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.
中國抗體-B(03681.HK):SM17新藥研究申請獲FDA批准
格隆匯 03-14 19:02

格隆匯3月14日丨中國抗體-B(03681.HK)公吿,於2022年3月11日,公司所提交治療哮喘的第一類(First-in-Class)治療產品SM17(注射用人源化抗IL-17RB單克隆抗體)新藥研究申請,已獲美國食品藥品監督管理局(U.S. Food and Drug Administration)。公司將依據此獲批新藥研究申請,最早於2022年第一季度在美國啟動首次人體臨牀(FIH)研究。

SM17為以白細胞介素17受體B(IL-17RB)為靶點的人源化IgG4-κ單克隆抗體。SM17結合IL-17RB後,可抑制人白細胞介素25(IL-25,一類關鍵的'警戒素”)導致的Th2細胞相關免疫反應,而警戒素已被證明與氣道細胞的病毒感染反應以及過敏性疾病如哮喘的病理變化有關。患有未受控制的嚴重哮喘的患者,會承受哮喘反覆發作及住院的風險;而未受控制的嚴重哮喘疾病會引發羣體死亡率╱患病率升高、生活質素下降以及醫療支出增加等社會性問題。目前已獲批上市的嚴重哮喘療法(包括生物製劑),可一定程度降低哮喘年度發作率。然而,嚴重哮喘的有效治療仍存在未滿足的醫療需求,尤其是對當前療法無應答的患者而言。

公司相信靶向Th2炎性細胞因數通路的上游(例如IL-17RB))的療法,預計將對氣道炎症相關的病理變化產生廣譜的作用並改善疾病病情;相信SM17在哮喘治療未被滿足醫療需求中的巨大潛力。

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