嘉應制藥(002198.SZ):處方標準修訂短期內不會影響到產品的生產、銷售和患者用藥成本
格隆匯 11 月 23日丨嘉應制藥(002198.SZ)公佈,公司下屬全資子公司湖南金沙藥業有限責任公司(“金沙藥業”)收到國家藥品監督管理局(“藥監局”)下發的《國家藥品標準(修訂)頒佈件》,藥監局根據《藥品管理法》及其有關規定,對金沙藥業主要產品接骨七釐片/膠囊的處方標準進行修訂,將標準中處方項下“龍血竭”恢復為“血竭”,該標準過渡期為自標準頒佈之日起12個月,相關內容詳見2020年11月12日公司披露的《關於子公司收到〈國家藥品標準(修訂)頒佈件〉的公告》(公告編號:2020-048)。
此次處方標準修訂是品種接骨七釐片/膠囊原材料中“龍血竭”恢復為“血竭”,“血竭”價格導致產品成本有增加。
金沙藥業公司收到藥監局《頒佈件》後,召集了公司生產、採購、銷售、財務及研發各部門負責人召開了專題會議,充分評估了此次處方標準修訂對公司帶來的影響,會議結合當前市場原材料供應情況、生產應急儲備能力、市場銷售周期後認為:
(一)此次處方標準修訂短期內不會影響到產品的生產、銷售和患者用藥成本,按照藥監局《頒佈件》給予12個月的過渡期及藥品期限測算,金沙藥業公司現在生產的品種接骨七釐片/膠囊在2023年之前繼續有效,在此之前不會增加生產成本,亦不會影響患者用藥成本。
(二)金沙藥業公司現在生產的接骨七釐片/膠囊已依法依規取得國家生產批文,在2004年即成為《國家基本藥物目錄》的品種,且獲得了“湖南省產品質量獎”、“湖南名牌產品”稱號。該產品深得廣大患者認可,療效確切,價格合理,公司後續保持與國家藥監局溝通並提出申請,有機會延長原處方標準使用期限。
(三)金沙藥業公司後續在修訂後的處方下,將通過優化工藝降低生產成本、提高產品銷售單價等措施,以消除修訂處方中原材料成本給公司帶來的影響。
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