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Chiesi Group and Haisco Pharmaceutical have entered a licence agreement to jointly develop HSK31858 to treat respiratory diseases such as bronchiectasis. 

As part of the agreement, Haisco will receive an upfront payment, future milestone payments, and royalties on product sales. 

HSK31858 is a reversible dipeptidyl peptidase 1 (DPP1) inhibitor, currently in a Phase II clinical trial (NCT05601778) in China. The randomised, double-blind study is assessing the safety and efficacy of HSK31858 in non-cystic fibrosis bronchiectasis subjects, with an estimated completion date of 1 January 2024. 

Bronchiectasis is a chronic respiratory condition characterised by the widening and inflammation of the airways (bronchi) in the lungs. This leads to the accumulation of mucus and makes the airways more susceptible to infections. It is a progressive condition that can lead to severe lung damage over time.  

There are currently no approved therapies for the treatment of bronchiectasis. HSK31858 joins the list of investigational drugs currently in clinical trials for this condition, including AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’s icenticaftor (QBW251). 

According to a report on the GlobalData Pharma Intelligence Centre, the bronchiectasis market in the three major pharmaceutical markets of the US, UK and Germany, was valued at $408.2m in 2021. The market is projected to grow at a compound annual growth rate (CAGR) of 9%, reaching $965.8m by 2031, with pipeline agents adding over $450m in sales. 

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In the announcement accompanying the agreement, the head of global research and development at Chiesi Thomas Eichholtz said: “HSK31858 is an important addition to our pipeline, and it offers a great opportunity to combine the two partners’ strong experience in this field.” 

Earlier this year, Chiesi signed a definitive agreement to acquire Amryt Pharma in a total deal valued at up to $1.48bn. Through this deal, Chiesi planned to expand its rare disease medicine portfolio.