恆瑞醫藥(600276.SH)：惡性腫瘤及B細胞淋巴瘤治療藥獲臨牀試驗通知書
格隆匯3月2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。
SHR2554是公司開發的新型、高效、選擇性的口服EZH2抑制劑，擬被應用於惡性腫瘤的治療。2020年1月23日，美國食品藥品監督管理局批准Epizyme公司研發的口服EZH2抑制劑Tazverik(tazemetostat)上市，規格為200mg/片，用於治療成人與16歲以上青少年轉移性或局部晚期上皮樣肉瘤。國內外目前在研的口服EZH2抑制劑還包括Constellation開發的CPI-1205和CPI-0209，第一三共製藥開發的valemetostat和輝瑞公司開發的PF-06821497。其中，除PF-06821497處於I期臨牀階段以外，其他均處與II期臨牀階段。
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。全球最早上市的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(zanubrutinib)二線治療套細胞淋巴瘤，成為繼伊布替尼和Acalabrutinib後第三個上市的BTK抑制劑。2017年國家藥監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AC-0058，杭州和正醫藥開發的HZ-A-018等。伊布替尼2018年全球銷售額約為45.1億美元，Acalabrutinib2018年全球銷售額約為6,025.9萬美元。
截至目前，公司在SHR2554片項目上已投入研發費用約3,393萬元人民幣，SHR1459片項目已投入研發費用約為5,184萬元人民幣。
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