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.
諾誠健華-B(09969.HK):國家藥品監督管理局批准奧布替尼在中國上市
格隆匯 12-28 08:23

格隆匯 12 月 28日丨諾誠健華-B(09969.HK)發佈公吿,由公司開發的一種新型、高度選擇性且有效的小分子布魯頓酪氨酸激酶(“BTK”)抑制劑奧布替尼已獲國家藥品監督管理局的上市批准,用於治療中國的套膜細胞淋巴瘤(“MCL”)和慢性淋巴細胞白血病╱小細胞白血病(“CLL/SLL”)患者。自2015年公司註冊成立以來,奧布替尼是公司第一個獲得國家藥監局批准的藥物。

淋巴瘤是從淋巴細胞發展而來的血癌。淋巴瘤的兩種主要類型是霍奇金淋巴瘤(“HL)和非霍奇金淋巴瘤(“NHL”)。所有NHL中有85%是B細胞淋巴瘤,可通過BTK抑制劑治療。NHL包括由淋巴樣組織引起的一組異質性惡性腫瘤,在中國最常見的亞型包括MCL、CLL/SLL等。

BTK是治療B細胞惡性腫瘤的循證靶點。BTK抑制劑具有治療NHL的巨大市場潛力。根據弗若斯特沙利文的數據,2018年中國的NHL患病率達454,982人,從2014年至2018年的複合年增長率為5.9%,預計從2023年的複合年增長率為3.1%,到2030年將達到約73萬人。

公吿表示,公司正在對奧布替尼進行廣泛的臨牀研究,包括在中國和美國針對B細胞惡性腫瘤和自身免疫性疾病的單一療法和聯合療法。奧布替尼對BTK以外的激酶的活性極低。迄今為止可獲得的臨牀和臨牀前數據表明,基於報導的數據,與已批准的BTK抑制劑相比,奧布替尼在保持良好療效的同時,具有更高的靶點選擇性、靶點佔有率及安全性。

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