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上海醫藥(601607.SH):甲氨蝶呤片通過仿製藥一致性評價
格隆匯 03-11 17:19

格隆匯3月11日丨上海醫藥(601607.SH)公佈,近日,公司全資子公司上海上藥信誼藥廠有限公司(“上藥信誼”)收到國家藥品監督管理局(“國家藥監局”)頒發的關於甲氨蝶呤片的《藥品補充申請批准通知書》(通知書編號:2022B00974),該藥品通過仿製藥一致性評價。

甲氨蝶呤片主要用於各型急性白血病,特別是急性淋巴細胞白血病、惡性淋巴瘤、蕈樣肉芽腫、多發性骨髓病;頭頸部癌、肺癌、各種軟組織肉瘤、銀屑病;乳腺癌、卵巢癌、宮頸癌、惡性葡萄胎、絨毛膜上皮癌、睾丸癌。2020年11月,上藥信誼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。截至公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣764萬元。

截至公吿日,中國境內該藥品的主要生產廠家有通化茂祥製藥有限公司、湖南正清製藥集團股份有限公司等。

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。因此信誼甲氨蝶呤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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