眾生藥業(002317.SZ)：格列吡嗪片通過仿製藥質量和療效一致性評價
格隆匯9月10日丨眾生藥業(002317.SZ)公佈，近日，公司全資子公司廣東華南藥業集團有限公司(“華南藥業”)收到國家藥品監督管理局批準簽發的《藥品補充申請批准通知書》， 通知書編號：2021B02884。
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吿》(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。
糖尿病是一種由於胰島素絕對不足或相對不足，產生以高血糖為主要特徵，伴有糖、脂肪和蛋白質代謝紊亂的全身慢性代謝病。目前採用世界衞生組織(1999年)糖尿病病因學分型體系，共分為4類，其中2型糖尿病是臨牀最常見類型。
臨牀上應用的口服降糖藥物主要有3大類，格列吡嗪屬於磺脲類降糖藥，與β細胞的選擇性結合能力顯著增強，且引發低血糖、粒細胞減少及心血管不良反應率較低，對大多數2型糖尿病患者有效。
格列吡嗪片是我國國家基本藥物目錄藥品和國家醫保目錄藥品。米內網中國城市公立醫院化學藥終端競爭格局數據庫顯示，格列吡嗪片2018至2020年銷售額分別為人民幣22213萬元，23847萬元，25415萬元。
公司積極順應國家仿製藥質量和療效一致性評價政策，已開展一致性評價品種十多個，除已通過仿製藥一致性評價的鹽酸二甲雙胍片、異煙肼片、頭孢拉定膠囊、氫溴酸右美沙芬片、鹽酸乙胺丁醇片、格列齊特片、吡嗪酰胺片、利巴韋林片、頭孢克肟分散片和格列吡嗪片以外，還有羧甲司坦片等品種已獲得仿製藥一致性評價CDE 受理，處於審評審批中。
此次格列吡嗪片仿製藥質量和療效一致性評價的通過，是公司研發能力、生產及質量管理體系等綜合實力的體現，也是國家藥品監管部門對上述綜合能力和產品質量的認可。公司擁有鹽酸二甲雙胍片、格列齊特片、格列吡嗪片等治療糖尿病藥物，有利於擴大該類產品的市場份額及夯實公司在糖尿病藥物領域的市場地位，對公司有積極影響。
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