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.
榮昌生物(09995.HK):泰它西普獲得中國國藥監局完全批准用於治療系統性紅斑狼瘡成年患者

格隆匯11月22日丨榮昌生物(09995.HK)宣佈,泰它西普(商品名:泰愛®)正式獲得中國國家藥品監督管理局("NMPA")同意,由附條件批准轉為完全批准,用於與常規治療聯合,針對在常規治療基礎上仍具有高疾病活動性、自身抗體陽性的系統性紅斑狼瘡("SLE")成年患者。

此次獲完全批准也是該藥物繼2021年首次獲附條件批准、成功納入2022版國家醫保藥品目錄(「NRDL」)後的又一重要進展,將進一步加速惠及更廣泛的中國系統性紅斑狼瘡("SLE")患者。

泰它西普在本適應症獲得完全批准,是基於一項隨機、雙盲、安慰劑對照、多中心的確證性III期臨牀試驗,共入組335例患者。該研究旨在評估泰它西普聯合標準療法對比安慰劑聯合標準療法用於治療中、重度系統性紅斑狼瘡患者的有效性和安全性。全分析集(FAS)結果顯示,給予泰它西普治療的患者在52周的SRI-4(系統性紅斑狼瘡反應指數4)的反應率明顯高於給予安慰劑的患者(82.6%對38.1%,p<0.001)。所有敏感性分析結果顯示,給予泰它西普治療的患者SRI-4反應率明顯高於安慰劑組患者(p<0.001),達到了該研究的主要終點。

系統性紅斑狼瘡(SLE)是一種慢性的、多系統的、無法治癒的自身免疫性疾病,有可能導致嚴重的器官損傷、系統性併發症,甚至死亡。根據弗洛斯特沙利文數據顯示,2020年,中國系統性紅斑狼瘡患者數量約為103萬人,全球系統性紅斑狼瘡患者數量約為780萬人。而現有療法存在復發風險高、副作用明顯等問題。泰它西普作為一種新的專有新型融合蛋白,可被認為對SLE患者治療具有重要的臨牀價值。

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