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康辰藥業(603590.SH):子公司特立帕肽注射液臨牀試驗申請獲得受理
格隆匯 12-02 18:26

格隆匯12月2日丨康辰藥業(603590.SH)公佈,近日,公司控股子公司北京康辰生物科技有限公司(“康辰生物”)收到國家藥品監督管理局核准簽發的《受理通知書》(受理號:JXSL2101143國),由康辰生物和美國Alvogen,Inc.共同申報的特立帕肽注射液臨牀試驗申請獲得受理。

公司控股子公司康辰生物通過產品許可方式獲得了Pfenex研發的特立帕肽注射液(商品名為Bonsity®)在中國境內、中國香港、新加坡、馬來西亞及泰國進行商業化、推廣、營銷等永久獨家商業化權益,並負責向國家藥品監督管理局藥品評審中心申請進口藥品註冊。

Pfenex研發並獲得FDA批准的特立帕肽注射液(商品名為Bonsity®)系原研廠家禮來特立帕肽注射液(商品名為Forteo®)的等效藥品。禮來的原研產品Forteo®於2002年11月獲得FDA批准,Pfenex研發的等效藥物Bonsity®於2019年10月獲得FDA批准。Pfenex於2020年6月與Alvogen,Inc.達成商業合作,並將Bonsity®的持證商變更為Alvogen,Inc.。

特立帕肽是一種由34個氨基酸組成的重組人甲狀旁腺激素(PTH)類似物(rhPTH[1-34]),能調節骨代謝、腎小管對鈣和磷的重吸收,以及腸道鈣吸收,適用於治療絕經後婦女高骨折風險的骨質疏鬆症,以及糖皮質激素持續治療誘發的高骨折風險的骨質疏鬆症。特立帕肽上市後,在美國、歐盟、中國等多個國家和地區都成為當地臨牀診療指南的推薦用藥,其有效性和安全性都得到廣泛認可。隨着人口老齡化日趨嚴重,我國骨質疏鬆治療藥物存在較大的市場潛力。

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