康寧傑瑞製藥-B(09966.HK)治療胸腺上皮腫瘤新藥獲孤兒藥資格認定
格隆匯 9 月 3日丨康寧傑瑞製藥-B(09966.HK)宣佈,美國食品藥品監督管理局("FDA")已向KN046授予孤兒藥資格。KN046為公司全資附屬公司江蘇康寧傑瑞生物製藥有限公司("江蘇康寧傑瑞")開發的一種重組人源化PD-L1/CTLA-4雙特異性抗體,用於治療胸腺上皮腫瘤("胸腺上皮腫瘤")。這是集團獲得的第二個孤兒藥資格。早在2020年1月,KN035(集團開發的一種重組人源化單域抗體)獲美國FDA授予孤兒藥資格,用於治療膽道癌。
孤兒藥資格認定源自1983年孤兒藥法案,是美國FDA鼓勵開發用於治療在美國患病人數低於200,000人的罕見疾病的創新藥措施。凡獲得孤兒藥資格認定的候選藥物,有機會獲得七年市場獨佔權,以及美國FDA提供的税收減免、生物製品許可證申報費減免、處方藥用户費用減免、研發資助、方案協助和快速監管審批通道等一系列配套支持政策。
胸腺上皮腫瘤主要包括胸腺瘤和胸腺癌。胸腺癌不可以手術治療且轉移性胸腺癌預後差。對於鉑基化療治療失敗的患者,目前尚無獲批的標準治療。後線化療或靶向治療的客觀緩解率不足20%,多線治療復發的患者中位存活期不足12個月。亟需有效的藥物改善患者治療。KN046澳大利亞I期臨牀試驗在胸腺上皮腫瘤患者中顯示出了較高的響應率、持久的應答時間和良好安全性。公司已在美國和中國啟動KN046治療胸腺癌的II期註冊臨牀試驗。
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