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創勝集團-B(06628.HK)獲國家藥監局有關啟動TST002 I期臨試IND批准
格隆匯 09-27 08:20

格隆匯9月27日丨創勝集團-B(06628.HK)發佈公吿,該公司於2021年9月22日獲得國家藥監局有關啟動TST002(Blosozumab)(一種用於治療絕經後女性骨質疏鬆的人源化硬骨素單克隆抗體)I期臨牀試驗的IND批准。

禮來公司已在美國和日本完成對Blosozumab的II期臨牀研究。該公司於2019年自禮來授權引進Blosozumab(TST002)以在大中華區進行開發及商業化,完成了技術轉讓,在其自有生產設施建立了製造工藝,並完成了供臨牀使用的GMP生產以及CDE要求在中國IND申請所需的所有額外臨牀前研究。

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