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榮昌生物(09995.HK):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(09995.HK)公告,近日,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。

重症肌無力(Myasthenia Gravis, MG)是一種由自身抗體介導、獲得性神經肌肉接頭傳遞障礙的罕見自身免疫性疾病。據國際重症肌無力基金會(MGFA)及研究數據顯示,全球 MG 患病率約爲每 10 萬人 15-25 例,在歐盟符合罕見病(患病率低於萬分之五)定義。儘管現有治療(如膽鹼酯酶抑制劑、糖皮質激素、免疫抑制劑、靜脈注射免疫球蛋白、血漿置換及靶向生物製劑)可在一定程度上控制症狀,但仍有部分患者療效不佳、無法耐受長期治療副作用或疾病反覆發作,重症肌無力領域仍存在重大未滿足的臨牀需求。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。 

基於本次歐盟委員會授予的孤兒藥資格認定,泰它西普在歐盟將享有包括研發方案科學建議、部分費用減免、上市申請費用優惠,以及獲批後十年的市場獨佔期等一系列政策支持,這將有力推動泰它西普重症肌無力適應症在歐盟開發進程。

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