舒泰神(300204.SZ)：複方聚乙二醇電解質散(Ⅳ)補充申請獲得受理通知書
格隆匯 12 月 4日丨舒泰神(300204.SZ)公佈，2020年12月03日，公司收到了國家藥品監督管理局下發的關於“複方聚乙二醇電解質散(Ⅳ)”的行政許可文書《受理通知書》。
受理通知書主要內容為：1、申請事項：境內生產藥品補充申請：國家藥品監管部門審批的補充申請事項；1.藥學變更中屬於重大變更的事項；1.3製劑生產工藝變更；1.5註冊標準變更；2、產品名稱：複方聚乙二醇電解質散(Ⅳ)；3、申請人：舒泰神(北京)生物製藥股份有限公司；4、結論：根據《中華人民共和國行政許可法》第三十二條的規定，經審查，決定予以受理。受理號：CYHB2010159國。
複方聚乙二醇電解質散(IV)(商品名：舒泰清)於2004年獲得國家食品藥品監督管理局頒發的新藥證書和生產批文並開始上市銷售，劑型為散劑，批准文號：國藥準字H20040034。舒泰清的適應症為1)用於治療功能性便祕；2)用於術前腸道清潔準備：腸鏡及其它檢查前的腸道清潔準備。舒泰清為患者帶來了符合國際“清腸、治療便祕金標準”的藥物，成為《中國消化內鏡診療腸道準備指南》和《中國慢性便祕診治指南》的一線用藥，市場份額位居第一。舒泰清獲得國家科技部“國家火炬計劃項目”，被認定為“北京市自主創新產品”。舒泰清2019年列入《國家醫保藥品目錄》。除西藏以外，銷售區域覆蓋全國。
舒泰清多年耕耘在清腸和便祕市場中，堅持樹立市場品牌，加強學術化推廣影響力。2019年舒泰清銷售收入為3.17億元，同比增長22.72%，佔2019年營業收入的51.81%；2020年，公司克服疫情期間的諸多影響，2020年上半年舒泰清實現銷售收1.10億元，其中第二季度較第一季度環比增長1.6倍。
此次複方聚乙二醇電解質散(Ⅳ)的申請事項包括：1.藥學變更中屬於重大變更的事項；1.3製劑生產工藝變更；1.5註冊標準變更，目的為進一步提高產品質量，加強產品質量控制，全面提升質量標準。
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