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澤璟製藥(688266.SH):簽署注射用重組人促甲狀腺激素獨家市場推廣服務協議

格隆匯6月5日丨澤璟製藥(688266.SH)公佈,公司於2025年6月5日與ATSA簽署《服務協議》,公司同意授權ATSA作爲注射用重組人促甲狀腺激素在中華人民共和國境內(爲本協議之目的,不包括香港特別行政區、澳門特別行政區和臺灣地區)的獨家市場推廣服務商。在滿足協議約定的條款下,公司將獲得授權款總金額爲最高人民幣25,000萬元,其中協議生效日期起30個工作日內ATSA將向公司支付第一筆預付款人民幣5,000萬元、標的產品首個適應症獲批後ATSA將向公司支付第二筆款項人民幣20,000萬元。公司將根據協議約定按淨銷售額兩位數百分比向ATSA支付市場推廣服務費。

標的產品注射用重組人促甲狀腺激素(rhTSH)是公司自主研發的生物大分子藥物,屬於治療用生物製品。人體內源性的促甲狀腺激素是糖蛋白激素家族成員,主要在人垂體表達、分泌入血並和表達於甲狀腺細胞和高分化的甲狀腺癌細胞表面的hTSHR蛋白結合,可刺激碘攝取和有機化,以及甲狀腺球蛋白(Tg)、三碘甲狀腺原氨酸(T3)和甲狀腺素(T4)的合成和釋放。rhTSH與人天然TSH氨基酸序列完全一致。rhTSH激活甲狀腺細胞的效應是增加放射碘的攝取,可以掃描檢測或者放射碘殺傷甲狀腺癌細胞。rhTSH激活也可以導致甲狀腺細胞釋放甲狀腺球蛋白,甲狀腺球蛋白是血液標本中甲狀腺癌的腫瘤標誌物。國外同類產品Thyrogen已經在甲狀腺癌的術後診斷及術後治療中廣泛應用,目前該產品尚未在國內進口銷售。

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