新華製藥(000756.SZ):獲批成為地西泮片(2.5mg、5mg)的上市許可持有人
格隆匯9月13日丨新華製藥(000756.SZ)公佈,近日,山東新華製藥股份有限公司收到國家藥品監督管理局核准簽發的地西泮片(以下簡稱“本品”)《藥品補充申請批准通知書》,批准本品上市許可持有人轉讓補充申請。
新華製藥與吉林顯鋒科技製藥有限公司(以下簡稱“吉林顯鋒”)於2023年2月簽訂了生產技術及持有人轉讓合同,合同約定:吉林顯鋒將擬取得的地西泮片上市許可持有人及所涉及的技術權屬(生產批件、生產技術的相關知識產權與商業化權益等所有權益,包括但不限於產品生產技術、銷售、市場推廣等)一次性全部轉讓給新華製藥,新華製藥根據合同約定向吉林顯鋒分階段支付相關轉讓費。
2024年8月,新華製藥向國家藥品監督管理局遞交上市許可持有人變更的補充申請資料並獲得受理,2024年9月獲得藥品補充申請批准通知書,審評結論為:經審查,本品上市許可持有人轉讓申請符合藥品上市後變更管理的有關要求,批准本品上市許可持有人變更。
地西泮片為長效苯二氮卓類中樞神經系統抑制藥,其作用機制主要涉及加強腦內抑制性神經遞質γ-氨基丁酸(GABA)的作用,主要用於焦慮、鎮靜催眠,抗癲癇和抗驚厥,緩解炎症引起的反射性肌肉痙攣,治療驚恐症,肌緊張性頭痛,家族性、老年性和特發性震顫,亦可用於麻醉前給藥。根據有關數據顯示,2023年中國城市公立醫院地西泮製劑的銷售額為人民幣5,065萬元。
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