Hanmi currently has about 30 innovative novel drug pipelines, including potential treatments for nonalcoholic steatohepatitis, better known as fatty liver disease, as well as some rare incurable diseases.
Hanmi shares had recently tumbled upon news of successive decisions by big global pharmas to return licensing rights to Hanmi. The latest case was in July, when Belgium’s Janssen Pharmaceuticals returned the development and global commercialization rights to Hanmi’s investigational diabetes treatment.
|Hanmi headquarters (Hanmi)|
But hitting walls is an expected hardship in the business of creating novel drugs, Hanmi said, adding that it will strengthen its research and development capabilities and resolutely pursue the more difficult path.
Despite the issues, industry insiders say the value of Hanmi’s novel drug pipelines remains unchanged.
Many of the company’s pipelines have been recognized as promising by authorities including the US Food and Drug Administration, the European Medicines Agency and the Korean Ministry of Food and Drug Safety.
Hanmi maintains strong partnerships with France’s Sanofi and with Spectrum Pharmaceuticals and Athenex in the US, in carrying out clinical phase 3 trials for diabetes and cancer treatments.
A clinical phase 3 trial is the step that directly precedes the commercialization of a new drug. Hanmi is currently running three clinical phase 3 trials, seven clinical phase 2 trials, eight clinical phase 1 trials and 11 preclinical trials on animals.
Eight of Hanmi’s novel drug pipelines are for diabetes and obesity treatments, four are for rare disease treatments, 13 are for cancer treatments and two are for autoimmune disease treatments. Others include growth hormone deficiency treatments.
Hanmi reiterated that it normally takes 12 years to develop a novel, global drug with a 0.02 percent probability of success.
Analyses show that each new drug costs an average of 1 trillion won ($825 million). Still, the company’s eyes are set on developing a blockbuster drug, a Hanmi representative said, adding that Hanmi will never cease to challenge itself.
Hanmi crossed the 1 trillion won revenue threshold last year.
Known to make aggressive investment in R&D, Hanmi allocated 170.6 billion won for research and development in 2017 and 193 billion won in 2018, roughly 19 percent of the company’s revenue.
By Lim Jeong-yeo (firstname.lastname@example.org)