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.
步長製藥(603858.SH):BC003項目正式啟動Ⅰ期臨牀試驗
格隆匯 09-28 16:01

格隆匯9月28日丨步長製藥(603858.SH)公佈,公司全資子公司山東丹紅製藥有限公司研製的“注射用重組人腦利鈉肽”(項目代號:BC003)獲得了四川大學華西醫院臨牀試驗倫理審查委員會批件,正式啟動Ⅰ期臨牀試驗。

BC003項目是山東丹紅製藥有限公司研發的治療用生物製品,臨牀擬用適應症為患有休息或輕微活動時呼吸困難的急性失代償性心力衰竭患者的治療。

人腦利鈉肽是B型利鈉肽,為人體分泌的一種內源性多肽,在病因誘導下發生心力衰竭後人體應激大量產生的一種補償代謝的機制,可迅速降低全身動脈壓、右房壓和肺毛細血管楔壓,從而降低心臟的前後負荷,並迅速減輕心衰患者的呼吸困難程度和全身症狀。

該項目於2019年9月取得國家藥品監督管理局頒發的《臨牀試驗通知書》,通知書編號CXSL1900064。

截至2020年8月31日,公司在BC003項目上投入的研發費用約6334萬元人民幣。

國內上市同類品種注射用重組人腦利鈉肽(商品名:新活素),批准適應症為用於患有休息或輕微活動時呼吸困難的急性失代償心力衰竭患者的靜脈治療,按NYHA分級大於Ⅱ級。該藥已納入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2019年版)》乙類範圍,2019年銷售額約8.15億元人民幣。

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