[Alpha Biz=(Chicago) Reporter Kim Jisun] HLB said on the 12th that the U.S. FDA's on-site inspection of the finished product of the anti-cancer drug "Rivoceranib" ended without any special issues or objections. The last-minute procedure for obtaining approval as a primary treatment for liver cancer continues to cruise.

Since the launch of the main examination (NDA filing) of new drug licenses for Rivoceranib and Camrelizumab in July, orientation meetings and on-site inspection (inspection) of Rivoceranib finished products have been carried out in rapid succession, and the speed of the main screening process seems to be increasing.

The on-site inspection was conducted at the Rivoceranib China production plant for 15 days from August 14 to 28. On-site inspections of the quality and manufacturing process of Rivoceranib's finished product (DP, Drug Product) were conducted.

Through on-site inspections, the FDA conducted all-round quality checks, ranging from manufacturing and packaging of Rivoceranib to labeling (medicine dose guidelines) and the stability of hygiene and efficacy. As there were no special problems with manufacturing and quality during the long-term detailed due diligence process, CMC (Chemical Manufacturing Quality) due diligence, which had been prepared throughout the company since entering the main review, has also exceeded an important milestone. Due diligence on raw materials is also expected to proceed soon.

With the on-site inspection cruising, Elevar Therapeutics, a U.S. subsidiary of HLB, which is preparing to approve and sell Rivoceranib in the U.S., will also be able to focus more on preparing for commercialization. Elevar has already received sales licenses in 11 states to date, starting with a New Jersey drug sales license.

 

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