復星醫藥(02196.HK)子公司申請撤回治療食物過敏導致特應性皮炎新藥上市許可註冊
復星醫藥(02196.HK)公布,控股子公司錦州奧鴻藥業向國家藥監局主動申請,撤回色甘酸鈉顆粒的上市許可註冊申請,並於近日收到國家藥監局關於同意該撤回申請的通知書。
該藥為自主研發的仿製藥,擬主要用於治療食物過敏導致的特應性皮炎。該新藥的註冊上市申請於2021年2月獲國家藥監局審評受理。本次撤回申請後,集團將綜合評估(其中主要包括)該新藥補充驗證性臨床試驗所需的周期、成本以及市場需求等因素,決定該新藥補充臨床研究及註冊申報等事宜。
截至今年10月,集團現階段針對該新藥累計研發投入約1,118萬元人民幣。
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