重藥控股(000950.SZ):子公司鹽酸普拉格雷片上市申請獲受理
格隆匯9月1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”)於近日收到國家藥監局簽發的鹽酸普拉格雷片境內註冊上市許可申請《受理通知書》,受理號為CYHS2101653國、CYHS2101654國。
鹽酸普拉格雷片原研公司為第一三共株式會社,是第三代的抑制ADP激活的血小板聚集的藥物,適應於預防接受經皮冠狀動脈介入治療後的急性冠狀動脈綜合徵、穩定型心絞痛,陳舊性心肌梗塞患者的血栓形成。目前已在全球70多個國家和地區上市(中國境內未上市)。
重藥股份投資引進了第一三共株式會社鹽酸普拉格雷片製劑技術及中國境內專利獨家授權,擬通過工藝、質量研究及臨牀試驗,獲得國家藥監局生產批件,並最終實現商業化。該次鹽酸普拉格雷片是境內第一個申請上市並獲得受理的品種,標誌着公司重要研發項目取得了新的進展。若該產品未來能順利獲批上市,將能為患者提供更多的用藥選擇。
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