舒泰神(300204.SZ):BDB-001注射液獲得西班牙臨牀試驗批准
格隆匯5月29日丨舒泰神(300204.SZ)宣佈,公司於近日收到通知,公司及全資子公司德豐瑞於近日取得了西班牙藥品和醫療器械管理局關於授權臨牀試驗申請的決定文件,批准BDB-001注射液在西班牙開展治療進展期重型COVID-19的多中心、開放、隨機平行對照的II期臨牀試驗,以評估其在治療中的有效性和安全性。
BDB-001注射液是公司全資子公司德豐瑞授權許可開發的德國Inflarx公司的針對人C5a分子的單克隆抗體藥物,能特異性結合C5a,使C5a喪失結合受體的能力,從而阻斷其誘導的生物學功能,如中性粒細胞趨化、細胞內溶菌酶的釋放、炎性細胞因子水平上升和氧呼吸爆發等,抑制炎症級聯反應,從而控制炎症進一步發展,且不抑制免疫功能。同時不影響C5裂解及膜攻擊複合物(MAC)的形成,保留了補體介導的溶菌作用。
BDB-001注射液於2018年2月7日獲得了國家食品藥品監督管理總局治療中重度化膿性汗腺炎的臨牀試驗申請受理;於2018年7月獲得批准,進行上述適應症的臨牀研究。
此外,公司及全資子公司德豐瑞於2020年1月向國家藥監局提出BDB-001注射液用於治療冠狀病毒感染所致重症肺炎和冠狀病毒感染所致相關疾病的臨牀試驗申請,並於2020年2月7日獲得臨牀試驗批件,批准適應症為:
1)用於新型冠狀病毒感染者降低重症肺炎的發生率、降低急性呼吸窘迫綜合徵的發生率。2)用於新型冠狀病毒感染者所致重症肺炎的治療。BDB-001注射液在中國共開展4項與新型冠狀病毒肺炎相關的臨牀試驗,包括針對健康受試者開展Ic期臨牀試驗;以及針對新冠冠狀病毒肺炎感染者開展的Ib期、II期(普通型)和II期(重症)臨牀試驗。
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.