Pre-payment without obligation to return KRW 260 billion
Excluding Korea, conditions for transfer of copyrights worldwide
Will be led by Genentech from the second phase of clinical trials

A panoramic view of Hanmi Pharmaceutical's headquarters. [HANMI Pharmaceutical Co., Ltd.] 사진 확대 A panoramic view of Hanmi Pharmaceutical’s headquarters. [HANMI Pharmaceutical Co., Ltd.]

Hanmi Pharmaceutical has decided to transfer its technology to “Genentech,” a subsidiary of Roche Group, for up to $2.3 billion (about 3.1723 trillion won).

This is the largest-ever single candidate material export by a domestic pharmaceutical and bio company to global big pharma, and Hanmi Pharmaceutical is also the largest single-material contract with Sanofi in 2015.

Hanmi Pharmaceutical announced on the 24th that it has signed an exclusive license agreement for its new drug candidate HM17321. If you include future clinical development, regulatory approval, and commercialization milestones in advance of $190 million (about 262.1 billion won), it will be worth up to $2.3 billion. The company said it will also receive separate royalties after the launch of the product.

Under the contract, Genentech has exclusive rights to develop, manufacture, and commercialize HM17321 in markets worldwide except Korea. Hanmi Pharmaceutical will complete the ongoing phase 1 clinical trial, and Genentech will lead the development of the phase 2 clinical trial.

HM17321 is a non-Incretin-based UCN2 (Eurocortin-2) analogue developed by Hanmi Pharmaceutical. It is aiming for a new ‘first-in-class’ drug that simultaneously implements weight loss and muscle preservation. In the case of existing glucagon-like peptide (GLP-1)-based obesity treatments, it has been pointed out as a limitation that despite the significant weight loss effect, the amount of fat such as muscles decreases together during the treatment process.

According to Hanmi Pharmaceutical, HM17321 showed excellent results in weight loss and body composition improvement in non-clinical studies not only when administered alone but also in combination with GLP-1 treatment. It is also developed based on peptides and has the advantage of expanding the area of combination treatment with a fixed-dose complex (FDC) with incremental drugs in the future.

Currently, Hanmi Pharmaceutical received approval from the U.S. Food and Drug Administration (FDA) in November last year for the phase 1 clinical trial plan (IND) of HM17321 and is evaluating safety, tolerability, and pharmacokinetics in healthy adult and obese patients.

Choi In-young, vice president of Hanmi Pharmaceutical, said, “The obesity treatment paradigm is evolving beyond simple weight loss to improve body composition and restore metabolic health. The differentiated scientific mechanism and potential of HM17321 have been recognized in the global market.”

Boris L. Zeitra Roche, head of corporate business development, also said, “We plan to pursue a differentiated treatment strategy that selectively reduces fat mass while improving muscle mass and muscle function.”