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兆科眼科-B(06622.HK):Tenpoint向FDA提交BRIMOCHOL™PF新藥申請,老花眼治療全球進程加速
格隆匯 04-11 17:23

格隆匯4月11日丨兆科眼科-B(06622.HK)發佈公告,BRIMOCHOLPF(公司候選藥物之一,適應症爲老花眼)的第II期臨牀試驗已於2025年3月24日入組首名患者。該第II期臨牀試驗爲一項多中心、隨機、雙盲、交叉及安慰劑對照研究。該試驗的主要目的爲評估BRIMOCHOLPF滴眼液對中國老花眼患者的療效及安全性。該試驗由溫州醫科大學附屬眼視光醫院瞿佳教授出任牽頭研究者,將涉及14箇中心,併入組合共119名患者。

2025年3月21日,公司與中東及北非地區的領先製藥公司Lunatus Marketing & Consulting FZCO(“Lunatus”)就BRIMOCHOL™PF訂立分銷及供應協議。根據協議條款,公司有權授予Lunatus於沙地阿拉伯王國、阿拉伯聯合酋長國、科威特、阿曼、巴林及卡塔爾進口、分銷、推廣、營銷及銷售BRIMOCHOL™PF的獨家權利。作爲協議的一部分,Lunatus將代表公司取得相關的當地藥物註冊。公司可按照若幹成就獲得里程碑付款。

2025年4月8日,公司的夥伴Tenpoint Therapeutics Ltd.(“Tenpoint”)宣佈已向美國食品藥品監督管理局(“FDA”)提交用於治療老花眼的BRIMOCHOLTMPF的新藥上市申請(“新藥申請”)。Tenpoint由Tenpoint Therapeutics Ltd.與Visus Therapeutics, Inc.合併而成,爲一間全球性臨牀階段生物技術公司,開發突破性的療法,以恢復老化眼睛的視力。

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