The U.S. Food and Drug Administration (FDA) will make a decision on whether to grant marketing authorization for Rolontis, Hanmi Pharmaceutical’s first new biotechnology drug candidate, in September. According to the FDA’s Prescription Drug User Fee Act (PDUFA), Rolontis’ approval deadline is September 9.

The FDA recently visited Hanmi’s biotech plant in Pyeongtaek, Korea and performed due diligence. Due diligence at the production plant is considered the final step in the FDA approval process. Industry insiders predict that due diligence will yield positive results.

Rolontis is a drug candidate for neutropenia, a disease in which neutrophils, a type of white blood cells, are reduced when cancer patients take anticancer drugs.

Hanmi Pharmaceutical used its own Labscovery technology platform to develop Rolontis. Labscovery plays a role in increasing the duration of effectiveness of drugs in the human body. Rolontis was approved by Korea’s Ministry of Food and Drug Safety as Korea’s 33rd new medicine in 2021.

When prescriptions start after obtaining approval, Hanmi Pharmaceutical will only have the rights to sell the drug in Korea, China and Japan, with Spectrum Pharmaceuticals of the United States holding the rights to sell the rest of the world. world, including the United States. If the drug sells in the US market, Hanmi Pharmaceutical will receive royalties from Spectrum.