Hanmi Pharm Obtains Marketing Authorization for 'Rollontis'... 33rd New Drug Developed Domestically

Hanmi Pharm 'Rolontis' (Provided by Hanmi Pharm)

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's first bio-new drug, 'Rolontis,' has been approved for sale as the 33rd newly developed drug in Korea.

The Ministry of Food and Drug Safety announced on the 18th that it has approved Hanmi Pharmaceutical's neutropenia treatment 'Rolontis Prefilled Syringe (Eflapegrastim).'

Rolontis is a biopharmaceutical developed using Hanmi Pharmaceutical's proprietary platform technology, 'Lapscovery.' It is a long-acting new drug administered for the treatment or prevention of neutropenia that may occur in cancer patients undergoing chemotherapy. It stimulates the bone marrow to promote neutrophil production by binding to the granulocyte colony-stimulating factor (G-CSF) receptor. In particular, it increases drug efficacy duration by connecting a specific protein to a human G-CSF analog manufactured using recombinant technology.

According to Hanmi Pharmaceutical, in a clinical trial involving 643 early breast cancer patients who developed neutropenia, Rolontis demonstrated non-inferiority in the duration of severe neutropenia (DSN) and superior relative risk reduction compared to competing drugs over four treatment cycles.

Currently, Hanmi Pharmaceutical is also proceeding with the U.S. marketing approval process for Rolontis in partnership with Spectrum. In May, the U.S. Food and Drug Administration (FDA) is scheduled to conduct a 'pre-approval inspection' of Hanmi Pharmaceutical's Pyeongtaek bio plant in Gyeonggi Province, where the Rolontis raw material is produced.

The domestic market size for neutropenia treatments is estimated at around 80 billion KRW, while the global market is estimated to be around 3 trillion KRW.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "Rolontis is a meaningful product as the first bio-new drug approved using Hanmi Pharmaceutical's proprietary platform technology, Lapscovery. Starting with the world's first approval in Korea, we will do our best to obtain approvals in the U.S. and other countries to become Korea's first bio-new drug to succeed in the global market."

This content was produced with the assistance of AI translation services.