復星醫藥(02196.HK)：治療頸部肌張力障礙新藥獲國家藥監局臨牀試驗受理
格隆匯 6 月 29日丨復星醫藥(02196.HK)公告，近日，上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海復星醫藥產業發展有限公司(以下簡稱“復星醫藥產業”)收到《受理通知書》，其獲許可的RT002(以下簡稱“該新藥”)用於頸部肌張力障礙治療獲國家藥品監督管理局(以下簡稱“國家藥監局”)臨牀試驗註冊審評受理。
復星醫藥產業於2018年12月獲美國Revance Therapeutics,Inc.(以下簡稱“Revance”)授權在區域內(即中國大陸、香港及澳門特別行政區，下同)獨家使用、進口、銷售及其他商業化(不包括製造)的權利，Revance仍為該新藥在區域內的權利人。該新藥為生物製品，擬用於(1)美容適應症，如治療中重度眉間紋；以及(2)治療適應症，如頸部肌張力障礙。
截至公告日，該新藥用於中重度眉間紋治療尚處於美國FDA(即美國食品藥品監督管理局，下同)上市申請階段、於中國境內(不包括港澳台地區，下同)已獲國家藥監局臨牀試驗註冊審評受理；該新藥用於頸部肌張力障礙治療於美國處於III期臨牀試驗中。
截至公告日，於中國境內尚無DaxibotulinumtoxinA型肉毒桿菌毒素的產品上市銷售，於中國境內已上市的類似產品A型肉毒桿菌毒素包括Allerganplc的Botox?A型肉毒桿菌毒素、蘭州生物製品研究所有限責任公司的衡力?治療用A型肉毒桿菌毒素。
根據IQVIACHPA最新數據(由IQVIA提供，IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商；IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場，不同的藥品因其各自銷售渠道佈局的不同，實際銷售情況可能與IQVIACHPA數據存在不同程度的差異)，2019年度，注射用A型肉毒桿菌毒素在中國境內銷售金額約為人民幣3.54億元。
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