恆瑞醫藥(600276.SH)：SHR1459片獲批臨牀試驗
格隆匯4月14日丨恆瑞醫藥(600276.SH)公佈，公司及子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》，並將於近期開展臨牀試驗，藥品名稱為SHR1459片。
SHR1459屬於BTK選擇性小分子抑制劑，臨牀前研究表明，SHR1459在體外顯示出很強的激酶選擇性，在體外和體內實驗中均顯示出良好的抗B細胞淋巴瘤活性，毒理結果也表明SHR1459的動物耐受性良好，預計對B細胞淋巴瘤將具很高的臨牀應用價值。目前全球範圍內共有四個BTK抑制劑獲批，最早上市的BTK抑制劑為伊布替尼，2013年獲得美國FDA的批准，用於B細胞淋巴瘤的治療。2017年美國FDA批准阿斯利康旗下Calquence（Acalabrutinib）上市用於治療套細胞淋巴瘤。2019年美國FDA批准百濟神州旗下Brukinsa (澤布替尼)二線治療套細胞淋巴瘤。2020年日本藥監局批准小野製藥旗下Velexbru (Tirabrutinib)治療原發性中樞神經系統淋巴瘤。
2017年國家藥品監督管理局批准伊布替尼膠囊上市，規格為140mg，商品名為億珂，用於治療慢性淋巴細胞白血病/小淋巴細胞淋巴瘤、套細胞淋巴瘤。目前國內在研的BTK抑制劑還包括北京諾誠健華開發的奧布替尼、杭州艾森醫藥開發的艾維替尼、百濟神州的澤布替尼、杭州和正醫藥開發的HZ-A-018等；其中奧布替尼、艾維替尼和澤布替尼已經向NMPA提交上市申請，目前在審評審批中。經查詢，2019年伊布替尼、Acalabrutinib 、澤布替尼全球銷售額約為57.17億美元。
截至目前，該產品項目已投入研發費用約5244萬元人民幣。
根據我國藥品註冊相關的法律法規要求，藥物在獲得臨牀試驗通知書後，尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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