智通财经APP讯，石药集团(01093)发布公告，集团与杭州英创医药科技有限公司合作开发的化学1类新药SYH2095片已获得美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。
该产品是一种新型的高选择性赖氨酸乙酰转移酶6(KAT 6)抑制剂，属于一类表观遗传抗癌药。该产品通过抑制组蛋白赖氨酸的乙酰化，阻滞开放染色质，进而调控细胞周期、雌激素受体表达及细胞衰老通路，从而发挥抗肿瘤作用，拟用于晚期恶性肿瘤。临床前研究表明，该产品对KAT 6显示出高效且具选择性的抑制作用，可显着抑制肿瘤生长，并具备良好的药代动力学特性与安全性。
目前，国内外尚无同靶点药物获批上市，该产品具有较高的临床开发价值。
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