恆瑞醫藥(600276.SH)：脯氨酸恆格列淨片、羥乙磺酸達爾西利片獲批上市
格隆匯1月3日丨恆瑞醫藥(600276.SH)公佈，近日，經查詢國家藥品監督管理局網站獲悉，國家藥監局批准公司的脯氨酸恆格列淨片、羥乙磺酸達爾西利片上市。
脯氨酸恆格列淨是一種鈉-葡萄糖協同轉運蛋白2(SGLT2)抑制劑，通過抑制SGLT2，減少腎小管濾過的葡萄糖的重吸收，從而增加尿糖排泄。經查詢，全球範圍內的SGLT2抑制劑上市產品包括阿斯利康的達格列淨、強生的卡格列淨、勃林格殷格翰的恩格列淨、默沙東的埃格列淨、賽諾菲的索格列淨，安斯泰來製藥的伊格列淨、中外製藥的託格列淨和大正製藥的魯格列淨。經查詢EvaluatePharma數據庫，SGLT2抑制劑相關產品2020年全球銷售額約76.81億美元。截至目前，脯氨酸恆格列淨相關項目累計已投入研發費用約27353萬元。
羥乙磺酸達爾西利片此次擬獲批適應症的上市申請於2021年4月被國家藥監局按優先審評範圍“(四)納入突破性治療藥物程序的藥品”納入優先審評審批程序。
羥乙磺酸達爾西利是恆瑞醫藥自主研發的化學藥品1類新藥，是一種口服、高效、選擇性的小分子CDK4/6抑制劑。全球首個上市的CDK4/6抑制劑為輝瑞公司研發的Palbociclib(商品名 Ibrance)，於2015年2月通過加快審評途徑獲美國食品藥品監督管理局批准上市，用於與來曲唑聯合作為初始內分泌療法治療HR+/HER2-的晚期乳腺癌，並於2016年2月獲批新適應症聯用氟維司羣治療HR+/HER2-內分泌治療後進展的晚期或轉移性乳腺癌。目前 Palbociclib已在歐盟、日本等多個國家和地區上市。2018年7月Palbociclib在中國獲批(商品名愛博新)，用於聯用芳香化酶抑制劑作為初始內分泌療法治療HR+/HER2-局部晚期或轉移性乳腺癌。其他已被FDA批准上市的 CDK4/6抑制劑有諾華研發的Ribociclib(商品名Kisqali)，禮來研發的Abemaciclib(商品名Verzenio)和G1 Therapeutics研發的Trilaciclib(商品名 Cosela)。目前，國內已有輝瑞公司的Palbociclib及禮來公司的Abemaciclib 獲批。
經查詢Evaluate Pharma數據庫，羥乙磺酸達爾西利片同類產品2020年全球銷售額約69.92億美元。截至目前，羥乙磺酸達爾西利相關項目累計已投入研發費用約36359萬元。
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