上海醫藥(601607.SH):抗精神病藥氯氮平片通過一致性評價
格隆匯5月29日丨上海醫藥(601607.SH)公佈,近日,公司控股子公司常州製藥廠有限公司(“常州製藥”)收到國家藥監局頒發的關於氯氮平片的《藥品補充申請批件》(批件號:2020B03113),該藥品通過仿製藥一致性評價。
氯氮平片主要適用於難治性精神分裂症,最早於1972年在瑞士上市。2019年5月,常州製藥就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至公告日,常州製藥針對該藥品的一致性評價已投入研發費用約人民幣761萬元。
根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。因此,常州製藥的氯氮平片通過仿製藥一致性評價,有利於擴大該藥品的市場份額,提升市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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