Two South Korean pharmaceutical companies are vying for FDA approval in 2024, following last year’s successful market entries by their domestic rivals.
HLB expects a decision by March 20 on its liver cancer therapy Rivoceranib, which is being developed in partnership with China’s Jiangsu Hengrui Pharmaceuticals. The treatment combines Rivoceranib with Hengrui’s immune checkpoint inhibitor Camrelizumab. After receiving a complete response letter last May, HLB’s resubmission got a boost when FDA inspectors gave its clinical data a clean bill of health in November.
Meanwhile, HK inno.N is preparing to seek FDA approval for K-CAB, its gastroesophageal reflux disease treatment. The company is wrapping up two Phase 3 trials, with one completed and another expected to conclude by mid-2024.
K-CAB belongs to a new class of acid blockers that are gaining ground over traditional treatments. The US market for such therapies is worth 3.3 trillion won ($2.27 billion). The drug is already available in 15 countries and generated 177.7 billion won in domestic prescription sales through November.
These potential approvals could mark another milestone for Korea’s pharmaceutical industry, following 2023 FDA clearances for Yuhan Corp.’s Leclaza and Hugel’s Letybo.
