博雅生物(300294.SZ)：降血糖藥格列美脲片通過仿製藥一致性評價
格隆匯4月6日丨博雅生物(300294.SZ)公佈，近日，公司之控股子公司貴州天安藥業股份有限公司(“貴州天安藥業”)收到國家藥品監督管理局頒發的關於格列美脲片2mg規格(商品名稱:安多美，“該藥品”)的《藥品補充申請批件》(批件號：2020B02732)，該藥品通過仿製藥質量和療效一致性評價。
格列美脲片(Glimepiride)為第三代磺酰脲類口服降血糖藥，為磺酰脲類胰島素促泌劑。是可供口服的中長效磺酰脲類抗糖尿病藥，其降血糖作用的主要機理是刺激胰島β細胞分泌胰島素，可能也與提高周圍組織對胰島素的敏感性有關，對於大多數2型糖尿病(也稱為非胰島素依賴型糖尿病)患者有效。
格列美脲片原研廠家為Sanofi-Aventis(賽諾菲-安萬特)公司，劑型為片劑，上市有多種規格，批准上市的適應症為2型糖尿病。首次於1995年6月20日獲得荷蘭藥品主管當局批准上市，後續相繼在歐盟其他成員國陸續上市，目前已在全球大多數國家均有上市。
在中國，格列美脲片是《國家基本醫療保險、工傷保險和生育保險藥品目錄》甲類品種(2019年版)和《國家基本藥物目錄》品種(2018年版)。目前，格列美脲片國內共有17個生產批文，主要生產廠家有揚子江藥業集團廣州海瑞藥業有限公司、山東新華製藥股份有限公司、重慶康刻爾製藥有限公司、北京北陸藥業股份有限公司、貴州聖濟堂製藥有限公司、上海天賜福生物工程有限公司、山東達因海洋生物製藥股份有限公司、賽諾菲(北京)製藥有限公司、江蘇萬邦生化醫藥集團有限責任公司、北大醫藥股份有限公司、悦康藥業集團股份有限公司等。
截至公告日，格列美脲片共有7個廠家(含貴州天安藥業)，8個品規通過國家藥品監督管理局一致性評價審批。貴州天安藥業開展該藥品一致性評價工作以來，累計投入研發費用約為人民幣767萬元。
根據國家相關政策，通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。貴州天安藥業產品格列美脲片通過仿製藥質量和療效一致性評價，能有效提升該藥品的市場競爭力，有利於增加該藥品的銷售收入，有利於提升盈利能力。同時為上市公司或子公司後續產品開展仿製藥一致性評價工作積累有益的經驗。
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