2010 and beyond
By around 2010, Hanmi's R&D had two areas of interest: developing longer-lasting peptide and protein therapeutics using its "Lapscovery" technology, and developing small molecule tyrosine-kinase inhibitors for cancer and autoimmune diseases. Its strategy was to developmental incremental modifications of existing drugs, create new combination drugs, and to develop novel drugs.[3][4]
In August 2014 Hanmi exclusively licensed rights in China for poziotinib, a small molecule EGFR inhibitor, to the Chinese company Luye Pharma; in February 2015 Hanmi licensed rights in the rest of the world outside of South Korea to Spectrum Pharmaceuticals.[3]
In March 2015 Hanmi and Lilly signed an exclusive license outside of Asia for Hanmi's small molecule Bruton's tyrosine kinase inhibitor in the field of autoimmune diseases; Lilly paid $50 million upfront and the deal included up to $640 million in milestones and royalties greater than 10%.[5]
In November 2015 Hanmi signed three agreements:
In April 2016 Hanmi announced that it had acquired land near Yantai in the Shandong province of China, where it would build a manufacturing plant and R&D facility; at that time it already had a facility in Beijing.[8] In July Hanmi said it intended to invest more heavily in developing candidate substances of promising new drugs at an early stage in new pharmaceutical and biotech related fields, including through a venture capital firm set up by Sung-ki and colleagues.
In May 2016 the Korean regulatory authority approved olmutinib as a second-line treatment for certain kinds of non-small cell lung cancer.[1]
On September 28 Hanmi and Zentec Pharmaceuticals agreed that Zentec would market Hanmi's small molecule cancer drug candidate, HM95573; Zentec paid $80 million upfront, with $830 million in milestones, and royalties.[9]
On September 29, Hanmi and Roche's cancer subsidiary Genentech announced a deal for Hanmi's Phase I cancer drug candidate, HM95573, which targets the MAPK/ERK pathway; Roche agreed to pay $80 million upfront, and the deal included $830 million in milestones.[10]
In December 2016 the Sanofi deal was reduced in scope, with Hanmi receiving back rights to the once-weekly insulin and the combination GLP1-RA/insulin product, and agreeing to repay Sanofi $250 million of the $434 million upfront payment.[11]
On December 3, 2019, Rapt Therapeutics and Hanami Pharmaceutical announced collaboration to develop and commercialize FLX475 in Asia.[12] FLX475 is an oral, small molecule CCR4 antagonist in development for the treatment of multiple cancers.
In August 2020, chairman and founder of Hanmi Pharmaceutical Lim Sung-ki died of a chronic disease. He was 80.[13]
On May 15, 2023, Athenex, which was Hanmi's U.S. partner for its anticancer product, Oraxol, filed for Chapter 11 bankruptcy protection.[14]
- An exclusive license outside of South Korea and China with Sanofi for Hanmi's Glucagon-like peptide-1 receptor agonist drug candidates for diabetes; Sanofi paid $434 million upfront and up to $3.2 billion in milestones and royalties over 10%. The deal included efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist; an insulin intended to be delivered once per week, and a fixed-dosed weekly GLP1-RA/insulin drug combination.[6]
- An exclusive license outside of South Korea and China with the J&J subsidiary Janssen Pharmaceuticals for Hanmi's oxyntomodulin-analog metabolic disease programs, including HM12525A; J&J paid $105 million upfront and the deal included $810M in milestones and royalties higher than 10%[7]
- An exclusive license in China with the Chinese company ZAI Labs for olmutinib.
