Hanmi’s neutropenia drug cleared by FDA after third attempt
The neutropenia drug Rolontis developed by South Korea’s Hanmi Pharmaceutical has finally been approved by the US Food and Drug Administration (FDA) after a third attempt for marketing approval in the world’s largest pharmaceutical market.
Rolontis is Korea’s 33rd local medicine and Hanmi’s first FDA-approved new therapy and Korea’s healthcare industry’s sixth.
Hanmi said on Monday that its US partner Spectrum Pharmaceuticals had received FDA approval for the product whose local brand name is Rolvedon as an injection to reduce the incidence of infection in cancer patients with neutropenia. febrile.
Rolontis was developed with Hanmi’s LAPSCOVERY technology which extends the half-life of bioproducts. It was approved by Korean health authorities in March last year.
Neutrophils are the largest population of white blood cells and play a central role in immunity. Neutropenia refers to abnormally low levels of neutrophils in the blood that can increase the risk of infection, usually in cancer patients receiving myelosuppressive cancer drugs. Amgen’s Neulasta is currently the most widely used treatment for neutropenia.
Hanmi licensed the drug to Spectrum in 2012 for worldwide development and commercial rights except for Korea, China and Japan. Spectrum filed for FDA approval in 2018 and 2019, but the FDA denied its request, requesting additional documentation. A third application was filed in March this year, but the road to approval was not easy as the FDA postponed its decision on the drug due to an incomplete inspection of Hanmi’s bioplant for production. local after Covid-19 travel restrictions. The FDA inspection was completed in June.
Hanmi and Spectrum have been expanding their sales networks across the United States since last August to ensure successful market penetration, with a sales team ready to launch the product available in Q4.
Hanmi expects to earn hundreds of billions of won in tiered royalties each year from selling the drug in the $2 billion US market.
Hanmi shares rose 1.7% to 307,000 won on the Kospi.
By Kim Si-gyun and Minu Kim
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