睿智醫藥(300149.SZ):與尚健生物簽署戰略合作框架協議
格隆匯 1 月 12日丨睿智醫藥(300149.SZ)公佈,公司全資孫公司睿智醫藥江蘇有限公司(“江蘇睿智”)於近日與杭州尚健生物技術有限公司(“尚健生物”)簽署了《戰略合作框架協議》。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。
甲方為杭州尚健生物技術有限公司,乙方為睿智醫藥江蘇有限公司;
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,乙方及其關聯公司凱惠睿智生物科技(上海)有限公司(“凱惠睿智”)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。
戰略合作內容:1、甲方有意委託乙方和凱惠睿智承擔甲方多個臨牀在研項目的臨牀樣品及商業化產品的研究與生產,並在後續合作階段簽署相關合同予以明確。
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。
合作期限:自合作協議生效之日起15年。
尚健生物作為一家專注於腫瘤等重大疾病領域的創新抗體藥物開發的生物醫藥企業,現階段已建立了包括計算機輔助設計和哺乳動物細胞展示有機結合在內的系列國際領先的創新抗體研發技術平台,並圍繞腫瘤領域佈局了豐富的產品管線,多個Best-in-Class品種處於臨牀及臨牀前研究階段,申請PCT及中國發明專利20多項。江蘇睿智擁有大規模的大分子抗體藥物研發與生產平台,並提供創新藥研發服務,公司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。通過本次協議簽署,公司與尚健生物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,既可促進尚健生物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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