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Yuhan Corporation entered into a licensing agreement worth up to $415 million with Processa Pharmaceuticals for the development of YH12852, a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders (FGID).

YH12852 is an agonist that exhibits excellent selectivity to a receptor (5-HT4) that plays an essential role in the regulation of intestinal movement and sensory. Unlike other 5-HT receptor agonists, which have been removed from the market or not approved because of the cardiovascular side effects associated with the drugs binding to other receptors, YH12852 has confirmed excellent bowel movement improvement effects without any cardiovascular side effects through its preclinical toxicity and phase 1 clinical trial in Korea.

Processa will have a clinical development meeting with the U.S. Food and Drug Administration and conduct a phase 2 clinical trial in functional GI motility-related disorder that needs better therapeutic options, such as postoperative intestinal obstruction or opioid-induced constipation, in 2021.

Under the agreement, Yuhan will receive a non-refundable upfront payment of $2 million in the form of processa shares, and also will be eligible to receive up to $415 million including additional payments, commercial milestones, and royalties on net sales.  In exchange, Processa will acquire global rights to the development, manufacturing, and commercialization of YH12852 except for South Korea, where Yuhan will retain such rights.