睿智醫藥(300149.SZ):子公司與宜明昂科簽訂戰略合作協議
格隆匯 12 月 25日丨睿智醫藥(300149.SZ)公佈,2020年12月25日,公司全資子公司上海睿智化學研究有限公司(“上海睿智”,乙方)與宜明昂科生物醫藥技術(上海)有限公司(“宜明昂科”,甲方)簽署了《戰略合作協議》。為加快雙方優勢資源的融合,雙方本着“平等自願、資源共享、優勢互補、協同發展”的原則,建立長期、穩定、緊密的戰略合作關係。
(一)戰略合作目標
甲方和乙方優勢互補,甲方擅長生物藥物的早期創新研發,乙方及其下屬全資子公司,凱惠睿智生物科技(上海)有限公司(“凱惠睿智”)和睿智醫藥江蘇有限公司(“江蘇睿智”),擅長生物藥物的CMC工藝開發及不同階段的GMP生產,能為甲方提供專業的CMC開發與生產服務,協助甲方快速推進生物藥物進入臨牀研究及商業化生產,加速產品成功上市。同時,乙方也將充分利用團隊在中美雙報方面的專業知識以及一流的cGMP生產設施和質量體系,提供符合國際藥品監管機構要求的高品質產品服務,幫助甲方藥物走向國際市場。
(二)戰略合作內容1、甲方同意委託乙方子公司凱惠睿智和江蘇睿智承擔甲方臨牀在研項目的臨牀樣品及商業化產品的研究與生產,並可根據雙方需求的不同階段採用不同的合作形式。具體的實施細則由甲乙雙方另行簽署相關合同進行約定。
2、甲乙雙方共同搭建完善穩定的對接平台,建立高效的溝通機制,將對方當作新藥研發的全面合作戰略伙伴,發揮自身優勢,積極探索多種形式的合作,以促進甲方在新藥研發上的快速進展。
(三)合作期限
自合作協議生效之日起 15年。
宜明昂科作為國內先進的生物醫藥創新企業,致力於腫瘤免疫治療產品開發研究,其研發管線豐富,主要包括雙特異性抗體、新型重組蛋白、以及TANK細胞治療等。其中宜明昂科自主開發的同時靶向CD47/CD20的抗體-受體重組蛋白(mAb-Trap)藥物IMM0306屬於世界首創(First-in-class),目前已進入臨牀試驗階段。上海睿智提供創新藥研發服務,具有完善的生物藥新藥研發體系,在成功推進多項抗體新藥的臨牀試驗申報和新藥上市上有豐富的經驗。可為客户提供生物藥臨牀前工藝研發、IND註冊申報、臨牀樣品和上市商業化產品的生產服務,滿足IND、BLA申報需求和上市藥物生產需求。通過此次協議簽署,公司與宜明昂科將進一步深化戰略合作伙伴關係,有助於充分挖掘雙方的核心資源,搭建完善穩定的對接平台,建立高效的溝通機制,既可促進宜明昂科在新藥研發上的快速進展,也進一步提升公司在醫藥研發服務領域的核心競爭力。
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