信達生物(01801.HK)與UNION THERAPUETICS達成戰略合作,引進治療炎症性皮膚病下一代PDE4抑制劑
格隆匯9月28日丨信達生物(01801.HK)發佈公吿,信達生物與UNION Therapeutics A/S(“UNION”)宣佈雙方就UNION用於治療炎症性皮膚病的主要候選藥物orismilast——一款處於臨牀2期的潛在同類最佳PDE4抑制劑,達成在中國(包括中國大陸、中國香港、中國澳門和中國台灣)的獨家授權協議。
根據協定條款,信達生物將獲得orismilast在中國研究、開發和商業化的獨家權益。UNION將收到2,000萬美元的首付款,並有權獲得累計不超過2.47億美元的里程碑付款,以及orismilast在中國年度銷售淨額的特許權使用費。UNION保留orismilast在除中國以外的全球其他地區的權益。
根據披露,中國大約有5,000萬特應性皮炎患者和600萬銀屑病患者,且發病率隨着生活方式的改變顯示出逐步上升的趨勢。目前標準治療方法為外用類固醇、口服免疫抑制劑和注射類生物製劑,在療效、安全性或給藥途徑上有一定的侷限性,存在明顯的未滿足臨牀需求。在2a期臨牀研究中,orismilast表現出潛在的同類最佳(best-in-class)潛質,顯示出更好的抗炎作用,以及通過創新的緩釋方式獲得更好的耐受性,有望解決炎症性皮膚病患者羣體的未滿足需求。
同時,銀屑病、特應性皮炎、化膿性皮炎等炎症性皮膚病屬於常見的慢性自免風濕疾病,與公司疾病領域的戰略佈局和研究資源高度契合。此次合作為公司的現有研發管線增加了一個處於臨牀開發中期的潛在最佳候選藥物。公司將全面負責orismilast中國區域臨牀開發和商業化工作。基於巨大的未滿足需求和紮實的臨牀資料,公司希望儘快將這一下一代同類最佳PDE4抑制劑儘快惠及中國的患者。
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