share_log

信達生物：自願公告 - 中國首個KRAS G12C抑制劑達伯特獲國家藥品監督管理局批准上市

INNOVENT BIO: VOLUNTARY ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION APPROVED CHINA'S FIRST KRAS G12C INHIBITOR DUPERT

HKEX ·  Aug 21 19:42

Summary by Futu AI

信達生物製藥有限公司宣布，其開發的KRAS G12C抑制劑達伯特®（氟澤雷塞片）已於2024年8月21日獲得中國國家藥品監督管理局（NMPA）的批准上市。該藥物用於治療至少接受過一種系統性治療的KRAS G12C突變型晚期非小細胞肺癌（NSCLC）成人患者。這是中國首個獲批的KRAS G12C抑制劑，基於在中國進行的臨床2期單臂註冊研究（NCT05005234）結果，該研究評估了氟澤雷塞片在標準治療失敗或不耐受且攜帶KRAS G12C突變的晚期NSCLC患者中的安全性、耐受性和療效。研究結果顯示，該藥物總體耐受性良好，客觀緩解率達49.1%，疾病控制率達90.5%。達伯特®的上市為KRAS G12C突變型的晚期NSCLC患者提供了新的治療選擇，有望改善患者的預後。
信達生物製藥有限公司宣布，其開發的KRAS G12C抑制劑達伯特®（氟澤雷塞片）已於2024年8月21日獲得中國國家藥品監督管理局（NMPA）的批准上市。該藥物用於治療至少接受過一種系統性治療的KRAS G12C突變型晚期非小細胞肺癌（NSCLC）成人患者。這是中國首個獲批的KRAS G12C抑制劑，基於在中國進行的臨床2期單臂註冊研究（NCT05005234）結果，該研究評估了氟澤雷塞片在標準治療失敗或不耐受且攜帶KRAS G12C突變的晚期NSCLC患者中的安全性、耐受性和療效。研究結果顯示，該藥物總體耐受性良好，客觀緩解率達49.1%，疾病控制率達90.5%。達伯特®的上市為KRAS G12C突變型的晚期NSCLC患者提供了新的治療選擇，有望改善患者的預後。
Innovent Biologics announced that its developed KRAS G12C inhibitor, Dabotert® (fluzelesine tablets), has been approved for listing by the National Medical Products Administration (NMPA) of China on August 21, 2024. The drug is used to treat adult patients with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC) who have received at least one systemic therapy. This is the first approved KRAS G12C inhibitor in China, based on the results of a phase 2 single-arm registration study conducted in China (NCT05005234). The study evaluated the safety, tolerability, and efficacy of fluzelesine tablets in advanced NSCLC patients with standard treatment failure or intolerance and carrying KRAS G12C mutation. The results of the study showed that the drug has good overall tolerability, with an objective response rate of 49.1% and a disease control rate of 90.5%. The listing of Dabotert® provides a new treatment option for patients with KRAS G12C mutant advanced NSCLC and is expected to improve patient prognosis.
Innovent Biologics announced that its developed KRAS G12C inhibitor, Dabotert® (fluzelesine tablets), has been approved for listing by the National Medical Products Administration (NMPA) of China on August 21, 2024. The drug is used to treat adult patients with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC) who have received at least one systemic therapy. This is the first approved KRAS G12C inhibitor in China, based on the results of a phase 2 single-arm registration study conducted in China (NCT05005234). The study evaluated the safety, tolerability, and efficacy of fluzelesine tablets in advanced NSCLC patients with standard treatment failure or intolerance and carrying KRAS G12C mutation. The results of the study showed that the drug has good overall tolerability, with an objective response rate of 49.1% and a disease control rate of 90.5%. The listing of Dabotert® provides a new treatment option for patients with KRAS G12C mutant advanced NSCLC and is expected to improve patient prognosis.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

The translation is provided by third-party software.


The information provided by Futu AI is automatically generated by third-party artificial intelligence (AI) software based on news content. It is only available to users located outside of China mainland.


The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.
    Heat List
    US
    SymbolLatest Price% Chg

    No Data

    Hot News
    Updated