[뉴스락] Hanmi Pharmaceutical announced on the 9th that HM43239, an innovative new drug for the treatment of acute myeloid leukemia (AML) developed in-house, has been designated as a fast-track development item by the US FDA.
HM43239 is a new drug that was licensed out to Aptos, a biotech company listed on NASDAQ in the US in November last year.
Aptoz, a partner of Hanmi Pharm, announced this through its press release on the 4th (Korean time) and said, “The FDA’s designation of HM43239 as a fast-track development item recognizes the potential of HM43239 to satisfy the unmet needs of the AML patient group.” said.
Fast-track designation is one of the new drug development promotion procedures implemented by the FDA for the early supply of new drugs in important fields such as treatment for severe diseases to patients.
Fast-track designation new drugs can receive full support from the FDA at each stage of development, and through close consultation with the FDA, the new drug development process proceeds more quickly than usual. In addition, the benefit of ‘Rolling Review (sequential submission and review as soon as the approval data is available when applying for marketing approval)’ is granted, and with the FDA, ‘Priority Review (FDA review period when applying for marketing approval has been reduced from 10 months to 6 months) shortened)’ can be negotiated.
HM43239 is a once-daily oral myelokinome inhibitor (MKI) targeting key kinases acting in myeloid malignancies. In the current phase 1/2 global clinical trial, HM43239 showed complete remission (CR) responses in various relapsed or refractory AML patients, and it was also effective in patients who participated in clinical trials after receiving the previously approved FLT3 inhibitor and failed treatment. Confirmed.
In addition, a new ‘CRi’ was recently confirmed in the 120mg dose expansion cohort.
Kwon Se-chang, president of Hanmi Pharmaceutical, said, “HM43239 is a powerful blood cancer treatment that targets mutations expressed in acute myeloid leukemia and can overcome resistance to existing treatments. We will do our best to speed up and commercialize it at an early stage.”
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