Korean pharmas racing for first-in-class title in Korea
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According to sources on Sunday, Daewoong Pharmaceutical received FDA approval for IND application for Phase 2 study of its pulmonary fibrosis drug DWN12088 on June 17. The company is developing the industry¡¯s first therapeutic agent with a new mechanism of action to inhibit the production of PRS protein. Reducing PRS activation suppresses the excessive production of collagen, which is the cause of pulmonary fibrosis.
Hanmi Pharmaceutical is conducting Phase 2 clinical trials of LAPSTriple Agonist, a candidate for a triple-acting first-in-class nonalcoholic steatohepatitis (NASH) drug that simultaneously activates glucagon, which increases energy metabolism, GLP-1 that promotes insulin secretion and suppresses appetite, and GIP receptors that regulate adipose inflammation. The trials are underway in Korea and in the United States. The drug was granted fast track designation from the FDA in 2020 to expedite the drug development for NASH treatment. In 2021, it received orphan drug designation for the treatment of idiopathic pulmonary fibrosis.
JW Pharmaceutical is also looking for a breakthrough with new atopic dermatitis drug JW1601 that targets histamine H4 receptor (H4R).
Bridge Biotherapeutics is a Korean biotech startup dedicated to clinical trials of fourth-generation non-small cell lung cancer drug BBT-176, which inhibits gene mutation to maximize treatment benefits in lung cancer patients. Tagrisso is commonly used to treat lung cancer, but some patients develop resistance to the drug due to C797S gene mutation.
Chong Kun Dang is developing CKD-510, a novel therapy to treat Charcot Marie Tooth (CMT) disease, a rare hereditary disorder where the peripheral nerves are affected, resulting in muscle weakness and atrophy. There is no proven cure for this disease.
Medical research has advanced with a growing number of clinical trials for novel therapeutics in Korea, but no single company has won the title to date.
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