恆瑞醫藥(600276.SH)：氟唑帕利膠囊及甲磺酸阿帕替尼片獲批臨牀試驗
格隆匯 2 月 18日丨恆瑞醫藥(600276.SH)公佈，公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於氟唑帕利膠囊及甲磺酸阿帕替尼片的《藥物臨牀試驗批准通知書》，並將於近期開展臨牀試驗。
公司的氟唑帕利膠囊已於2020年12月11日獲得國家藥監局批准用於既往經過二線及以上化療的伴有胚系BRCA突變(gBRCAm)的鉑敏感複發性卵巢癌、輸卵管癌或原發性腹膜癌患者的治療。2021年1月，本品用於鉑敏感的複發性上皮性卵巢癌、輸卵管癌或原發性腹膜癌在含鉑化療達到完全緩解或部分緩解後的維持治療已被國家藥監局藥品審評中心納入優先審評。除用於鉑敏感的複發性卵巢癌、輸卵管癌或原發性腹膜癌治療外，氟唑帕利膠囊單藥或聯合甲磺酸阿帕替尼片的多個適應症開發已處在III期臨牀研究階段，另有多種聯合治療方案，包括與阿比特龍聯合、與抗PD-L1抗體SHR-1316聯合、以及與替莫唑胺聯合治療多種實體腫瘤已處於臨牀開發階段。
氟唑帕利是一種聚腺苷二磷酸核糖聚合酶(poly (ADP-ribose) polymerase, PARP)抑制劑，可特異性殺傷BRCA突變的腫瘤細胞。經查詢，氟唑帕利目前國外有同類產品Olaparib (商品名Lynparza)、Rucaparib (商品名Rubraca)、Niraparib (商品名Zejula)和Talazoparib (商品名Talzenna)於美國獲批上市銷售，Olaparib (商品名Lynparza)於2018年8月在中國獲批上市，商品名為利普卓。國內再鼎醫藥的甲苯磺酸尼拉帕利膠囊(商品名則樂)於2019年12月在中國獲批上市，用於鉑敏感的複發性上皮性卵巢癌、輸卵管癌或原發性腹膜癌成人患者在含鉑化療達到完全緩解或部分緩解後的維持治療。經查詢，2019年Olaparib (商品名Lynparza)、Rucaparib (商品名Rubraca)、Niraparib (商品名Zejula)和Talazoparib (商品名Talzenna)全球銷售額約13.57億美元，美國銷售額約6.74億美元。截至目前，氟唑帕利相關項目累計已投入研發費用約為31405萬元。
甲磺酸阿帕替尼已於2014年11月獲得國家藥監局批准單藥用於既往至少接受過2種系統化療後進展或復發的晚期胃腺癌或胃-食管結合部腺癌患者；於2020年12月獲得國家藥監局批准用於既往接受過至少一線系統性治療後失敗或不可耐受的晚期肝細胞癌患者。經查詢，目前國內外有索拉非尼、舒尼替尼、培唑帕尼等多種同類產品獲批上市。索拉非尼由拜耳公司開發，最早於2005年在美國獲批上市；舒尼替尼由輝瑞公司開發，最早於2006年在美國獲批上市；培唑帕尼由諾華研發，2009年在美國獲批上市。索拉非尼、舒尼替尼、培唑帕尼均已在國內上市。經查詢，2019年索拉非尼、舒尼替尼和培唑帕尼全球銷售額合計約21.59億美元。截至目前，甲磺酸阿帕替尼相關項目累計已投入研發費用約39025萬元。
根據我國藥品註冊相關的法律法規要求，藥物在獲得藥物臨牀試驗批准通知書後，尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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.
