You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
雙成藥業(002693.SZ):注射用胸腺法新通過注射劑質量和療效一致性評價
格隆匯 12-18 17:35

格隆匯 12 月 18日丨雙成藥業(002693.SZ)公佈,公司於近日從國家藥品監督管理局網站獲悉,公司產品注射用胸腺法新已通過注射劑仿製藥質量和療效一致性評價。

藥品名稱:注射用胸腺法新;劑型:注射劑;規格:1.6mg;受理號:CYHB1850046國;批准文號:國藥準字H20030407;產品分類:化學藥品;申請內容:注射劑仿製藥質量和療效一致性評價;審批結論:本品通過一致性評價;生產企業:海南雙成藥業股份有限公司。截至公告披露日,國家藥品監督管理局網站已公示,公司暫未收到批件。

胸腺法新是由28個氨基酸組成的化學合成的多肽類免疫調節劑。注射用胸腺法新適用症為:1)慢性乙型肝炎;2)作為免疫損害病者的疫苗免疫應答增強劑。免疫系統功能受到抑制者,包括接受慢性血液透析和老年病患者,本品可增強病者對病毒性疫苗,如流感疫苗或乙肝疫苗的免疫應答。

公司於2018年4月24日向國家藥品監督管理局藥品審評中心遞交了注射用胸腺法新一致性評價申請。於2018年5月4日獲得受理。公司為注射用胸腺法新國內同品種首家獲得藥品一致性評價批准的企業。

截至公告披露日,公司對該藥品一致性評價累計研發投入金額約為人民幣2,748.29萬元(未經審計)。

注射用胸腺法新通過一致性評價,有利於提高市場競爭力,擴大市場份額,併為公司後續產品開展一致性評價工作積累寶貴經驗。

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.
uSMART
Wealth Growth Made Easy
Open Account