甲磺酸阿美替尼片(阿美乐)
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翰森制药:甲磺酸达麦利替尼片上市许可申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2026-02-27 12:33
Core Viewpoint - Hansoh Pharmaceutical (03692) has announced that its New Drug Application (NDA) for the innovative drug HS-10241, a high-selectivity c-MET TKI, has been accepted by the National Medical Products Administration (NMPA) in China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive epidermal growth factor receptor (EGFR) gene mutations and MET amplification after failure of EGFR tyrosine kinase inhibitor (TKI) therapy [1] Group 1 - The NDA acceptance date is February 27, 2026 [1] - HS-10241 is developed independently by the company [1] - The drug targets a specific patient population that has not responded to previous TKI treatments [1]
派林生物收到行政监管措施决定书;吉利德用2亿多美元了结行贿案
Mei Ri Jing Ji Xin Wen· 2025-05-11 23:42
Group 1 - Palin Bio received an administrative regulatory decision from Shanxi Securities Regulatory Commission due to internal control deficiencies and inaccurate information disclosure, leading to warnings for its management [1] - Maiwei Bio's chairman Liu Datao is under investigation for suspected short-term trading, which may affect investor confidence and the company's reputation despite claims of no impact on daily operations [2] - Gilead Sciences reached a settlement of $202 million with the U.S. government over kickback allegations, which could negatively impact investor confidence and the company's reputation if compliance issues are not addressed [3] Group 2 - Rongchang Bio's ADC drug, Vidisicimab, received approval from NMPA for treating HER2-positive advanced breast cancer, marking a significant market opportunity and potential revenue increase for the company [4] - Hansoh Pharma's innovative drug Amivantamab received NMPA approval for a new indication, expanding its market potential and likely boosting sales and investor interest [5]