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CANbridge Files NDA for Approval of Breast Cancer Drug in China

publication date: Oct 2, 2018

CANbridge Pharma of Beijing has filed a New Drug Application in China for Nerlynx® (neratinib) as an adjuvant treatment in patients with early-stage HER2-positive breast cancer, following adjuvant Herceptin therapy. China’s National Medical Products Administration (NMPA) has accepted the filing. CANbridge in-licensed Greater China rights to Nerlynx from Puma Biotech (NSDQ: PBYI) in January 2018. In the US, Nerlynx was approved for the same indication in July 2017. CANbridge also intends to test Nerlynx in patients with HER2-positive gastric cancer. If approved, Nerlynx would be the third imported drug to be approved in China without a clinical trial. More details....

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