眾生藥業(002317.SZ)：利巴韋林片通過仿製藥質量和療效一致性評價
格隆匯 11 月 27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籤發的《藥品補充申請批準通知書》，通知書編號：2020B04997。華南藥業為國內通過利巴韋林片仿制藥質量和療效一致性評價的前三家企業。
利巴韋林適用於呼吸道合胞病毒引起的病毒性肺炎與支氣管炎；皮膚皰疹病毒感染。與幹擾素α聯合使用，治療成人慢性丙型肝炎。
利巴韋林為人工合成的核苷類藥物，具有廣譜抗病毒作用，對20多種DNA和RNA病毒都有明顯的抑制作用，多年來一直是用於治療病毒性感染疾病的首選藥，臨牀常用於呼吸道合胞病毒引起的病毒性肺炎、支氣管炎，以及聯合幹擾素用於各型肝炎的治療。
利巴韋林作為一種廣譜抗病毒藥，適應症較廣泛，是多年來用於治療病毒性感染疾病的首選藥。利巴韋林片是我國國家基本藥物目錄藥物，同是也是醫保目錄甲類藥物。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，利巴韋林片2017至2019年銷售額分別為人民幣4873萬元，4228萬元，4652萬元。
公司積極順應國家仿制藥質量和療效一致性評價政策，公司已開展一致性評價品種十多個，除已通過仿制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、吡嗪酰胺片和利巴韋林片以外，還有鹽酸小檗鹼片、格列吡嗪片等4個品種已獲得仿制藥一致性評價CDE受理，處於審評審批中，目前研發進度符合預期。本次利巴韋林片仿制藥質量和療效一致性評價的通過，是公司及華南藥業研發能力、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。對公司有積極影響，有利於提升產品市場競爭力，擴大產品的市場份額及夯實公司在抗病毒藥品領域的市場地位。
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