Yunovia and Daewon Pharm agree to co-develop P-CAB stomach medicine
Yunovia, a new drug research and development subsidiary of Ildong Pharmaceutical, said Thursday that it has signed a joint development and licensing agreement with Daewon Pharmaceutical to develop a new drug for peptic ulcer disease based on P-CAB (Potassium-Competitive Acid Blockers).
Under the agreement, Daewon Pharmaceutical will conduct clinical development related to Yunovia's P-CAB drug candidate, ID120040002. It will retain all rights to commercialize the drug in Korea, including pursuing licensure, manufacturing, and sales.
By providing the information necessary to obtain a license for ID120040002, Yunovia will receive a certain upfront payment from Daewon Pharmaceutical, royalties upon commercialization, and the right to manufacture and sell off-brand medicines with the same ingredients.
ID120040002 is a member of the P-CAB class of drugs for gastroesophageal reflux disease (GERD) that inhibits gastric acid secretion by acting on the proton pump (H+/K+-ATPase) in the cells of the stomach wall and interfering with the exchange of potassium ions (K+) and hydrogen ions (H+).
Earlier, Yunovia confirmed ID120040002's differentiated pharmacologic properties and safety in a phase 1 clinical trial.
According to Yunovia, ID120040002 demonstrated better-sustained efficacy than competitors in the same class, with about 90 percent of patients maintaining a stomach pH of 4 or higher and about 60 percent maintaining a pH of 6 or higher over 24 hours.
Yunovia recently received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 2 IND to evaluate the efficacy and safety of ID120040002 in patients with erosive GERD and has completed patent registrations in major market countries, including Korea, the United States, Japan, and Australia, to secure rights related to the new drug substance.
“We have created a best practice among Korean pharmaceutical companies to collaborate rather than compete in each stage of drug development, Daewon Pharmaceutical CEO Baek In-hwan said. “As two companies with strengths in the digestive system therapeutic area have joined hands, we will do our best to bring excellent new drugs to the market as soon as possible.”
Yunovia CEO Lee Jae-joon said, “Through this joint development agreement and investment, the value of ‘ID120040002’ has been recognized externally, and we have gained the necessary momentum to proceed with new drug projects, including partnerships and funding. We plan to continue our R&D strategies, including commercialization and open innovation for many promising pipelines in Yunovia's pipeline and out-licensing to global markets such as China.”
According to statistics from the Health Insurance Review and Assessment Service, the number of patients with GERD in Korea increased from 4.27 million in 2017 to 4.9 million in 2022, an increase of about 15 percent in five years. BCC Research, a global market research firm, forecasts the global P-CAB market to grow at an annual average growth rate of 25 percent from 61 billion won ($44.3 million) in 2015 to 1.87 trillion won in 2030.