勵晶太平洋(00575.HK):向中國國家藥監局提交Senstend™的新藥申請
格隆匯3月25日丨勵晶太平洋(00575.HK)宣佈,公司的商業戰略合作夥伴江蘇萬邦生化醫藥集團有限責任公司("江蘇萬邦醫藥",爲上海復星醫藥(集團)股份有限公司的完全控股公司)已於2025年3月24日收到國家藥品監督管理局的確認,先前於2024年12月17日提交的新藥申請註冊檔案已通過國家藥品監督管理局評審程序第一階段,該檔案已滿足所有監管規定。
國家藥品監督管理局現將繼續進行下一階段的評審程序,其將對新藥申請所提交的數據進行技術評估,並預計自提交日期起12個月內獲批。
誠如先前所公佈,江蘇萬邦醫藥須負責自費從國家藥品監督管理局獲得新藥申請並維持在中國進口Senstend™所需的任何及所有監管批準。此外,重要的是,江蘇萬邦醫藥全權負責Senstend™在中國的市場營銷、銷售及分銷,並與製造商聯絡以採購及供應Senstend™,以實現其銷售目標。
儘管集團將向江蘇萬邦醫藥提供合理協助以獲得在中國的監管批準,但集團仍然依賴江蘇萬邦醫藥獲得國家藥品監督管理局的有關批準並實現其銷售目標。此外,江蘇萬邦醫藥已於2024年8月26日與(其中包括)Genetic及江蘇萬邦醫藥營銷有限公司("江蘇萬邦營銷",爲江蘇萬邦醫藥的聯屬公司)簽署獨家制造及供應協議,據此,Genetic將根據自江蘇萬邦醫藥獲得的採購訂單向其生產及供應Senstend™。
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