Hanmi Pharm’s neutropenia treatment’Rolontis (Eflavegras Team)’, developed by Hanmi Pharm, has obtained domestic marketing approval. It is Hanmi Pharmaceutical’s first new bio drug and its 33rd domestic drug.
The Ministry of Food and Drug Safety approved Hanmi Pharmaceutical’s neutropenia treatment’Rolontis’ on the 18th.
Rollontis is a biopharmaceutical to which Hanmi Pharm’s proprietary platform technology’Labs Coverage’ is applied, and is a new drug that is administered for the treatment or prevention of neutropenia that occurs in cancer patients receiving chemotherapy.
According to Hanmi Pharmaceutical, in two phase 3 clinical trials led by Spectrum, Rolontis was proven to be inferior to competing drugs in terms of severe neutropenia (DSN) and excellent relative risk reduction rate. Both trials were conducted in 643 patients with early breast cancer who developed neutropenia.
Hanmi Pharm, along with its partner Spectrum, is also in the process of licensing Rolontis in the US. The U.S. Food and Drug Administration’s (FDA) Pyeongtaek bioplant inspection, which was postponed last year due to a novel coronavirus infection (Corona 19), is scheduled to take place in May.
Hanmi Pharmaceutical estimates the domestic market for neutropenia treatment at 80 billion won and the global market at 3 trillion won.
“Rolontis is the first significant biopharmaceutical product to which Labscovery, Hanmi Pharmaceutical’s proprietary platform technology, is applied,” said Sechang Kwon, President of Hanmi Pharmaceutical. “We will do our best to become the first new bio drug in Korea that succeeds in the world.”