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復星醫藥(600196.SH):芍藥舒筋片用於治療膝骨關節炎的上市申請獲受理

格隆匯11月22日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司江蘇萬邦生化醫藥集團有限責任公司及其控股子公司河北萬邦復臨藥業有限公司就芍藥舒筋片(簡稱“該新藥”)用於治療膝骨關節炎(肝腎不足、筋脈瘀滯證)提交的藥品註冊申請獲國家藥監局審評受理。

該新藥為中藥1.1類新藥,擬主要用於治療膝骨關節炎(肝腎不足、筋脈瘀滯證)。該新藥為上海中醫藥大學附屬曙光醫院著名骨科專家石印玉教授的經驗方,其處方及製備方法已申請專利。根據公開信息,中國內地暫無與其處方一致的藥品上市或註冊申報信息。

截至該公吿日,於中國內地獲批上市的用於治療膝關節骨性關節炎類似適應症的口服藥物有華潤雙鶴藥業股份有限公司的伯司莊®(複方杜仲健骨顆粒)、江蘇康緣藥業股份有限公司的抗骨增生膠囊等。

截至2022年10月,集團現階段針對該新藥累計研發投入約為人民幣5352萬元(未經審計)。

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