中國生物製藥(01177.HK):消化系統用藥“注射用泮托拉唑鈉”獲通過一致性評價
格隆匯 12 月 1日丨中國生物製藥(01177.HK)發佈公告,集團的消化系統用藥“注射用泮托拉唑鈉”(商品名:納爾復)(規格:60mg和80mg)已獲中國家藥品監督管理局頒發藥品補充申請批准通知書,通過了仿製藥質量和療效一致性評價,為國內同品種規格首家通過一致性評價。
根據披露,泮托拉唑鈉為第三代質子泵抑制劑,主要用於十二指腸潰瘍、胃潰瘍、急性胃粘膜病變、複合性胃潰瘍等引起的急性上消化道出血。泮托拉唑鈉對肝臟CYP450酶的親和力弱,藥物相互作用影響大大降低,可使治療變得更加安全。質子泵抑制劑是多種消化道疾病治療指南推薦用藥,納爾復60mg和 80mg雙規格國內首家過評,將以高質量繼續惠及更多患者。
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