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China's NMPA Accepts New Drug Application for HER2+ Gastric Cancer Treatment KN026

The acceptance of a new drug application highlights the advancement in treating HER2-positive...
Key Metrics

10.55

Heat Index
  • Impact Level
    Medium
  • Scope Level
    National
  • Last Update
    2025-09-11
Key Impacts
Positive Impacts (7)
Alphamab Oncology
CSPC Pharmaceutical Group
HER2 Diagnostic Test Providers (e.g., Agilent Dako, Roche Diagnostics)
Chinese Biotechnology Equities
Contract Biologics Manufacturing Organizations (e.g., WuXi Biologics, Lonza)
STAR Market Biotech/Pharma Index
Negative Impacts (1)
Roche Holding AG
Total impacts: 10 | Positive: 7 | Negative: 1
Event Overview

The acceptance of a new drug application highlights the advancement in treating HER2-positive gastric cancers. The combination therapy, involving an innovative bispecific antibody, represents a significant development in oncology, potentially improving patient outcomes and expanding treatment options.

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KN026 New Drug Application for HER2+ Gastric Cancer Treatment Accepted by NMPA
2025-09-11 19:33

The new drug application for KN026, a drug developed by Alphamab Oncology and Shanghai Jinmantang Biotechnology Co., Ltd. (a subsidiary of CSPC Pharmaceutical Group), has been accepted by the National Medical Products Administration (NMPA) of China. The application is for the use of KN026 in combination with chemotherapy to treat HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma. KN026 is the first anti-HER2 bispecific antibody in China to show positive results in second-line treatment of gastric cancer. Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer.

Total records: 1
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