華森製藥(002907.SZ)收到藥品補充申請批件
格隆匯11月6日丨華森製藥(002907.SZ)公佈，公司於2019年11月5日收到重慶市藥品監督管理局核准簽發的《藥品補充申請批件》(批件號：渝B201900045)。
根據重慶市藥品技術審評認證中心《關於重慶華森製藥股份有限公司聚乙二醇4000散藥品註冊補充申請技術審評情況的報告》(渝藥審認【2019】147號)的相關意見，經審查，同意聚乙二醇4000散的有效期由18個月延長為24個月；説明書、標籤按本批件對相應內容進行修訂。
聚乙二醇4000散為新一代生理性滲透緩瀉劑，小劑量通便，大劑量清腸，不吸收、不代謝、促排泄，安全性高，適用人羣廣，廣泛適用於成人及8歲以上兒童(包括8歲)便祕的症狀治療(兒童應為短期治療，最長療程不應超過三個月)。
長鬆(聚乙二醇4000散)為國內首仿藥品，取得國家發明專利。華森製藥為聚乙二醇4000散國內首家通過一致性評價的企業。該產品用於緩解成人便祕的症狀，安全性高，還適用於老年人、孕婦等人羣，適應人羣廣，是《中國慢性便祕指南》IA級推薦藥物，被列入2018年版《國家基本藥物目錄》及2019年版《國家醫保目錄》（甲類），並於2015年被認定為重慶市高新技術產品。此外，華森製藥為該品種質量標準起草單位。
長鬆(聚乙二醇4000散)是公司的重點產品之一，2016年～2018年該產品分別實現銷售收入2126.14萬元、2703.07 萬元及3538.24萬元，最近三年的年均復合增長率為29.00%，增長速度較快。根據米內網的統計，2018年長鬆(聚乙二醇4000散)佔國內城市公立醫院市場份額為22.45%，位居國產品牌第1名。
根據南方醫藥經濟研究所——標點信息的數據，2012-2016年，我國聚乙二醇醫院市場規模由1.12億元增長到1.66億元，年均複合增長率為10.34%。按照上述增長率測算，至2022年我國聚乙二醇醫院市場規模有望達到3.00億元。
經國家藥監局官網查詢，除華森製藥外，聚乙二醇4000散的主要生產廠家有法國博福-益普生工業公司、湖南華納大藥廠股份有限公司、馬應龍藥業集團股份有限公司和重慶賽諾生物藥業股份有限公司。
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