北海康成(01228.HK):治療戈謝病CAN103 2期臨床試驗核心部分已完成招募
北海康成(01228.HK)公布,針對年齡為12歲或以上的戈謝病I型和III型初始患者開展的CAN103 2期臨床試驗核心部分已完成招募。該2期臨床試驗為隨機雙盲、劑量比較研究,以評估CAN103在初治的戈謝病患者中的有效性、安全性和藥代動力學,同時作為CAN103的潛在註冊性臨床試驗。
CAN103是中國首個針對戈謝病開發的已進入臨床階段的(酉每)替代療法(ERT)。據弗若斯特沙利文統計,2020年中國約有3,000名戈謝病患者。由於報銷支付尚未得到有效解決,中國大多數戈謝病患者無法獲得ERT治療。CAN103是北海康成與藥明生物(02269.HK)在罕見病領域的首個合作項目,用於戈謝病I型和III型成人及兒童患者的長期治療。(ca/k)
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