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Foreign Partners Hurry to Commercialize Hanmi's New Anticancer Drugs

Hanmi Pharmaceutical said Thursday that its foreign partners are facilitating the global commercialization of the company's anticancer drug candidates, such as HM43239, belvarafenib, and poziotinib.

Hanmi Pharmaceutical CEO Kwon Se-chang says the company's global partners are pushing hard to commercialize its licensed-out anticancer drug candidates.

Aptose Bioscience, Roche and its subsidiary Genentech, and Spectrum Pharmaceuticals are speeding up their development process by conducting clinical trials of anticancer drug candidates licensed out by the Korean drugmaker.

Last Thursday, Aptose Bioscience signed an exclusive license agreement with Hanmi and gained the rights to develop and commercialize HM43239 that inhibits FMS-like tyrosine kinase 3 (FLT3) mutation in myeloid kinome inhibitor (MKI). The U.S. company plans to continue the follow-up clinical trials based on phase 1 and 2 studies in the U.S.

Aptose Bioscience will present the interim results of a single dose of HM43239 in relapsed or refractory AML patients with FLT3 mutants at the 63rd annual meeting of the American Society of Hematology (ASH) in Georgia, U.S., from Dec. 11-14.

Roche and its affiliate, Genentech, also added belvarafenib to their main pipeline by starting global clinical trials. The drug candidate demonstrates selective anti-tumor activity in solid tumors with renin-angiotensin system (RAS) or rapidly accelerated fibrosarcoma (RAF) mutation.

Genentech conducted clinical trials of belvarafenib with Hanmi and Professor Kim Tae-won of the Department of Oncology at Asan Medical Center, confirming the anti-tumor effect and safety of belvarafenib in 135 people with solid cancer.

Poziotinib, a non-small cell lung cancer treatment Hanmi is co-developing with Spectrum, is awaiting approval as a new drug by U.S. Food and Drug Administration (FDA). Spectrum plans to apply for the FDA's authorization of poziotinib later this year.

Spectrum conducted a phase 2 ZENITH20 trial of poziotinib with seven cohorts. Based on the study results, FDA granted fast-track designation for poziotinib in early 2021.

“Our global partners are conducting clinical trials to speed up developing Hanmi's excellent anticancer drugs,” CEO Kwon Se-chang said. “We will scale up efforts to commercialize new drug candidates to help patients in intractable conditions with no treatment options.”