Hanmi’s anti-cancer drug Rolontis gets FDA approval; US sale via Spectrum

South Korea’s Hanmi Pharmaceutical Co. said on Tuesday that Rolontis, an anti-cancer drug it has jointly developed with its US partner, has obtained marketing approval from the US Food and Drug Administration.

The white blood cell disease treatment to be sold under the Rolvedon brand in the US is Hanmi’s first and Korea’s sixth new medicine to receive the FDA’s marketing authorization.

Hanmi said the new treatment will be available through the marketing channels of its US partner, Spectrum Pharmaceuticals Inc., from the fourth quarter.

“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion market,” Tom Riga, Spectrum’s chief executive, said in a statement.

The US drug administration in August 2021 rejected a previous marketing request by Spectrum for Rolontis, also known as eflapegrastim, citing manufacturing deficiencies at Hanmi’s drug substance facility in Korea.

In April 2022, Spectrum, a US biotechnology firm focused on novel and targeted oncology therapies, resubmitted a biologics license application (BLA) to the FDA, which accepted it after remediation of the Hanmi facility.

Rolontis, licensed out to Spectrum in 2012, is an anti-cancer drug for the treatment of chemotherapy-induced neutropenia, which occurs when a patient has too few neutrophils, a type of white blood cell. While all white blood cells help the body fight infections, neutrophils are important for fighting certain infections, especially those caused by bacteria.

The molecule of the agent is manufactured by Hanmi at its biomanufacturing site in Korea.

COMPETITIVE VS AMGEN’S NEULASTA

In Korea, Hanmi obtained the Ministry of Food and Drug Safety’s approval for Rolontis as its new drug No. 33 in March of last year.

For marketing in the US, Hanmi transferred its technology to Spectrum in 2012 and has been jointly developing it since then.

Currently, Amgen's Neulasta controls 60% of the white blood cell disease treatment market.

Hanmi said Rolvedon is competitive versus Amgen's Neulasta, which is administered once a week.

The Korean company said its product, developed using its proprietary drug delivery technology, Labscovery, extends the duration of action of the drug, or half life, to three weeks.

Hanmi said its Labscovery technology is being applied to 10 of its 30 drug candidates in the pipeline.

“The launch of Rolvedon is meaningful in that it has demonstrated the commercialization potential of Labscovery, which will also boost the value of our other products,” said Kwon Se-chang, chief executive of Hanmi Pharmaceutical.

Hanmi, a leading pharmaceutical company in Korea, is also seeking to obtain FDA marketing approval for its lung cancer medicine Poziotinib by the end of this year.

Write to Jung-Eun Kim at likesmile@hankyung.com
In-Soo Nam edited this article.