羅欣藥業(002793.SZ):注射用蘭索拉唑通過一致性評價
格隆匯6月22日丨羅欣藥業(002793.SZ)宣佈,公司下屬子公司山東裕欣藥業有限公司(簡稱“山東裕欣”)於近日收到國家藥監局核准簽發的關於注射用蘭索拉唑(30mg)的《藥品補充申請批准通知書》。經審查,該藥品通過仿製藥質量和療效一致性評價。
注射用蘭索拉唑適用於口服療法不適用的伴有出血的胃、十二指腸潰瘍、急性應激潰瘍、急性胃粘膜損傷。
蘭索拉唑為質子泵抑制劑,屬苯並咪唑類,分子結構中在吡啶環4-位加入了三氟乙氧基,使其生物利用度增加至85%,化學穩定性及脂溶性均增加,從而更快地出現活性作用。蘭索拉唑是繼奧美拉唑之後的新一代質子泵抑制劑,抑制質子泵的作用更完全,抑制胃酸分泌更快、更明顯。
注射用蘭索拉唑由日本武田藥品工業株式會社(以下簡稱“日本武田”)研究開發,2004年5月在美國批准上市,2006年10月在日本批准上市,日本武田注射用蘭索拉唑目前未在國內上市銷售。山東裕欣於2020年首次獲得注射用蘭索拉唑生產批件,批准文號為國藥準字H20203161。
根據IQVIA數據,注射用蘭索拉唑2020年度在全球的銷售金額為2.1億美元(以出廠價計算),在我國境內銷售金額為17.7億人民幣(以招標價計算)。
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