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翰宇藥業(300199.SZ):亮丙瑞林原料藥收到CEP證書
格隆匯 05-07 20:14

格隆匯5月7日丨翰宇藥業(300199.SZ)公佈,近日,公司的亮丙瑞林原料藥收到了歐洲藥品質量管理局(“EDQM”)簽發的CEP(歐洲藥典適用性認證)證書。

亮丙瑞林為促性腺素釋放素(GnRH)類似物,是由9個氨基酸構成的多肽類藥物,能有效抑制垂體-性腺系統的功能,通過一系列激素調節作用對性激素依賴性疾病有治療作用。臨牀主要適用於子宮內膜異位症;伴有月經過多、下腹痛、腰痛及貧血等的子宮肌瘤;絕經前乳腺癌,且雌激素受體陽性患者;前列腺癌;中樞性性早熟症。

亮丙瑞林由武田公司研究開發,目前已在全球多個國家上市銷售。根據IQVIA數據顯示,2019年全球亮丙瑞林原料藥的消耗量約91kg。

公司是目前國內唯一一家取得亮丙瑞林原料藥CEP證書的企業,該證書的獲得顯示了EDQM對公司相應原料藥質量的肯定,該產品的CEP證書可以直接應用於所有相關製劑在歐盟的上市申請,標誌着公司的亮丙瑞林原料藥產品已具備在歐盟所有國家銷售的資格,體現了公司優秀的工藝研發和質量管控能力,對公司進一步拓展國際市場提供了競爭基礎和優勢,有利於提升公司的國際品牌影響力,對公司未來業績有積極作用。

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