Hanmi Pharmaceutical said Friday that Rolontis, its biologic drug for the management of chemotherapy-induced neutropenia, has been submitted for approval to the US Food and Drug Administration. Neutropenia refers to an abnormally low level of neutrophils, a type of white blood cell.

Spectrum Pharmaceuticals, which has been developing Rolontis for commercialization since in-licensing the drug from Hanmi in 2012, submitted a biologics license application to the US FDA for Rolontis (eflapegrastim) on Thursday, local time.

“Rolontis is an important and significant future growth driver for our company,” Joe Turgeon, president and CEO of US-based Spectrum Pharmaceuticals, said in a statement.

“Today’s milestone brings us one step closer to bringing the first novel G-CSF to healthcare providers in over 15 years in a large market that is familiar to Spectrum.”


Originally developed by Hanmi, Rolontis is also the first-ever drug employing the Korean drugmaker’s proprietary Lapscovery technology to seek commercialization in the US.

Lapscovery -- short for “long-acting protein and peptide discovery” -- is Hanmi’s exclusive drug-delivery technology, which extends the efficacy and potency of a drug by extending the life of a peptide or protein in the body.

Spectrum said it had filed a BLA for Rolontis based on data from two phase 3 clinical trials evaluating the safety and efficacy of Rolontis in 943 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytoxic chemotherapy.

The clinical trials demonstrated that Rolontis was similar in terms of efficacy and safety to pegfilgrastim, a drug marketed under the trade name Neulasta, according to Spectrum.

Hanmi’s Lapscovery technology is employed in other drugs that have been licensed out to global pharmaceutical companies. They include efpeglenatide, in-licensed by Sanofi, and HM12525A, in-licensed by Janssen.

By Sohn Ji-young (jys@heraldcorp.com)