Hanmi Pharmaceutical "Expecting FDA Approval for Rolontis and Pogziotinib Within the Year"

"Securing an Independent mRNA Platform... Expanding Development Areas Including COVID-19 Vaccines"
Hanmi Pharm President Kwon Se-chang Presents Hanmi R&D Core Strategy at JP Morgan

Sechang Kwon, CEO of Hanmi Pharmaceutical

[Asia Economy Reporter Kim Daehyun] Hanmi Pharm announced that the FDA approval for Rolontis and Poziotinib is expected within this year.

On the 13th, Kwon Sechang, CEO of Hanmi Pharm, introduced various new drug candidates (pipeline), including Rolontis (a biopharmaceutical for neutropenia) and Poziotinib (an innovative anticancer drug), at the 40th JP Morgan Healthcare Conference.

Hanmi Pharm completed Phase 1 clinical trials for Poziotinib in 2015 and Rolontis in 2017, and licensed the technology to Spectrum Pharmaceuticals in the U.S. Rolontis is the 33rd domestically developed new drug and was launched in Korea last November as a treatment for neutropenia, while Poziotinib is being developed as a treatment for non-small cell lung cancer.

Spectrum plans to resubmit the Biologics License Application (BLA) for Rolontis to the FDA in the first quarter of this year and completed the FDA New Drug Application for Poziotinib last month. Approval for both products is expected as early as this year.

They also revealed various new drug development strategies based on the recently successfully secured mRNA platform. CEO Kwon said, "We have successfully developed an independent mRNA platform and are applying it not only to COVID-19 vaccine development but also to metabolic diseases, cancer, cardiovascular and renal diseases, and enzyme replacement therapy."

Currently, Hanmi Pharm has over 600 R&D personnel, accounting for more than 25% of its employees, working on about 30 new drugs, including 13 in oncology, 8 in metabolic and cardiovascular/renal (CVRM) diseases, 5 in rare diseases, and 4 in other areas.

CEO Kwon stated, "We expect this year to be a breakthrough year for Hanmi Pharm in R&D. We will make this a year of leap forward by building strong new growth engines for Hanmi Pharm Group through internal research and open innovation, not only in existing fields such as oncology, rare diseases, and metabolic diseases but also in new innovative areas like mRNA."

This content was produced with the assistance of AI translation services.