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長春高新(000661.SZ):子公司取得台灣逸達公司甲磺酸亮丙瑞林產品相關權益
格隆匯 11-17 17:55

格隆匯 11 月 17日丨長春高新(000661.SZ)公佈,公司控股子公司——長春金賽藥業有限責任公司(“金賽藥業”)與逸達生物科技股份有限公司(股票代號:6576.TWO“台灣逸達”)達成協議,台灣逸達將其持有的兩個規格的甲磺酸亮丙瑞林產品中國區權益(包含該產品的開發、推廣、銷售、技術轉移、技術轉移後的本土化生產以及產品的全球非獨佔性生產供貨)轉移給金賽藥業。

甲磺酸亮丙瑞林產品為台灣逸達自行研發、尚未在中國上市505(b)(2)品種,目前已經在歐美進行上市申報,並進入了實質性審查階段,後續考慮在國內進行註冊(暫按前列腺癌適應症申報)。該產品是基於台灣逸達新一代原位凝膠技術平台SIF長效原位凝膠劑平台研發產生,具有生產成本低、藥品性質穩定、使用便捷、緩釋週期持續更長等技術優勢。

促性腺激素釋放激素(GnRH)類產品適應症為子宮內膜異位症(女性健康)伴有月經過多、下腹痛、腰痛及貧血等的子宮肌瘤(女性健康)絕經前乳腺癌且雌激素受體陽性患者(腫瘤)前列腺癌(腫瘤)中樞性性早熟症(兒童健康(生長髮育))。根據IMS數據顯示,國內促性腺激素釋放激素(GnRH)類產品主要以促性腺激素釋放激素激動劑(GnRHa)為主,產品主要為亮丙瑞林、戈舍瑞林、曲普瑞林三種均為注射劑。目前,亮丙瑞林緩釋微球平台競爭已較為激烈,而本次合作的甲磺酸亮丙瑞林產品是基於新一代的原位凝膠技術平台有一定技術優勢

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