Article source: Medical Cube Info
Author: info
On May 5, the CDE official website showed that the clinical application for Orismilast sustained-release tablets jointly developed by Innovent Bio and UNION therapeutics was accepted by the State Food and Drug Administration
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orismilast is a potent and highly selective next-generation PDE4 inhibitor with broad anti-inflammatory properties
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orismilast was developed by LEO Pharma and acquired by UNION in 2020
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Orismilast has generated positive proof-of-concept (PoC) data in the oral treatment of psoriasis and the topical treatment of atopic dermatitis, and is expected to be a potentially optimal or preferred treatment option for both diseases
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Compared to other PDE4 inhibitors, orismilast's high selectivity for PDE4 isoforms B and D and the excellent therapeutic window brought by the innovative sustained-release approach is expected to lead to better anti-inflammatory efficacy and tolerability
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In September 2021, Cinda and UNION reached an exclusive right to research, develop and commercialize orismilast in China (including mainland China, Hong Kong, Macau and Taiwan)
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UNION will receive an upfront payment of $20 million and is entitled to cumulative milestone payments of up to $247 million, as well as royalties on annual net sales of orismilast in China
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UNION retains orismilast's rights and interests in the rest of the world except China
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There are about 50 million patients with atopic dermatitis and 6 million patients with psoriasis in China, and the incidence shows a gradual upward trend with life>
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The current standard treatment methods are topical steroids, oral immunosuppressants and injectable biologics, which have certain limitations in terms of efficacy, safety or route of administration, and there are obvious unmet clinical needs
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In Phase IIa clinical studies, orismilast showed potential Best-in-Class potential, showing better anti-inflammatory effects, and better tolerability through innovative sustained-release methods, which are expected to address Unmet needs in the inflammatory skin disease patient population
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