SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 Zai Lab Limited today announced that the Center for Drug Evaluation of China’s National Medical Products Administration has granted. | May 18, 2023
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Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China
Sotorasib is for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS G12C Mutation
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THOUSAND OAKS, Calif., Jan. 29, 2021 /PRNewswire/ Amgen (NASDAQ: AMGN) today announced that its investigational KRAS
G12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of patients with
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the first BTD submission for Amgen in China, as well as the first under Amgen s strategic collaboration with BeiGene.