康華生物(300841.SZ)獲得藥品補充申請批件
格隆匯 2 月 24日丨康華生物(300841.SZ)公佈，近日，公司收到四川省藥品監督管理局簽發的《藥品補充申請批件》(編號：川B202100001)。
藥品通用名稱：凍幹人用狂犬病疫苗(人二倍體細胞)；批件號：川B202100001；劑型：注射劑；藥品分類：預防用生物製品；規格：復溶後每支1ml，含狂犬病疫苗效價應不低於2.5IU；藥品批准文號：國藥準字S20120007；藥品標準：YBS00112012；藥品生產企業：成都康華生物製品股份有限公司(生產地址：成都經濟技術開發區北京路182號)；申請內容：申請凍幹人用狂犬病疫苗(人二倍體細胞)的生產地址在“成都經濟技術開發區北京路182號”原生產線的基礎上增加原液生產車間“病毒性疫苗二車間”。
申請理由：因公司發展需要，該公司已在成都經濟技術開發區北京路182號新建原液生產車間“病毒性疫苗二車間”。現申請本品的生產地址在“成都經濟技術開發區北京路182號”原生產線的基礎上增加原液生產車間“病毒性疫苗二車間”。
審批結論：根據《藥品註冊管理辦法》及相關規定，經審查，同意本品生產地址在“成都經濟技術開發區北京路182號”原生產線的基礎上增加原液生產車間“病毒性疫苗二車間”，請對藥品説明書及包裝標籤作相應修訂。
公司核心產品凍幹人用狂犬病疫苗(人二倍體細胞)為國內首個上市銷售的人二倍體細胞狂犬病疫苗，用於預防狂犬病。
公司此次獲得的《藥品補充申請批件》是公司病毒性疫苗二車間取得生產許可的前提條件，公司將持續積極推進病毒性疫苗二車間的生產許可獲批工作，病毒性疫苗二車間投產後有助於公司凍幹人用狂犬病疫苗(人二倍體細胞)產量的提升。
公司病毒性疫苗二車間通過藥品生產質量管理規範符合性檢查並完成《藥品生產許可證》許可事項變更後，病毒性疫苗二車間方可投產。
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