貝達藥業(300558.SZ)：BPI-28592藥品臨牀試驗申請獲受理
格隆匯2月19日丨貝達藥業(300558.SZ)公佈，近日，公司收到國家藥品監督管理局簽發的《受理通知書》(受理號：CXHL2000065國、CXHL2000066國)，公司申報的BPI-28592片的藥品臨牀試驗申請已獲得國家藥品監督管理局受理。
BPI-28592是一個由貝達藥業自主研發的擁有完全自主知識產權的新分子實體化合物，是一種新型強效、高選擇性的原肌球蛋白受體激酶(Tropomyosin receptorkinase，縮寫為TRK，又名神經營養受體酪氨酸激酶 Neurotrophin receptor kinase，縮寫為NTRK)二代口服小分子抑制劑，可覆蓋多種癌種，擬用於攜帶NTRK基因變異的局部晚期或轉移性實體瘤患者的治療。
截至公告披露日，僅有2款TRK抑制劑實現商業化，其中Larotrectinib(由Bayer 和 Loxo Oncology共同開發)在美國上市，Entrectinib(由Roche集團成員Ignyta開發)在美國和日本上市，中國區域尚未有TRK抑制劑上市，TRK變異癌症患者的醫療需求遠未得到滿足。BPI-28592屬於二代TRK抑制劑，臨牀前數據顯示，其在動物體內外生物學活性一致，能有效抑制腫瘤細胞增殖，並能對Larotrectinib耐藥的突變如TRKA G595R、TRKC G623等有效，有望提供一種新的分子靶向的治療方法，為NTRK突變的腫瘤患者提供更多益處。
BPI-28592屬於“境內外均未上市的創新藥”，其註冊分類為化學藥品1類。
此次申請的臨牀試驗是BPI-28592片在晚期實體瘤患者中的Ⅰ期臨牀研究，在臨牀試驗申請獲得受理後，若在受理繳費之日起60日內未收到藥品審評中心的否定或質疑意見，公司便可以按照提交的方案開展臨牀試驗，在開展一系列臨牀試驗並經國家藥品監督管理局批准後方可上市，短期內對公司經營業績不會產生大的影響。
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.
