HLB's 'Lenvatinib' Passes FDA On-Site Inspection... Approval Anticipated in May Next Year

HLB's new liver cancer treatment drug, 'Rivoceranib,' which has challenged the U.S. Food and Drug Administration (FDA) for approval, has successfully passed the on-site inspection stage by the FDA, and the drug approval process is progressing smoothly, with a decision expected around May next year.

HLB logo [Photo by HLB]

HLB announced on the 12th that from the 14th to the 28th of last month, a 15-day on-site inspection was conducted at the Chinese manufacturing plant of Rivoceranib, covering the quality and overall manufacturing process of the finished product (DP) of Rivoceranib.

As a result of a comprehensive quality check covering the manufacturing, packaging, labeling (medication instructions), hygiene, and stability of efficacy of Rivoceranib, HLB stated that no particular issues regarding manufacturing and quality were raised. After submitting the New Drug Application (NDA) to the FDA in May and receiving notification of entry into the main review in July, the company has been preparing intensively, and the Chemistry, Manufacturing, and Controls (CMC) inspection has passed an important milestone. Additionally, an inspection of the raw materials is expected to be conducted soon. Previously, Jinyang Gon, Chairman of HLB Group, anticipated the FDA's decision deadline under the Prescription Drug User Fee Act (PDUFA) to be May 16 next year.

Elevar Therapeutics, HLB's U.S. subsidiary preparing for the approval and sales of Rivoceranib in the United States, has been accelerating commercialization preparations by obtaining pharmaceutical sales licenses in 11 states so far, starting with New Jersey.

Han Yonghae, Chief Technology Officer (CTO) of HLB Group, said, “Since the NDA submission in May, various processes have been progressing rapidly and sequentially over about three months, raising the company's expectations for the launch of Rivoceranib combination therapy,” adding, “At the same time, HLB Panagen has been officially registered with CancerX, accelerating its entry into the U.S. diagnostic field. HLB Group will continue to expand its participation to improve human quality of life through conquering cancer.”