重藥控股(000950.SZ):重藥股份的米拉貝隆緩釋片境內註冊上市許可申請獲受理
格隆匯7月31日丨重藥控股(000950.SZ)公佈,公司控股子公司重慶醫藥(集團)股份有限公司(簡稱“重藥股份”)於近日收到國家藥品監督管理局簽發的米拉貝隆緩釋片(規格:25mg、50mg)境內註冊上市許可申請《受理通知書》,受理號為CYHS2302037國、CYHS2302038國。
米拉貝隆緩釋片由日本安斯泰來醫藥公司(Astellas)研發,2011年9月米拉貝隆緩釋片在日本上市銷售,2012年6月經美國FDA批准在美國上市,2017年9月在中國上市。作為首個用於治療膀胱過度活動症(Overactive bladder,OAB)的口服有效的β3腎上腺激素受體激動劑類藥物,米拉貝隆緩釋片可選擇性地與膀胱肌肉的β3腎上腺激素受體結合並將其激活,這有助於促進膀胱充盈和儲尿。由於這種治療膀胱過度活動症的新機制,米拉貝隆緩釋片的成功上市填補了β腎上腺素受體激動劑在治療膀胱過度活動症方面的空白。與治療OAB中的一線藥物抗膽鹼能藥物相比,米拉貝隆緩釋片不良發生率更低,尤其是在良性前列腺增生患者中,不增加後空隙殘留,這是優於抗膽鹼能藥物的優點。目前已成為最受歡迎的替代抗膽鹼能藥物治療OAB患者的替代藥物。
重藥股份擬通過工藝、質量研究及臨牀試驗,獲得米拉貝隆緩釋片國家藥監局生產批件,並最終實現商業化。
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