3rd new drug in 2021 after Yuhan Corp.’s Leclaza and Celltrion’s Regkirona
The ‘Made in Korea new drug,’ which has been cut off for a while, continues to be active in the Year of the Ox.
Hanmi Pharmaceutical’s Rolontis has received marketing authorization for Rolontis, a neutropenia biologic drug, from the Ministry of Food and Drug Safety on the 18th.
Rolontis is applied with Hanmi Pharmaceutical’s own platform technology, ‘Labscovery,’ and is a long-acting bio-new drug administered to treat or prevent neutropenia occurring in cancer patients receiving chemotherapy.
The domestic market for neutropenia therapy is estimated at KRW 80 billion and KRW 3 trillion for the global market.
Hanmi and its partner Spectrum are currently working together to launch Rolontis in the U.S.
With the Ministry of Food and Drug Safety’s approval of Rolontis, Hanmi Pharmaceutical now has two Korean new drugs, along with the lung cancer treatment ‘Olita (Olmutinib),’ which was approved in 2016. Rolontis is Hanmi’s first biologic drug.
The authorization of Rolontis is also meaningful in that news of the development of Korean new drugs continues without any gaps.
The new drug genealogy in Korea, which began on July 15, 1999, when SK Chemicals was granted the anti-cancer drug ‘Sunpla (Heptaplatin),’ maintained until July 5, 2018, when CJ Healthcare (now HK inno.N)’s ‘K-CAB (Tegoprazan)’ was approved as the 30th Korean new drug.
Since Boryung Pharmaceutical’s high blood pressure drug ‘Kanarb (Fimasartan)’ was accepted in September 2010, Korean new drugs have been made every year for nine years until 2018, but no longer developed for two years in 2019 and 2020.
On January 18 of this year, Yuhan Corporation was granted the non-small cell lung cancer drug ‘Leclaza (Lazertinib mesylate monohydrate)’ and carried on its new drug genealogy in Korea.
After that, Celltrion’s Regkirona Inj. (Regdanimav), a monoclonal antibody with activity against COVID-19 has been approved, and in 40 days, Rolotins became Korea’s 33rd new drug.
