華東醫藥(000963.SZ):阿卡波糖片因價格因素未能中標第2輪藥品集採
格隆匯1月20日丨華東醫藥(000963.SZ)公佈,2020年1月17日,公司全資子公司杭州中美華東製藥有限公司(下稱“中美華東”)參加了國家組織藥品集中採購和使用聯合採購辦公室(下稱“聯合採購辦公室”)組織實施的第二批國家組織藥品集中採購的投標。
中美華東已通過國家藥品監督管理局仿製藥質量和療效一致性評價的產品阿卡波糖片(商品名:卡博平)參與了本次投標,經聯合採購辦公室開標並根據規則評標後,中美華東阿卡波糖片本次因價格因素未能中標。本次阿卡波糖產品集中採購實際擬中選企業為2家,首年約定採購量為19.14億片,採購有效期原則定為2年。
阿卡波糖片是中美華東的核心品種之一,2019年銷售收入預計達到30億元以上。本次集中採購未能中標將給公司阿卡波糖產品未來發展帶來新的挑戰。
長期來看,隨着國家分級診療政策的持續推進,國家對慢病用藥醫保的優先納入、報銷政策的支持以及基層診療率的提升將使更多糖尿病人納入規範日常治療的範疇,基層市場用藥患者的持續增加,將使阿卡波糖集採以外的市場(包括基層和社區市場、民營醫院、OTC市場)迎來快速增長。公司對國內糖尿病藥物市場的未來充滿信心,也將大有可為。
儘管此次未能中標,但中美華東仍然在糖尿病用藥領域具備產品管線豐富、原料製劑一體化以及成本和質量的整體優勢,並將通過國內最大的阿卡波糖原料產能以更高的生產效率滿足持續增長的臨牀用藥需求。公司繼續致力於製造符合國際標準的高品質藥品,中美華東的阿卡波糖片在國內首家通過一致性評價,並已獲得歐盟奧地利地區市場準入,正在開展美國FDA註冊工作。
公司今後將繼續以患者為中心,以科研為基礎,以市場為導向,通過一系列措施繼續開拓糖尿病用藥市場,並通過技術和管理創新全面提升產品的市場競爭能力。
公司正在積極加強和完善創新藥研發體系建設,同時也將加大新藥產品研發及國內外產品引進力度。已在糖尿病領域儲備了眾多產品管線,其中全球創新藥口服GLP-1TTP273已按計劃正式啟動一期臨牀試驗,利拉魯肽注射劑正在開展3期臨牀,西格列汀二甲雙胍片已提交註冊申請。公司力爭通過糖尿病管線產品的系列化佈局,加快創新轉型步伐,逐步減小今後集中採購政策對單品種市場的影響和壓力。
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