苑東生物(688513.SH):帕立骨化醇注射液通過注射劑質量和療效一致性評價
格隆匯7月23日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的化學藥品“帕立骨化醇注射液”的《藥品補充申請批准通知書》。
帕立骨化醇注射液系公司與成都國為生物醫藥有限公司的合作產品。該品種用於治療接受血液透析的慢性腎功能衰竭患者的繼發性甲狀旁腺功能亢進。
據悉,帕立骨化醇是一種人工合成的具有生物活性的維生素D類似物,對骨化三醇側鏈(D2)和A環(19-nor)進行了修飾。維生素D與帕立骨化醇可以通過抑制甲狀旁腺激素(PTH)的合成與分泌,降低PTH水平。
帕立骨化醇注射液本次通過一致性評價,有利於提高該產品的市場競爭力,對公司未來的經營業績產生積極的影響,同時為公司後續一致性評價產品研究工作積累了寶貴經驗。
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