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諾誠健華堅信奧布替尼血腦穿透屏障能力 加速推進全球自免疾病臨牀開發

諾誠健華(以下簡稱公司)2月15日宣佈,渤健已通知公司,為便利而終止(Terminate for Convenience)雙方就有望治療多發性硬化(MS)和其他自身免疫性疾病的口服小分子布魯頓酪氨酸激酶(BTK)抑制劑奧布替尼的全球開發和商業化達成的合作和許可協議。諾誠健華將重獲協議項下授予渤健的所有全球權利,包括相關知識產權、研發決策權、生產和商業化權益,以及源自奧布替尼的商業收益。雙方將在90天內完成權益過渡。

諾誠健華歡迎奧布替尼重回公司的自身免疫性疾病管線。奧布替尼治療MS的II期研究仍在進行中,諾誠健華預計2023年第二季度公佈中期分析結果。基於奧布替尼在多種自身免疫性疾病臨牀試驗中取得的令人鼓舞的結果,諾誠健華對奧布替尼依然充滿信心,並將加速推進奧布替尼作為潛在同類最佳BTK抑制劑在MS和其他自身免疫性疾病中的全球臨牀開發。

“我們歡迎奧布替尼在自身免疫性疾病領域的全球權益重回公司充滿競爭力的管線,未來公司在自免管線的綜合佈局將有更多主動性和靈活性。我們堅信奧布替尼在中樞神經系統的血腦穿透屏障(BBB)能力,具備抑制B細胞和髓樣細胞功能的潛力,有望為所有MS亞型以及其他自身免疫性疾病進展提供有益的臨牀價值,”諾誠健華相關負責人表示。

由於奧布替尼的高選擇性和可穿透血腦屏障,諾誠健華已在國際頂尖學術會議EULAR以重磅口頭報吿了奧布替尼治療系統性紅斑狼瘡II期臨牀試驗所取得的積極效果,公司也觀察到奧布替尼治療原發免疫性血小板減少症(ITP)從臨牀前到II期研究中的令人鼓舞的治療潛力。

2021年7月,諾誠健華和渤健就有望治療MS和其他自身免疫性疾病的奧布替尼的全球開發和商業化達成合作和許可協議,約定公司將奧布替尼在MS領域的全球獨家權利以及除中國(包括香港、澳門和台灣)以外區域內的某些自身免疫性疾病領域的獨家權利授予渤健。根據協議約定,渤健已向公司一次性支付不可退還和不予抵扣的首付款1.25億美元。本次協議終止不會影響首付款及其他相關已確認收入。

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