衞信康(603676.SH):子公司獲得複方氨基酸注射液(20AA)藥品註冊證書
格隆匯10月14日丨衞信康(603676.SH)公佈,近日,西藏衞信康醫藥股份有限公司全資子公司內蒙古白醫製藥股份有限公司(簡稱“白醫製藥”)收到國家藥品監督管理局核准簽發的複方氨基酸注射液(20AA)《藥品註冊證書》。
截至2022年9月30日,公司針對該藥品累計研發投入為人民幣1349.69萬元。複方氨基酸注射液(20AA)為多種氨基酸組成的複方製劑,為靜脈用胃腸外營養輸液,適用於嚴重肝功能不全和即將或者已經發展為肝性腦病患者,為其腸外營養提供氨基酸。
該品種原研產品為B.Braun Melsungen AG(德國貝朗公司)於1987年6月在德國上市的Aminoplasmal®Hepa-10%,目前該品已獲批進口(商品名為“安平”)。
經查詢,目前國內已批准的複方氨基酸注射液(20AA)生產廠家有辰欣藥業股份有限公司、遼寧海思科製藥有限公司、吉林四長製藥有限公司、湖北一半天製藥有限公司。
經檢索,目前有費森尤斯卡比華瑞製藥有限公司按照新分類申報,正在審評審批中。遼寧海思科製藥有限公司於2021年進行了該品種一致性評價的補充申請註冊。
複方氨基酸注射液(20AA)系國家醫保目錄(乙類)藥品。根據米內網(注:全國放大版的中國城市及縣級公立醫院化學藥終端競爭格局)數據統計,2021年度複方氨基酸注射液(20AA)銷售金額合計約1.81億元。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.