Hanmi Pharm’s Rolontis cruising toward a blockbuster in Korea and the US < Pharmaceutical Industry < Pharma & Distribution < Main article

[의학신문·일간보사=김영주 기자]Differentiated clinical evidence for Rolontis Freefilled Syringe, a new biologic drug for neutropenia treatment by Hanmi Pharmaceutical, which has successfully entered the US market, is continuously accumulating.

Hanmi Pharmaceutical announced the results of a study that confirmed the efficacy and safety of Rolontis through clinical analysis of Korean and Asian breast cancer patients at the 2023 Korean Society of Oncology Satellite Symposium breast cancer session held at the Lotte Hotel in Sogong-dong, Seoul on the 19th. It was announced on the 26th.

This study is the result of an integrated and post-analysis of the global phase 3 clinical trial, which served as the basis for the marketing approval of Rolontis by the US FDA. Professor Moon contributed to the marketing approval in Korea and the United States by enrolling the largest number of subjects in Korea and leading the research in the Phase 3 clinical trial of Rolontis. The session was chaired by Professor Inhye Park of the Department of Oncology, Korea University Guro Hospital.

Professor Moon said, “Consistent validity was confirmed in all subgroups, including Koreans and Asians, for various evaluation indicators, such as the duration of severe neutropenia (DSN) and the recovery time of neutrophil counts that may occur after chemotherapy. , The overall safety profile was also similar in all subgroups,” he said. “Especially, the LAPSCOVERY™ platform, Hanmi’s proprietary technology, is applied to facilitate distribution to the bone marrow, where neutrophil differentiation is promoted, so the increase in neutrophil count compared to the reference drug It could be even higher,” he said.

Prof. Moon continued, “Cancer patients whose anticancer treatment may be stopped due to neutropenia need appropriate prevention and treatment.” It is expected to be a reasonable treatment option for Asian breast cancer patients.”

Meanwhile, Rolontis (US product name: Rollbedon), launched in the U.S. in the second half of last year, recorded sales of about 13.3 billion won within three months of its launch in the country, and sales of about 20.6 billion won in the first quarter of this year alone, successfully entering the market. settled down Hanmi Pharmaceutical expects that Rolontis will grow into a blockbuster drug, with prescription sales of 10 billion won in Korea alone this year.