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哈藥股份(600664.SH):阿奇黴素片通過仿製藥質量和療效一致性評價
格隆匯 11-29 17:08

格隆匯11月29日丨哈藥股份(600664.SH)公佈,公司所屬企業哈藥集團製藥總廠收到國家藥品監督管理局頒發的關於阿奇黴素片的《藥品補充申請批件通知書》,該藥品通過仿製藥質量和療效一致性評價。

阿奇黴素(Azithromycin)為半合成的十五元大環內酯類抗生素,是臨牀常用的大環內酯類抗生素。

説明書【適應症】為:阿奇黴素是一種大環內酯類抗菌藥物,適用於治療由指定微生物敏感菌株在下列具體病症中引起的輕度至中度感染。流感嗜血桿菌、卡他莫拉菌或肺炎鏈球菌引起的慢性支氣管炎細菌感染急性發作;肺炎衣原體、流感嗜血桿菌、肺炎支原體或肺炎鏈球菌引起的社區獲得性肺炎;流感嗜血桿菌、卡他莫拉菌或肺炎鏈球菌引起的急性中耳炎;流感嗜血桿菌、卡他莫拉菌或肺炎鏈球菌引起的急性細菌性鼻竇炎;化膿性鏈球菌引起的咽炎/扁桃腺炎;金黃色葡萄球菌、化膿性鏈球菌或無乳鏈球菌引起的單純性皮膚和皮膚結構感染;沙眼衣原體或淋病奈瑟氏球菌引起的尿道炎和子宮頸炎;杜克雷嗜血桿菌引起的男性生殖器潰瘍病(軟下疳)。由於臨牀試驗招募的女性人數太少,因此尚未確定阿奇黴素治療女性軟下疳的療效。

目前國內共有3個規格87個阿奇黴素片生產批文,中國境內主要生產廠家有輝瑞製藥有限公司、浙江華潤三九眾益製藥有限公司、石藥集團歐意藥業有限公司等。截至本公吿日,共有6個廠家阿奇黴素片通過國家藥品監督管理局仿製藥質量和療效一致性評價審批。米內網數據庫顯示,中國2020年阿奇黴素片,城市零售藥店銷售額為1.49億元,醫療機構銷售額為2.1億元,共計3.59億元。截至本公吿日,哈藥總廠針對該藥品仿製藥質量和療效一致性評價已投入研發費用約1326萬元人民幣(未經審計)。

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