HLB Liver Cancer Drug Completes US FDA CMC Inspection

The final hurdle for HLB's liver cancer drug approval by the U.S. Food and Drug Administration (FDA), the manufacturing and quality control (CMC) inspection, has been completed.

The CMC inspection was conducted on the production facilities of the partner company, China's Hansoh Pharmaceutical, for the immuno-oncology drug 'Camrelizumab.' The inspection for HLB's anticancer drug, Rivoceranib, has already been completed.

The CMC inspection is a procedure where FDA inspectors visit the drug production facilities to directly verify the entire production setup and processes. It was conducted at a level that re-examined all facilities and processes from scratch, including the supplementary items notified during the first approval review.

HLB explained that Hansoh Pharmaceutical received requests for improvements on three minor issues and conveyed that these can be sufficiently resolved. HLB's U.S. subsidiary, Elevate, which received these matters, judged that the requested items would not affect the new drug approval.

Considering that the clinical hospital monitoring (BIMO) inspection completed last November and this CMC inspection were conducted earlier than scheduled, and that only three minor issues were pointed out in the extensive inspection, this is interpreted as a positive signal. An official stated, "Both Hansoh Pharmaceutical and Elevate agreed that they can quickly make the necessary improvements."

HLB introduced that Hansoh Pharmaceutical is preparing supplementary documents for the three issues and plans to submit them to the FDA within 15 business days in accordance with FDA regulations. The FDA is expected to decide on the new drug approval by the decision deadline of March 20, reflecting the improvements.

HLB Group CTO Yonghae Han said, "Since this is a combination therapy of two drugs not previously approved, it seems that the FDA thoroughly reviewed all matters from the ground up during this CMC inspection as well." He added, "Both Hansoh Pharmaceutical and Elevate will do their best to ensure there are no minor deficiencies until the new drug approval results are announced."

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