Hanmi`s first biologic drug Rolontis cleared as Korea’s 33rd novel therapy

2021.03.19 11:43:18 | 2021.03.19 11:43:53

[Photo provided by Hanmi Pharmaceutical]이미지 확대

[Photo provided by Hanmi Pharmaceutical]

South Korea’s Hanmi Pharmaceutical has received marketing authorization for Rolontis (eflapegrastim), a long-acting neutropenia drug, as the country’s 33rd novel therapy from the Ministry of Food and Drug Safety, raising expectation for similar approval in overseas markets, the company said on Thursday.

Rolontis is Hanmi`s first approved biologic drug optimized with its proprietary Labscovery platform technology to extend the drug’s half-life in vivo.

The drug is indicated for the treatment of neutropenia, an abnormally low concentration of neutrophils (a type of white blood cell) that help the body fight infection. It is often induced by chemotherapy among cancer patients.

In 2012, Hanmi Pharmaceutical signed a licensing agreement to grant exclusive development and marketing rights over Rolontis to its U.S. partner Spectrum Pharmaceuticals for global markets except Korea, China, and Japan.

Hanmi and Spectrum are currently working together to launch the drug in the U.S. The FDA’s pre-approval due diligence for Hanmi’s manufacturing site in Korea is due in May. The neutropenia care market is valued at some 80 billion won ($70.6 million) domestically and some 3 trillion won globally.

Clinical trial results showed that Rolontis is comparable to rival drug pegfilgrastim with superiority in terms of relative risk reduction rate.

Hanmi shares rose 1.49 percent to 340,500 won in morning trade on Friday, outperforming the main Kospi index that fell more than 1 percent.

By Chung Ji-sung and Minu Kim

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