步長製藥(603858.SH):瀘州步長與美國瑞美德簽訂合作開發和許可協議
格隆匯9月7日丨步長製藥(603858.SH)公佈,此前披露,公司全資子公司山東丹紅製藥有限公司(簡稱“山東丹紅”)與四川瀘州步長生物製藥有限公司(簡稱“瀘州步長”)簽訂了《在研產品技術轉讓合同》,將山東丹紅所擁有的“REMD-288”研發項目轉讓至瀘州步長。
瀘州步長基於戰略考慮,決定不再根據原合同約定對REMD-288單抗分子進行進一步的臨牀開發和商業化,而是選擇BC008-1A和BC008-1B雙抗分子(即REMD-288的修飾分子)在目標地域內進行工藝化研發、開發、生產和商業化。
2022年9月7日,瀘州步長(“甲方”)與美國瑞美德(“乙方”)簽訂了《合作開發和許可協議》。雙方確認,乙方授予甲方對REMD-288專利在目標地域的獨佔許可使用權,以使甲方在目標地域可基於REMD-288單抗的基因序列、氨基酸序列、成藥性研究數據等進行進一步開發修飾分子,修飾分子包括但不限於雙特異性抗體、雙功能性抗體、抗體藥物偶聯物(ADC)等(但BC008-1A和BC008-1B除外),且甲方享有由此產生的銷售收益及其他收益,甲方享有由此產生的包括但不限於產品申報各項扶持資金收益。乙方確認,就前述許可,甲方已全額支付了原合作合同項下約定的前期付款,前述許可將繼續有效,但根據該協議約定在協議被提前終止或解除時甲方不再享有協議項下的許可授權的情形除外。
雙方同意並確認,甲方不再根據原合同對 REMD-288單抗進行臨牀開發和商業化,而是選擇BC008-1A和BC008-1B雙抗分子在目標地域內進行許可產品的工藝化研發、開發和商業化,故雙方將根據該協議共同合作研發BC008-1A以及BC008-1B,最終由甲方在目標地域內實現許可產品的研發、註冊、生產和商業化。
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