華潤三九(000999.SZ)：阿奇黴素片通過一致性評價
格隆匯12月3日丨華潤三九(000999.SZ)公佈，近日，公司全資子公司浙江華潤三九眾益製藥有限公司(“眾益製藥”)收到國家藥品監督管理局(“國家藥監局”)核准簽發的阿奇黴素片的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。
藥品名稱：阿奇黴素片；劑型：片劑；規格：以阿奇黴素(C38H72N2O12)計0.25g註冊分類：化學藥品；批件號：2019B04385；原藥品批准文號：國藥準字H20084458；審批結論：根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定，經審查，本品通過仿製藥質量和療效一致性評價。
阿奇黴素片是大環內酯類抗生素，適用於敏感細菌引起的下列感染：支氣管炎、肺炎等下呼吸道感染；皮膚和軟組織感染；急性中耳炎；鼻竇炎、咽炎、扁桃體炎等上呼吸道感染；可用於男女性傳播疾病中由沙眼衣原體所致的單純性生殖器感染；亦可用於由非多重耐藥淋球菌所致的單純性生殖器感染及由杜克嗜血桿菌引起的軟下疳（需排除梅素螺旋體的合併感染）。
眾益製藥為阿奇黴素片該劑型第二家通過仿製藥一致性評價的企業。
華潤三九致力於成為“大眾醫藥健康產業的引領者”，在醫藥行業環境不斷變化的背景下，公司處方藥業務聚焦核心領域，積極開展品類規劃與產品佈局，加強產品研發與引進，不斷提升產品市場競爭力，驅動創新發展。
根據國家相關政策規定，對於通過仿製藥一致性評價的藥品品種，在醫保支付方面予以適當支持，醫療機構應優先採購併在臨牀中優先選用。同品種藥品通過仿製藥一致性評價的生產企業達到 3家以上的，在藥品集中採購等方面不再選用未通過仿製藥一致性評價的品種。此次阿奇黴素片通過一致性評價，有利於提升該藥品的市場競爭力。此前公司的鋁碳酸鎂咀嚼片已視同通過一致性評價，上述產品為公司其他產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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