Can HLB receive US FDA approval for Rivoceranib liver cancer drug after initial failure?

HLB has vowed to seek approval with the U.S. Food and Drug Administration (FDA) again quickly for its liver cancer drug Rivoceranib following the FDA's rejection on Friday, but it is unclear whether the drug will be approved next time, according to industry officials, Monday.

HLB submitted a new drug application to the FDA for the commercialization of its liver cancer treatment, a combination therapy of its Rivoceranib and Camrelizumab, a drug from its partner China's Jiangsu Hengrui, in May last year.

However, HLB Chairman Jin Yang-gon said Friday that the company received a complete response letter (CRL) from the FDA.

A CRL is a letter issued by the FDA when it determines that approval is not possible in the current state, making the U.S. commercialization timeline for this combination therapy uncertain.

The HLB chairman said Friday, "There were no issues with Rivoceranib, but there were issues related to Camrelizumab."

"Jiangsu Hengrui was pointed out for minor details regarding the CMC — chemistry, manufacturing and control — inspection of Camrelizumab during the review process," he added.

He added that he does not believe there are fundamental and unamendable problems with the manufacturing process of Jiangsu Hengrui, which holds 17 global pharmaceutical products, and that this could be amended quickly.

On Saturday, the chairman announced through the company's blog that it would restart the process of seeking approval from the FDA.

"If we submit the amended documents, the FDA will make a decision on approval within a maximum of six months from then. Depending on the case, the time could be reduced significantly," Jin said.

However, the industry view is skeptical about the possibility of FDA approval. The clinical trials of this combination therapy, which were conducted in hospitals in Russia and Ukraine, are in question regarding their effectiveness in treating white people, and it could be difficult for the FDA to inspect these regions currently due to Russia's ongoing invasion of Ukraine.

Additionally, there are concerns about the uncertainty of the drug's approval due to the time needed to resolve the chemistry, manufacturing and quality control issues with Camrelizumab.

HLB has been waiting for the U.S. commercialization approval of its liver cancer drug for the past five years, but now it seems it will take longer.

Assuming it takes more than a year for HLB to submit the necessary documentation, it is expected to take at least a year and a half to receive notification of the drug approval status from the FDA.

The chairman noted that the FDA did not raise issues with the drug's efficacy or safety itself and that these issues could be resolved promptly.

Following the failed approval of the liver cancer drug last Friday, HLB's stock dropped by 29.96 percent on the Kosdaq stock market — close to the daily stock fail limit of 30 percent.

On Monday, the company's stock also closed down 29.96 percent at 47,000 won ($34.60), and over two trading days, its stock value plummeted from 12.5 trillion won on Thursday to 6.1 trillion won.