Hanmi Pharm Signs Technology Export Deal Worth Up to 482.9 Billion KRW for New Acute Myeloid Leukemia Treatment Drug

Hanmi Pharm Headquarters Exterior (Photo by Hanmi Pharm)

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's innovative drug for the treatment of acute myeloid leukemia (AML) under development has been licensed out in a deal worth up to $407.5 million (approximately 482.9 billion KRW).

Hanmi Pharmaceutical announced on the 4th that it has licensed out the FLT inhibitor (code name 'HM43239'), an innovative drug under development for the treatment of acute myeloid leukemia (AML), to Aptose Biosciences.

HM43239 is an innovative drug that dual-inhibits FLT3 mutations and SYK, which cause AML. It is involved in the treatment process of proliferation, differentiation, and resistance of myeloid malignancies. Hanmi Pharmaceutical previously announced that administering HM43239 to patients who do not respond to existing drugs confirmed complete remission, indicating the potential to overcome resistance in patients with refractory hematologic diseases. Currently, phase 1/2 clinical trials are underway in the United States targeting relapsed and refractory AML patients, and strong antitumor activity has been demonstrated in dose-escalation studies. In 2018, the U.S. Food and Drug Administration (FDA) designated it as an Orphan Drug (ODD), and the following year, it was also designated as an orphan drug in the development stage by the Korea Ministry of Food and Drug Safety.

Aptose is a biotechnology company specializing in research and development in the field of hematologic diseases, headquartered in Toronto, Canada, and listed on the NASDAQ in the United States. Aptose holds four new drug candidates for the treatment of hematologic tumors, including relapsed and refractory AML and high-risk myelodysplastic syndrome (MDS). Under this contract, Aptose will secure exclusive rights for the global development and commercialization of HM43239.

Under the terms of the agreement, Hanmi Pharmaceutical will receive a confirmed upfront payment of $12.5 million (approximately 1.48 billion KRW) from Aptose, divided into $5 million in cash and $7.5 million worth of Aptose shares. Subsequently, Hanmi will receive up to $407.5 million through milestone payments for stepwise clinical trials, development, approval, and commercialization for various indications. They will also receive tiered royalties based on sales.

William Rice, Chairman of Aptose, said, “HM43239 is an excellent therapeutic agent proven in very challenging malignancies such as AML, and it fits very well with Aptose’s strategic goals, technical expertise, and clinical experience.” He added, “The two companies will proceed with a clear development and commercialization process based on a close partnership.”

Kwon Se-chang, CEO of Hanmi Pharmaceutical, stated, “HM43239 is a powerful hematologic cancer treatment that targets mutations expressed in AML and can overcome resistance to existing therapies.” He added, “Through the partnership with Aptose, which has innovative competitiveness in the hematologic tumor field, we will do our best to accelerate clinical development and advance commercialization.”

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