a request for supplementation regarding chemistry, manufacturing, and controls (CMC) last May, deciding that additional inspections of the hospitals participating in the clinical trials were necessary. The issues highlighted by the FDA at that time were production facility defects revealed in the inspections at Antengene. Subsequently, Antengene supplemented this and submitted additional documents to the FDA at the end of January.
According to the company, the FDA's second request for supplementation, like the previous decision, relates to manufacturing process issues with Antengene's camrelizumab. However, it is reported that Antengene has not yet specifically identified what the problem areas were. Chairman Jin stated, 'It seems we will be able to identify which areas were lacking within 2 to 3 weeks,' and added, 'Antengene plans to resubmit the documents addressing the issues as early as May.'
Regarding the opinion that the FDA's second request for supplementation was due to U.S.-China tensions, Chairman Jin stated that it is unrelated. Jin noted, 'Given that Chinese biopharmaceuticals developed and manufactured in China have consecutively obtained FDA approvals over the past 2 to 3 years, I believe there is no impact from U.S.-China conflicts.'
In addition to the FDA's resubmission application, HLB also announced plans to apply for approval in Europe in September and to submit a new drug application for bile duct cancer this year. Chairman Jin said, 'Alongside the swift resubmission to the FDA, we plan to proceed with the European Medicines Agency (EMA) approval application in July, so please be patient and wait a little longer.'