Neutropenia drug Rolontis developed by South Korea’s Hanmi Pharmaceutical has been finally approved by the U.S. Food and Drug Administration (FDA) after third attempts for marketing authorization in the world’s largest pharmaceutical market.

Rolontis represents Korea’s 33rd home-grown medicine and the first FDA-approved novel therapy from Hanmi and the sixth from the Korean healthcare industry.

Hanmi said on Monday its U.S. partner Spectrum Pharmaceuticals has received FDA approval for the product whose local brand name is Rolvedon as injection to decrease the incidence of infection in cancer patients with febrile neutropenia.

Rolontis was developed with Hanmi’s LAPSCOVERY technology which extends the half-life time for bio-products. It was approved by Korean health authorities in March last year.

Neutrophils are the largest population of white blood cells and play a pivotal 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 anti-cancer drugs. Amgen’s Neulasta is the most widely used neutropenia treatment now.

Hanmi licensed the drug to Spectrum in 2012 for global development and commercial rights except Korea, China and Japan. Spectrum filed for approval with the FDA in 2018 and 2019, but the FDA rejected its application, requesting additional documents. A third application was filed in March this year, but the path toward approval was not easy as the FDA postponed its decision on the drug due to unfinished inspection of Hanmi’s bioplant for local production after Covid-19 travel restrictions. The FDA’s inspection was completed in June.

Hanmi and Spectrum have been expanding their sales networks across the U.S. since last August to ensure successful market penetration, with a commercial team ready to launch with product available in the fourth quarter.

Hanmi expects to earn hundreds of billions of won in tiered royalty payments annually from the drug’s sale in the $2 billion U.S. market.

Shares of Hanmi rose 1.7 percent to 307,000 won on the Kospi.

By Kim Si-gyun and Minu Kim

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