HLB Completes FDA’s CMC Inspection for Liver Cancer Drug Approval

· Jiangsu Hengrui received three minor improvement requests from the FDA

 

HLB completes FDA’s CMC inspection for liver cancer drug approval (IT Times)

SEOUL, South Korea, January 14, 2025 (IT Times) - HLB, a leading biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has completed the Chemistry, Manufacturing, and Controls (CMC) inspection required for its liver cancer drug approval.

The CMC inspection, conducted earlier this month, focused on the manufacturing facilities of HLB’s partner, China-based Jiangsu Hengrui Pharmaceuticals, for the immuno-oncology drug Camrelizumab. The inspection for HLB’s own anti-cancer drug Rivoceranib had already been completed.

CMC inspections involve FDA inspectors visiting pharmaceutical manufacturing facilities to thoroughly review production processes and facilities. This inspection also reassessed all aspects previously noted during the first approval review, including corrective actions required at the time.

According to HLB, Jiangsu Hengrui received three minor improvement requests from the FDA and assured that these issues can be promptly addressed. HLB’s U.S. subsidiary, Elevar Therapeutics, confirmed that the requested improvements are not significant enough to impact the approval process.

Following the successful Bioresearch Monitoring (BIMO) inspection in November 2024, the completion of the CMC inspection earlier than scheduled and the minimal findings have raised optimism about the drug’s approval. Jiangsu Hengrui is currently preparing documentation to address the FDA’s requests, which will be submitted within 15 business days as required by FDA regulations.

The FDA will review the responses before making its final decision on the drug approval by the PDUFA (Prescription Drug User Fee Act) date, set for March 20, 2025.

"As this is a combination therapy involving two previously unapproved drugs, the FDA has conducted a thorough review of all processes from the ground up during the CMC inspection," said Han Yong-hae, CTO of HLB Group. "Both Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics are committed to resolving all minor issues to ensure the approval process proceeds smoothly."

Read more: https://www.ittimes.com/news/articleView.html?idxno=61324

HLB Completes FDA’s CMC Inspection for Liver Cancer Drug Approval - IT타임스