Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
HLB resolves issues behind FDA setback for novel liver cancer drug
HLB Life Science R&D office in Gyeonggi Province / Courtesy of HLB Life Science
By Nam Hyun-woo
The U.S. Food and Drug Administration (FDA) has determined that the inspection findings behind its rejection of HLB's liver cancer drug Rivoceranib can be addressed through voluntary corrective actions, easing market concerns over the treatment.
HLB said Wednesday that its U.S. subsidiary Elevar Therapeutics has received a close-out letter regarding the FDA's current good manufacturing practice (cGMP) inspection of a facility operated by its Chinese partner Jiangsu Hengrui Pharmaceuticals that produces the drug substance for Rivoceranib.
In the letter, the FDA said the facility was generally in compliance with cGMP requirements and classified the inspection findings as Voluntary Action Indicated (VAI).
VAI is an inspection classification indicating that the FDA identified issues at a facility but did not consider them serious enough to force regulatory action. HLB said the letter also stated that the VAI classification itself would not affect the FDA's review of the pending application related with the facility.
HLB has received three Complete Response Letters (CRLs) from the FDA regarding its new drug application for Rivoceranib.
The company has been seeking approval for Rivoceranib in combination with Jiangsu Hengrui Pharmaceuticals' Camrelizumab as a treatment for liver cancer. While the first two CRLs took issues with manufacturing quality issues involving Camrelizumab, the most recent one pointed to problems at Hengrui's drug substance manufacturing facility, which also produces Rivoceranib.
"The FDA said it found no significant issues with the matters it had asked to be addressed in the previous CRLs related to Camrelizumab," an HLB official said.
"As the cGMP inspection issue cited in the latest CRL also concluded with a VAI classification, we believe most of the key issues behind the FDA's delay in approving the drug have now been resolved."
HLB said Elevar will submit a formal inquiry to the FDA to confirm the agency's position following the VAI classification of the inspection.
The company added that Hengrui's drug product facility had also received similar observations from the FDA and that the Chinese drugmaker plans to submit a corrective and preventive action plan to address them.
"We will work closely with the FDA to resume the drug approval process as soon as possible," the HLB official said.
Following the announcement, shares of HLB Group companies, including HLB Global and HLB Pharmaceutical, all surged to the daily 30 percent upper limit during Wednesday’s trading.