舒泰神(300204.SZ)：BDB-001注射液(中重度化膿性汗腺炎適應症)取得I期臨牀研究總結報吿
格隆匯6月3日丨舒泰神(300204.SZ)公佈，近日，公司及全資子公司北京德豐瑞生物技術有限公司(“德豐瑞”)收到關於隨機、雙盲、安慰劑對照、單劑量遞增評價BDB-001 注射液在健康受試者中的安全性、耐受性及藥代動力學I 期臨牀試驗的臨牀研究總結報吿。適應症為中重度化膿性汗腺炎。
主要研究結論：以評價BDB-001注射液單次靜脈給藥在健康受試者中的安全性和耐受性為主要研究目的的I期臨牀試驗結果顯示，在健康受試者中，BDB-001注射液按照方案擬定的不同劑量單次靜脈給藥安全且耐受良好，未報吿與研究藥物相關的嚴重不良事件。
單克隆抗體藥物BDB-001注射液是國家I類治療用生物製品。2018年02月07日，舒泰神及子公司德豐瑞取得了關於BDB-001注射液治療中重度化膿性汗腺炎的臨牀試驗的受理通知書，並於2018年07月獲得臨牀試驗批件，批准進行臨牀研究。
單克隆抗體藥物BDB-001注射液治療中重度化膿性汗腺炎的I期臨牀試驗達到預期試驗目的。國家藥品監督管理局藥物臨牀試驗登記與信息公示平台於2021年03月公示了單克隆抗體藥物BDB-001注射液治療中重度化膿性汗腺炎的II期臨牀試驗的相關信息。
化膿性汗腺炎(Hidradenitis suppurativa，HS)，又名反常性痤瘡(Acne inversa，AI)，是一種具有家族傾向、反覆發作、慢性炎症性皮膚病，其常見臨牀表現為黑色粉刺、疼痛的囊腫、膿腫以及頂漿腺聚集區域出現的竇道。多發於葉腋、乳房下皺襞、腹部皺襞、腹股溝、臀部和大腿內側。疾病引起的疼痛、慢性化膿和持續惡臭給患者的生活帶來很大的痛苦以及巨大的經濟負擔。
從作用機理上，單克隆抗體藥物BDB-001注射液針對的靶點是C5a。C5a具有強烈的趨化作用，可以誘導中性粒細胞、嗜酸粒細胞和單核細胞向炎症部位的移動。此外，C5a對免疫應答有明顯增強作用，可誘導單核細胞分泌IL-1、IL-6、IL-8及TNF-α等細胞因子。因此提示阻斷C5a具有對HS強有力的治療潛力，其可以有效控制導致HS關鍵致病因素的炎症因子水平，從而控制HS相關疾病症狀。
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