恆瑞醫藥(600276.SH)及子公司獲得臨牀試驗通知書
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(“國家藥監局”)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：SHR1459片；劑型：片劑；規格：50mg；申請事項：臨牀試驗；受理號：CXHB2000010；審批結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年2月12日受理的SHR1459片符合藥品註冊的有關要求，同意批准本品增加50mg規格用於臨牀試驗。
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為5244萬元人民幣。
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