榮昌生物(688331.SH):泰它西普獲歐盟孤兒藥資格認定
格隆匯6月17日丨榮昌生物(688331.SH)公佈,公司的產品泰它西普(商品名:泰愛®,研發代號:RC18)獲得歐盟委員會(EC)授予的孤兒藥資格認定(Orphan Drug
Designation,ODD),用於治療重症肌無力。
泰它西普是全球首個上市的治療重症肌無力的 BLyS/APRIL 雙靶點融合蛋白創新藥。在重症肌無力中,病理性 B 細胞會產生攻擊神經肌肉接頭處蛋白(如乙酰膽鹼受體AChR、肌肉特異性酪氨酸激酶 MuSK 等)的自身抗體,而泰它西普則通過同時阻斷BLyS 和APRIL信號通路,能夠更有效地抑制異常活化的 B 細胞,減少致病性自身抗體的產生,從而有望從源頭上幹預重症肌無力的疾病進程。
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