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復星醫藥(02196.HK)擬就HLX04與億勝投資及珠海億勝進行開發合作
格隆匯 10-15 16:25

格隆匯10月15日丨復星醫藥(02196.HK)公告,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海復宏漢霖生物技術股份有限公司(以下簡稱“復宏漢霖”)擬就HLX04(即重組抗VEGF人源化單克隆抗體注射液,以下簡稱“該新藥”)用於濕性年齡相關性黃斑變性等眼病治療與EssexBio-InvestmentLimited(以下簡稱“億勝投資”)、珠海億勝生物製藥有限公司(以下簡稱“珠海億勝”)(億勝投資與珠海億勝以下合併簡稱“Essex”)進行開發合作,並於區域內(即全球範圍,下同)及領域內(即眼科治療領域,下同)就該新藥授予Essex註冊、生產及商業化(包括但不限於出口、進口、推廣、儲存、要約出售及分銷等商業化行為)的獨家許可等(以下簡稱“本次合作”)。

該新藥為集團(即本公司及控股子公司/單位,下同)自主研發的貝伐珠單克隆抗體生物藥,擬主要用於濕性年齡相關性黃斑變性、糖尿病性視網膜病變、轉移性結直腸癌和非小細胞肺癌等適應症的治療。截至2020年9月,集團現階段針對該新藥累計研發投入約為人民幣47,781萬元(未經審計)。

截至公告日,該新藥用於濕性年齡相關性黃斑變性和糖尿病性視網膜病變適應症治療已獲國家藥監局臨牀試驗批准,該新藥用於轉移性結直腸癌及晚期、轉移性或複發性非小細胞肺癌治療已獲國家藥監局藥品註冊審評受理。截至本公告日,該新藥用於眼科適應症治療在其他國家或地區尚未獲得相關監管機構的臨牀試驗批准。

億勝投資成立於2000年,註冊地為英屬維爾京羣島,董事長為嚴賢龍。珠海億勝成立於1999年,註冊地為中國廣東省,董事長為鄭贊順。億勝投資、珠海億勝均為億勝生物科技有限公司(於香港聯合交易所有限公司上市,證券代碼為“01061”,以下簡稱“億勝生物科技”)的控股子公司,億勝生物科技主要專注投資控股,以及開發、製造及銷售生物藥品。

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