復鋭醫療科技(01696.HK):注射用A型肉毒毒素產品達希斐®在中國獲批
格隆匯9月9日丨復鋭醫療科技(01696.HK)發佈公吿,由上海復星醫藥產業發展有限公司(以下簡稱“復星醫藥產業”)再授權產品注射用A型肉毒毒素,(DaxibotulinumtoxinA-lanm,中國境內商標達希斐®,英文商標DAXXIFY®,項目代號RT002,以下簡稱“該產品”)用於暫時性改善成人因皺眉肌和╱或降眉間肌活動引起的中度至重度眉間紋的藥品註冊申請於近日收到國家藥品監督管理局的批准。截至本公吿日,除該產品外,於中國境內尚無其他DaxibotulinumtoxinA-lanm產品獲批。
公司全資附屬公司於2022年12月獲復星醫藥產業再授權關於該產品在區域內(即中國內地、中國香港及中國澳門,下同)及領域內(即美容適應症,如改善成人中度至重度眉間紋)使用、進口、銷售及其他商業化(不包括製造)的權利許可,原授權方美國Revance Therapeutics, Inc.仍為該產品在區域內的權利人。
公司相信,此次該產品的註冊批准將成為公司推向中國內地的首款注射填充產品。作為注射填充產品矩陣中的核心產品,達希斐®在業務發展過程中將持續發揮其基石作用,並不斷加強公司在中國內地的產品組合和差異化競爭優勢,持續貢獻新的收入來源,不斷鞏固公司在全球美麗健康行業的領導者地位。
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