長春高新(000661.SZ):控股子公司凍幹鼻噴流感減毒活疫苗獲批生產
格隆匯3月2日丨長春高新(000661.SZ)公佈,公司控股子公司長春百克生物科技股份公司於2020年2月29日收到了國家藥品監督管理局核准簽發的藥品註冊批件。獲批產品為凍幹鼻噴流感減毒活疫苗;劑型為鼻用製劑;註冊分類為預防用生物製品;藥品批准文號為國藥準字S20200002;藥品批准文號有效期至2025年2月24日。
凍幹鼻噴流感減毒活疫苗生產批件的取得將對子公司疫苗產品線的豐富及市場拓展產生積極影響。該疫苗獲得藥品註冊批件後,公司將嚴格按照國家法律法規相關規定,積極組織開展該疫苗的生產經營工作,積極做好產品上市的相關工作。按現行法規,疫苗銷售須獲得招標準入,且每批產品在上市銷售前須獲得批簽發證明,同時受到流感疫苗銷售季節性的影響,正式上市時間存在一定的不確定性。
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