甘李藥業(603087.SH):甘精胰島素注射液獲得巴基斯坦藥品註冊批件
格隆匯12月8日丨甘李藥業(603087.SH)公佈,近日,甘李藥業股份有限公司收到巴基斯坦藥品監督管理局(Drug Regulatory Authority of Pakistan,DRAP)核准簽發的甘精胰島素注射液(預填充)註冊批件(批件號:Reg.No.111178)。
甘精胰島素注射液屬於長效胰島素類似物產品,又稱基礎胰島素類似物,每天注射一次,注射起效後作用時間可持續24小時。甘精胰島素具有作用時間長、血藥濃度無峯值、平穩地降低患者血糖的作用,有較好的療效和安全性,因此,甘精胰島素注射液成為糖尿病治療中尤為重要的基礎胰島素類似物。
巴基斯坦位於南亞,總人口2.25億(2021年),人均GDP為1537.9美元(2021年,國際匯率)。國際糖尿病聯盟(IDF)全球糖尿病概覽第10版(2021)發佈的最新數據顯示,2021年度巴基斯坦20-79歲的糖尿病患者達3300萬人,患者規模位列世界第三位,僅次於中國和印度。在巴基斯坦20-79歲的成年人口中,糖尿病的發病率為30.8%,高居世界第一。
截至公吿發布日,在巴基斯坦境內,甘精胰島素注射液的主要供貨商為賽諾菲。賽諾菲作為原研廠家,其甘精胰島素產品Lantus®2021年的全球銷售額約26億美元(賽諾菲2021年財報)。
截至2022年9月30日,甘李藥業在甘精胰島素項目中累計投入研發費用8.06億元人民幣。
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