Korea-based bio corporations HLB plans to apply to the U.S. Food and Drug Administration (FDA) in Jan. next year for approval of the liver cancer drug rivoceranib. This will already be the third attempt. Rivoceranib has applied for new drug approval twice but was not accepted in the United States. Why has rivoceranib kept applying?
Rivoceranib first tried in the United States in May 2023. At that time, rivoceranib was filed with the FDA as a combination therapy with camrelizumab from China's Jiangsu Hengrui Pharmaceuticals. Camrelizumab is an immune checkpoint inhibitor, a type of anticancer drug. It prevents binding to immune checkpoints that cancer cells need to disguise themselves as normal cells, enabling them to be attacked again by immune cells.
However, the attempt fell through after the FDA issued a complete response letter. A complete response letter is a procedure that rejects a new drug application while explaining why it was not approved. At the time, rivoceranib's efficacy and safety were reportedly not the issue. The concerns were said to be about the camrelizumab plant facilities.
Rivoceranib and camrelizumab tried again with the FDA but received another complete response letter in Mar. this year. Again, the issue was camrelizumab's manufacturing process. The company said, "The manufacturing process issues are not related to sterilization or disinfection." Still, even if rivoceranib has no issues, it cannot be approved on its own because the application was for a regimen used together with camrelizumab.
Some analysts say U.S.-China tensions may have played a role. The United States is keeping the rising Chinese pharmaceutical and bio industries in check. Camrelizumab is a blockbuster drug with more than 1 trillion won in annual sales in China.
HLB, however, says U.S.-China tensions are unrelated to the FDA decision. If the company files for new drug approval early next year, the FDA review is expected to take two to six months.
One reason HLB is pressing ahead with a third application is that the U.S. pharmaceuticals market cannot be ignored. According to market research firm Fortune Business Insights, the U.S. pharmaceuticals market is estimated to grow from 1,253 trillion won this year to 2,169 trillion won in 2032. The larger the market, the greater the sales potential.
Many other corporations are also targeting the United States. HK inno.N is a prime example. The company plans to file with the FDA for approval of its third-generation gastrointestinal drug K-CAB as early as the end of the year.
K-CAB, introduced in 2019, is Korea's 30th new drug. Existing gastrointestinal drugs only took effect 30 minutes after dosing and sometimes caused heartburn at night. K-CAB suppresses gastric acid secretion to improve these symptoms and is considered to act quickly. It is currently preparing an FDA filing with its U.S. partner Sebela.
In the United States, K-CAB's competing product is considered to be Vonoprazan from Japan's Takeda Pharmaceutical. Vonoprazan has patent exclusivity in the United States through 2032, and it is difficult to file generics with the FDA. If K-CAB establishes itself in the U.S. market by then, it would be in a position to compete with Vonoprazan. The securities industry expects K-CAB sales in the United States to begin in earnest in 2027.
Medical artificial intelligence (AI) corporations are also eyeing the United States. Lunit recently filed for premarket approval with the FDA for "Lunit INSIGHT Risk," which uses AI to predict the likelihood of developing breast cancer within five years. This is a process that must be completed before launching a medical device in the United States. It demonstrates that a new device is as safe and effective as one already on the market. Lunit is targeting FDA approval next year.
Of course, submitting a new drug or medical device to the FDA does not guarantee approval. Some applications fail. Why, then, are domestic corporations still turning their attention to the United States?
An industry official said, "Once you pass the FDA's stringent review, it can be an advantage when entering other countries, so there is a willingness to try." The industry is watching to see whether the door will open for domestic corporations knocking on the U.S. market.