海創藥業(688302.SH)：HP537片用於治療血液系統惡性腫瘤的臨牀I/II期試驗申請獲得FDA批准
格隆匯7月7日丨海創藥業(688302.SH)公佈，近日，公司收到美國食品藥品監督管理局（以下簡稱“FDA”)簽發的《臨牀研究繼續進行通知書》（Study MayProceed Notification），公司自主研發的HP537片用於治療血液系統惡性腫瘤的臨牀I/II期試驗申請正式獲得FDA批准。此前，HP537片中國臨牀試驗申請已於2024年2月獲國家藥品監督管理局（以下簡稱“NMPA”）批准。經查詢，截至本公吿披露日，國內外均無同類靶點產品獲批上市。
HP537片是公司獨立自主研發的p300/CBP（E1A-binding protein P300/CREBbinding protein, p300/CBP）抑制劑小分子抗腫瘤藥物，HP537片通過結合p300/CBP溴結構域（bromine domain, BRD）阻斷p300/CBP信號通路。p300/CBP參與細胞週期進展和細胞生長、分化和發展，在腫瘤中高度表達和激活，是腫瘤細胞生長的關鍵調控因子。HP537通過抑制p300/CBP酶的活性，從而達到抑制腫瘤細胞的生長而達到抗腫瘤的效果。HP537片主要用於治療血液系統惡性腫瘤，包括但不限於多發性骨髓瘤（multiple myeloma, MM）、非霍奇金淋巴瘤（non-Hodgkin’s lymphoma, NHL）、急性髓系白血病（acute myeloid leukemia, AML）及骨髓增生異常綜合徵（myelodysplastic syndromes, MDS）。根據GLOBOCAN統計，全球2022年血液系統惡性腫瘤新發病例超131萬例，中國2022年血液系統惡性腫瘤新發病例超21.5萬例。
HP537片具有較好的化學穩定性和生物活性。臨牀前研究顯示HP537具有良好的有效性及安全性，其具有高活性、高選擇性，同時具有良好的口服暴露量和生物利用度。根據臨牀前體內外藥效學研究結果，HP537片有望成為治療血液系統惡性腫瘤並具有重要臨牀價值的有效藥物。此前，HP537片中國臨牀試驗申請已於2024年2月獲NMPA批准。
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.
