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Hanmi Pharmaceutical scores 1st US FDA approval

Images of Rolontis (left) and Hanmi Pharmaceutical Pyeongtaek Bio Plant (Hanmi Pharmaceutical)
Images of Rolontis (left) and Hanmi Pharmaceutical Pyeongtaek Bio Plant (Hanmi Pharmaceutical)
Hanmi Pharmaceutical has scored its first approval from the US Food and Drug Administration with its novel biomedicine Rolontis.

Rolontis -- Hanmi Pharmaceutical's treatment for neutropenia, a disease that occurs when a specific type of white blood cells is lacking so that the body cannot fight infections, especially those caused by bacteria -- was given the FDA’s approval on Friday, according to the Korean firm’s US partner Spectrum Pharmaceuticals’ announcement.

Neutropenia's common causes include blood cancer, chemotherapy for cancer and viral infections.

With the green light, Hanmi Pharmaceutical became the sixth South Korean company to have received FDA approval for a self-developed drug. Rolontis was given approval as the 33rd novel homegrown drug by South Korea’s Ministry of Food and Drug Safety in March.

Hanmi Pharmaceutical noted that Rolontis’ approval marked the country’s first FDA nod for anticancer therapy. Hanmi and Spectrum failed to get the FDA’s nod twice in 2018 and 2019 as they were asked to submit more data.

“It not only marks the first FDA approval among Hanmi Pharmaceutical's new drugs but also carries significance in that it has proven the possibility of commercialization of ‘Lapscovery,’ a unique platform technology of Hanmi Pharmaceutical,” said Kwon Se-chang, CEO of Hanmi Pharmaceutical.

Lapscovery refers to the drug maker’s long-acting protein and peptide discovery platform technology to develop biomedicines. The technology is known for slowing down the time it takes for the concentration level of biomedicine to decrease in the blood.

According to the drug maker, Rolontis is also the country’s first FDA-approved biomedicine produced from a local site at Hanmi Pharmaceutical Pyeongtaek Bio Plant in Gyeonggi Province. The plant passed the FDA’s on-site inspection of due diligence in June.

Rolontis’ US product name is Rolvedon.

“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar (2.75 trillion won) market and offers a unique value proposition. This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical” said Tom Riga, president and CEO of Spectrum Pharmaceuticals.

The companies said they plan to release the novel drug in the US market before the end of this year.

By Kan Hyeong-woo (
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Korea Herald daum