Daewoong Pharmaceutical and CS Pharmaceuticals sign a licensing agreement for Bersiporocin. Credit: Daewoong Pharmaceutical Co., Ltd. / PRNewswire.

Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF).

Under the deal, CSP will have exclusive rights for the development and marketing of Bersiporocin to treat IPF as well as other respiratory indications in the region, including mainland China, Macau, Hong Kong, and Taiwan.

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As per the terms of the agreement, Daewoong will receive a total consideration of up to $336m, including upfront and development milestone payments of up to $76m, along with royalties on net sales.

Being developed by Daewoong, Bersiporocin has already received FastTrack Designation and Orphan Drug Designation from the US Food and Drug Administration (FDA) to treat IPF.

Last year, the company commenced a multi-regional Phase II clinical trial of Bersiporocin for IPF treatment, with results expected in the first half of next year.

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The Korea Drug Development Fund is supporting the trial by providing funds.

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CSP CEO Darren Mercer said: “Securing the Chinese commercial rights to Bersiporocin with the initial focus in IPF marks another milestone for CSP, as we continue to expand our portfolio of innovative products in China.

“IPF is a priority rare disease in China, which marks a huge unmet need. It is currently estimated that nearly 50% of IPF patients in China will die within two to three years after diagnosis.

“Completing this transaction further strengthens our rare disease portfolio as we continue to focus on bringing innovative rare disease and ophthalmology medicines to Chinese patients, to address the significant unmet medical needs in this rapidly growing market.”